COLLABORATIVE NETWORK FOR CLINICAL RESEARCH ON IMMUNE TOLERANCE (UM1): RFA-AI-12-043
Components of Participating Organizations
National Institute of Allergy and Infectious Diseases
Application Receipt Date(s): March 07, 2013
The purpose of this FOA is to solicit applications for the Collaborative Network for Clinical Research on Immune Tolerance (hereinafter referred to as ’Network’). The major objective of the Network is to develop new tolerogenic approaches for the treatment of disease in three clinical areas: asthma and allergic diseases; autoimmune diseases; and immune-mediated rejection of transplanted solid organs, tissues and cells. The scope of research to be carried out by the Network includes: 1) the design and conduct of clinical trials at all phases to evaluate the safety and efficacy of investigational products and approaches for the induction and maintenance of immune tolerance in humans; 2) the design and conduct of mechanistic studies and the development of tolerance assays as integral components of the clinical trials undertaken; and 3) the provision of bioinformatics, data collection, validation and analysis resources. On a selective basis, the Network may also support limited product development and nonclinical studies (e.g., toxicology, pharmacology, pharmacokinetics, etc.) essential for the subsequent evaluation of promising tolerance induction approaches in humans. For the purpose of this FOA and the resulting grant award, immune tolerance is broadly defined as a selective elimination of pathogenic immune responses to relevant antigens (e.g., alloantigens, autoantigens or allergens) by any of a variety of approaches, including deletion, induction of anergy, immune deviation, sequestration, or suppression, while preserving protective immunity and does not require ongoing treatment with the intervention.
Network Structure: The Network will consist of multiple functional elements to carry out the broad scope of research delineated above. These components include:
Leadership Group – with responsibility for: 1) scientific planning and priority setting; 2) soliciting and evaluating proposed research projects and determining those projects to be supported; 3) directing and managing the implementation of approved research projects; 4) establishing and implementing collaborations with other Federal and non-Federal organizations/institutions for the co-sponsorship of research in areas of mutual interest; 5) establishing and implementing industry collaborations for the evaluation of specific products/approaches; and 6) planning and directing the technical, operational, administrative and fiscal aspects of the Network’s activities.
Clinical Operations Group – with responsibility for clinical site assessments and other pre-study initiation requirements, assistance in the development of clinical protocols, and study implementation and monitoring.
Core Laboratory Group – with responsibility for the conduct of mechanistic studies and the performance of tolerance assays to assess the induction, maintenance and loss of tolerance.
Bioinformatics Group – with responsibility for establishing and maintaining a data management system for the collection, storage, archiving and exchange of mechanistic data, and integration of mechanistic and clinical data derived from the Network Statistical and Data Coordinating Center, and for conducting analyses of such data across Network clinical trials and mechanistic studies.
In addition, the Network will function as a cross-disciplinary, open consortium with proposals for clinical trials and integrated mechanistic studies accepted from investigators both within and outside of the Network’s infrastructure and with support provided to Network and non-Network institutions and researchers.
The successful induction of immune tolerance is a major therapeutic goal for the treatment of immune-mediated diseases, including asthma and allergic diseases; autoimmune disorders, such as rheumatoid arthritis and type 1 diabetes; and immune-mediated rejection of transplanted solid organs, tissues, and cells. Tolerance induction strategies aim to selectively block or prevent deleterious immune responses, while leaving protective immunity intact. More than two decades of highly intensive and productive basic research in immunology have provided a solid foundation of knowledge and understanding that will enable the application of promising tolerance induction strategies to the treatment of immune-mediated diseases and transplantation, and enhanced understanding of the underlying mechanisms of disease and therapeutic effect.
Asthma and allergic diseases are among the major causes of illness and disability in the U.S., affecting nearly 1 in 5 Americans. Asthma afflicts over 24 million Americans or 8.2 percent of the U.S. population; chronic sinusitis afflicted 12.9 percent of Americans age 18 and older in 2009; and food allergy was reported to afflict 3 million children under the age of 18 in 2007. In asthma and allergic diseases, the goal of tolerance research is to develop methods to block immune responses, especially allergic (IgE) responses, to allergens such as cockroach, house dust mite, and peanut that cause or exacerbate these diseases. Autoimmune diseases are chronic disabling disorders in which underlying defects in the immune response lead the body to attack its own organs and tissues. More than 80 autoimmune diseases have been identified and, for reasons that are not clear, the prevalence of these diseases is rising. Collectively, autoimmune diseases affect approximately 14–22 million people in the U.S., and represent a significant physical, emotional, social, and fiscal burden for patients and their families and to society. These diseases can affect any organ or organ system, and all ages are affected, with onset from childhood to late adulthood. In autoimmune diseases, novel approaches to block immune responses that cause the body to mistakenly attack its own organs, tissues, or cells are evaluated. The benefits of organ transplantation, as evidenced by prolonged survival and/or improved quality of life, have been clearly demonstrated for children and adults suffering from a wide range of congenital and acquired diseases. In 2011, 30,986 transplants were performed in the U.S., with 14,146 organ donors; in 2011, there were 113,237 candidates on the transplant waiting list. Although one-year survival after transplantation has improved markedly for every organ, barriers to long-term graft and patient survival include incompatibility between donor and recipient, acute rejection, chronic graft dysfunction, and complications of long-term use of immunosuppressive drugs. In transplantation, donor-specific immune tolerance - a selective blockade of immune responses directed against the graft - would enable long-term graft survival without the complications and risks of systemic immunosuppressive therapy (e.g., infection, malignancy, and atherosclerosis).
The NIAID has a long-standing commitment to supporting basic, translational and clinical research on immune tolerance with the ultimate goal of developing novel, efficacious therapies for the induction and maintenance of antigen-specific immune tolerance in humans. The NIAID Plan for Research on Immune Tolerance and the Report of the NIAID Expert Panel on Immune Tolerance are located on the NIAID website at http://www.niaid.nih.gov/topics/immuneTolerance/researchplan/Pages/immuneToleranceReport.aspx.
In 1999, the NIAID awarded a seven-year contract to establish the Collaborative Network for Clinical Research on Immune Tolerance - a major program resulting from the scientific planning process, designed to: (1) develop a long-term scientific agenda for clinical trials and mechanistic studies; (2) design and conduct clinical trials at all phases to determine the safety, toxicity and efficacy of tolerogenic treatment strategies for multiple immune system diseases; and (3) design and conduct research to delineate the underlying mechanisms of immune tolerance as an integral part of the clinical trials undertaken by the Network, as well as clinical trials sponsored by other Federal and private sector organizations and companies. In 2007, the contract was recompeted and expanded to include nonclinical research and product development, as well as bioinformatics, data collection and analysis. The contract (N01-AI-15416) is currently held by the University of California San Francisco, with Dr. Jeffrey Bluestone as the contract Principal Investigator and Dr. Gerald Nepom, of the Benaroya Research Institute, as the Network Director.
Since the establishment of this Network in 1999, substantial progress has been made in evaluating diverse tolerogenic products and approaches for a broad range of immune-mediated diseases, enhancing our understanding of underlying mechanisms, and assessing the induction, maintenance and loss of tolerance through multiple assays. Achieving complete tolerance in a single human trial is quite challenging; studies that provide step-wise advances towards achieving this goal have been an important strategy in advancing tolerance research. The Network has initiated 43 clinical trials with associated mechanistic studies, and 13 tolerance assay studies: 9 clinical trials and 3 tolerance assay studies in asthma and allergic diseases; 18 clinical trials and 8 tolerance assay studies in autoimmune diseases, with approximately 47% of each in type 1 diabetes; and 16 clinical trials and 2 tolerance assay studies in transplantation. It is anticipated that 15 studies will be ongoing at the completion of the current contract and will be continued and completed during the new award period. Additional information about the research activities of the current Network, publications, the status of the studies, as well as information on organizational structure and membership, may be obtained from the Network website at http://www.immunetolerance.org.
Research Scope: The scope of research to be performed by the Network includes:
Clinical Trials. The design and conduct of Phase I–IV clinical trials to evaluate the safety and efficacy of investigational products, approaches and techniques intended to lead to a functional state of immune tolerance in three clinical areas: autoimmune diseases; asthma and allergic diseases; and immune-mediated rejection of transplanted solid organs, tissues and cells. Tolerogenic strategies may target antigen specific receptors, molecules of the co-stimulation pathways, homing molecules, or other relevant approaches; may use any of a variety of agents including antigens, peptides, altered peptides, monoclonal antibody blockade, cytokines, molecularly engineered cells or tissues, DNA vectors, or other relevant molecules; and may be administered by a variety of routes. Tolerance studies may include projects that are intended to achieve incremental advances and are clear steps towards tolerance. In addition, the Network will be responsible for the continuation and completion of ongoing clinical trials and integrated mechanistic studies being conducted under the current Network contract. Additional information on responsibilities for ongoing clinical trials is provided under Section VI. Award Administration Information, item 2. Administrative and National Policy Requirements – Cooperative Agreement Terms and Conditions of Award.
Mechanistic Studies. The design and conduct of mechanistic studies and the development and evaluation of assays to measure/assess stages of disease and likelihood of progression, effect of treatment on immunological status and/or clinical outcome, maintenance of protective immunity, and safety of immunosuppressive withdrawal, and to identify and evaluate potential immune/surrogate markers of the induction, maintenance, and loss of tolerance. Such assays include, but are not limited to: microarray and PCR analyses of gene expression, quantitative assays of T cell reactivity, assays of B cell activity, assays of cytokines and other proteins, and novel tissue morphology studies to analyze tissue changes due to disease progression and therapeutic effect. These studies are performed, often through central laboratory resources, as integral components of the clinical trials undertaken.
Bioinformatics Resources. The provision of biostatistics, data collection, validation and analysis resources for integrated mechanistic and clinical data analyses, including analyses across Network studies.
Nonclinical Studies and Product Development. On a limited basis, support for product development activities and the design and conduct of nonclinical studies essential for the subsequent evaluation of promising tolerance induction strategies in humans. Such activities may include, but are not limited to: proof-of-principle studies and pharmacokinetics and pharmacodynamics animal studies; and nonclinical toxicity studies in suitable animal models; and production. Manufacturing and laboratory studies will be conducted under current Good Manufacturing Practices (cGMP) or Good Clinical Laboratory Practices (GCLP), as appropriate.
Disease-specific Research Priorities: Research priorities within each of the three clinical areas include, but are not limited to, the following:
Allergic Diseases and Asthma
Tolerance induction through innovative allergen immunotherapy strategies, including but not limited to:
Selectively amplify responses, making immunotherapy more robust and durable
Shorten time required to achieve beneficial and long-lasting immune responses
Bring greater safety to the clinical practice of immunotherapy
Apply immunotherapeutics more widely:
○ where no safe and effective treatments are available, such as food allergy
○ to prevent or delay the development of disease, such as asthma and food allergy
○ that use well characterized and purified antigens (allergens) which facilitate dosing strategies as interventions
○ although immunosuppressive interventions are generally not considered safe for use in treating allergic diseases, other immunomodulatory approaches are encouraged
Autoimmune Diseases
Immune-based approaches to restore tolerance, while preserving protective immunity, targeting T and B cell subsets and pathways, including but not limited to:
Co-stimulatory blockade to inhibit T cell activation
Cytokine modulation to induce immune deviation and suppression
Depletion of autoreactive lymphocyte populations to promote immune homeostasis
Cellular therapies to restore the balance of regulatory cells
Antigen specific therapies to modulate autoreactive immune responses
Transplantation
Tolerogenic approaches to improve long-term graft survival and decrease the rates of acute and chronic rejection, including but not limited to:
Costimulatory blockade regimens to inhibit T cell activation
Cell-based therapies, including, e.g., T regulatory cells or mesenchymal stem cells
Bone marrow chimerism to induce tolerance in solid organ transplantation
Strategies using potentially tolerogenic induction immunotherapeutic approaches
Strategies involving novel tolerogenic agents
Observational studies of transplant recipients who are functionally tolerant
Detailed mechanistic analyses to increase understanding of the tolerant state
Network Structure and Governance. The Network will consist of four functional elements: (i) the Leadership Group, composed of national and international clinical investigators and basic scientists with the full range of expertise and experience necessary to plan and direct the implementation of the Research Agenda and Strategic Plan; (ii) the Clinical Operations Group to oversee the development, implementation, and monitoring of clinical trials; (iii) the Core Laboratory Group to perform mechanistic studies and tolerance assays for all Network clinical trials/studies; and (iv) the Bioinformatics Group to collect, validate and analyze mechanistic data, and integrate these mechanistic data with clinical data. Additional committees, subcommittees and/or functional components may be established to carry out specific scientific, technical and administrative responsibilities. Each organizational entity must: establish and define effective communication and decision-making processes; identify clear lines of authority; establish processes to identify and resolve operational issues; and coordinate and collaborate effectively both within the Network and with other Federal and private sector research organizations/programs. The Network should use effective approaches to project management, including project plans with identified key milestones, provide for ongoing evaluation of projections against actual performance, adjust project plans as necessary, and develop and implement contingency plans.
PD/PI Time Commitment. The PD/PI will be required to commit not less than 3.6 person months per year to the project.
NIAID Resources. The NIAID will provide certain contract resources to support the design, development, implementation, and monitoring of Network clinical trials and the analysis of final study data. The Network will cooperate with NIAID contractors to ensure that clinical research complies with Federal regulatory requirements as well as NIAID policies and procedures. These resources include:
Statistical and Data Coordinating Center contract to provide a broad range of support services, including: assistance in the development of statistical design and analysis plans and other clinical protocol components (e.g., data and safety monitoring plans); a central data management system for the collection, storage, quality control and retrieval of clinical and other trial related data; a safety database system for the receipt, reporting and disposition of Serious Adverse Events (SAEs); and the analysis of final clinical study data and preparation of final clinical study reports. The Request for Proposals can be found at https://www.fbo.gov/index?s=opportunity&mode=form&id=4402094af6db51fefb94671d355adebc&tab=core&_cview=0. The contract is held by Rho (http://www.rhoworld.com/).
Clinical Site Monitoring Center contract to assist in monitoring the conduct of clinical trials in accordance with protocol-specific and regulatory requirements, including initial site assessments, interim site monitoring of ongoing clinical trials, and site and study close-out. The Request for Proposals can be found at https://www.fbo.gov/index?s=opportunity&mode=form&id=07021adff3bc56d94503c38c83f32bdb&tab=core&_cview=1. The contract is held by PPD (http://www.ppdi.com/).
Clinical Products Center contract for the receipt, storage, inventory, packaging/repackaging, quality assurance, distribution and disposal of study products. The Request for Proposals can be found at https://www.fbo.gov/index?s=opportunity&mode=form&id=96d65718068fb0a5d34086876b3f8a11&tab=core&_cview=1. The contract is held by Eminent Services Corporation (http://www.eminentservices.com/).
