Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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

This funding opportunity announcement (FOA) seeks applications to addresses ethical, legal, and policy challenges in HIV-related research and program implementation among key populations. The term "key populations" describes populations that experience high risk of HIV acquisition due to certain behaviors and risk exposures. 2014 WHO Guidance states: "Key populations are defined groups who, due to specific higher-risk behaviors, are at increased risk of HIV irrespective of the epidemic type or local context. Also, they often have legal and social issues related to their behaviors that increase their vulnerability to HIV The 2014 WHO guidance addresses five key populations: (1) men who have sex with men; (2) people who inject drugs; (3) people in prisons and other closed settings; (4) sex workers and (5) transgender people. This FOA calls for research related to those five groups and also includes research related to adolescent girls and young women at high risk of HIV acquisition or living with HIV.

Adolescent girls and young women are not at high risk in all settings, and therefore, this FOA is directed to research in settings known to have a high incidence of HIV in this age group. Young women are included in this FOA because social, legal and ethical issues related to inclusion of minors in research, structural factors affecting risk, and other complex contextual issues can pose challenges for research with adolescents and young women.

Research applications may include scholarship in ethical, legal or policy areas and can include conceptual analysis, empirical analysis using qualitative or quantitative methodology, or combined conceptual and empirical work. This FOA will not include clinical trials.

Support for the "Ethical, Legal and Policy Issues in HIV Research with Key Populations" is available under two separate companion FOAs that are being published concurrently. This FOA is soliciting for R21 applications that will support shorter term (up to two years) developmental/exploratory research activities, whereas the companion R01 FOA will support more developed (up to 5 years) applications.

HIV prevention, care and treatment for key populations are critical. Because key populations have a high risk of HIV acquisition, reaching them with effective prevention, care and treatment is critical to ending the epidemic. But the same behaviors or characteristics that lead to high risk of acquisition also lead to significant challenges in engaging with them, due to stigma, criminalization of certain behaviors, violence, marginalization, social isolation, and other social and economic factors. Thus, development of effective research studies and accessible prevention, care and treatment programs is both necessary and profoundly complex in key populations.

There are challenges in research and program implementation with key populations. Research and program activities involving key populations can be risky for study participants, care providers, and researchers. Cultural, legal and political environments can increase stigma, risk of violence, social harm, or criminal sanctions. These conditions also complicate the scientific and ethical conduct of research studies, including epidemiology, social science and behavioral studies, structural and policy interventions, clinical trials, and implementation studies.

At the same time, failure to include key populations in important research activities, or exclusion from health programming, leads to further exacerbation of HIV risk, poor health outcomes and increased transmission dynamics within affected communities. Previous studies have documented severe disparities in access to prevention, care and treatment for key populations in many settings. These conditions are serious public health and human rights concerns, and impede efforts to control and reduce the impact of HIV.

In addition to challenging background conditions, many of the prevention and treatment interventions that have been tested or are under development do not address specific health needs of key populations, or may not be suited to the social, political or economic context in which they live. Research studies developing and testing new approaches will need to include key populations at all stages of research and in some cases, tailor or adapt interventions to ensure their effectiveness, feasibility, acceptability and safety in these groups.

Research projects addressing ethical, legal and policy issues of particular interest are described below. This list is not exhaustive and applications may address other topics within the scope of the FOA.

Minimizing and Managing Risk

Social and political conditions lead to key populations experiencing diverse risks, including social harm, violence, stigma, criminalization, aggressive policing practices, social isolation, loss of employment or housing, or other adverse outcomes. Research studies have the potential to exacerbate these risks, to provide some level of protection from harm, or to elicit a mixture of harms and benefits. Researchers and care providers may also experience some risks in settings where working with specific populations is illegal or stigmatized. While it is critical for relevant research studies to include key populations, any risks imposed by the research itself, or exacerbation of background risks, must be minimized and managed appropriately. The assessment of overall risks and benefits of research will need to take into account the level of baseline risk, whether or how research may affect risk, ways to mitigate these risks, and what kinds of benefits of research participation, if any, may offset risks.

