Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Cancer Institute (NCI) National Heart, Lung, and Blood Institute (NHLBI) (No Longer Participating per NOT-OD-14-033) National Human Genome Research Institute (NHGRI) National Institute on Aging (NIA) National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Biomedical Imaging and Bioengineering (NIBIB) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Deafness and Other Communication Disorders (NIDCD) National Institute on Dental and Craniofacial Research (NIDCR) National Institute on Drug Abuse (NIDA) National Institute of Environmental Health Sciences (NIEHS) National Institute of Mental Health (NIMH) National Institute of Neurological Disorders and Stroke (NINDS) National Institute of Nursing Research (NINR) National Center for Complementary and Integrative Health (NCCIH formerly NCCAM) Office of Behavioral and Social Sciences Research (OBSSR)
Funding Opportunity Title	Research on Ethical Issues in Biomedical, Social, and Behavioral Research (R21)
Activity Code	R21 Exploratory/Developmental Research Grant Award
Announcement Type	Reissue of PA-06-368
Related Notices	June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. December 13, 2013 - See Notice NOT-OD-14-033. Notice of Extension of Expiration date & the removal of NHLBI's participation. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
Funding Opportunity Announcement (FOA) Number	PA-11-182
Companion FOA	PA-11-180 R01 Research Project Grant PA-11-181 R03 Small Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.395, 93.837, 93.838, 93.172, 93.866, 93.273, 93.855, 93.856, 93.286, 93.865, 93.173, 93.121, 93.279, 93.113, 93.242, 93.853, 93.361, 93.213
FOA Purpose	The purpose of this funding opportunity announcement (FOA) is to support investigator-initiated Exploratory/Developmental Research Grant Award (R21) applications that propose to study high priority bioethical challenges and issues associated with the types of biomedical, social, and behavioral research supported by the participating NIH Institutes/Centers. The Office of Behavioral and Social Sciences Research (OBSSR) joins this FOA as part of its efforts to promote research on the behavioral and social aspects of health and illness. However, only participating ICs will provide direct grant support under this FOA.

Posted Date	March 24, 2011
Open Date (Earliest Submission Date)	May 16, 2011
Letter of Intent Due Date	Not applicable
Application Due Date(s)	Standard dates apply , by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Standard dates apply by 5:00 PM local time of applicant organization.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	Standard dates apply
Expiration Date	(Extended to May 8, 2015 per NOT-OD-14-033), Originally May 8, 2014
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Background:

This program announcement and two related announcements (R01, PA-11-180; R03, PA-11-181) comprise the fourth set in a series of consecutive FOAs published by NIH since 1999 to encourage research on ethical issues related to the conduct of biomedical, social and behavioral research within the NIH mission. The prior FOA’s in this series focused specifically on ethical issues related to the conduct of human subjects research. This set of announcements broadens that focus to include ethical issues related to new and emerging biomedical technologies.

With continuing advances in biomedical, social, and behavioral sciences and technologies and the diversification and expansion of research settings and subjects, researchers face evolving bioethical challenges related to the conduct of research, the management of related data and information, and the application of findings. For example, the NIH has a vested interest in promoting research at the cutting edge of science and technology which has potential benefits, yet risks may be unknown and ethical guidance may be lacking. Research is needed to anticipate the evolution of bioethical issues, to ensure NIH supported research is conducted in the most ethical manner possible, and to inform policy discussions that may emerge from NIH-supported research.

The NIH is in the process of developing an agency-wide strategic plan for bioethics research and training which will be used to formulate future funding opportunity announcements and guide investments over the next five to ten years. As part of the planning process, NIH is assessing priority areas for the support of bioethics research. Future issuances of this FOA may include changes to reflect the outcomes of this assessment.

Research Objectives:

This FOA seeks applications for research projects that propose to analyze and address ethical challenges and issues related to the conduct and output of biomedical, clinical, social and behavioral research within the NIH mission. The results of projects funded under this program announcement should enhance the ethical conduct and social value of research within the NIH mission, optimize the protection of human research participants, ensure research burdens and benefits are equitably distributed across populations, and contribute to policy development regarding the implementation and oversight of new research discoveries and methods.

Proposals to conduct empirical research as well as those that propose to develop new theoretical and conceptual ethical frameworks will be considered. Interdisciplinary and collaborative projects utilizing multiple approaches are strongly encouraged.

