Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Allergy and Infectious Diseases (NIAID) National Cancer Institute (NCI) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Mental Health (NIMH) National Institute on Drug Abuse (NIDA)
Funding Opportunity Title	Ethical Issues in Research on HIV/AIDS and its Co-morbidities (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	June 9, 2015 - This PA has been reissued as PAR-15-274. June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. 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	PAR-12-244
Companion Funding Opportunity	PAR-12-243, R21 Exploratory/Developmental Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.855, 93.856, 93.279; 93.865; 93.242; 93.399; 93.396; 93.395; 93.394; 93.393
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) invites applications addressing ethical issues in research relevant to populations with HIV and associated co-morbidities, and populations at high risk of HIV acquisition. The bioethics projects supported through this program announcement will focus on at least one of the following three goals: 1) Development of the empirical knowledge base for human subjects protection and ethics standards in HIV/AIDS research; 2) Development of conceptual bioethics approaches to advance scholarship on difficult ethical challenges in HIV/AIDS research; 3) Supporting the integration of bioethics work with ongoing research in HIV/AIDS.

Posted Date	July 24, 2012
Open Date (Earliest Submission Date)	November 7, 2012
Letter of Intent Due Date	Not Applicable.
Application Due Date(s)	January 7, 2013; January 7, 2014; January 7, 2015, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	February-March, 2013, February-March, 2014; February-March, 2015
Advisory Council Review	May, 2013; May, 2014; May, 2015
Earliest Start Date(s)	July, 2013; July, 2014; July, 2015
Expiration Date	January 8, 2015
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

Since the beginning of the HIV epidemic, research on HIV/AIDS has raised ethical challenges. The rapidly emerging epidemic and corresponding research and clinical care responses have made these ethical tensions highly visible. Controversies have arisen over clinical trial design, access to drugs, regulatory approval pathways, stigmatized populations, and global health disparities. The populations at risk for acquiring or living with HIV are often economically, socially or politically vulnerable, and HIV transmission is frequently linked to socially sensitive behaviors. These characteristics have heightened the ethical tensions in HIV/AIDS research, across the spectrum from observational studies, early phase/translational trials, product development, behavioral research, and public health intervention.

Applications for support under this FOA may include conceptual work in bioethics, or empirical work gathering and analyzing data relevant to ethical issues in research, or a combination of the two. For empirical projects, data collection may include quantitative or qualitative methods, or both.

For all applications, the research team is strongly encouraged to include at least one person with demonstrated expertise and scholarship in bioethics, as demonstrated by academic work and publications in the field.

For projects involving empirical data collection, applicants should describe how the data collection will inform current or future ethical deliberations or ethical oversight processes; the research team should include at least one social scientist or other researcher with relevant expertise in theory and methodology for conducting the proposed empirical research.

For projects which are purely conceptual or analytical bioethics work and do not involve empirical investigation, applicants should describe: the current state of scholarship on the topic; why the proposed project is significant and innovative, for example, whether new reasoning is applied to a familiar problem, or whether a new problem is addressed; and what type of theoretical framework or approach will be used to address the problem.

For projects which combine conceptual work in bioethics with empirical data collection, applicants should describe how the data collection informs ethical analysis or decision making, in addition to addressing the requirements for conceptual work as stated above.

Applications addressing empirical research on informed consent will not be funded under this Program Announcement, with the exception of informed consent/assent/parental permission related to adolescents as research participants, as described below. For other funding opportunities related to informed consent, please see PA-11-180, PA-11-181, and PA-11-182.

The following selected bioethics topics are of particular interest; however, other ethical issues are relevant and this list is not intended to be exhaustive.

Ethical Issues in Research Utilizing Human Specimens

Research utilizing specimens is vital to progress in biomedical science and public health. Although research utilizing specimens is usually classified as minimal risk, international collaborative research involving specimens can involve ethical, legal and political complexities that sometimes stymie important projects. For example, the burden of oversight and regulation of research with specimens may seem disproportionate to the level of risk. There are divergent views amongst stakeholders about how research utilizing specimens should be regulated, whose interests are at stake, and how these interests ought to be protected. A variety of other issues have been raised by stakeholders, including perceptions and misconceptions about likelihood of breaches of confidentiality, worries about the acceptability of research with banked specimens, concern about potential impact of research findings on communities, and issues regarding control of specimens in multi-national research collaborations.