Possible topics related to risk minimization and management include, but are not limited to:

• Risk assessment and risk mitigation strategies for social, legal or other kinds of harms in the context of research; including threats to physical or mental health; problems with family or other relationships; economic issues such as loss of housing or employment, and other types of adverse consequences; risks related to data security or data breaches in the context of research or clinical care.
• Development and testing of methods for risk management as part of site-preparedness activities for clinical research; activities might include rapid policy assessment, stakeholder engagement; creation of partnerships with government agencies or NGOs; agreements for referral arrangements for needed ancillary care, social services, or other mechanisms
• Development and assessment of strategies for capacity building for risk assessment and risk mitigation in the context of research and implementation studies; for example, strategies to improve sustainability of risk mitigation efforts.
• Empirical and conceptual analysis of benefits and risks of research participation for key populations; for example, questions of whether benefits of research participation can reasonably offset risks; whether any limits on research participation ought to be imposed based on background risks, and whether or how these limits could be set.

Policy and Legal Issues Affecting Research

Restrictive or punitive local and national policies, laws, regulations and practices may be directed at key populations or at some of their activities. The conduct of research in these settings raises difficult practical, legal and ethical challenges. In addition to making risk management more difficult, as described above, researchers may encounter difficulties reaching agreements with key stakeholders about whether or how to conduct research; may face a prohibition on the use of specific health interventions or strategies; may have difficulties in obtaining accurate public health data especially as it relates to key populations and HIV risk; and numerous other challenges.

Questions related to policy and legal issues include, but are not limited to:

• Empirical analysis of the effects of specific policies, laws or criminal justice practices on health or health care outcomes related to HIV and its co-morbidities using standard empirical methodologies, including qualitative and/or quantitative methods.
• Research on stakeholder engagement to address policy or legal factors affecting HIV risk and HIV outcomes for key populations. Diverse stakeholders may need to be involved in different settings. Project outputs may include specific training, consultation methods or strategies for engaging with stakeholder and partners for research or program implementation.
• Investigation into the relationship between and among structural factors and HIV risk, mitigation of risk, access to HIV prevention, care and treatment for key populations. Structural factors could include economic, policy, political, human rights, or legal factors.
• Research on ethical, social or policy responses to publication of data or research findings on key populations; or ethical, legal or policy concerns involved in sharing data, releasing data, or other aspects of data transfer and disclosure regarding key populations.

Standard of Care, Access to Care and Ancillary Care

Standard of care questions are frequently challenging in the context of research in low and middle income countries (LMICs) or in regions within specific countries that lack resources for effective health care systems. Furthermore, members of key populations experience significant barriers to access to prevention, care and treatment. Questions about what level of care to provide in a clinical trial as an intervention or control group are referred to as standard of care issues. Needed medical care or social services that are not directly related to the research question are often referred to as ancillary care. Researchers and implementers attempting to address evidence gaps and improve standards of care often face ethical dilemmas with regard to standards of care, ancillary care, or post trial access to prevention, care and treatment. For example, ethical issues arise in choice of best interventions for study when national or local policies diverge from accepted standards of care; design of clinical trials or programs may be complicated by tradeoffs with regard to ethics, feasibility, acceptability and cost. Often, research participants need ancillary medical care or social services that are locally unavailable or unaffordable, and researchers may be asked to provide additional care. Also, some groups may benefit from access to care during a trial but then have difficulties after a trial is over, due to difficult background conditions.

Topics of interest include, but are not limited to:

• Empirical research on the effects of standard of care choices on research utility, risks and benefits, feasibility, acceptability, or translation/implementation of interventions for key populations.
• Ethical and empirical analysis of ancillary care needs of key populations; development and testing of methods to address ancillary care.
• Research on linkage between access to care in clinical trials and larger clinical context in host countries, including ethical and empirical investigation of standard of care and ancillary care and post-trial access questions in research settings and non-research settings.
• Research on factors affecting differential access to care for key populations in comparison to other non-stigmatized groups.

Stakeholder Engagement, Awareness, or Training

Stakeholder engagement is important in all research studies, but critically important for research with key populations. Diverse stakeholders may need to be involved in research that is considered sensitive or where populations at high risk of social harms are involved. While stakeholder engagement plans should be part of every research study, some studies may investigate the process of stakeholder engagement in more depth as one of the research questions. Because legal, political and social issues are more complicated with key populations than low risk populations, developing robust mechanisms for engagement may require additional preparatory work or improved methods.