Areas of Interest:

Applications should address bioethical challenges and ethical issues relevant to the research mission area(s) of the participating NIH Institutes and Centers (ICs). The participating ICs have identified specific bioethics topics below as the highest priority for consideration. These are organized into seven categories: 1) ethical considerations of new and emerging technologies; 2) research study design issues; 3) issues associated with therapeutic misconception and the interface between treatment and research; 4) research involving vulnerable populations and urgent situations; 5) research with existing specimens, data, and health information; 6) dissemination and translation of research findings; and 7) oversight of research. In addition, a description of the research mission areas of the participating ICs is also provided below. Applications that address other bioethical issues directly related to these mission areas will also be considered.

Please note, NINDS will not accept R21 applications for this FOA that include clinical trials or other clinical studies of potential therapies. NINDS places a high priority on the development and evaluation of such clinical interventions and has established specific mechanisms for supporting these types of applications. R21 applications that involve human subjects may be submitted to NINDS if the applications do not include any clinical interventions AND if safety monitoring of study participants can be performed appropriately within the budgetary and time constraints of an R21.

1) Ethical Considerations of New and Emerging Biomedical Technologies

NHGRI; NIA; NIBIB:

• Recent advances in genomics, biotechnology and biomedical science (e.g. tissue engineering, nanomedicine, and synthetic biology) including but not limited to dual use research, privacy, safety, equitable distribution of benefits and benefits versus potential risks, intellectual property, commercialization and conflict of interest;
• Current oversight and regulatory structures to address ethical, legal and social issues related to new and emerging genomic and other biomedical technologies, including identification of oversight gaps and/or the need for revised or new oversight approaches.

NIAAA:

• The use of biotechnology to track compliance with enforced treatment programs (e.g., drug testing, SCRAM).

NIDA; NIMH; NCCAM:

• Potential ethical issues in mental health and drug abuse research associated with new and/or evolving scientific areas (e.g., personalized medicine, biomarkers) and technologies (e.g., internet delivered therapies, automated assessment strategies.)

2) Research Study Design Issues (including community engagement; equity in selecting and recruiting study populations; general informed consent issues)

NCI:

• Evaluation and/or mitigation strategies for ethical challenges in cancer genome studies.

NCI; NIA; NIDA; NINDS:

• Novel approaches to informed consent;
• Approaches to the assessment of research participants' comprehension;
• Ethical challenges in conducting population-based research including community and privacy issues.

NHGRI:

• Evaluate the effectiveness and appropriateness of existing research policies and guidelines for the conduct of genomic studies;
• Examine issues surrounding genomics research, such as how researchers can recruit a fair representation from all groups of society;
• How to explain to potential participants current genomics study designs that raise complex ethical dilemmas and require the development and implementation of multifaceted research protocols, including data sharing;
• Obligations to biological or social family members when deceased individuals are involved in genomic research.

NIA:

• Barriers and solutions to ensuring adequate inclusion of older subjects in clinical research studies and clinical trials;
• Consenting issues for potential participants who may have experienced elder mistreatment and whether legal requirements for reporting such abuse may impact research participation.

NIA; NICHD; NIDA; NINDS:

• Stakeholder’s views on research protocols, access, study design, and dissemination of results related to developmental disorders and neurodegenerative (e.g., autism spectrum disorders, idiopathic mental retardation, muscular dystrophy, language disorders, fragile X, etc.);
• How research risks differ among individuals, parents, or families with different characteristics and expectations about research.

NIAAA; NIDA:

• The use of Certificates of Confidentiality in research.

NIAID; NINDS; NCCAM: Research on healthy control study participants such as:

• Parameters that influence the demographics of healthy controls (especially for inpatient studies) and group over- or under-representation;
• the influence of study design on the decision to participate in research, e.g., study purpose, duration, frequency of protocol interventions, risks, invasiveness;
• the influence of the demographics and overall health status of healthy control participants on study findings;
• the relationship of compensation to undue influence, especially for disadvantaged populations.

NIEHS:

• Community level review in community based participatory research ;
• Ethical considerations in the selection of appropriate control group for studies of common environmental exposures;
• Appropriate guidance to study participants about exposure assessments and timely, appropriate referrals (for biomonitoring and/or remediation in homes and environments).