Possible topics include, but are not limited to, the following:

• Empirical assessments and ethical analysis of documented harms and benefits associated with specimen research, including effects on individuals, communities, clinical practice, public health and science;
• Development of interventions to address misconceptions or lack of information about HIV-related research with specimens, amongst the general public, communities and individuals at risk of or affected by HIV, ethics committees and IRBs, both in the US and in other countries;
• Development of models of shared decision-making and governance for use of specimens in international collaborative research, with particular focus on developing countries.

Ethics of Research Involving Pregnant Women

The care and treatment of pregnant women in the US and around the world is hampered by a lack of rigorous clinical trial evidence to support treatment choices. The vast majority of interventions needed by these millions of women are either used without specific evidence of efficacy or safety during pregnancy, or avoided due to concerns about effects on fetal health. As a result, pregnant women and their offspring often suffer from suboptimal health care. Research involving pregnant women is often limited by the difficulty of adjudicating risks and benefits to mother and fetus, and the challenges of obtaining associated regulatory approvals. In HIV research, the early advent of antiretrovirals for prevention of mother to child HIV transmission has resulted in a substantial evidence base for use of these drugs during pregnancy. However, significant gaps remain. More research is needed on treatment of HIV-infected pregnant women for indications other than prevention of maternal to child transmission. Serious co-morbidities such as tuberculosis (TB) are often under-treated in pregnant women, and research to extend new treatment modalities for this population remains ethically challenging. HIV-uninfected pregnant women urgently need HIV prevention agents that have been proven safe and effective, especially since there are data showing significant, perhaps even heightened, risk of HIV acquisition during pregnancy.

Projects which help advance the ethical agenda for research with pregnant women could include, but are not limited to, the following:

• Gathering and analyzing information from stakeholders (patients, clinicians, researchers, ethics committees/IRBs, regulators) about ethical priorities and challenges in research with pregnant women, including comparative ethical analysis of research with pregnant women in other disease areas;
• Projects to gather and analyze biomedical data related to pregnancy and create a scientific and ethical framework for analyzing risks and benefits of research with pregnant women;
• Analysis of ethical and regulatory oversight of research with pregnant women, in the US or in other countries; development of policy strategies for improving the research agenda for pregnant women.

Ethics of Research Involving Adolescents and Young Adults

Care and treatment efforts for HIV-infected adolescents and young adults in the US and around the world as well as prevention efforts for those at risk of infection are compromised by a lack of rigorous clinical trial evidence to support management approaches and treatment choices. A vast proportion of biomedical interventions and therapies used in these populations are implemented in the absence of specific data to support indications for their use and are often justified by extrapolation from studies in much older adult populations. Substantial biomedical and psychosocial data suggest that adolescents are simply not smaller adults and that such dogmatic approaches result in less than optimal care.

Investigators frequently encounter a variety of difficulties in working with youth which create a disincentive to carry out research in these populations, such as individual factors (non-adherence, risk behaviors and other psychosocial challenges) and structural barriers (ethical, legal and regulatory issues). There have been important milestones achieved in HIV prevention and treatment; however, concerns about adherence problems in youth are barriers to their implementation in this group. There is an urgent need for primary and secondary prevention among youth populations who are at high risk of acquisition or transmission of HIV, both globally and domestically. An adolescent’s evolving autonomy, decisional capacity and individuality argues for a right to independence and self-determination when it comes to their health care. However, there are ethical, legal and regulatory considerations that vary by jurisdiction and geography which impact these rights and create obstacles to research and health care. Projects to address issues related to adolescents in research could include, but are not limited to, the following:

• Conceptual and empirical work on issues of evolving adolescent autonomy, decisional capacity, consent, assent and parental permission, particularly in regard to youth at risk for HIV infection and other STDs in the US and in other countries;
• Analysis of legal provisions for protection of confidentiality of minors and for rights to self-determination and decision-making by adolescents about participation in research; analysis of these legal and ethical issues in various research settings. Relevant research contexts include research on mood disorders, sexual behaviors, and substance use, as well as other potential risk determinants for HIV acquisition, such as homelessness, incarceration, truancy, and other circumstances and conditions;
• Projects to gather and analyze biomedical, behavioral and other psychosocial data related to adolescents and young adults to create a scientific and ethical framework for analyzing risks and benefits of research with youth; legal and ethical analysis of minimal risk standard for research as applied to adolescents.