Topics of interest include, but are not limited to:

• Developing and testing methodologies, tools or best practices in stakeholder engagement for key populations.
• Conducting analysis of effects of stakeholder engagement on opinions, attitudes or practices with regard to key populations, and/or investigation of attitudes and beliefs of members of key populations with regard to HIV risk, HIV prevention and treatment, HIV research, and facilitators and barriers to health care or research participation that they may experience.
• Developing and testing training methods and materials for sensitization regarding key populations, to be implemented with stakeholders such as health care providers, community health workers or others.
• Community based participatory research with key populations, engaging members of the study population in developing research plans, study design, conduct and reporting.

Unique Prevention, Care or Treatment Needs and/or Customizing HIV Interventions for Key Populations

Some successes in HIV prevention technology have emerged in recent prevention research. However some interventions may be more challenging to implement or may be less acceptable to members of key populations due to social pressures, stigma, criminalization and other factors. HIV treatment for HIV-infected individuals may also be more complex due to stigma, incarceration, co-morbidities, and other issues. In some cases existing interventions need to be adapted or tailored for key populations; while in other cases, new modalities or product designs will be needed. Studies should focus on unique characteristics of key populations that affect their experiences with HIV prevention, care and treatment; studies that reflect more general questions about design of HIV interventions (not focused on key populations) are not encouraged under this FOA.

Topics of interest include, but are not limited to:

• Formative research on needs, preferences, and potential user behavior relating HIV prevention, care or treatment for key populations.
• Studies investigating user experiences with existing prevention, care and treatment methods, addressing such issues as adherence, acceptability, social harms, or other positive or negative characteristics of user experiences.

Applications for clinical trials will not be accepted for review.

The views and experiences of members of key populations and their communities should be sought, both in the planning stages of research and in the conduct of empirical research studies. Input from representatives of the study population may be included in several ways; for example, through the use of community advisory boards or other comparable mechanisms; additionally or alternatively, assessing opinions or experiences of individuals who are members of key populations may be one of the research questions in the proposed research. In many cases views of ethics committees, scientific review committees, policy makers, government officials, clinicians, researchers, program implementers and other stakeholders will also be relevant; again, this input may be incorporated through advisory processes, or as one of the research questions, or both, depending on what is most appropriate for the overall objectives of the study. Applicants are encouraged to partner with knowledgeable and relevant organizations that work with key populations in the design and conduct of the research.

Research on topics involving key populations is likely to be sensitive and will require agreement by relevant in-country authorities. Applicants are encouraged to initiate discussions early in the planning stages of the application process so as to be able to document in their application the feasibility of the research plan.

In general, multidisciplinary approaches will be needed, including in some cases expertise in social or behavioral science, bioethics, philosophy, legal scholarship, policy analysis, clinical research, epidemiology, health systems research, or other disciplines, all dependent on the combination of expertise that is relevant and necessary for the project goals. Applicants are very strongly urged to include representatives of the population under study in the design, planning and conduct of the research.

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
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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)

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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

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, including Supplemental Grant Application Instructions 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.

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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

Letters of Support: Letters of support should be provided for critical reagents, resources, or collaborations.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date 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 SF424 (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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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 SF424(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. See Section III of this FOA for information on registration requirements.

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 System for Award Management. 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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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, or technologies that have the potential for significant impact on biomedical or biobehavioral 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 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.

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?

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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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?

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 human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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 score, but will not give separate scores for these items.

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 Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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.

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.

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.

Not Applicable

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 score.

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.

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).

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) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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 NIH Center for Scientific Review (CSR), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group 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 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'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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this 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 Research Performance Progress Report (RPPR) 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.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)

Telephone: 301-710-0267

Liza Dawson, PhD
National Institute for Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3210
Email: [email protected]

Susannah Allison, PhD
National Institute of Mental Health (NIMH)
Telephone: 240-627-3861
Email: [email protected]

Robert Freund, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1050
Email: [email protected]

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2988
Email: [email protected]

Aleisha S. James, MPH
National Institute of Mental Health (NIMH)
Telephone: 301-451-9948
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 Part 75.