NIMH:

• Strategies for identifying and evaluating effective approaches to ensuring adequate consent and implementing appropriate safeguards for post-marketing (Phase 4) studies of psychoactive medications, where short and long-term side effects may not have been elucidated; and for identifying such effects, conducting ongoing monitoring, and assuring that such new information is provided to new, current, and/or previous mental health study subjects;
• Potential ethical issues in unique research platforms (e.g., practice networks, community based approaches) or designs (e.g., adaptive treatment strategies) and strategies to address them.

NCCAM:

• The potential use of placebos as a treatment approach; selection of appropriate control groups for placebo/sham interventions; potential confidentiality / privacy concerns surrounding patient/practitioner interactions;
• Ethical implications of deception, manipulation of expectancy when using placebos.

3) Therapeutic Misconception and Interface of Treatment and Research (including overlap of clinical and research data; providing clinical care in the context of research).

NHLBI; NCCAM:

• Potential conflicts of commitment when the roles of health care provider and investigator overlap.

NHGRI:

• Potential conflicts of interest when the roles of health care provider and investigator overlap, particularly in pharmacogenetics and pharmacogenomics and rural research networks.

NIA:

• Decision making processes of participants and/or proxies for participating in studies and treatment trials for dementia, especially for those at risk or positive for a potential biomarker but not yet symptomatic;
• What side effect profiles asymptomatic subjects are willing to accept in potential therapeutic agents for treating dementia; how does this change if subjects are at increased risk (e.g., positive for disease biomarkers).

NIAAA; NIDA; NINDS; NCCAM:

• Trends blurring the distinction between clinical practice and research, as associated with therapeutic misconception and misconceptions about the use of patients data in clinical research.

NIAID; NIBIB; NIDA; NINDS; NINR:

• The interface of research and clinical care, such as the provision of medical care in the context of research, post-trial and ancillary care, arrangements for coverage of research related injury, research with rare diseases, research with individuals with life-limiting illness, and/or research associated with public health emergencies.

4) Research that involves vulnerable populations (including research in developing countries; disadvantaged and underserved populations; populations with unique challenges to health and well-being), or research in urgent situations (such as emergency research, research during public health emergencies).

NCI:

• Understanding the determination of risks and harms for children in early phase cancer clinical trials;
• Strategies to successfully promote the ethical inclusion of minorities and special populations in clinical cancer research;
• The design and conduct of international cancer clinical trials and/or development of strategies to mitigate or eliminate associated ethical challenges.

NHLBI:

• The participation of children and women in clinical research, especially high risk research involving gene therapy and stem cells;
• Interventional research in low and middle income countries, including but not limited to cultural differences in research value and perception,

NHLBI; NINDS:

• Surrogate or waiver of consent in emergent situations when potential participants cannot consent (e.g., ambulance, emergency departments, intensive care settings);
• Models for community consultation/public disclosure of studies that will invoke an Emergency Medical Research consent waiver.

NHGRI:

• How researchers can best assure adequate recruitment of underserved minority populations in genetics research;
• How researchers understand and explain the variables of race and biomarkers of ancestral origin;
• Ways in which the benefits learned from research and research participation can be shared with underserved populations.

NIA; NIAAA; NIAID; NIDA; NIMH; NINDS; NINR:

• Relevant and efficient approaches in determining: a) an individual’s capacity to provide informed consent for research participation; b) when surrogate (legally authorized representative) consent should be obtained, and how to best involve surrogates in the consent process and ongoing research issues;
• Issues raised by surrogate consent for specific populations, e.g. impaired decisional capacity, understudied populations, individuals with LLI, adolescents.

NIA; NIAAA; NIDA; NINDS; NCCAM:

• Access to participation in research for populations such as: those under-represented in biomedical and clinical research of U.S. minority populations, underserved populations, and populations who may be vulnerable to coercion or undue influence; barriers to participation and potential approaches to overcome these ;
• Conducting biomedical and clinical research in resource-limited countries.

NIA; NIAAA; NIAID; NIDA:

• Special safeguards or protections for and inclusion of vulnerable and at-risk study populations (e.g. those with or at risk for sexually transmitted diseases (STDs) and/or HIV infection, asthmatic pregnant women, drug users, criminal justice populations, and patients with rare diseases) in research;
• Inclusion of adolescents in clinical research on STD's.