Ethical Issues in Research on an HIV Cure

A new area in HIV research is the search for a means to eradicate the virus from the body an HIV cure. While effective antiretroviral treatment has been hugely successful in reducing morbidity and mortality from HIV infection, the virus is never wholly eliminated from the body and patients must remain on lifelong treatment. The goal of cure research is to determine where and how the virus lies dormant and develop treatment algorithms that stimulate and eliminate virus reservoirs. A significant ethical challenge with this area of research is that early phase and translational trials will need to be conducted with relatively healthy HIV-infected patients. Specifically, risks and benefits of this type of research are difficult to assess, and patients may develop misconceptions about the likelihood of success. Projects addressing these issues could include the following:

• Analysis of risks and benefits of HIV cure research to individuals and future patients, including social value of research for developing future biomedical interventions;
• Developing mechanisms for stakeholder engagement and communication about ethical challenges in HIV cure research;
• Learning from and applying ethical frameworks from early phase research in other disease areas; conducting comparative ethical analysis of early phase research in different settings.

Standards of Care and the Interaction of Statistics and Ethics in Clinical Trial Design

Ethical dilemmas in the choice of standard of care or prevention in clinical trials have been deep and enduring. Key considerations in clinical trials, such as the need to provide adequate benefit to trial participants, the need for research to be socially valuable and useful, the need for rigorous design that enables sound scientific inferences, and the need for efficiency, often result in difficult tradeoffs in trial design. Trial designs that maximize one important aspect may, to some extent, sacrifice others. Discussions of optimum design must include stakeholders with expertise in statistics, clinical medicine, health policy, and ethics. Interdisciplinary projects addressing standards of care or prevention could include the following:

• Ethical and scientific analysis of current clinical trial design approaches to address changing standards of care in HIV prevention and treatment;
• Conceptual research in bioethics addressing stakeholder obligations in standard of care dilemmas in HIV-related research;
• Analysis of ethical and scientific advantages and disadvantages of innovative statistical methods and trial designs to HIV related research to address changing standards of care; methods for predicting value of different trial designs for decision making in clinical care and health policy; ethical and policy analysis of social value of different trial designs.

Effectiveness of Research Ethics Committee Review

The process of research ethics oversight by ethics committees and IRBs, a critical part of the ethical conduct of research, by necessity creates some burden on the research enterprise. It is essential to ensure that these review processes are effective and efficient. Multi-center clinical trials and international collaborative research projects pose particular challenges for ethics/IRB review. Some approaches include, but are not limited to, the following:

• Developing methods for ongoing education and communication amongst IRBs, ethics committees and researchers about scientific developments and ethical challenges in HIV research;
• Development of tools for the measurement of the effectiveness of ethics committees/IRB deliberations and substantive decision-making (as distinct from adherence to bureaucratic procedures), both in the US and in other countries;
• Development of models for coordination and communication between and among IRBs and ethics committees, including shared or collaborative review processes, where appropriate, with particular focus on international collaborative research;
• Programs to assess challenges, opinions and expectations of research ethics committees in international HIV/AIDS-related research and to develop tools to strengthen capacity and improve performance.

Ethical Issues in HIV Research Using New Forms of Technology

New technological developments or adoption of technologies in the research setting may raise ethical concerns relating to protection of research participants and their communities. For example, privacy and confidentiality concerns may arise in the context of internet research such as online recruitment or data collection. Use of technologies such as mobile communication devices and home testing kits could raise issues about communication of health information and complexities of family and partner relationships in the context of testing and disclosure. Worries about privacy and confidentiality may be particularly acute in HIV related research due to continued stigma and risk of social harms from disclosure of actual or presumed HIV status. Other new technologies, including biomedical technology as well as electronic tools, may pose new challenges for the ethical conduct of research. Projects to assess ethical issues arising in use of new technologies could include, but are not limited to, the following:

• Empirical assessments and ethical analysis of documented harms and benefits associated with the use of new forms of technology in HIV research, including effects on individuals, communities, clinical practice, public health and science;
• Development of best practices for minimizing risks, monitoring adverse events and social harms, or addressing these consequences as they arise when data are collected remotely using internet, mobile devices or other technology;
• Research to determine best practices for ethics committees and IRBs, both in the US and in other countries, when providing oversight of research using newer forms of technology.