Regulatory Management Center contract to provide technical and administrative assistance for a broad range of functions pertaining to regulatory sponsorship, including preparation of regulatory submissions, reports and other materials, communications with Regulatory Health Authorities, implementation of protocol-specific site registration requirements, and maintenance and management of Sponsor Essential Clinical Documents (SECDs). The Request for Proposals can be found at https://www.fbo.gov/index?s=opportunity&mode=form&id=ffaa80e09ae0c5c612502ac077bcca97&tab=core&_cview=1. The contract is held by PPD (http://www.ppdi.com/).
In addition, it is anticipated that, with rare exceptions, the NIAID will serve as the regulatory sponsor for Network clinical trials conducted under Investigational New Drug (IND) Applications, Investigational Device Exemptions (IDEs), and Biologic Licensing Agreements (BLAs) with full responsibility for carrying out sponsor regulatory requirements. The NIAID will also coordinate the activities of independent Data and Safety Monitoring Boards (DSMBs) to review final clinical protocols and interim and final study data to ensure the safety of clinical trial subjects.
The NIAID will provide funds to the Leadership Group (LG) to support personnel, consultants, and other research-related resources for: (i) continuation and completion of ongoing clinical trials and mechanistic studies; (ii) review and evaluation of proposed research projects; (iii) study design and development for new clinical trials and mechanistic studies; (iv) new clinical trials and mechanistic studies to cover the costs associated with implementation, follow-up, and analysis of final integrated study data; and (v) centralized operational, administrative and fiscal support.
Research Agenda and Strategic Plan
Research Agenda. The Network will develop and implement a Research Agenda to advance immune tolerance induction strategies through clinical trials and to integrate studies of underlying mechanisms of the induction, maintenance and loss of tolerance. It is anticipated that Network research will evolve during the award period as new investigational products/approaches and developing technologies provide additional opportunities, and as findings eliminate some approaches from further consideration. Therefore, the Network is expected to refine and revise the Research Agenda as necessary to accommodate new opportunities and expanded knowledge.
The Research Agenda will include the following:
A description of the state-of-the-art of research to induce immune tolerance and define underlying mechanisms in animal models and human studies, including discussions of: safety concerns; knowledge gaps; scientific opportunities relevant to the clinical application of tolerance induction strategies in human immune-mediated diseases and transplantation; and reasons for the failure of past approaches.
Delineation of promising investigational approaches to tolerance induction for the prevention and treatment of asthma, allergic and autoimmune diseases, and for the prevention of immune-mediated rejection of solid organ, tissue and cell transplants.
A description of: (i) the state-of-the-art of research on the identification, assessment and validation of immune/surrogate markers, biological samples (e.g., blood, tissue, cellular isolates), and existing and new techniques for measuring tolerant states; (ii) knowledge gaps and opportunities relevant to further development and improvement in immune/surrogate markers, samples and techniques, including the major sources of variability that may confound clinical applications (biological and sampling diversity, specimen handling, shipping, storage and variability of detection procedures), validation against acknowledged disease endpoints, and proposed strategies for overcoming and/or reducing variability; and (iii) the use of bioinformatics tools to analyze combined mechanistic and clinical data.
A detailed description of research priorities for both clinical trials and mechanistic studies and the rationale for their selection.
Identification of the immediate and long-range goals of the Network, potential barriers to success, and potential solutions to overcome those barriers.
Delineation of approaches to identify and capitalize on opportunities for industry partnerships to accomplish the research goals of the Network.
Strategic Plan. The Network will develop a Strategic Plan delineating standards, policies, criteria and processes for implementing the Research Agenda with respect to: (i) setting scientific priorities and refining priorities based on new opportunities and findings; (ii) identifying and integrating new clinical strategies and technologies; (iii) soliciting, evaluating and making funding decisions for proposed clinical trials, integrated mechanistic studies, and tolerance assays; (iv) assessing the productivity, continued need for, and continued relevance of approved trials/studies, and discontinuing unneeded or unproductive research projects; (v) assessing the soundness, feasibility and anticipated contributions of proposed bioinformatics projects for the analysis of combined mechanistic and clinical data; and timelines and milestones to assess success in meeting the major objectives of the Research Plan.
Leadership Group
The Leadership Group (LG) will be responsible for planning and directing the implementation of the Network’s research activities and for carrying out multiple technical and centralized operational, administrative and fiscal functions. LG responsibilities include:
Developing and updating, as necessary, the Research Agenda
Developing the Strategic Plan to implement the Research Agenda, including the establishment of standards, policies, criteria and processes for the submission, evaluation, prioritization and funding of proposed clinical trials and associated mechanistic studies
Reviewing and assessing proposed clinical trials and mechanistic studies with respect to: soundness, feasibility and relevance to achieving the goals of the Research Agenda; adequacy and appropriateness of the number and capabilities of proposed clinical sites; and ethical considerations
Determining those clinical trials and mechanistic studies to be supported
Managing the implementation and monitoring of clinical trials and mechanistic studies, including establishing and directing a network of core laboratories
Providing a network architecture capable of managing complex and dispersed information communication systems with secure, access controlled storage of data and other confidential information as well as arrangements for secure back-up of data
Implementing and managing an information system to support the day-to-day activities of the Network Clinical Operations and Core Laboratory Groups, including hardware and software support
Determining the need for additional nonclinical studies and product development services for high priority clinical trials and directing the implementation of approved studies and product development activities
Assessing the soundness, feasibility and value of proposed biostatistical analyses and determining those analyses to be conducted
Establishing and implementing other research-related policies and procedures, including: publication of the research results; communications with scientific and lay audiences, including a publicly accessible website on Network goals, composition and research activities; and conflict of interest
Establishing and implementing collaborations with other Federal and non-Federal research programs and with industry partners
Directing activities associated with the administrative and fiscal planning and management of the Network
Establishing financial management capacity and systems to support a high volume of sub-awards and the timely review of invoices; disbursement of funds; and tracking of Network financial resources
An Executive Committee and a Steering Committee will be established to carry out the LG functions specified below.
Executive Committee
The Executive Committee, chaired by the PD/PI, will be responsible for providing scientific leadership and overall governance of the Network, including: (i) developing the Research Agenda and the Strategic Plan for the implementation of the Research Agenda; (ii) serving as the main decision-making body and providing for the second-level of review and for the approval of recommendations for research support emanating from the Steering Committee and other organizational entities; (iii) establishing and implementing collaborations with other Federal and non-Federal organizations for support of research in areas of mutual interest; (iv) establishing and implementing industry partnerships for the evaluation of specific products/approaches in Network clinical trials; and (v) assessing the performance, productivity, continued need for, and continued value of Network-sponsored research, discontinuing unproductive/unneeded projects, and redirecting research resources as necessary to achieve the goals of the Research Agenda.
Steering Committee
Under the overall direction of the PD/PI, the Steering Committee will serve as the primary governing body for clinical trials, mechanistic studies and tolerance assays, nonclinical research and product development, and bioinformatics/data analyses. Specific functions include: (i) developing and implementing a process for the solicitation, preparation and submission of proposals from Network and non-Network investigators, including standardized requirements, templates and instructions; (ii) conducting reviews to assess the scientific merit, soundness and feasibility of all proposed studies, including the adequacy and appropriateness of the number and capabilities of proposed clinical sites; (iii) preparing written reports to document the results of all reviews; (iv) making recommendations to the Executive Committee on support of proposed projects; and (v) directing and overseeing the implementation of approved studies, including adherence to established timelines and milestones. Steering Committee members must represent the breadth of clinical and scientific expertise and experience necessary to: evaluate proposals for clinical trials and mechanistic studies for asthma and allergic diseases, autoimmune diseases, and transplantation; assess the need for further nonclinical studies and product development; and determine feasibility and value of proposed analyses of combined clinical and mechanistic data.
Clinical Operations Group
A Clinical Operations Group (COG) will be established to assist investigators and institutions in the development, implementation and monitoring of Network-funded clinical trials. Specific functions of the COG include: (i) performing detailed feasibility assessments of proposed research projects and ongoing protocols as needed and submitting documentation to the LG; (ii) participating in the preparation of draft and final clinical protocols and protocol-related documents and coordinating their review and modification; (iii) assessing the adequacy and appropriateness of the capabilities of approved clinical sites with respect to staffing, standard operating procedures, data management systems, and clinical, laboratory and pharmacy facilities; (iv) monitoring overall progress in clinical trial implementation, including clinical site performance with respect to subject screening and enrollment and the ongoing adequacy of site-specific recruitment and retention plans; (v) working with clinical site staff to address problems and deficiencies in adherence to protocol-specific requirements; and (vi) serving as the primary contact for NIAID project managers, medical monitors and regulatory affairs officers.
Core Laboratory Group
A consortium of institutions/organizations will be established to serve as the Core Laboratory Group (CLG). Specific functions of the CLG include: (i) designing and conducting mechanistic studies and evaluations of immune/surrogate markers of the induction, maintenance and loss of tolerance as integral components of clinical trials for asthma and allergic diseases, autoimmune diseases, and transplantation; (ii) establishing and operating a repository of clinical specimens for Network-supported clinical trials and mechanistic studies; (iii) developing and implementing laboratory performance standards and metrics, including new performance standards for emerging technologies; (iv) developing and implementing standard operating procedures for the conduct of mechanistic studies and assays, including quality assurance and quality control, and timelines for generating and reporting on mechanistic data from each clinical trial; (v) developing protocol-specific instructions for clinical sites regarding the collection, storage, inventory, packaging and shipping of clinical specimens and distributing sample collection kits; (vi) collaborating in the preparation of interim and final analyses of study data; (vii) assessing and implementing new technologies and transitioning from existing to new technologies; and (viii) participating in NIAID collaborations with other Federal and non-Federal organizations to assist in the design and conduct of mechanistic studies. All laboratories must meet Good Clinical Laboratory Practices (GCLP) or equivalent standards.
Bioinformatics Group
A consortium of multi-disciplinary experts will be established to serve as the Bioinformatics Group (BG), including experts in statistics, epidemiology, data modeling and marginal structural modeling, etc., in the context of biomedical research and, more specifically, in the context of clinical trials and mechanistic studies. The BG will develop and operate a data management system for mechanistic study data and clinical data derived from the Network Statistical and Data Coordinating Center and conduct and/or participate in the design and conduct of data analyses.
Specific functions of the BG pertaining to the data management system include: (i) establishing and operating a system for the collection, storage, retrieval, archiving and exchange of data from Network-supported mechanistic studies, and integrating mechanistic data with clinical data derived from the Network Statistical and Data Coordinating Center, including genetic, cellular, and molecular data; (ii) utilizing open source/customizable off the shelf software for data capture, storage, query and analysis, as well as for disseminating data to the scientific community; (iii) building a scalable network and computer infrastructure to meet the needs of end users, e.g., Network staff, Network-supported investigators, and NIAID staff; (iv) creating an integrated electronic data repository of relevant scientific data for each research subject or patient sample, including clinical, laboratory and other information, in a format that permits rapid and efficient production of files for analysis, and verifying all repository data in collaboration with originating laboratories and the Statistical and Data Coordinating Center; (v) developing and implementing standard operating procedures for the collection, storage, archiving and exchange of data for participating laboratories and the Statistical and Data Coordinating Center; (vi) designing and implementing a reliable system for data quality control and system security; (vii) developing and implementing a plan for the long-term maintenance and survival of the data and the data system; (viii) documenting systems and software developed; and (ix) establishing and maintaining an end-to-end tracking system for laboratory samples with the capacity to generate audit trails and reports at any point in the process.
Specific functions of the BG pertaining to primary and secondary data analyses include: (i) providing input into the development, review and implementation of proposed studies/sub-studies, e.g., defining research questions, selecting appropriate study populations and control/comparison groups, developing innovative statistical methods, alternative study designs, and data analysis plans, assessing the feasibility of access to appropriate data for retrospective analyses, and ensuring the availability of the necessary number, type and volume of clinical samples; (ii) conducting analyses of mechanistic study data and combined clinical and mechanistic data; and (iii) participating in the preparation of manuscripts.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian-serving institutions; Asian American Native American Pacific Islander-serving institutions; nonprofit organizations with 501(C)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
System for Award Management (SAM)– must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple PD(s)/PI(s) are not allowed for this FOA.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-12-043.html.
EARLY-STAGE INNOVATIVE MOLECULAR ANALYSIS TECHNOLOGY DEVELOPMENT FOR CANCER RESEARCH (R21): RFA-CA-13-001
Components of Participating Organizations
National Cancer Institute
Application Receipt Date(s): February 20, 2013; May 20, 2013; September 20, 2013
This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), solicits grant applications proposing exploratory research projects focused on the inception and development of early stage, highly innovative, molecular analysis technologies or emerging technologies with significant transformative potential that has not yet been explored in a cancer-relevant use.
Definition of Emerging Technology. An emerging technology is defined (for the purpose of this FOA) as one that has passed the initial developmental stage, but has not yet been evaluated within the context of a cancer-relevant intended use and requires significant modification for the proposed application.
FOA Emphasis. The emphasis of this FOA is on technologies with a high degree of technical innovation with the potential to significantly affect and transform investigations exploring the molecular and cellular bases of cancer. If successful, these technologies would accelerate and/or enhance research in the areas of cancer biology, prevention, diagnosis, treatment, control, epidemiology, and/or cancer health disparities. Technologies proposed for development may be intended to have widespread applicability but must be based on molecular and/or cellular characterizations of cancer. This funding opportunity is part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program (http://imat.cancer.gov/).
This FOA utilizes the R21 award mechanism for exploratory/developmental pilot projects. The R21 mechanism is suitable for projects that are at their inception, conceptual, or idea-based phase. In this phase, technical feasibility of the proposed technology or methodology may not yet have been established. Preliminary or proof-of-concept data are not required, but are accepted if available.
The IMAT Program
Since its inception in 1998, the IMAT Program has focused on stimulating and accelerating the development, integration, maturation, and dissemination of the most novel and highly innovative technologies in support of cancer research and medicine. Together with the NCI’s other technology-focused programs, the IMAT program continues to support the development of tools and methods that enable cancer researchers to make new discoveries, enhance our understanding of cancer etiology and proliferation, improve detection capabilities, develop diagnostic methods and treatment strategies, conduct large population studies, address and reduce disparities in clinical care, and assist in clinical decision-making.
The current issuance of the IMAT Program consists of four separate FOAs that cover the following three areas:
Innovative Molecular Analysis Technology Development for Cancer Research (this FOA, RFA-CA-13-001, using the R21 funding mechanism), which is intended to support research projects that are centered on the inception and preliminary development of highly innovative molecular analysis technologies with potentially high impact on cancer research;
Emerging Molecular Analysis Technology Development for Cancer Research (RFA-CA-13-002, using the R33 funding mechanism), designed to support further development (beyond the initial phase) of emerging molecular analysis technologies that have the potential to be transformative when used for cancer research and/or in cancer-relevant clinical care; and
Innovative and Applied Emerging Technologies in Biospecimen Science is centered on the development and validation of novel technologies to improve or assess the quality of cancer-relevant biospecimens for research or clinical care. The emphasis is on issues related to pre-analytical variations in the collection, processing, handling, and preservation of cancer-relevant biospecimens or their derivatives to improve their quality and utility for cancer research or patient clinical care.