NIA; NICHD; NINDS:

• Children s, adolescents and cognitively impaired adults' comprehension of consent and assent during surrogate permission and assent processes;
• Best methods for facilitating informed consent and presentation of research risks for research involving vulnerable populations;
• Context-specific and/or culturally appropriate approaches to obtaining informed consent (e.g. in different cultures, with illiterate populations, with vulnerable populations).

NIA; NINR:

• Ethical issues associated with inclusion of patients with life-limiting illness (LLI) or at the end of life, or in hospice care and their caregivers in research including confidentiality, non-malfeasance, and participation in clinical trials.

NINR:

• Inclusion or exclusion of individuals with LLI, or those at the end of life in clinical research
• The nexus of acute emergency research and palliative and end of life care, including inclusion/exclusion in research, informed consent, and surrogate consent, protections, confidentiality, and advance care planning

5) Research with Specimens, Data, and/or Health Information (including specimen/data sharing; privacy and confidentiality issues; biobanking)

NCI:

• Evaluation and/or mitigation strategies for ethical challenges in cancer genome studies.

NCI; NINDS:

• Strategies for obtaining advance consent for specimen collection;
• Assessment of methods to ensure the privacy and confidentiality of research information;
• Clarifying what constitutes a modified derivative of a cell line (e.g., iPS cells) and the consequences of this for informed consent.

NHLBI; NIDCR; NINDS:

• Consent issues for sharing of specimens and data including but not limited to: what constitutes adequate consent; what risks to participants should be outlined in informed consent; what are the appropriate elements of informed consent for the use of banked specimens and data.

NHGRI, NIA:

• Issues for the use of retrospective tissue samples/biobanks or data repositories that were established when future use was not fully anticipated
• Issues for prospective collection where storage and future use was anticipated and specific consent obtained The informed consent process for prospectively collected tissue samples and data, especially as it relates to the concept of potential future donor identification.

NIA; NINDS:

• Subject re-identifiability in behavioral and social research, even when data are de-identified, including feasibility with very few data points (individual, demographic, and biological data including biomarkers and genetic data).

NIAAA; NIBIB; NIDCR; NIDA; NINDS; NCCAM:

• Broad sharing of data from electronic health information systems and the sharing of health information for patient care and research including but not limited to studies to assess risks associated with health information technology and the broad sharing of health information for research, and novel approaches for mitigating them.

NICHD:

• Population/community-specific concerns related to shared tissue samples;
• Understanding and perception of risks associated with storage of biologic samples for future research.

NICHD; NIDA; NINDS:

• Understanding and perception of participation in genetic studies among diverse and vulnerable populations including developed and developing countries;
• Issues related to the collection and storage of specimens in developing countries and ability to ship specimens out of the country for testing;
• Sharing the benefits of research using international biobanks.

NIEHS

• Confidentiality and/or privacy concerns for exposure modeling (geographic information systems, etc.)

NINR:

• Electronic sharing of health information for those with LLI or at end of life, such as potential loss of privacy, stigmatization, loss of insurance coverage;
• Use of existing specimens or biobanking for those with LLI or at end of life.

6) Dissemination and Translation of Research Findings (including return of research results; data ownership)

NCI:

• Assessment of approaches to providing new information to participants; assessment of the level of understanding of new information by participants.

NHLBI; NIA; NINDS:

• Approaches to the return of results to study participants including but not limited to: what to say, timing, to whom results should be given (especially in the case of minors and deceased participants), how results should be provided and by whom.

NHGRI:

• What factors should be considered in making a decision to return research results to participants;
• Who makes the decision to return results to participants;
• What should the qualifications be of individuals returning results;
• What role does CLIAA certification, analytic validity, clinical validity, clinical utility, availability of interventions have in research results;
• What the effects are of gene patenting and licensing on the future use of genomics in health care.
• Are there categories of research results that should not be returned to participants such as those which are poorly understood or poorly predictive, those which are unanticipated or incidental findings; or those in which penetrance is unknown or there is no prevention or intervention available;

NIA:

• Returning diagnosis or risk profile results given the lack of effective disease modifying treatments for dementing illnesses.

NIA; NINR:

• Confidentiality, data ownership, and the content of what is reported to family members of deceased research participants when translating or disseminating research findings or return of results among those with LLI or at the end of life.