Research in Settings of Stigma, Discrimination and Oppression

There is widespread stigma, discrimination and oppression directed at men who have sex with men (MSM), sex workers, and intravenous drug users (IDU) throughout the world, which, beyond direct adverse effects on these groups, hampers HIV prevention, care and treatment efforts. For these groups, criminal sanctions exist in many countries and both the threat and reality of incarceration are widespread. Women and girls at risk for, or experiencing, violence or sexual abuse are at increased risk of HIV acquisition, and may face additional barriers in accessing appropriate care. In addition to these conditions, disclosure of HIV status continues to be a major challenge for people living with HIV around the world. Access to care and treatment, social support, coping, and prevention of transmission of HIV to others are all adversely affected by difficulties with HIV disclosure.

Projects addressing these issues could include, but are not limited to, the following:

• Ethical analysis of potential obligations of stakeholders, including researchers and research sponsors, to address background conditions in the context of research studies with oppressed groups; development and assessment of training tools for investigators and research staff to promote appropriate and ethical conduct of research with vulnerable populations;
• Analysis of risks and benefits of conducting research in these settings; determining ethical approaches to conducting research while minimizing risks of further harms; assessment of potential for research to contribute to, exacerbate, or alleviate inadvertent disclosure or stigma;
• Gathering and analyzing information from stakeholders (patients, clinicians, researchers, ethics committees/IRBs, regulators) about ethical priorities and challenges in research with individuals living with HIV, or at high risk of HIV infection, facing stigma, discrimination, legal sanctions and/or interpersonal violence;
• Use of rapid policy assessment and other analytic approaches to evaluate legal, economic or political barriers to research in settings of stigma or oppression; developing ethical and policy frameworks to appropriately guide research in difficult political contexts.

Ethical Issues in Research Related to HIV and Tuberculosis (TB)

Research and public health programs on TB raise multiple ethical issues, due to the characteristics of the disease and its clinical management. These characteristics include the transmissibility of TB, difficulties in TB diagnosis, challenges of TB treatment and follow-up, and the rise of multiple drug resistant (MDR) or extensively drug resistant (XDR) TB. TB in the context of HIV infection is more challenging to prevent, diagnose, and treat, as is TB infection in children; research and clinical practice in these groups raise more difficult issues related to risks and benefits of research and effectiveness of public health policies. Ethical issues related to TB to be addressed could include, but are not limited to, the following:

• Analysis of ethical challenges of research on diagnostic tests; should tests that are not fully validated or approved by regulatory authorities be used to inform clinical care, and if so, what parameters should affect these decisions? How should risks and benefits of use of new diagnostic tests, both for patients and others in the community, be evaluated and communicated?
• Analysis of ethical issues in introducing new TB drugs: how can the need for potential benefits of new drugs be balanced with necessary caution in avoiding development of drug resistance, at the level of individual patient care, TB programs, and policies? How do these competing obligations influence the conduct of research and transitions from research to clinical practice, including the challenges of determining when new agents should be used outside a clinical trial setting, especially when not all uses or combinations have been tested in trials; what are the additional challenges of implementing compassionate use or expanded access programs?
• Ethical analysis of risks, benefits and social value of research on new TB regimens, especially in cases where individual patient benefit is unlikely or highly uncertain. Examples include studies of new drug regimens in patients with TB strains already resistant to one or more components of the regimen being tested; or studies of latent TB, where new agents may be studied in TB-infected patients who are otherwise healthy, to ascertain anti-latent TB effects.
• Ethical issues arising in drug development and regulatory approval pathways for new TB drugs, including challenges of testing and approving combination regimens from multiple companies, and difficulties reconciling commercial and public health concerns;
• Challenges of TB vaccine testing; determining what groups or populations should be included in TB vaccine studies when individual and population benefit may vary, and how potential risks and benefits to individuals and populations can be evaluated and balanced;
• Ethical issues in pediatric TB research, including questions of when new drugs or agents should be studied in children and what kind of information must be available from adult research or treatment programs to inform these decisions. When there is uncertainty about TB or MDR TB diagnosis in children, what is the appropriate threshold for inclusion in TB research studies? How might potential risks, benefits and social value of research be evaluated in the context of these uncertainties? When can children be ethically enrolled in non-beneficial TB research? How can risks and benefits of TB research and treatment in children be evaluated in the context of treatment for HIV, where drug interactions may compromise the effectiveness of one or more treatment regimens?
• Ethical issues concerning end of life care for patients with TB. How can resource allocation, training and decision making for end of life care be addressed? These ethical challenges may be especially acute in settings where resources are constrained, and where it may be difficult to determine when patients are untreatable.