○RFA-CA-13-003 (R21): Supports an early-stage feasibility study (inception through preliminary development) to demonstrate core functional capabilities of the proposed technology.
○RFA-CA-13-004 (R33): Assumes completion of the initial phase of development and supports the advanced development and robust validation of the technology.
Additional information about the IMAT Program and its individual FOAs can be found at http://innovation.cancer.gov.
The proposed projects must be focused on the initial development and application of an innovative molecular analysis technology in a biologically relevant system. In addition, all projects proposed in response to this FOA must involve all of the following general attributes:
Potential for substantial improvements over conventional approaches and/or adding qualitatively new research capabilities not provided by current technologies.
Transformative Potential. The emphasis of the IMAT program is on technologies that have significant potential to transform research in laboratory and/or clinical settings.).
Rigorous, Verifiable Approach (based on well-defined quantitative milestones.).
For details on addressing these requirements, see Section IV.2. Content and Form of Application Submission.
Responsive Technologies and Scientific Scope
Responsive technologies include relevant techniques, tools, instrumentation, devices, and associated methods. These technologies may be intended for molecular and/or cellular analyses in vitro, in situ, and/or in vivo (with some exceptions listed below), and may be targeted for the needs of basic, translational, epidemiology, health disparities, and/or clinical cancer research. However, it must be clear that proposed projects are focused on the development of generally applicable technologies to facilitate research in certain areas (e.g., drug development, biomarker discovery and validation, or epidemiology), NOT on pursuing specific discoveries in those areas.
Projects in any area of cancer-related technology are encouraged provided that the technology proposed meets the requirements stated above, including transformative potential for cancer research. Technologies may target atomic, molecular, sub-cellular, and cellular levels of detection and/or analysis. At the core of any project must be a novel molecular analysis technology (encompassing novel devices, materials, or chemical/biochemical approaches).
General areas of interest include, but are not limited to, the following:
Novel technologies to distinguish, assess, and/or monitor cancer stages and progression;
Novel technologies that may aid the elucidation of basic mechanisms underlying cancer initiation and progression;
New methods, tools, and procedures that may generally facilitate processes related to early cancer detection and/or cancer risk assessment;
Technologies that can facilitate and/or enhance molecular analyses in cancer epidemiology (e.g., by allowing for rigorous and/or expeditious collection of various relevant types of data);
Technologies to facilitate/accelerate the processes of drug discovery or development of generic approaches to improve drug delivery;
Technologies or tools that may help overcome various barriers in research on the incidence, prevalence, mortality, and burden of cancer among members of underserved populations; and
Technologies to facilitate the collection of relevant biological data for examining the factors contributing to cancer health disparities (e.g., for cancer sub-types and differences across individuals with diverse racial/ethnic backgrounds).
IMPORTANT NOTE: Researchers uncertain as to whether their intended technology development project meets the requirements of this FOA are encouraged to contact the Program Official listed below (under Scientific/Research Contact).
Non-Responsive Projects
The following aspects/characteristics remain outside the scope of the IMAT Program and this FOA. Applications proposing projects with any of the following characteristics will not be reviewed:
Pursuit of a biological or clinical hypothesis for which the novelty resides in the biological or clinical question (i.e., traditional biological-hypothesis driven research);
Use of existing technologies (for which a proof-of-concept has already been obtained) that may be ready for the targeted applications without substantial further developmental efforts;
Technologies for whole-body or in vivo imaging methods;
Inclusion of clinical trials or toxicology studies beyond those required to demonstrate the capabilities of the technology;
Biomarker discovery or biomarker validation;
Development of specific contrast agents;
Development of drugs or therapies; and/or
Projects focused primarily on software/informatics solutions, database development, data mining, statistical tools, and computational/mathematical modeling (including those applicable to drug and/or patient responses) with the exception of projects which include software development for embedding in new devices or limited amounts of computational efforts as might be needed to develop new devices or methods;
Applications that may have appropriate scientific scope but do not include the required specific components (Statement of Potential Impact and Quantitative Milestones) will also be considered non-responsive to this FOA and will not be reviewed. For example, not reviewed will be applications that fail to provide the following elements:
Tangible information that reviewers can use to assess whether the proposed project is truly exploring more than incremental technical advances to existing technologies;
Tangible information that reviewers can use to assess the potential of the proposed project for transforming cancer research.
Alternative Opportunities
Related IMAT FOA: Applicants proposing projects that are for the advanced stage of development and validation of an emerging technology, rather than pilot projects, should consider applying to the parallel FOA (RFA-CA-13-002) that uses the NIH R33 mechanism.
Other technology-related funding opportunities: Researchers focusing on new bioinformatics or statistical techniques, tools, and/or software solutions should consider one of the Informatics Technologies for Cancer Research (ITCR; http://itcr.nci.nih.gov) opportunities or one of the Biomedical Information Science and Technology Initiative (BISTI; http://bisti.nih.gov) opportunities.
Researchers who emphasize the assessment of whole body or in vivo imaging technologies as the primary focus of their projects should contact the Cancer Imaging Program (CIP; http://imaging.cancer.gov/) for information on appropriate funding opportunities.
An annual 2-day meeting of all investigators funded through this program will be held to share progress and research insights that may lead to further progress in the program
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; Asian American Native American Pacific Islander-serving institutions; nonprofit organizations with 501(C)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct. NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide. Resubmissions are only eligible for applications originally submitted to this FOA or a prior issuance of this FOA (RFA-CA-12-002).
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-13-001.html.
VALIDATION AND ADVANCED DEVELOPMENT OF EMERGING MOLECULAR ANALYSIS TECHNOLOGIES FOR CANCER RESEARCH (R33): RFA-CA-13-002
Components of Participating Organizations
National Cancer Institute
Application Receipt Date(s): February 20, 2013; May 20, 2013; September 20, 2013
This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), solicits grant applications proposing research projects on the advanced development of emerging molecular and cellular analysis technologies through technical/analytical validation in an appropriate cancer-relevant biological system.
Definition of Emerging Technology: An emerging technology is defined as one that has passed the pilot developmental stage and shows promise, but has not yet been evaluated within the context of its intended use. If successful, these technologies would accelerate research in cancer biology, diagnosis, treatment, prevention, control, epidemiology, and/or cancer health disparities.
FOA Emphasis: This FOA solicits projects where proof-of-principle of the proposed technology or methodology has been established and supportive preliminary data are available. Projects proposed to this FOA should reflect the potential to produce a molecular analysis technology with a major impact in a broad area of cancer-relevant research. Projects proposing to use established technologies where the novelty resides in the biological or clinical question being pursued are not appropriate for this solicitation and will not be reviewed.
This funding opportunity is part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program (http://imat.cancer.gov/).
The IMAT Program
Since its inception in 1998, the IMAT Program has focused on stimulating and accelerating the development, integration, maturation, and dissemination of the most novel and highly innovative technologies in support of cancer research and medicine. Together with the NCI’s other technology-focused programs, IMAT continues to support the development of tools and methods that enable cancer researchers to make new discoveries, enhance our understanding of cancer etiology and proliferation, improve detection capabilities, develop diagnostic methods and treatment strategies, conduct large population studies, address and reduce disparities in clinical care, and assist in clinical decision-making.
The current issuance of the IMAT Program consists of four separate FOAs that cover the following three areas:
Innovative Molecular Analysis Technology Development for Cancer Research (RFA-CA-13-001, using the R21 funding mechanism), which is intended to support research projects that are centered on the inception and preliminary development of highly innovative molecular analysis technologies with potentially high impact on cancer research;
Emerging Molecular Analysis Technology Development for Cancer Research (this FOA, RFA-CA-13-002, using the R33 funding mechanism), designed to support further development (beyond the initial phase) of emerging molecular analysis technologies that have the potential to be transformative when used for cancer research and/or in cancer-relevant clinical care; and
Innovative and Applied Emerging Technologies in Biospecimen Science is centered on the development and validation of novel technologies to improve or assess the quality of cancer-relevant biospecimens for research or clinical care. The emphasis is on issues related to pre-analytical variations in the collection, processing, handling, and preservation of cancer-relevant biospecimens or their derivatives to improve their quality and utility for cancer research or patient clinical care.
○ RFA-CA-13-003 (R21): Supports an early-stage feasibility study (inception through preliminary development) to demonstrate core functional capabilities of the proposed technology.
○ RFA-CA-13-004 (R33): Assumes completion of the initial phase of development and supports the advanced development and robust validation of the technology.
Additional information about the IMAT Program and its individual FOAs can be found at http://innovation.cancer.gov.
The proposed projects must be focused on the validation and advanced development of an innovative molecular analysis technology that targets the needs of basic, preventative, diagnostic, translational, epidemiological, and/or clinical cancer research or for broad potential use in cancer research.
In addition, all projects proposed in response to this FOA must involve all of the following general attributes:
Potential for substantial Improvements over conventional approaches and/or adding qualitatively new research capabilities not provided by current technologies.
Transformative Potential. The emphasis of the IMAT program is on technologies that have significant potential to transform research in laboratory and/or clinical settings.
For details on addressing these general requirements, see Section IV.2. Content and Form of Application Submission.
Responsive technologies include relevant techniques, tools, instrumentation, devices, and associated methods. These technologies may be intended for molecular and cellular analyses in vitro, in situ, and/or in vivo (with some exceptions listed below), and may be targeted for the needs of basic, translational, epidemiology, and/or clinical cancer research. However, it must be clear that proposed projects are focused on the development of generally applicable technologies to facilitate research in certain areas (e.g., drug development, biomarker discovery and validation, or epidemiology), NOT on pursuing specific discoveries in those areas.
In addition, NCI has an interest in innovative technologies that can facilitate studies on factors contributing to cancer health disparities and thus aiding the goal of reducing the unequal burden of cancer.
Projects in any area of cancer-related technology are encouraged provided that the technology proposed meets the requirements stated above, including transformative potential for cancer research and/or oncologic practice. Technologies may target atomic, molecular, sub-cellular, and cellular levels of detection and/or analysis. At the core of any project must be a novel molecular analysis technology (encompassing novel devices, materials, or chemical/biochemical approaches).
General areas of interest include, but are not limited to, the following:
Novel technologies to distinguish, assess, and/or monitor cancer stages and progression;
Novel technologies that may aid the elucidation of basic mechanisms underlying cancer initiation and progression;
New methods, tools, and procedures that may generally facilitate processes related to early cancer detection and/or cancer risk assessment;
Technologies that can facilitate and/or enhance molecular analyses in cancer epidemiology (e.g., by allowing for rigorous and/or expeditious collection of various relevant types of data);
Technologies to facilitate/accelerate the processes of drug discovery or development of generic approaches to improve drug delivery
Technologies or tools that may help overcome various barriers in research on the incidence, prevalence, mortality, and burden of cancer among members of underserved populations; and
Technologies, devices, and methods to facilitate the collection of relevant biological data examining the factors contributing to cancer health disparities (e.g., for cancer sub-types and differences across individuals with diverse racial/ethnic backgrounds).
IMPORTANT NOTE: Researchers uncertain as to whether their intended technology development project meets the requirements of this FOA are encouraged to contact the program official listed below (under Scientific/Research Contact).
Non-Responsive Projects
The following aspects/characteristics remain outside the scope of the IMAT Program and this FOA. Applications proposing projects with any of the following characteristics will not be reviewed:
Pursuit of a biological or clinical hypothesis for which the novelty resides in the biological or clinical question (i.e. traditional biological-hypothesis driven research);
Use of existing technologies (for which proof-of-concept has already been obtained) that may be ready for the targeted applications without substantial further developmental efforts;
Technologies for whole-body or in vivo imaging methods;
Inclusion of clinical trials or toxicology studies beyond those required to demonstrate the capabilities of the technology;
Biomarker discovery or biomarker validation;
Development of specific contrast agents;
Development of drugs or therapies; and/or
Projects focused primarily on software/informatics solutions, database development, data mining, statistical tools, and computational/mathematical modeling (including those applicable to drug and/or patient responses) with the exception of projects which include software development for embedding in new devices or limited amounts of computational efforts as might be needed to develop new devices or methods.
Applications that may have appropriate scientific scope but do not include the required specific information (Statement of Potential Impact) will also be considered non-responsive to this FOA and will not be reviewed. For example, not reviewed will be applications that fail to provide the following elements:
Tangible information that reviewers can use to assess whether the proposed project is truly exploring more than incremental technical advances to existing technologies;
Tangible information that reviewers can use to assess the potential of the proposed project for transforming cancer research.
Alternative Opportunities
Related IMAT FOA: Applicants proposing projects that are for investigating the feasibility or the exploratory stage of development of an innovative technology, rather than advanced development and validation of an emerging technology, should consider applying to the parallel FOA (RFA-CA-13-001) that uses the NIH R21 mechanism.
Other technology-related funding opportunities: Researchers focusing on new bioinformatics or statistical techniques, tools, and/or software solutions should consider one of the Informatics Technologies for Cancer Research (ITCR; http://itcr.nci.nih.gov) opportunities or one of the Biomedical Information Science and Technology Initiative (BISTI; http://bisti.nih.gov) opportunities.
Researchers who emphasize the assessment of whole body or in vivo imaging technologies as the primary focus of their projects should contact the Cancer Imaging Program (CIP; http://imaging.cancer.gov/) for information on appropriate funding opportunities.
An annual 2-day meeting of all investigators funded through this program will be held to share progress and research insights that may lead to further progress in the program.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; Asian American Native American Pacific Islander-serving institutions; nonprofit organizations with 501(C)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organization. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide. Resubmissions are only eligible for applications originally submitted to this FOA or a prior issuance of this FOA (RFA-CA-12-003).
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-13-002.html.
VALIDATION AND ADVANCED DEVELOPMENT OF EMERGING TECHNOLOGIES FOR BIOSPECIMEN SCIENCE (R33): RFA-CA-13-004
Also note: Early-Stage Development of Innovative Technologies for Biospecimen Science (R21): (RFA-CA-13-003)
Details at: http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-13-003.html.
Components of Participating Organizations
National Cancer Institute
Application Receipt Date(s): February 20, 2013; May 20, 2013; September 20, 2013
This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), solicits grant applications proposing research projects on the advanced development and validation of cancer-relevant technologies that address issues related to pre-analytical variations in the collection, processing, handling, and storage of biospecimens or their derivatives. The overall goal is to develop technologies capable of interrogating and/or maximizing the quality and utility of biospecimens or their derived samples for downstream analyses.
FOA Emphasis: This FOA will support the development of tools, devices, instrumentation, and associated methods to assess sample quality, preserve/protect sample integrity, and establish verification criteria for quality assessment/quality control and handling under diverse conditions. The R33 mechanism is suitable for projects where proof-of-principle of the proposed technology or methodology has already been established and supportive preliminary data are available. Projects proposing to use established technologies where the novelty resides in the biological or clinical question being pursued is an example of a topic not appropriate for this solicitation as non-responsive and will not be reviewed.