NIEHS:

• Data ownership for environmental exposure studies;
• Decision making about providing post-study interventions and community pressure to provide unproven interventions;
• Reporting biomonitoring results back to community.

NINDS; NCCAM:

• The translation of genetic knowledge to clinical practice: Studies are needed to better understand the factors that influence the translation of genetic information to improved human health and the associated ethical issues.

7) Research Oversight (including IRBs; data and safety monitoring; conflict of interest management)

NCI; NHLBI; NHGRI; NIA; NIAID; NIDA; NIMH; NINDS; NINR:

• Research oversight bodies (IRBs, DSM Committees, FCOI Committees, and other research oversight bodies), including efforts to examine oversight to better understand/improve current practices, metrics for the effectiveness of systems of oversight, ways to improve oversight;
• Strategies for assessing potential investigator financial conflicts of interest (FCOI); the extent to which institutional FCOI management plans are able to minimize the effects of such on mental health research; and possible biasing effects of FCOI on current and prior mental health studies.

NHGRI:

• How IRBs weigh risks and benefits where large amounts of genomic information will be examined and shared;
• Regulatory guidance that may be needed or recommended related to the deposition and use of stored tissue samples/biobanks or data repositories for genetics research;
• Oversight for stored tissue samples/biobanks or data repositories, including possible entities who might provide the oversight; the potential need for governance structuresor should other mechanisms .

NIAAA; NIBIB; NIDCR; NIDA; NINDS; NCCAM:

• Enhancing current oversight paradigms for data sharing and electronic health systems and how privacy risks may change in the future.

In addition to the high priority topics noted above, applications that address ethical issues which are directly related to the specific research missions of the participating NIH ICs will also be considered. A brief description of these missions is provided here.

NCI: The National Cancer Institute coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.

NHLBI: The National Heart, Lung, and Blood Institute provides leadership for a national program in diseases of the heart, blood vessels, lung, and blood; blood resources; and sleep disorders. Since October 1997, the NHLBI has also had administrative responsibility for the NIH Woman's Health Initiative. The Institute plans, conducts, fosters, and supports an integrated and coordinated program of basic research, clinical investigations and trials, observational studies, and demonstration and education projects.

NHGRI: The National Human Genome Research Institute is devoted to advancing health through genome research. Building on the foundation laid by the sequencing of the human genome, NHGRI’s work now encompasses a broad range of research aimed at expanding understanding of the structure and function of the human genome and its role in health and disease. In addition, a critical part of NHGRI’s mission continues to be the study of the ethical, legal and social implications of genome research.

NIA: The National Institute on Aging leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life. NIA provides leadership in aging research, training, health information dissemination, and other programs relevant to aging and older people and is the primary Federal agency that supports Alzheimer s disease research.

NIAAA: The National Institute on Alcohol Abuse and Alcoholism conducts and supports research to improve the treatment and prevention of alcoholism and alcohol-related problems to reduce the health, social, and economic consequences of this disease.

NIAID: The National Institute of Allergy and Infectious Diseases conducts and supports basic and applied research to better understand, treat and ultimately prevent infectious, immunologic, and allergic diseases. Areas of particular interest include prevention, therapeutics, diagnostics, and countermeasures for infectious, immunologic, and allergic diseases both in the US and internationally.

NIBIB: The National Institute of Biomedical Imaging and Bioengineering improves health by promoting fundamental discoveries, design, development, translation, and assessment of technological capabilities in biomedical imaging and bioengineering.

NICHD: The Eunice Kennedy Shriver National Institute of Child Health and Human Development conducts and supports research on fertility, pregnancy, growth, development and medical rehabilitation to ensure that each child is born healthy and wanted, that women suffer no harmful effects from the reproductive process, that all children have the chance to fulfill their potential to live healthy and productive lives free from disease or disability, and to ensure the health, productivity, independence, and well-being of all people through optimal rehabilitation.

NIDCD: The National Institute on Deafness and Other Communication Disorders supports and conducts biomedical and behavioral research and research training in normal and disordered conditions of hearing, balance, taste, smell, voice, speech, and language.

NIDCR: The National Institute of Dental and Craniofacial Research provides leadership for a national research program to understand, treat, and ultimately prevent infectious and inherited craniofacial-oral-dental diseases and disorders.