Research on Community Engagement: Principles and Practices

Community engagement has been a mainstay of research in the HIV/AIDS arena. However, continuing challenges exist in implementing effective strategies for community engagement while keeping up with the rapid pace of research and changes in technology and public health practice. Community Advisory Boards (CABs) have served a critical function in providing input to researchers and sponsors about community perspectives on research, yet community engagement efforts need to be broader and more diverse to effectively address the multiple challenges of education, communication and dialogue about complex research and public health issues.

Projects to address community engagement could include, but are not limited to, the following:

• Assessment of community perceptions and understanding of research programs; including disagreements or conflicts within communities around research or public health issues, if any; developing interventions to improve communication and understanding at the community level;
• Assessment of the role of community engagement existing strategies and interventions in collaborative research including rationale, experience, effectiveness and lessons learned; assessing benefits and burdens of community engagement;
• Designing and evaluating new community engagement interventions; developing strategies to ensure that minority voices or views in communities are heard, or strategies to activate community representation in settings where no representative structures exist; and exploration of CAB alternatives;
• Developing tools and strategies for measuring benefits and burdens of research at the community level; ethical analysis of appropriateness of benefits of burdens in different kinds of community settings;
• Developing and testing mechanisms for carrying out community based participatory research (CBPR).

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	Application budgets are not limited, but need to reflect actual needs of the proposed project.
Award Project Period	Scope of the proposed project should determine the project period. The maximum period is 5 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 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.

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

All Program Director(s)/Principal Investigator(s) (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 4-6 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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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 submission of applications for this FOA. 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) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions 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(s)/PI(s) 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 requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.

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.

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(s)/PI(s), 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(s)/PI(s), 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) in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

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(s)/PI(s) 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’s 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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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.

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]

NIAID

Liza Dawson, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3210
Email: [email protected]

NCI

Rebecca Liddell Huppi, Ph.D.
Office of HIV and AIDS Malignancy
National Cancer Institute (NCI)
Building 31, Room 3A33, MSC-2440
31 Center Drive
Bethesda, MD 20892-2440
Telephone: 301-496-4995
FAX: 301-480-4137
Email: [email protected]

NICHD

Bill G. Kapogiannis, M.D.
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Room 4B11J, MSC-7510
6100 Executive Boulevard
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express mail)
Telephone: 301-402-0698
FAX: 301-402-0698
Email: [email protected]

NIDA

Richard A. Jenkins, Ph.D.
Prevention Research Branch
National Institute on Drug Abuse (NIDA)
Room 5185, MSC-9589
6001 Executive Boulevard
Bethesda, MD 20892-9589
Rockville, MD 20852 (for express mail)
Telephone: 301-443-1923
FAX: 301-480-2542
Email: [email protected]

NIMH

Susannah Allison, Ph.D.
Division of AIDS Research
National Institute of Mental Health (NIMH)
Room 6116, MSC-9619
6001 Executive Boulevard
Bethesda, MD 20892-9619
Rockville, MD 20852 (for express mail)
Telephone: 301-443-3952
FAX: 301-443-6000
Email: [email protected]

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

NIAID

Ann Devine
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 4G60, MSC 9824
5601 Fishers Lane
Bethesda, MD 20892-9824
Rockville, MD 20852-9824 (for express mail)
Telephone: 240-669-2988
FAX: 301-493-0597
Email: [email protected]

NCI

Shane Woodward
Office of Grants Administration
National Cancer Institute (NCI)
Suite 243, MSC-7150
6120 Executive Plaza South
Bethesda, MD 20892-7150
Rockville, MD 20852 (for express mail)
Telephone: 301-496-8791
FAX: 301-496-8601
Email: [email protected]

NICHD

Bryan S. Clark, M.B.A.
Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Room 8A01A, MSC-7510
6100 Executive Boulevard
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Phone: 301-435-6975
FAX: 301-451-5510
Email: [email protected]

NIDA

Maryellen Connell
Grants Management Branch
National Institute on Drug Abuse (NIDA)
NSC Building, Room 5000, MSC-9560
6001 Executive Boulevard
Bethesda, MD 20892-9560
Rockville, MD 20852 (for express mail)
Telephone: 301-774-3803
FAX: 301-594-6849
Email: [email protected]

NIMH

Aleisha S. James, MPH
Grants Management Branch
National Institute of Mental Health (NIMH)
Room 6138, MSC-9605
6001 Executive Boulevard
Bethesda, MD 20892-9605
Rockville, MD 20852 (for express mail/overnight mail)
Telephone: 301-451-9948
FAX: 301-443-6885
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.