This funding opportunity is part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program (http://innovation.cancer.gov).
The IMAT Program
Since its inception in 1998, the IMAT Program has focused on stimulating and accelerating the development, integration, maturation, and dissemination of the most novel and highly innovative technologies in support of cancer research and medicine. Together with the NCI’s other technology-focused programs, the IMAT Program continues to support the development of tools and methods that enable cancer researchers to make new discoveries, enhance our understanding of cancer etiology and proliferation, improve detection capabilities, develop diagnostic methods and treatment strategies, conduct large population studies, address and reduce disparities in clinical care, and assist in clinical decision-making.
The current issuance of the IMAT Program consists of four separate FOAs that cover the following three areas:
Innovative Molecular Analysis Technology Development for Cancer Research (RFA-CA-13-001, using the R21 funding mechanism), which is intended to support research projects that are centered on the inception and preliminary development of highly innovative molecular analysis technologies with potentially high impact on cancer research;
Emerging Molecular Analysis Technology Development for Cancer Research (RFA-CA-13-002, using the R33 funding mechanism), designed to support further development (beyond the initial phase) of emerging molecular analysis technologies that have the potential to be transformative when used for cancer research and/or in cancer-relevant clinical care; and
Innovative and Applied Emerging Technologies in Biospecimen Science is centered on the development and validation of novel technologies to improve or assess the quality of cancer-relevant biospecimens for research or clinical care. The emphasis is on issues related to pre-analytical variations in the collection, processing, handling, and preservation of cancer-relevant biospecimens or their derivatives to improve their quality and utility for cancer research or patient clinical care.
○ RFA-CA-13-003 (R21): Supports an early-stage feasibility study (inception through preliminary development) to demonstrate core functional capabilities of the proposed technology.
○ This FOA, RFA-CA-13-004 (R33): Assumes completion of the initial phase of development and supports the advanced development and robust validation of the technology.
Additional information about the IMAT Program and its individual FOAs can be found at http://innovation.cancer.gov.
The proposed projects must be focused on the validation and advanced development of technologies and methodologies that improve the quality and utility of biospecimens and/or samples derived from biospecimens for cancer research and clinical care. The proposed technology may be targeted for the biospecimen/sample preparation needs of basic, preventative, diagnostic, translational, epidemiological, health disparities, and/or clinical cancer research or for broad potential use in cancer research
In addition, all projects proposed in response to this FOA must involve all of the following general attributes:
Potential for substantial improvements over conventional approaches and/or adding qualitatively new research capabilities not provided by current technologies.
Transformative Potential. The emphasis of the IMAT program is on technologies that have significant potential to transform research in laboratory and/or clinical settings.
Responsive technologies include relevant techniques, tools, instrumentation, devices, and associated methods. These technologies must focus on the procurement, preservation and/or preparation of specified molecular and/or cellular targets. Each application submitted in response to this FOA should contain a clear description of the novelty of the proposed technology and its anticipated long-term use to advance cancer research or clinical care (see “Statement of Potential Impact,” above).
Projects in any area of technology development for cancer-related biospecimen science are encouraged provided that the technology proposed meets the requirement for transformative potential. Technologies may target all levels of biospecimen procurement, preservation, and/or preparation for analysis.
General areas of interest include, but are not limited to, the following:
Novel technologies to benchmark or otherwise assess the biological integrity of classes of molecular analytes (i.e., determine fitness-for-purpose);
Novel technologies and techniques to provide high-quality preservation of specific classes of molecules, sub-cellular components, whole cells or bulk tissue;
New methods, tools, and procedures that may generally facilitate the preparation of biospecimens for classes of molecular analysis (e.g., genomic sequencing, profiling of protein or RNA extract);
Technologies that can facilitate and/or enhance molecular analyses in cancer epidemiology (e.g., by allowing for rigorous and/or expeditious collection of various relevant types of biospecimens);
Technologies or tools that may help overcome various barriers in research on the incidence, prevalence, mortality, and burden of cancer among members of underserved populations; and
Technologies to facilitate the collection of relevant biological data for examining the factors contributing to cancer health disparities (e.g., for cancer sub-types and differences across individuals with diverse racial/ethnic backgrounds).
IMPORTANT NOTE: Researchers uncertain as to whether their intended technology development project meets the requirements of this FOA are encouraged to contact the program official listed below (under Scientific/Research Contact).
Non-Responsive Projects
The following aspects/characteristics remain outside the scope of the IMAT Program and this FOA. Applications proposing projects with any of the following characteristics will not be reviewed:
Pursuit of a biological or clinical hypothesis for which the novelty resides in the biological or clinical question (i.e. traditional biological-hypothesis driven research);
Use of existing technologies (for which proof-of-concept has already been obtained) that may be ready for the targeted applications without substantial further developmental efforts;
Technologies for whole-body or in vivo imaging methods;
Inclusion of clinical trials or toxicology studies beyond those required to demonstrate the capabilities of the technology;
Biomarker discovery or biomarker validation;
Development of specific contrast agents;
Development of drugs or therapies; and/or
Projects focused primarily on software/informatics solutions, database development, data mining, statistical tools, and computational/mathematical modeling (including those applicable to drug and/or patient responses) with the exception of projects which include software development for embedding in new devices or limited amounts of computational efforts as might be needed to develop new devices or methods.
Applications that may have appropriate scientific scope but do not include the required specific components (e.g., Statement of Potential Impact) will also be considered non-responsive to this FOA and will not be reviewed. For example, not reviewed will be applications that fail to provide the following elements:
Tangible information that reviewers can use to assess whether the proposed project is truly exploring more than incremental technical advances to existing technologies;
Tangible information that reviewers can use to assess the potential of the proposed project for transforming cancer research.
Alternative Opportunities
Related IMAT FOA: Applicants proposing projects that are for investigating the feasibility or the exploratory stage of development of an innovative technology, rather than advanced development and validation of an emerging technology, should consider applying to the parallel FOA (RFA-CA-13-003) that uses the NIH R21 mechanism.
Other technology-related funding opportunities: Researchers focusing on new bioinformatics or statistical techniques, tools, and/or software solutions should consider one of the Informatics Technologies for Cancer Research (ITCR; http://itcr.nci.nih.gov) opportunities or one of the Biomedical Information Science and Technology Initiative (BISTI; http://bisti.nih.gov) opportunities.
Researchers who emphasize the assessment of whole body or in vivo imaging technologies as the primary focus of their projects should contact the Cancer Imaging Program (CIP; http://imaging.cancer.gov/) for information on appropriate funding opportunities.
An annual 2-day meeting of all investigators funded through this program will be held to share progress and research insights that may lead to further progress in the program.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; Asian American Native American Pacific Islander-serving institutions; nonprofit organizations with 501(C)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide. Resubmissions are only eligible for applications originally submitted to this FOA or a prior issuance of this FOA (RFA-CA-12-005).
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-13-004.html.
AHRQ CONFERENCE GRANT PROGRAM (R13): ADMINISTRATIVE SUPPLEMENTS FOR RESEARCH ON SEX/GENDER DIFFERENCES (ADMIN SUPP): PA-13-018
Components of Participating Organizations
Office of Research on Women’s Health
John E. Fogarty International Center
National Center for Complementary and Alternative Medicine
National Cancer Institute
National Eye Institute
National Human Genome Research Institute
National Heart, Lung, and Blood Institute
National Institute on Aging
National Institute on Alcohol Abuse and Alcoholism
National Institute of Allergy and Infectious Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Biomedical Imaging and Bioengineering
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institute on Drug Abuse
National Institute on Deafness and Other Communication Disorders
National Institute of Dental and Craniofacial Research
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Environmental Health Sciences
National Institute of General Medical Sciences
National Institute of Mental Health
National Institute on Minority Health and Health Disparities
National Institute of Neurological Disorders and Stroke
National Institute of Nursing Research
National Library of Medicine
Office of Behavioral and Social Science Research
Office of Dietary Supplements
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs
Application Receipt/Submission Date(s): Multiple dates, see announcement.
The mission of the NIH is to seek fundamental knowledge about the nature and behavior of living systems, and to apply that knowledge to enhance health, lengthen life, and reduce burdens of illness and disability. The Office of Research on Women’s Health (ORWH) works in partnership with the NIH institutes, centers, and offices to ensure that women’s health and sex/gender differences research is part of the scientific framework.
This FY 2013 Administrative Supplement program is designed to support research that increases understanding of sex and gender differences in health and disease, as part of the implementation of the strategic plan entitled Moving Into The Future With New Dimensions and Strategies: A Vision for 2020 for Women’s Health Research, http://orwh.od.nih.gov/NIHStrategicPlan.ORWH.pdf.
Women and men are characterized by both sex and gender, as highlighted in the Institute of Medicine (IOM) report, entitled Exploring the Biological Contributions to Human Health: Does Sex Matter? (2001). In this context, sex referred to being male or female according to reproductive organs and biologic functions assigned by chromosomal complement. Factors that contribute to biological sex differences include chromosomes, reproduction, and hormones. Gender referred to socially defined and derived expectations and roles rooted in biology and shaped by the environment and experience. Sex and gender are important considerations in many areas of research, including basic biological, psychological, social, and behavioral studies. Consideration of these variables is critical to the accurate interpretation and validation of research findings that affect the various aspects of women’s health and sex/gender differences research and to the development of personalized approaches to medicine. Sex and gender variables may also determine how health and disease processes differ among women, or between women and men, and inform the development and testing of preventive and therapeutic interventions in both sexes.
The 2010 NIH Strategic Plan for Women’s Health and Sex Differences Research, Moving into the Future with New Dimensions and Strategies, includes five research goals to advance women’s health and a number of specific objectives under each of the five goals to which the reader is referred for examples of general areas in which sex/gender differences research is encouraged. These include a broad range of research on sex/gender differences in basic science, incorporation of sex/gender differences in the design of new medical and communication technologies, medical devices and therapeutic drugs; global health research and in the development of approaches to personalized medicine. The proposed research in the supplement needs to clearly demonstrate how the funding will address sex/gender differences. However, the specific examples under the objectives are meant to be illustrative but not restrictive of the kinds of research that could be conducted to fulfill the goal of the administrative supplement. Please see the NIH Strategic Plan, http://orwh.od.nih.gov/research/strategicplan/index.asp.
The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives as long as they are within the original scope of the project. Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes.
The research proposed under the administrative supplement program must be within the original scope of the parent grant. Applicants should propose research that, if successful, would contribute to a greater understanding of the implications of sex/gender differences (or similarities) in human health or disease outcomes. Applicants must address how the proposed research supports the goals and objectives of the NIH Strategic Plan for Women’s Health and Sex Differences Research by including a statement at the beginning of the Research Strategy section of the application.
For example, applicants may use the following approaches to address sex/gender comparisons:
The addition of another group of subjects (human or animal) of the opposite sex when subjects of only one sex were used in the original study for comparative analyses of sex/gender. Applicants proposing to use subjects of only one sex/gender will be considered non-responsive UNLESS the data will be compared with those from the opposite sex within the administrative supplement period;
The addition of more subjects (human or animal) of both sexes to sufficiently power a study that was insufficiently powered to conduct or detect a sex/gender difference (or similarity) in the original study; or
The analyses of preexisting data where sex-specific data are included and power is sufficient, but a sex/gender analysis was not performed as part of the original study.
Applicants proposing the addition of subjects to Phase III clinical trials will be considered non-responsive.
IC Specific Considerations
Applicants are strongly encouraged to discuss their proposed supplement project with the IC Program Officer of the parent grant prior to submission of a supplement application in order to ensure that the supplement content area fits with the scientific priorities of the IC and is within the scope of the parent grant; and to ensure that the parent grant mechanism is one the IC will support for a supplement.
NIDDK-specific Programmatic Interests Language: Areas of interest for NIDDK include studies that address the importance of sex/gender differences for disorders and disease mechanisms within our scientific mission. Examples include the influence of sex/gender differences in urologic, kidney, hematologic disease; diabetes; endocrinology; metabolic and digestive disease; and nutrition and obesity. Basic, translational, and clinical science studies of sex/gender influences are appropriate provided they address important questions relevant to the NIDDK’s research programs. Please refer to the NIDDK’s website for more complete information on our scientific mission (http://www2.niddk.nih.gov/).
NHLBI-specific Programmatic Language: Only R01 grants can be considered for administrative supplements in this funding opportunity.
All other ICs: Please contact the official listed in the Scientific/Program Contact(s).
All organizations administering an eligible parent award may apply for a supplement under this announcement. Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; Asian American Native American Pacific Islander-serving institutions; nonprofit organizations with 501(C)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.
IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project. Applications that propose to add human subjects in order to conduct exploratory analyses, facilitate sex/gender differences analysis /or to analyze existing data sets that are adequately powered are considered to be within the scope of the parent grant
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Foreign institutions or domestic institutions with foreign components must have clearance for shipping of biological samples across international lines prior to the administrative supplement award.
Applicant organizations must complete the following registrations as described in the Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov (required for all electronic application submissions)
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are invited to work with their organizations to develop applications for support.For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center.
Since applications in response to this announcement will only receive administrative review by the awarding Institute or Center, and will not receive a peer review, the NIH policy on resubmissions will not apply. However, applications not accepted by the Institute or Center for review, or not funded by the Institute or Center, should not be submitted again without either responding to any written concerns or contacting the awarding Institute or Center for instructions first.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PA-13-018.html.
NINDS COOPERATIVE PROGRAM IN TRANSLATIONAL RESEARCH (U01): PAR-13-022
Components of Participating Organizations
National Institute of Neurological Disorders and Stroke
Application Receipt/Submission Date(s): February 7, 2013; August 20, 2013; February 7, 2014; August 20, 2014
Recent discoveries across a broad range of research areas in the neurosciences offer promising opportunities for treatment of neurological disorders. As part of its mission to reduce the burden of neurological disease, NINDS is committed to encouraging the translation of these discoveries into new treatments. This Funding Opportunity Announcement (FOA) supports milestone-driven projects focused on the optimization, preclinical testing, and early stage clinical testing of candidate therapeutics (Phase 0 or proof-of-concept/pilot studies). The program will facilitate therapy-directed projects and will accelerate the translation of basic research discoveries into therapeutic candidates for clinical testing.
This FOA is one of five coordinated programs released by NINDS to promote translational research, including NINDS Exploratory/Developmental Projects in Translational Research (R21) (PAR-13-023), NINDS Cooperative Program in Translational Research Small Business Awards (SBIR [U44]) (PAR-11-296), Advanced Neural Prosthetics Research and Development (SBIR [U44]) PAR-12-054, and Advanced Neural Prosthetics Research and Development (U01) PAR-12-053. The extramural research community may use these translational research initiatives in whatever combinations are necessary to achieve the most rapid and effective development of investigational interventions for neurological disorders.
Translational research is the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease.