NIDA: The National Institute on Drug Abuse leads the nation in bringing the power of science to bear on drug abuse and addiction through support and conduct of research across a broad range of disciplines and rapid and effective dissemination of results of that research to improve drug abuse and addiction prevention, treatment, and policy.

NIEHS: The National Institute of Environmental Health Sciences reduces the burden of human illness and dysfunction from environmental causes by defining how environmental exposures, genetic susceptibility, and age interact to affect an individual's health.

NIMH: The mission of the National Institute of Mental Health is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure.

NINDS: The National Institute of Neurological Disorders and Stroke supports and conducts basic and clinical research on the normal and diseased nervous system to improve the understanding, diagnosis, treatment and prevention of neurological disorders.

NINR: The mission of the National Institute of Nursing Research is to promote and improve the health of individuals, families, communities, and populations by supporting and conducting clinical and basic research on health and illness across the lifespan. The research focus encompasses health promotion and disease prevention, quality of life, health disparities, and end-of-life care.

NCCAM: The National Center for Complementary and Alternative Medicine supports rigorous scientific research to explore complementary and alternative medical practices.

Funding Instrument	Grant
Application Types Allowed	New Resubmission The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	A project period of up to two years and a budget for direct costs of up to $200,000 per year may be requested with a maximum of $275,000 direct costs over two years).
Award Project Period	The scope of the proposed project should determine the project period. The maximum period is 2 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• 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. Territory or Possession

Other

• 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
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations)

Foreign (non-U.S.) components of U.S. Organizations 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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) 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 four (4) 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 Project 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 in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, technologies, or theoretical or conceptual frameworks that have the potential for significant impact on bioethics research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items..

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not applicable

Revisions

Not applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. In particular, we encourage questions regarding specific priority topics listed above by participating ICs or about IC-specific research missions to be directed to the Scientific/Research Contacts listed below for the applicable ICs.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Central NIH Program Contact (for general inquiries):

Ann Hardy
Office of Extramural Programs, OER, OD
Telephone: 301-435-2690
Email: [email protected]

Kim Witherspoon
National Cancer Institute (NCI)
Telephone: 240-276-6141
Email: [email protected]

Donna Dimichele
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-435-0080
Email: [email protected]

Joy T. Boyer
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-4997
Email: [email protected]

Nina Silverberg
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: [email protected]

Troy Zarcone
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-1285
Email: [email protected]

Larry Prograis
National Institute on Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3528
Email: [email protected]

Steven Krosnick
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-594-3049
Email: [email protected]

Lisa Freund
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6879
Email: [email protected]

Gordon Hughes
National Institute on Deafness and Other communication Disorders (NIDCD)
Telephone:301-435-4085
Email: [email protected]

Jane Atkinson
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone:301-435-7908
Email: [email protected]

Lynda Erinoff
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1972
Email: [email protected]

Symma Finn
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4258
Email: [email protected]

Matthew Rudorfer
National Institute of Mental Health (NIMH)
Telephone: 301-443-1111
Email: [email protected]

Joanne Odenkirchen
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-3104
Email: [email protected]

Susan Marden
National Institute of Nursing Research (NINR)
Telephone: (301) 496-9623
Email: [email protected]

Wendy Weber
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-402-1272
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Shane Woodward
National Cancer Institute (NCI)
Phone: 240-276-6303
Email: [email protected]

Ryan Lombardi
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-435-0182
Email: [email protected]

Cheryl Chick
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-0733
Email: [email protected]

Jeff Ball
National Institute on Aging (NIA)
Telephone: (301) 402-7732
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Greg Smith
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (240) 669-2948
Email: [email protected]

[Nancy Curling
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4782
Email: [email protected]

Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

Christopher Myers
National Institute on Deafness and Communication Disorders (NIDCD)
Telephone: 301-435-0713
Email: [email protected]

Diana Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: [email protected]

Pam Fleming
Grants Management Branch
National Institute on Drug Abuse (NIDA)
Telephone: 301-253-8729
Email: [email protected]

Donald Ellis
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1874
Email: [email protected]

Rebecca Claycamp
National Institute of Mental Health (NIMH)
Telephone: (301) 443-2811
Email: [email protected]

Tijuanna DeCoster
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: [email protected]

Lawrence Haller
National Institute of Nursing Research (NINR)
Telephone: 301-402-1878
Email: [email protected]

Cornice Martin
National center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-594-6059
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.