Remarkable advances have been made recently in our understanding of the molecular and genetic bases of disease. In addition, new advances in device technology enable safer and more effective means of interacting with physiological systems to alleviate the symptoms and treat the underlying causes of many diseases and disorders. The potential therapeutic opportunities offered by these scientific findings create an opportunity for basic, applied, and clinical scientists to combine and coordinate their efforts. The realization of the potential for translating accumulated new knowledge will depend on the cooperation and partnering of public and private funding organizations, universities, academic medical centers, research institutes, contract research organizations, biotechnology companies, and pharmaceutical companies.
The NINDS Cooperative Program in Translational Research is intended to catalyze the development of partnerships between basic and clinical investigators, and to stimulate agreements between the academic and industrial sectors, so that translational research in neuroscience can flourish as a cooperative, iterative process leading to new and effective interventions for neurological disorders.
The NINDS Translational Research Program is specifically focused on the preclinical therapy development necessary to begin clinical testing of therapeutic candidates for neurological disorders. The program supports the preclinical development of drugs, biologics, and devices leading to IND or IDE applications to the FDA. For devices there are alternative viable pathways to IDE (510(k) and 510(k) de novo), and testing in support of those paths is also supported through this announcement. All proposed studies should be directed at the most efficient route to regulatory submission.
General Entry Criteria
For entry to the program, projects must have one or more identified therapeutic leads, a strong biological rationale for the intended approach, supporting data and proposed studies that exhibit methodological rigor, and where available in vivo proof-of-concept data on efficacy, which is ideally efficacy data in one or more animal models representative of the intended patient population.
Drug/Biologic Therapies Entry Criteria
Where efficacy models are not readily available, the project must have in vivo models that include the measurement of a pharmacodynamic biomarker of the intended therapeutic using the intended clinical route of administration. Efficacy data could also be obtained through clinical observations. Preliminary data should demonstrate rigor in the preliminary evaluation of candidate therapeutics entering the program, including, for example, preliminary assessments of drug-like characteristics.
Within scope examples for Drugs/Biologics include, but are not limited to:
Preclinical efficacy testing
Predictive ADME (absorption, distribution, metabolism, and excretion)
Toxicology testing
Biodistribution and gene expression level
Optimization of candidate therapeutics
Formulation and stability studies
Cell bank development and testing
Process development-manufacturing process development
Manufacturing of candidate therapeutics for IND and Phase 0/proof-of-concept/pilot clinical trials only
IND-enabling safety pharmacology, toxicology, biodistribution, tumorigenicity, and immunogenicity
Regulatory affairs
IND submission. An IND must be submitted to the FDA during the project period.
Phase 0, proof-of-concept
For applications proposing Phase 0 clinical trials, an exploratory IND (eIND) may be required before starting the clinical trial; refer to NOT-NS-11-018 regarding NINDS Policy for the Requirement of Authorization from the Food and Drug Administration (FDA) to use an Investigational Drug, Biologic Product or Device in a Clinical Trial Prior to Submission of an Application.
Such Phase 0/proof-of-concept/pilot clinical trials for drugs/biologics:
Involve very limited human exposure. The duration of dosing in such studies is expected to be limited (e.g., 7 days), and usually includes sub-therapeutic doses of the intended therapeutic
Have no therapeutic or diagnostic intent (e.g., screening studies, microdose studies)
Are intended to measure pharmacokinetics of one or more development candidates to allow for the selection of a clinical candidate
It is expected that all preclinical safety studies supporting the safety of an eIND application will be performed in a manner consistent with Good Laboratory Practices (GLP).
Device Therapies Entry Criteria
For entry to the program, projects must have identified one or more clinically meaningful device outcomes based on input from both clinicians and patients. Ideally, preliminary proof-of-concept data would be available, preferably obtained using an in vivo animal model representative of the intended patient population. When projects do not include a representative animal model for efficacy testing, an acceptable alternative for entry to the program is efficacy data obtained through laboratory work and in vivo proof-of-concept demonstrated in normal animals. As preliminary proof-of-concept data are strongly recommended for entry into this program, innovation will in part be judged on presenting a credible path towards regulatory submission at the end of the project period.
Within scope examples for Devices include, but are not limited to:
Non-GLP animal studies to develop surgical techniques relevant to device, define relevant therapeutic parameters, and refine device design
Bench-top and animal testing to meet FDA Recognized ISO/ASTM Standards
GLP compliant large animal model safety and/or testing of an implanted device
Activities to become Good Manufacturing Practice (GMP) compliant
Activities to bring the development process under Design and Quality Systems Control
Device, software, and firmware design verification and validation activities
Regulatory affairs
IDE, 510(k) or 510(k) de novo submission. An IDE, 510(k), or 510(k) de novo application must be submitted to the FDA during the project period
Device proof-of-concept or pilot clinical trials
Additional Considerations
There is increasing awareness among neurological disease communities that to assess the predictive value of preclinical research, sufficient information must be available about study design, execution, analysis, and interpretation. Program Directors/Principal Investigators (PD(s)/PI(s)) should consider including blinding, randomization, power analysis for sample size, and independent replication in their application. Examples of the critical elements of a well-designed study are summarized on the NINDS website http://www.ninds.nih.gov/funding/transparency_in_reporting_guidance.pdf. NINDS urges applicants to the program to consider these elements when describing supporting data and designing the proposed studies.
It is the responsibility of applicants proposing Phase 0/proof-of-concept/pilot clinical trials to be aware of and responsive to the regulatory requirements relevant to the drug, biologic or device therapy being proposed. These requirements differ between the Centers at FDA, based on risk and existing mechanisms for early phase clinical testing.
Please note that IND/IDE, 510(k) or 510(k) de novo remains an expected goal of the U01 program. Hence, all applicants, including those who propose such Phase 0/proof-of-concept/pilot clinical trials need to include the filing of an IND/IDE, 510(k) or 510(k) de novo application to the FDA as an objective of the application.
Out of scope examples for all therapies include:
Animal model development -Animal models must be available
Basic research and studies of disease mechanism or mechanistic/mechanism of action studies of the intended therapeutic
Development of diagnostics, diagnostic devices, or biomarkers
Developing and performing screening assays to identify candidate therapeutics
Non-exempt human studies, other than those specified above
Production of therapeutics for clinical trials, other than what would be needed to perform the phase 0 studies, if proposed.
Rehabilitation strategies
Definitive clinical trials of therapeutic agents or devices
Overall Plan for Therapy Development
Applicants must include an overall plan for therapy development to be within program scope (See Section IV.2. Research Strategy for details.)
Milestones
Applications must include proposed annual milestones to be within program scope. Milestones toward therapeutic intervention are goals that create go/no-go decision points in the project and include quantitative success criteria. For example, refer to http://www.ninds.nih.gov/funding/research/translational/DevelopingMilestones.htm and http://www.ninds.nih.gov/research/npp/example_milestones_advanced_neural-prosthetics_research_dev.htm. Achievement of milestones will be evaluated by NINDS program staff, and funding of non-competing award years will depend on milestone accomplishment. Because therapy development is an inherently high-risk process, it is anticipated that there will be a significant attrition rate as projects move through the pipeline. Go/no-go milestones will be agreed upon at the start of each project and milestone progress should be included by investigators in their progress report. If a funded project does not make sufficient progress toward the agreed-upon milestones at any stage, funding for the project may be decreased or discontinued.
Intellectual Property
Since the ultimate goal of the cooperative agreement program is to bring new therapeutics to the market, the creation and protection of appropriate intellectual property are significant considerations in designing research strategies and prioritizing projects for funding. Each U01 applicant is expected to address intellectual property issues related to the proposed therapeutics, with input from the institution’s technology transfer officials, if applicable. Peer reviewers will be instructed to comment on the intellectual property landscape for each U01 application. The project milestone plan may include commercialization milestones to protect and leverage intellectual property. Recipients of U01 awards are encouraged to identify potential licensing and commercialization partners early in the therapy development process. The U01 PD(s)/PI(s) is encouraged to work closely with technology transfer officials at his or her institution, if applicable, to ensure that royalty agreements, patent filings, and all other necessary intellectual property arrangements are completed in a timely manner. (See Section IV.2. Other Project Information for details.)
Implementation
The NINDS Cooperative Program in Translational Research Single-Component Research Projects provides funding through the U01 cooperative agreement mechanism. As a cooperative agreement, implementation will involve participation of NINDS program staff in the planning and execution of the therapy-directed projects. The U01 cooperative agreements support translational research projects that are focused on a single approach to therapy development for a neurological disorder or a group of closely related neurological disorders. A U01 project plan leads and supports the submission of one IND, IDE, 510(k) or 510(k) de novo application to the FDA and supports the planning for one clinical trial.
Applicants are strongly encouraged to consult with NINDS program staff as plans for an application are being developed. Consultations will include conference calls with NINDS program staff. Early contact provides an opportunity for NINDS program staff to discuss the program scope and goals, and to provide information and guidance on how to develop an appropriate milestone plan. Other aspects of an application that are unique to this program are also discussed. Applicants should contact NINDS program staff at least 12 weeks before a receipt date.
Shortly after receipt, applications will be examined to determine if they are within the scope of this FOA. PD(s)/PI(s) who submit applications that are outside the scope will be asked to consider whether their proposed studies fall within the scope of other FOAs.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; nonprofit organizations with 501(C)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the SAM.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-022.html.
NINDS EXPLORATORY/DEVELOPMENTAL PROJECTS IN TRANSLATIONAL RESEARCH (R21): PAR-13-023
Components of Participating Organizations
National Institute of Neurological Disorders and Stroke
Application Receipt/Submission Date(s): Multiple dates, see announcement.
Remarkable insights have been made recently into the genetic, molecular, and cellular bases of neurological disease. NINDS is committed to encouraging the translation of promising discoveries and available data on the nervous system into therapies for neurological disorders. The goal of the NINDS Exploratory/Developmental Projects in Translational Research (R21) program is to support any research activities required to advance candidate therapeutics through Investigational New Drug (IND), Investigational Device Exemption (IDE), or 510(K) submission to the Food and Drug Administration (FDA), and ready them for clinical testing for neurological disorders. Translational R21 projects, if successful, should lead directly to or support another project (e.g. cooperative agreement in translational research) that will include all remaining activities for submission of an IND, IDE, or 510(k) application to the FDA.
This FOA is one of five coordinated programs released by NINDS to promote translational research, including NINDS Cooperative Program in Translational Research (U01) PAR-13-022, NINDS Cooperative Program in Translational Research Small Business Awards (SBIR [U44]) PAR-11-296, Advanced Neural Prosthetics Research and Development (SBIR [U44]) PAR-12-054, and Advanced Neural Prosthetics Research and Development (U01) PAR-12-053. The extramural research community may use these translational research initiatives in whatever combinations are necessary to achieve the most rapid and effective development of investigational interventions for neurological disorders. Translational R21 projects can be supported prior to or in parallel with cooperative agreement funding.
The program will facilitate therapy-directed projects to accelerate the translation of basic research discoveries into therapeutic candidates for clinical testing. Translational R21 projects should include a strong biological rationale for the intended approach, supporting data from rigorously designed experiments, and proposed studies that exhibit methodological rigor. In order to assess the predictive value of preclinical research, sufficient information should be available about study design, execution, analysis, and interpretation. Examples of the critical elements of a well-designed study are summarized on the NINDS website http://www.ninds.nih.gov/funding/transparency_in_reporting_guidance.pdf. (See Section IV.2. Research Strategy for details.)
Translational research is the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease.
Within scope examples (Drugs/Biologics) include, but are not limited to:
Creation and validation of screening assays for therapy development. The assays may be intended for primary or secondary screening efforts at any level of throughput. Optional: applicants may find this assay guidance manual a useful reference: http://ncgcweb.nhgri.nih.gov/guidance/manual_toc.html
Development of animal models of neurological disorders for therapy development, or animal models that allow for the direct or downstream readout of target engagement of the intended therapeutic.
Identification of candidate therapeutics, including primary or secondary screening efforts at any level of throughput.
Development of pre-clinical in vivo efficacy data for identified candidate therapeutics
Investigation of structure-activity relationships (SAR) through medicinal chemistry. This may include hit-to-lead chemistry, scaffold-hopping, and studies aimed at prioritizing scaffolds for further development.
Development and investigations of direct or downstream readouts of target engagement and/or pharmacodynamics biomarker(s) linked to the action of the therapeutic, which could be translated for use in the clinic. A pharmacodynamic biomarker is a dynamic assessment that shows that a biological response has occurred after having received a therapeutic intervention.
Exempt human studies.
Within scope examples (Devices) include, but are not limited to:
Prototype optimization activities (for example, evaluation of multiple prototype designs to finalize the design)
Therapy refinement in an animal model (for example, optimization of stimulation protocol)
Development of animal models relevant to therapy development. This can include identification of appropriate animal model(s) to represent both the relevant anatomical geometries and physiological response in humans for safety and efficacy studies
Optimization of surgical procedure for the device, including development and testing of procedure specific tools and imaging techniques
Bringing device development under Design Controls
Activities to generate a final system design and final manufacturing processes and protocols for GLP animal testing in support of regulatory submission
Exempt human research studies to gather data to support efficacy or inform device design
Out of scope examples (Drugs/Biologics/Devices) include, but are not limited to:
Use of tool compounds to identify targets relevant to disease
Development of animal models that will be used for basic research
Initial testing of device prototypes for efficacy in animal models
Basic research and studies of disease mechanism
Development of diagnostics or rehabilitation strategies
Manufacture of therapeutics for clinical trials
Development of risk, detection, diagnostic, prognostic, predictive, and prevention biomarkers
Clinical research and clinical trials involving non-exempt human subjects
Overall Plan for Therapy Development
Applicants must include an overall plan for therapy development to be within program scope (See Section IV.2. Research Strategy for details.)
Intellectual Property
Since the ultimate goal of the NINDS Exploratory/Developmental Projects in Translational Research program is to bring new therapeutics to the market, the creation and protection of appropriate intellectual property are significant considerations in designing research strategies and prioritizing projects for funding. Each R21 applicant is expected to address intellectual property issues related to the proposed therapeutics, with input from the institution’s technology transfer officials, if applicable. Peer reviewers will be instructed to comment on the intellectual property landscape for each R21 application. Recipients of R21 awards are encouraged to identify potential licensing and commercialization partners early in the therapy development process. The R21 PD(s)/PI(s) is encouraged to work closely with technology transfer officials at his or her institution, if applicable, to ensure that royalty agreements, patent filings, and all other necessary intellectual property arrangements are completed appropriately and in a timely manner. (See Section IV.2. Other Project Information for details.)
Shortly after receipt, applications will be examined to determine if they are within the scope of this FOA. PDs/PIs that submit applications that are outside the scope will be asked to consider whether their proposed studies fall within the scope of other FOAs.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; Asian American Native American Pacific Islander-serving institutions; nonprofit organizations with 501(C)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-023.html.
INTERNATIONAL RESEARCH ETHICS EDUCATION AND CURRICULUM DEVELOPMENT AWARD (R25): PAR-13-027
Components of Participating Organizations
John E. Fogarty International Center
National Cancer Institute
National Human Genome Research Institute
National Institute of Allergy and Infectious Diseases
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Application Receipt/Submission Date(s): May 22, 2013, May 22, 2014, May 22, 2015
The Fogarty International Center and several ICs have supported International Research Ethics Education and Curriculum Development awards since FY2000 (see http://www.fic.nih.gov/Grants/Search/Pages/Awards-Program-Bioethics.aspx for list of current awards). The goal of this initiative is to strengthen research ethics capacity in low- and middle-income countries (LMICs) through increasing the number of scientists, health professionals and relevant academics from these countries with in-depth knowledge of the ethical principles, processes and policies related to international clinical and public health research as well as the critical skills to develop research ethics education, ethical review leadership and expert consultation to researchers, their institutions, governments and international research organizations. FIC and the participating ICs invite applications for International Research Ethics Education and Curriculum Development Program Award programs:
To develop a comprehensive ethics education program including master’s level curricula and practicum opportunities for LMIC academics, researchers and health professionals in ethics related to performing research involving human subjects in their home countries or;
To revise and renew existing master’s level international ethics education programs or;
It is expected that such master’s level research education will enhance the career development of participants from LMICs, as well as strengthen ethics scholarship and sustain their capacity to design and direct ethics activities related to clinical and public health research at their home institutions and countries. Participant recruitment and selection strategies should be designed to identify the strongest potential LMIC leaders in research ethics as well as create institutional or regional networking and collaboration opportunities to sustain a critical mass of ethics leadership for maximum impact after participation. Faculty and mentors from LMICs with research ethics expertise should play significant roles in proposed programs to insure the relevance of the curriculum and sustainable impact of the participants afterward. Innovative approaches for continuing research ethics education and networking for participants that will sustain their development as research ethics leaders at their home institutions are encouraged.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities, and Alaska native- and native Hawaiian- serving institutions.; Non-domestic (non-U.S.) entities (foreign institutions) are eligible to apply. All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be completed by the application due date.
The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.
Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving NIH support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research ethics education as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide. The PD/PI should have documented experience in international research ethics and capable of providing both administrative and ethics education leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is programmatically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
To the greatest extent possible, faculty and mentors from LMICs with research ethics expertise should be included in significant roles in proposed programs. Research ethics experts from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as faculty or mentors. Faculty and mentors should have research ethics expertise and international experience relevant to the proposed program, including but not limited to expertise in the philosophical foundations of bioethics, behavioral or social science or other empirical methods in empirical bioethics investigation, health policy or legal analysis and scholarship and ethics of medical care. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.
Participants in proposed programs must be recruited from low- and middle-income countries as defined by the World Bank (according to Gross National Income (GNI) per capita as “low-income,” “lower-middle-income,” and “upper-middle-income” see: http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS). Applications must describe the intended participants, and the eligibility and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels essential for participation in the planned program.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-027.html.
RESEARCH USING SUBJECTS FROM SELECTED TYPE 1 DIABETES CLINICAL STUDIES (LIVING BIOBANK) (DP3): PAR-13-028
Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases
Application Receipt/Submission Date(s): April 02, 2013
The NIDDK seeks to accelerate the pace of scientific research towards more effective prevention, treatment, or cure of type 1 diabetes and its complications. To this end, NIDDK is committed to providing access to research resources which will increase our understanding of type 1 diabetes pathogenesis, and pathogenesis of its complications, in humans. This opportunity is intended to fund projects using subjects who have been phenotypically and genetically characterized for risk of developing type 1 diabetes through the Type 1 Diabetes TrialNet Pathway To Prevention clinical research network, and projects using subjects currently enrolled and followed for diabetic complications in the Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC).
Type 1 Diabetes TrialNet
The Type 1 Diabetes TrialNet is an international network of investigators, clinical centers, and core support facilities that recruits patients and conducts research to advance knowledge about type 1 diabetes and to test strategies for its prevention and early treatment. TrialNet supports the development and implementation of clinical trials of agents aimed at preventing the disease in at-risk patients and slowing the progression of type 1 diabetes in new onset patients. The network’s “Pathway To Prevention Study” enhances understanding of how the disease develops in individuals at risk and thus helps in the formulation of future trials. The Pathway To Prevention Study provides the basis for risk assessment and recruitment of at-risk subjects into clinical trials aimed at preventing the disease in susceptible individuals.
Currently there are two ongoing clinical trials for prevention in TrialNet. One is the Oral Insulin Trial which tests the ability of insulin taken orally to prevent the disease in subjects with moderate risk of disease. The other is the Anti-CD3 Prevention Trial which tests whether a course of teplizumab therapy can prevent the disease in high risk subjects. Other trials are planned and could be in progress at the receipt date for this FOA. See the TrialNet website for more detailed information: http://www.diabetestrialnet.org/researchers/index.htm.
Identification of subjects at risk for type 1 diabetes requires enormous effort. Currently TrialNet screens nearly 20,000 relatives of people with type 1 diabetes annually to identify those with evidence of autoimmunity. The NIDDK seeks to obtain maximum value from this effort by expanding access to the population screened for mechanistic studies. This FOA provides a means of accessing this unique at risk population as well as support for mechanistic studies in the population of subjects screened and monitored for type 1 diabetes risk in TrialNet. Mechanistic studies can be cross-sectional or longitudinal. Applicants may propose to perform tests on subjects and/or collect samples “on demand” from well-defined at risk populations identified through TrialNet. The FOA would support studies that seek access to participants in the Pathway To Prevention Study or in prevention studies for sample collection or testing. Access to Pathway To Prevention Study participants for mechanistic studies that may require some brief and safe intervention may also be proposed.
Studies funded by this FOA must not interfere with recruitment and participation of subjects in ongoing and approved clinical trials and studies within TrialNet. After the review of applications submitted in response to this FOA and prior to funding, the TrialNet Steering Committee will evaluate projects NIDDK is considering for funding for feasibility and potential impact on ongoing TrialNet studies as described below.
The TrialNet Pathway To Prevention Study screens first and second degree relatives of persons with type 1 diabetes, and collects serum, RNA, plasma, and peripheral blood mononuclear cells (PBMC) every six months from enrolled subjects at risk for disease, and a smaller number of control subjects. It is anticipated that additional specific “on demand” samples could be collected at these regular visits or before and after a brief and safe intervention. A more detailed description of the schedule of assessments in the TrialNet Pathway To Prevention Study and the ongoing and approved TrialNet clinical trials is provided here: (http://www.diabetestrialnet.org).
Exploratory research related to understanding type 1 diabetes pathogenesis in humans is encouraged if the question is significant and the investigators are well qualified. Small exploratory pilot studies to gather information relevant to type 1 diabetes prediction and prevention are encouraged.
This FOA is NOT intended to fund clinical trials to test efficacy of interventions for type 1 diabetes prevention or treatment. Efficacy endpoints include C-peptide preservation or insulin dose, for example. Other funding mechanisms, including TrialNet (http://www.diabetestrialnet.org/researchers/index.htm), are available for the development and implementation of clinical trials with clinical efficacy endpoints. Clinical pilot studies involving safe interventions of short duration, involving a minimal number of subjects, and using mechanistic endpoints, are allowed under this FOA.
This FOA is NOT intended to fund studies using samples currently stored in the TrialNet or NIDDK or any other samples repository. Other funding mechanisms (http://grants.nih.gov/grants/guide/pa-files/PAR-09-247.html, and PAR-11-350) are available for ancillary studies using non-renewable longitudinal stored samples.
Examples of projects include but are not limited to:
New technology for measurement of biomarkers of type 1 diabetes in peripheral blood, including correlates of: disease susceptibility, environmental triggers, autoimmunity, disease progression (including measures of beta cell mass or function);
Evaluation of blood glucose excursions in persons at high risk for type 1 diabetes using continuous glucose monitoring to better understand dysglycemia, especially in its earliest stages and as it progresses to overt clinical symptoms or diagnosis;
Minimally invasive, targeted imaging of pancreatic inflammation or beta cell mass in persons at high and low risk of developing type 1 diabetes, with or without a short course of anti-inflammatory intervention;
Evaluation of vaccine responses in persons with type 1 diabetes risk; including effects of vaccines on metabolic as well as immunological measures;
Evaluation of changes in immune parameters in response to short term treatment with immunomodulatory drugs
Measuring functional correlates of type 1 diabetes risk, assays requiring special collection techniques or specimens not currently collected in TrialNet.
The Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Study.
EDIC (1994-present) is an observational follow-up study of the cohort from the Diabetes Control and Complications Trial (DCCT, 1983-93). The DCCT, established through an Act of Congress, addressed the role of diabetes control, and in particular hyperglycemia, on long-term diabetic complications. 1441 type 1 diabetic individuals age 13–39 years were recruited from 29 clinical centers across the U.S. and Canada. The cohort, consisting of 726 primary prevention subjects with no pre-existing microvascular complications and 715 secondary intervention subjects with mild retinopathy and <200 mg albuminuria/24 h, were randomly assigned to receive either intensive therapy aimed at near normal glycemia or conventional therapy aimed at maintenance of clinical well-being with no specific glucose targets. The objective was to determine whether intensive therapy would reduce the development or progression of retinopathy primarily, and secondarily nephropathy and neuropathy. The randomized phase of the study was terminated in 1993 by the DSMB after a mean follow-up of 6.5 yrs, owing to the overwhelming beneficial effects of intensive diabetes therapy. Compared with the conventional therapy which achieved a median HbA1c level of ∼9%, intensive therapy with at least three insulin injections per day or insulin pump therapy, guided by self-monitored glucose levels, achieved a median HbA1c of ∼7% and reduced the development and progression of early stages of long-term complications by 35–76%.
The relatively young age (mean age of 33 years) and brief duration of diabetes (12 years) of the cohort at DCCT study-end in 1993 precluded exploration of the effects of intensive compared with conventional therapy on the more advanced sequelae of microvascular disease or on cardiovascular disease (CVD). EDIC (1994-present) was launched as an observational follow-up study of the DCCT, using the same methods and annually following 95% of the surviving original cohort representing 1277 participants. Participants are seen in 28 of the original 29 clinical centers (2 in Canada, 26 across the U.S.). Mean age of the participants is currently 52 years.
Overarching goals of EDIC are to 1) determine the long-term effects of the original interventions on advanced complications, including CVD; 2) delineate the modern-day clinical course of diabetic complications including the interactions among complications and co-occurrence of complications; 3) explore the pathophysiologic mechanisms that underlie the development and progression of microvascular, neurologic, and cardiovascular complications, and 4) define the long-term economic impact of intensive therapy.
Annual evaluations include a history and physical examination, ECG, Doppler evaluation of brachial:ankle pressure, a standardized neurologic examination, measurement of A1c and serum creatinine, documentation of hypoglycemia and diabetic ketoacidosis; lipids, albumin excretion/creatinine clearance, dietary assessment, and quality of life are measured every other year. An eye exam measuring visual acuity and including fundus photography is completed every four years. Episodically, a carotid ultrasound is performed.
Other ancillary study procedures and assessments that have been conducted include coronary calcium CT scans, cardiac MRIs, nerve conductions studies, cognitive impairment testing, urologic and sexual function assessment, genetics studies through family/association studies and GWAS, epigenetic studies, measurement of haptoglobin, measurement of skin advanced glycation end-products by fluorescene spectroscopy, cheiroarthropathy assessment, and a survey to study reasons for the long-term high participation rate.
This FOA provides a means of accessing this unique population being followed in DCCT/EDIC. Proposed studies can be cross-sectional or longitudinal (within the time frame of the award).
Applicants may propose to perform tests on subjects and/or collect samples “on demand” at regularly scheduled EDIC study visits.
Studies funded by this FOA must not interfere with recruitment and participation of subjects in ongoing core and ongoing ancillary studies being conducted in the DCCT/EDIC. After the review of applications submitted in response to this FOA and prior to funding, the DCCT/EDIC study group will evaluate projects NIDDK is considering for funding for feasibility and potential impact on the participants and staff of these ongoing studies.
This FOA is NOT intended to fund studies using DCCT/EDIC samples currently stored in the NIDDK or any other samples repository. Other funding mechanisms (http://grants.nih.gov/grants/guide/pa-files/PAR-09-247.html, and PAR-11-350) are available for ancillary studies using non-renewable longitudinal stored samples.
Examples of projects include but are not limited to:
Evaluation of blood glucose variability as an independent risk factor for diabetic complications;
Evaluation of adverse outcomes or predictors of hypoglycemia;
Use of novel technologies to elucidate pathogenesis of complications;
Evaluation of comorbidities such as bone disease and fractures, hearing impairment, or other disorders that may be associated with diabetes in the DCCT/EDIC cohort, and correlates of these measures with DCCT treatment, glycemia, and other demographic, clinical, biochemical, behavioral and environmental factors;
Identification of biomarkers predictive of development of diabetes complications.
In many studies proposing to simply collect samples at centers and utilize the samples in the applicant’s lab, the applicant can remain blinded to subject identity using masking identifiers by the relevant study’s Coordinating Center. However, if subject identity cannot be blinded, or an intervention is planned, a plan for human subjects protection including local IRB review and review by Data and Safety Monitoring Board (DSMB) or Observational Study Monitoring Board (OSMB) may be required (see NIH guidelines for clinical research) (see also below under review criteria). If review by an external board is required, applicants may use the established TrialNet DSMB or DCCT/EDIC OSMB.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; Asian American Native American Pacific Islander-serving institutions; nonprofit organizations with 501(C)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-028.html.
OPPORTUNITIES FOR COLLABORATIVE RESEARCH AT THE NIH CLINICAL CENTER (U01): PAR-13-029
Components of Participating Organizations
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Cancer Institute
National Eye Institute
National Human Genome Research Institute
National Heart, Lung, and Blood Institute
National Institute on Alcohol Abuse and Alcoholism
National Institute of Allergy and Infectious Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Biomedical Imaging and Bioengineering
National Institute on Drug Abuse
National Institute on Deafness and Other Communication Disorders
National Library of Medicine
Office of Dietary Supplements
Office of Research on Women’s Health
Application Receipt/Submission Date(s): March 20, 2013, March 20, 2014, March 20, 2015
The goal of this funding opportunity announcement (FOA) is to support collaborative translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. This opportunity is specifically to promote partnerships between NIH intramural investigators (e.g., those conducting research within the labs and clinics of the NIH) and extramural investigators (e.g., those conducting research in labs and clinics oustide of the NIH). It will provide support for extramural investigators to take advantage of the unique research opportunities available at the NIH Clinical Center by conducting research projects in collaboration with NIH intramural investigators. Details about the unique resources available at the NIH Clinical Center may be found at: http://www.cc.nih.gov/translational-research-resources/resources.html.
While translating basic research into clinical practice is increasingly difficult, time consuming, and expensive, translational research is crucially important in converting basic scientific discoveries into new diagnostics and therapies for patients. As such, this FOA intends to broaden and strengthen translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science. All teams will have at least one intramural and one extramural investigator.
This grant program will provide access for external researchers to the NIH Clinical Center (CC) and will leverage the diverse CC resources, expertise, and infrastructure available to test promising laboratory- and animal-based discoveries with potential implications for disease diagnosis, treatment and prevention. The NIH Clinical Center is a hospital exclusively dedicated to clinical research, thus research is the culture and research studies are routine. Its mission includes the support of clinical studies that are considered intellectually challenging and risky but with the potential of high reward with new breakthroughs in medicine. The special environment of the Clinical Center supports studies that may not be readily supported elsewhere. Examples include:
A host of special resources, such as:
○ A good manufacturing practices (GMP) pharmacy facility for new biological or clinical products,
○ Specialized clinical phenotyping facilities (including a metabolic and other units),
○ The manufacturing and use of newly designed PET ligands for imaging studies,
○ The availability of blood products for special research studies, and
○ A number of other resources
○ Collaborative opportunities on clinical protocols on unique pharmaceutical agents and/or other modes of therapy, or extraordinarily rare diseases with investigators who are known experts (http://clinicalstudies.info.nih.gov/).
○ A robust training curriculum in clinical research.
○ The ability to support long-term clinical studies at minimal cost to patients and their families.
○ On-campus amenities (e.g., Family Lodge and Children’s Inn) to assist patients and families in supportive, home-like environments as they leave their own homes to participate in clinical research. (http://clinicalcenter.nih.gov/familylodge/index.shtml; http://www.childrensinn.org/site/c.kkI1KiMXIvF/b.2001915/k.3871/Welcome_to_The_Childrens_Inn_at_NIH.htm).
For entry to the program, projects must have a collaborating Investigatorin the NIH Intramural Program. As a collaborative partner, the intramural investigator will be actively involved in the planning and execution of the research project.
Applications for this program will be submitted by the extramural institution with the participation of the intramural investigator(s) integrated into the application as described in the Collaboration Plan, and with the budget requirements for the NIH Clinical Center and intramural investigators included in the Budget Component of the application. Funded projects will include an award to the applicant organization which will exclude funds to support the participation of the Clinical Center. Support for intramural participation will be provided by a budget allocation within the NIH. Annual progress reports will be prepared and submitted by the extramural institutions, with the participation and input of the intramural investigator(s) and should include the project findings, publications, impact of the project, a description of what CC unique resources were utilized and any new intramural-extramural partnerships that developed.
Specific Areas of Research Interest
Awards for high quality science demonstrating the potential to result in understanding an important disease process or lead to a new therapeutic intervention will be available in topics relevant to the research interests and priorities of the participating NIH Institutes/Centers, to include:
NEI
The National Eye Institute’s mission is to “conduct and support research, training, health information dissemination, and other programs with respect to blinding eye diseases, visual function, preservation of sight, and the special health problems and requirements of the blind.” www.nei.nih.gov. Specific areas of interest include:
Eye movement recording facility including stimuli presentation, video and eye coil recording equipment, and software to analyze the recordings is available for collaborative research in eye movement research.
Collaborative genetic research through eyeGENE: http://www.nei.nih.gov/resources/eyegene/professionals.asp
Collaborative research using cohorts of children and adults with inherited eye diseases and ocular malformations including but not limited to: uveal coloboma, Stargardt disease/ABCA4 retinopathy, for spinocerebellar ataxia, type 7 (SCA7), albinism, and modeling disease pathogenesis using induced pluripotent (iPS) cells derived from patients: http://www.clinicaltrials.gov/ct2/show/NCT01432847?term=brian+p+brooks&rank=2
Collaboration in ongoing studies with a focus on retinal vascular diseases and uveitis. Examples can be found at: http://clinicalstudies.info.nih.gov/cgi/protinstitute.cgi?NEI.0.html
Collaborative research using cohorts of children with ocular inflammatory disease, including JIA as well as monogenic disorders
Collaboration in evaluating African Americans with ocular inflammatory disease with a particular emphasis on Sarcoidosis. In addition, studying the role of the immune system in African American patients with AMD
Collaboration with those interested in investigating autoimmune retinopathy, the underlying pathophysiology and treatment.
Evaluating patients with ocular toxoplasmosis
NCI
The National Cancer Institute (NCI) invites applications in research areas relevant to the Institute’s mission, which is to provide global leadership for research, training, health information dissemination, and other programs with respect to the cause, prevention, diagnosis, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients. The NCI encourages bedside-to-bench research (www.cc.nih.gov/ccc/btb/) to: increase understanding of the molecular and physiological basis of health and disease; stimulate clinical discoveries about the mechanisms underlying disease to develop improved prevention, diagnosis, and treatment; enable the translation of basic discoveries into clinical practice for the benefit of personal and public health; foster training and mentoring of emerging scientists and physicians; and communicate research advances to the public. The NCI Vision and Priorities are found at cancer.gov.
NHGRI
The National Human Genome Research Institute research areas of interest include: biochemical genetics, vesicular trafficking defects, pigment defects, storage diseases, holoprosencephaly, and autoinflammatory diseases. More detail may be found in the NHGRI website, at: http://www.nhgri.nih.gov
NHLBI
The National Heart, Lung, and Blood Institute (NHLBI) invites applications in research areas relevant to the Institute’s mission, which is to provide global leadership for a research, training, and education program to prevent and treat heart, lung, blood, and sleep disorders and diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI encourages basic research to increase understanding of the molecular and physiological basis of health and disease; stimulates clinical discoveries about the mechanisms underlying disease to develop improved prevention, diagnosis, and treatment; enables the translation of basic discoveries into clinical practice for the benefit of personal and public health; fosters training and mentoring of emerging scientists and physicians; and communicates research advances to the public. Specific research interests of the Institute are identified in the NHLBI Strategic Plan (http://www.nhlbi.nih.gov/about/strategicplan/index.htm).
NIAAA
NIAAA invites translational, collaborative research projects aimed at reducing alcohol related problems in a wide range of scientific areas including genetics; neuroscience; epidemiology; health risks and benefits from alcohol consumption on prevention and treatment. Of particular interest are studies which increase the understanding of normal and abnormal biological functions and behavior relating to alcohol use as well as improving the diagnosis, prevention and pharmacological treatment of alcohol use disorders across the lifespan.
NIAID
The mission of the National Institute of Allergy and Infectious Diseases (NIAID) is to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. To accomplish its mission, NIAID conducts and supports a comprehensive portfolio of research on the biology, pathogenesis, and host response to microbes; the mechanisms of normal immune function and immune dysfunction resulting in autoimmunity, immunodeficiency, allergy, and transplant rejection; and translational research to develop vaccines, therapeutics, and diagnostics to prevent and treat the many infectious, immune-mediated, and allergic diseases that afflict people throughout the world. Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID http://www3.niaid.nih.gov/about/whoWeAre/planningPriorities/.)
NIAMS
The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. Areas of particular interest to the NIAMS intramural clinical program which would enhance the use of Clinical Center resources include studies on the genetics, genomics, prevention, and treatment of immune deficiencies associated with inflammation, systemic lupus erythematosus, inflammatory muscle disease, genetic autoinflammatory diseases, osteoporosis, ankylosing spondylitis and spondyloarthropathies, and the development and use of stem cells in therapy.
NIBIB
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) seeks to improve human health through the development and acceleration of applications of biomedical technologies. The Institute is committed to integrating engineering and physical sciences with the life sciences to advance basic research and medical care. The NIBIB Intramural Research Program plays a key role in fulfilling the Institute’s mission, particularly to advance knowledge in imaging and bioengineering research using a combination of basic, translational, and clinical science and to develop effective training programs in related fields. Advanced imaging resources at the NIH Clinical Center available for investigators include high field MR imaging, MRI/PET, advanced cardiovascular CT/ MRI/ PET capability, and interventional oncology capabilities. Multiple cyclotrons are on-site, and advanced radiotracer synthesis is available for application in oncology, neurological, cardiovascular, and infectious disease research. Image processing services are available for 3D analysis and processing, as well as transfer/ storage of large scale image data. More information about research conducted by NIBIB intramural investigators can be found at http://www.nibib.nih.gov/Research/Intramural.
NICHD
The Eunice Kennedy Shriver National Institute of Child Health and Human Development invites research project grant applications in research areas relevant to the institute’s scientific objectives. The general mission of NICHD is to ensure that every person is born healthy and wanted, that women suffer no harmful effects from reproductive processes, and that all children have the chance to achieve their full potential for healthy and productive lives. In pursuit of these goals, NICHD supports a broad spectrum of research on normal and abnormal human development, including contraception, fertilization, pregnancy, childbirth, prenatal and postnatal development, and childhood development through adolescence. The mission areas also include research on intellectual and developmental disabilities and rehabilitation medicine. More detailed information can be found at: http://www.nichd.nih.gov/research/org/supported_by.cfm.
NIDCD
NIDCD seeks to conduct and support biomedical and behavioral research and research training in the normal and disordered processes of hearing, balance, taste, smell, voice, speech, and language. The faculty and research interests of the NIDCD intramural research program can be found at http://www.nidcd.nih.gov/research/faculty/pages/alpha.aspx. The intramural program uses a variety of tools of molecular and cellular biology, genetics, development, physiology, neuroimaging and systems biology to understand normal and disordered processes. The research areas of focus for intramural/extramural collaborations under this FOA include hearing, balance, taste, voice, speech and language.
NIDA
The National Institute on Drug Abuse is interested in collaborative translational projects addressing programmatic priorities of the Institute. NIDA’s mission is to lead the Nation in bringing the power of science to bear on drug abuse and addiction. To achieve this mission, NIDA encourages researchers to build strategic alliances, including those with the NIH Clinical Center that will increase the pace at which translational research findings can become clinical applications that improve community and population health. The research areas of focus for this FOA include neuroscience, human genetics, imaging, medication development, the comorbidity of HIV and substance use, and the intersection of pain, analgesia and addiction.
NLM
For this initiative, the National Library of Medicine is interested in projects relating to enhancement or use of electronic health records.
ORWH
Office of Research on Women’s Health (ORWH) is responsible for fostering and facilitating research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) through the Trans-NIH ME/CFS Working Group (WG). One of the goals of the WG is to increase focus on collaborative ME/CFS research by identifying NIH resources that may be useful to advance the translational research within this field. ORWH encourages applications from investigators to address research questions focused on the etiology, diagnosis, underlying mechanism, or treatment of ME/CFS.
For more complete listing of resources in these areas at the NIH Clinical Center and for assistance in identifying intramural scientists for possible collaboration, please refer to the web-based listing of resources at, http://clinicalcenter.nih.gov/translational-research-resources/index.html.
IMPORTANT: Applicants are strongly encouraged to consult with the Scientific/Research Contacts for the area of science for which they are planning to develop an application. Early contact provides an opportunity for Institute or Center staff to discuss the program scope and goals, and to provide information and guidance. Other aspects of an application that are unique to this program including collaboration with Intramural Investigators may also be discussed.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; Asian American Native American Pacific Islander-serving institutions; nonprofit organizations with 501(C)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This program requires the full collaboration of the (extramural) PD/PI of the applicant institution and the intramural investigator. Accordingly, the Multiple PD/PI model is strongly encouraged but not required. For those applicants opting not to use the Multiple PD/PI model, the intramural investigator can hold any role other than the PD/PI role.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-029.html.
EXCEPTIONAL UNCONVENTIONAL RESEARCH ENABLING KNOWLEDGE ACCELERATION (EUREKA) FOR NEUROSCIENCE AND DISORDERS OF THE NERVOUS SYSTEM (R01): RFA-NS-13-007
Components of Participating Organizations
National Institute of Neurological Disorders and Stroke
National Institute on Aging
National Institute on Drug Abuse
National Institute of Mental Health
Application Receipt Date(s): March 21, 2013
The purpose of the EUREKA (Exceptional Unconventional Research Enabling Knowledge Acceleration) initiative is to foster exceptionally innovative research that, if successful, will have an unusually high impact on the areas of science that are germane to the mission of one or more of the participating NIH Institutes. EUREKA is for new projects, not for continuation of existing projects, and is not intended for support of pilot projects, i.e., projects of limited scope that are designed primarily to generate data that will enable the PD/PI to seek other funding opportunities. Rather, it is anticipated that EUREKA projects will begin and be completed during the funding period.
Before submitting an application, it is extremely important to verify that the proposed research is of interest to at least one of the NIH Institutes that is participating in this FOA, since applications that are not germane to the mission of one or more of the participating Institutes will not be reviewed.
The participating Institutes for this FOA are listed in Part 1. Prior to preparing an application, applicants should read the following paragraphs describing the participating Institutes’ missions and goals for this initiative, and consult the appropriate Institute website (listed with each Institute’s name at the beginning of this announcement) for details of research areas supported by that Institute. Applicants are encouraged to contact the appropriate Institute representative listed below in Section VII to ensure that the proposed research will be responsive to this FOA. As indicated in the application instructions (Section IV, below) applicants are strongly advised to include a cover letter indicating the appropriate Institute.
NINDS: The mission of the NINDS is to reduce the burden of neurological disease. In pursuit of this goal, NINDS supports research on the normal and diseased nervous system, including basic cellular/molecular biology and genetics, cognitive/behavioral and systems neuroscience, neuroplasticity, neurodevelopment, neurodegeneration, neurovascular, and studies aimed at detection, prevention, and treatment of neurological diseases. For more information on NINDS research funding listed by Program Area (including Program staff contact listings), see http://www.ninds.nih.gov/funding/areas/index.htm. Applicants are encouraged to contact Program staff associated with a given area of research to determine relevance of a particular application.
NIMH: The NIMH mission is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure (http://www.nimh.nih.gov). To fulfill its mission, the Institute conducts research on mental disorders and the underlying basic science of brain and behavior. NIMH welcomes EUREKA applications for all program areas supported by the Institute. Applicants should focus on one of the following NIMH Strategic Objectives:
Strategic Objective 1: Promote Discovery in the Brain and Behavioral Sciences to Fuel Research on the Causes of Mental Disorders
Strategic Objective 2: Chart Mental Illness Trajectories to Determine When, Where, and How to Intervene
Strategic Objective 3: Develop New and Better Interventions for Mental Disorders that Incorporate the Diverse Needs and Circumstances of People with Mental Illness
Strategic Objective 4: Strengthen the Public Health Impact of NIMH-Supported Research
Applicants are encouraged to contact Program staff associated with a given area of research to determine relevance of a particular application to NIMH.
NIDA: NIDA’s mission is to lead the nation in bringing the power of science to bear on understanding, preventing and treating drug abuse and addiction. NIDA is interested in fostering technologically innovative and conceptually creative research that advances our understanding of the genetic and environmental antecedents, the behavioral and physiological consequences, and the neurobiological mechanisms of drug abuse and addiction, and in novel prevention and treatment research. For the EUREKA program, NIDA is interested in supporting high-risk/high-impact innovative research that encompasses the areas aligned with NIDA’s programs, priorities, and strategic plan (see http://www.nida.nih.gov/StrategicPlan/Index.html and http://www.nida.nih.gov/about/organization/Organization.html). Of particular interest are applications in (1) basic and clinical neuroscience (2) drug discovery for medications development and (3) genetics research involving genetic model systems or human genetics (see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-012.html). Applicants are strongly encouraged to contact NIDA staff to discuss feasibility of their proposed research and relevance to NIDA’s mission.
NIA: Research supported by the Division of Neuroscience (DN), NIA is intended to address in a systematic way the study of all aspects of the aging brain, the outcome of which should improve our understanding of the aging nervous system with the goal to maintain health and improve the quality of life of the older population. Three branches constitute the Division’s extramural research program namely, Neurobiology of Aging, Behavioral and Systems Neuroscience, and Dementias of Aging. DN supports research on all aspects of Alzheimer’s disease (AD) and on a broad spectrum of research aimed at elucidating how the central nervous system and behavior are affected by normal as well as pathological aging. An emerging focus is how the processes of aging and age-related cognitive decline intersect with the development of AD and other dementias of aging as well as a focus on the etiology, diagnosis, and treatment of AD and other dementias. For more information on NIA research funding by Program Area, see http://www.nia.nih.gov/research/dn/research-areas. Applicants are encouraged to contact program staff associated with a given area of research to determine relevance of a particular application.
The EUREKA Program
To encourage exceptionally innovative research, this FOA solicits applications from investigators who want to test novel, unconventional hypotheses or pursue major methodological or technical challenges. The potential impact of the proposed research must be substantial, in terms of both the size of the scientific community affected and the magnitude of its impact on that community. The investigator should anticipate starting and completing the project during the term of the award, since this FOA is not for support of ongoing research or for pilot projects, and awards are not renewable. If it is the hypothesis that is novel, the investigator should be able to prove or disprove that hypothesis by the end of the funding period. If it is the methodology or technology that is exceptionally innovative, the investigator should be able to develop it by the end of the funding period or demonstrate conclusively that the approach is not feasible.
The rationale for EUREKA is that for science to move forward in leaps rather than in incremental steps, investigators must have opportunities to test unconventional, potentially paradigm-shifting hypotheses, and to attempt to use novel, innovative approaches to solve difficult technical and conceptual problems that severely impede progress in a field. However, applications proposing such research are difficult to evaluate in comparison to more typical investigator-initiated R01 research grant applications, in which the emphasis tends to be more on the feasibility of the proposed research than on its novelty.
Several key features of the EUREKA FOA have been designed to emphasize to applicants and peer reviewers that these applications are very different from conventional, investigator-initiated R01s. The application format, through its page limitations and requirements for explicitly addressing specific issues, focuses attention on the importance of the problem, the novelty of the hypothesis and/or the proposed methodology, and the magnitude of the potential impact rather than on experimental details. Reviewers will be instructed to emphasize significance and innovation in their evaluations, and these criteria will be the primary basis for funding decisions. Although reviewers will be asked to assess the logic of the experimental plan to determine whether the project has some (non-zero) likelihood of success, they will be reminded that risk is a hallmark of exceptionally innovative research and, in most cases, should not detract from the merit of an application. A PD/PI’s record of overcoming difficult scientific hurdles, appropriate to his/her career stage, may also be useful in assessing the likelihood of success, although the focus of this initiative is on the project rather than the investigator. These features are intended to steer applicants and reviewers, at each step of the process, toward the goals of the EUREKA initiative, which are to solicit and fund unusually bold and potentially transformative research.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; Asian American Native American Pacific Islander-serving institutions; nonprofit organizations with 501(C)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCRregistration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Complete details available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-13-007.html.
ERYTHROPOIESIS: COMPONENTS AND MECHANISMS (R01): PA-13-034
Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases
National Heart, Lung, and Blood Institute
Application Receipt/Submission Date(s): Multiple dates, see announcement.
Erythroid cells comprise a fairly well-established model system that has been used to understand molecular genetics, biochemistry, structural membrane biology, cell physiology and gene expression. Given the fact that erythroid cell suspensions are easy to obtain and that there are relatively few genes expressed during the latter stages of erythropoiesis, these cells provide a model system with which to characterize exactly how the genetic program specifies the formation of a particular cell type. In addition, the sheer number of erythroid cells available for harvest from a single individual makes it an ideal system to study. Finally, the precursor cells are available through bone marrow biopsy and cell purification schemes for particular stages of the erythroid lineages have been developed for human, rabbit, goat, mouse and most other mammalian species.
The declining number of expressed sequences during erythropoiesis facilitates studies to measure basic molecular biological processes, to develop mathematical models for quantitating the dynamic process of cell differentiation, to identify genes necessary for the successful formation of a mature red blood cell and to apply these principles to eukaryotic cells, in general. In the latter stages of erythropoiesis before nuclear extrusion, 90% of the mRNA transcription results in translation products necessary for hemoglobin production. These studies have led the way for a generalized understanding of the transcription process itself. In addition, the fact that each red blood cell must squeeze itself through a narrow capillary allows quantitation of biophysical parameters to be made.
The frequency with which red blood cell-related diseases affect humans is a public health issue and thus, is another focus of this program. Samples, easily obtained from patients, allow performance of multiple tests to monitor disease and to develop new therapies for treatment. Understanding the pathophysiology of diseases such as, sickle cell anemia, thalassemia and other hemoglobinopathies, as well as, Diamond-Blackfan anemia and other anemias may lead to the development of novel therapeutics. In addition, this model system provides a useful teaching and education tool.
The ultimate goals of this Funding Opportunity Announcement (FOA) will be to assemble a collection of genes expressed during erythroid development and differentiation, describe how they are expressed and where, including subcellular localization of the proteins translated during erythropoiesis. This collection and tangible reagents may be used to discover the structure-function relationships that exist in erythroid cells from normal and diseased states with possible application to other cell types.
Appropriate topics include, but are not limited to:
Development of molecular genetic descriptions of erythroid cells at various stages of development (i.e., embryonic, fetal liver and adult stages) and differentiation (i.e., committed CFU-E, pronormoblast, orthochromatophilic erythroblast, polychromatophilic erythroblast, and reticulocyte stages and red blood cells). Such global descriptions are needed as standards for the entire scientific community. This includes a determination of which sets of genes are expressed at the various stages of erythropoiesis and their function in the red blood cell lineages.
“Data mining” of these above mentioned descriptions to discover functionally important biological themes, including networks involved in commitment of hematopoietic stem cells to definitive lineages.
Generation of gene expression profiles that are standardized by use of a common set of microarrays, possibly from single cells. In addition, expression profiles need to be developed in cells with specific gene knockouts or knockdowns. Functional characterization of proteins affected in red blood cell disorders (e.g., subcellular localization, response to stress, binding partners in protein complexes, structure/function studies).
Generation of proteomic profiles. Some proteins may be present, but not active because of post-translational modification. Included in this may be: 1) an analysis of the sub-cellular localization of proteins in the erythroid proteome, 2) a protein-protein interaction map of the erythroid proteome, and 3) a comprehensive phenotypic map of loss-of-function of genes encoding the erythroid proteome. Results could be stored as maps, made widely available on the Internet.
Application of molecular knowledge to human diseases. Among inherited disorders of the red blood cell, sickle cell anemia and the thalassemias are the most prevalent worldwide. While the molecular bases of these diseases are known, more is needed to learn about the contribution of other genes to the clinical course of these illnesses and their overall severity. Experiments designed to reveal mechanisms regarding RNA processing, metabolism, and ribosome function with regards to red blood cell related bone marrow disorders.
Development of computational biologic programs capable of integrating data from all levels of biology, namely DNA, mRNA, protein-protein interactions and others. The goal is to develop mathematical models and graphical displays of the red blood cell.
Comparisons of genomes or sections of genomes that reveal highly conserved motifs in erythroid cell development and differentiation.
Age-related changes in surface receptor number and function of erythroid precursors (e.g., EPOR); age-related changes in gene expression and/or signaling pathways that regulate erythropoiesis; molecular mechanisms by which these changes interact with other age-associated physiological processes (e.g., mild persistent cytokinemia; decreased androgen production; decline in GFR) in development of geriatric syndromes such as unexplained anemia and frailty.
It is expected that research tools developed will be made readily available to the rest of the scientific community, such as animal models for inherited bone marrow failure syndromes, ribosomopathies, etc.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; Asian American Native American Pacific Islander-serving institutions; nonprofit organizations with 501(C)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PA-13-034.html.
NEI RESEARCH GRANT FOR SECONDARY ANALYSIS (R21): PAR-13-035
Components of Participating Organizations
National Eye Institute
Application Receipt/Submission Date(s): Multiple dates, see announcement.
The NEI supports an extensive portfolio of clinical trials and large-scale epidemiologic research projects, wherein numerous data collection activities are required to meet each project’s specific aims. The resultant wealth of data generated by these studies often provides unique, cost-effective opportunities to pursue new questions. This initiative may be used to develop new statistical methodologies or to test new hypotheses using existing data. While this initiative actively encourages the use of existing database resources to conduct exploratory/developmental research secondary to a project’s originally-intended purpose, it will not support the collection of new data. Datasets are not limited to those collected under NEI support but these data are of the highest programmatic interest. Applicants should consider the relevance of their proposed analyses to NEI programs and priorities as described in the National Plan for Eye and Vision Research, which is available at http://www.nei.nih.gov.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; Asian American Native American Pacific Islander-serving institutions; nonprofit organizations with 501(C)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education); small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-035.html.
UTILIZING THE PLCO BIOSPECIMENS RESOURCE TO BRIDGE GAPS IN CANCER ETIOLOGY AND EARLY DETECTION RESEARCH (U01): PAR-13-036
Components of Participating Organizations
National Cancer Institute
Application Receipt/Submission Date(s): February 20, 2013; June 20, 2013; February 20, 2014; June 20, 2014; February 20, 2015; June 19, 2015
This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), encourages the submission of grant applications that propose to advance research in cancer etiology and early detection biomarkers, utilizing the advantages of the unique biorepository resources of the NCI-sponsored Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial. The PLCO Biorepository offers high-quality, prospectively collected, serial pre-diagnostic blood samples from participants in the PLCO-screened arm, and a one-time collection of buccal cells from participants in the control arm. Tissue microarrays of formalin-fixed, paraffin-embedded (FFPE) tumor tissues are also available for a subset of the cases for selected cancers. This FOA supports a wide range of research including biochemical and genetic analyses of cancer risk, as well as discovery and validation of early detection biomarkers. The proposed research project must involve use of PLCO biospecimens; additionally, it should also take advantage of the unique characteristics of the PLCO biospecimens. Research projects that do not involve the use of PLCO biospecimens will not be supported under this FOA.
The PLCO, which was a randomized controlled cancer screening trial involving 155,000 participants from across the United States, was conducted to evaluate the effectiveness in reducing cancer-specific mortality of four screening programs: digital rectal examination and prostate specific antigen for prostate cancer; chest X-ray for lung cancer; flexible sigmoidoscopy for colorectal cancer; and the tumor marker CA125 in combination with transvaginal ultrasound for ovarian cancer. The main phase of the trial concluded in May 2012, and mortality outcomes have been published. PLCO participants are still being followed using a streamlined centralized approach in order to collect valuable data on cancer in the aging population. Information on trial design, screening protocols, publications, available types and numbers of biospecimens and associated data can be found on the PLCO website at http://www.plcostars.com.
The PLCO Biorepository offers high quality, pre-diagnostic, serial blood samples (serum/plasma/DNA/red cells/cryo-preserved whole blood) ideal for investigation of the causes and the natural history of various cancers, and for pivotal validation of promising blood-based early detection biomarkers. The PLCO Biorepository has supported a wide range of research in cancer etiology and early detection. To date, 118 research projects using the PLCO biospecimens have been initiated, resulting in over 150 research publications. More information about on-going research projects and publications can be found on the PLCO website at www.plcostars.com.
The purpose of this FOA is to stimulate areas of cancer research that require prospectively collected pre-diagnostic blood specimens available from the PLCO Biorepository. The proposed research project should not only involve use of PLCO biospecimens and data, but take advantage of their unique characteristics, in large part by focusing on research questions that cannot be adequately addressed by using clinical samples (samples collected following a diagnosis). In some cases, it may be necessary to include specimens from other sources in order to carry out the proposed research. In that case, the investigator should obtain approval from the other source to access the specimens and provide evidence of the approval.
Research projects that do not involve the use of PLCO biospecimens will not be supported under this FOA.
Some characteristics of the PLCO specimens and data include:
Pre-diagnostic serum/plasma/lymphocyte DNA samples collected months to years before cancer diagnosis;
Serial blood samples (which may include serum, plasma, and/or lymphocyte DNA) collected over a period of time up to 6 years;
Detailed demographic, dietary, lifestyle, and clinical data (all cancer incidence and all cause mortality);
Average-risk population;
Tissue microarrays of FFPE tumor samples available for a subset of cases for breast, prostate, colorectal, lung, and ovarian cancers, with matching blood or DNA samples from the same person; and
Genotype data from Genome Wide Association Studies (GWAS) available on a subset of prostate, lung, bladder, pancreatic, and kidney cancers.
Detailed information about the PLCO Biorepository, including sample availability, can be found on the PLCO website at www.plcostars.com. Given that any research project proposed in response to this FOA will be based on the use of PLCO specimens, interested investigators and applicants should first identify appropriate biospecimens and data by submitting a Preliminary Application Form on the PLCO website at www.plcostars.com. Instructions on how to submit the Preliminary Application Form will be provided on the same website. The PLCO staff will check if the needed biospecimens and data are available and the research can be done using the PLCO biospecimens. The applicant will be provided with a letter confirming the availability of the biospecimens and data within a short period of time. The applicant must include this letter in the grant application. If biospecimens from other resources are to be used, the investigator should provide a letter of approval from the other resource for accessing the required specimens.
Specific research areas of interest include, but are not limited to, the following:
Identifying biomarkers of various environmental, biochemical, and genetic risk factors of cancer;
Pivotal validation of early detection blood biomarkers in pre-diagnostic samples;
Developing early detection and/or risk prediction models based on longitudinal patterns of the biomarkers;
Identifying blood biomarkers that correlate with clinical behavior of the tumors, especially those that differentiate between aggressive and indolent cancers;
Correlating blood biomarkers to tissue biomarkers, histological and molecular subtypes, and clinical behaviors; and
Biomarker discovery in pre-diagnostic samples using high through-put, proven technologies.
Eligible institutions and organizations include: public or state controlled institutions of higher education; private institutions of higher education; Hispanic-serving institutions; Historically Black Colleges and Universities; Tribally Controlled Colleges and Universities; Alaska native- and native Hawaiian- serving institutions; Asian American Native American Pacific Islander-serving institutions; nonprofit organizations with 501(C)(3) IRS status (other than institutions of higher education); nonprofit organizations without 501(c)(3) IRS status (other than institutions of higher education; small businesses; for-profit organizations (other than small businesses); state governments; county governments; city or township governments; special district governments; Indian/Native American tribal governments (federally recognized); Indian/Native American tribal governments (other than federally recognized); eligible agencies of the Federal Government; U.S. territories or possessions; Independent School Districts; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); faith-based or community-based organizations, and regional organizations. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
Grants.gov
eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.
Complete details available at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-036.html.