It is critical that applicants follow the Research (R) 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) issued by the Fogarty International Center (FIC) seeks to stimulate new and impactful research towards the development of stigma reduction interventions leading to better outcomes for the prevention and treatment of HIV/AIDS and on the quality of life of People Living with HIV/AIDS (PLWH) in Low and Middle-Income Countries (LMICs). Specifically, this initiative will support research on a) novel stigma reduction interventions that link to increase in care-seeking behavior and/or decrease in transmission; b) reducing the impact of stigma on adolescent and/or youth health; c) strategies to cope with the complex burden of stigmatization due to HIV and one or more co-morbidities/co-infections; d) reducing the effects of stigma on and/or by family members or caregivers of PLWH; and e) innovative and improved stigma measurement in the context of intervention development or implementation. The R21 grant mechanism is intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development (https://grants.nih.gov/grants/funding/r21.htm). It is hoped that this preliminary research will lay the foundation for larger intervention studies that can be funded by other organizations or NIH institutes that support stigma research.

Background/Rationale:

Despite significant advances in biomedical approaches to prevent HIV transmission, acquisition of new infections has not abated, suggesting the need for further research into the possible causes of and new ways to mitigate the spread of the disease (1). While introduction of Pre-exposure Prophylaxis (PrEP) and anti-retroviral therapy (ART) use for PLWH had significant effects on preventing HIV transmission to seronegative partners, along with other known prevention approaches such as condom use and medical male circumcision, several pockets of new infection have emerged globally (2). Similarly, protocols for the prevention of mother-to-child transmission (PMTCT) have been very effective; however, women still bear the burden of increased infection globally, especially adolescent girls, who can potentially continue to transmit HIV to their newborns. These women may not be accessing health care services to obtain information about PMTCT due to stigma associated with their HIV status and/or pregnancy (3, 4). Professional health communities acknowledge that stigma is one of the many reasons for continued transmission of HIV (3, 4), and that stigma creates a barrier to getting tested, treated, and retained in care, especially in LMICs (4).

Stigma is a behavioral manifestation of self or societal disapproval of a condition affecting those that are stigmatized. Stigma affects PLWH overall, including key populations such as sex workers, people who inject drugs, transgender people, prisoners, and men who have sex with men. Adolescents and youth are vulnerable and suffer from public- and/or self- stigma. Early awareness of stigma and its consequences, and exposure to resources that can prevent infection and transmission, may have a large impact during this crucial period, suggesting the importance of further work with this group. Because of their unique psychological and physiological makeup, the ability of adolescents to respond to stigma-related stress have not been well studied. Interventions that increase resiliency and/or provide coping mechanisms may be effective for better health outcomes in all of these groups.

HIV-infected people often also suffer from other infections such as tuberculosis; and other non-communicable diseases such as mental health, metabolic and other neurological disorders, which are themselves subject to stigma. They also suffer stigma due to perceived lifestyle choices. The compounded effect of stigma associated with multiple conditions (layered or intersecting stigma) imposes an extra burden on these people. To develop effective interventions to improve the health outcomes in these groups, it will be important to understand and dissect out the major contributors to stigma and design appropriate interventions.

Another understudied population are exposed but uninfected people, especially children of infected parents and caregivers tending to the sick, who can themselves be targets of stigma that can affect their health in different ways. It is not clear how much of HIV/AIDS stigma related stress in this group of people is the cause of prevention failures and breakdown in care, and what type of interventions may be optimal for providing resilience and motivation to this group of caregivers and family members.

There is a need for better stigma measures that can help assess the efficacy of stigma reduction interventions at different stages of implementation, in different contexts and populations, and at different steps of the HIV/AIDS disease care continuum. This may be particularly necessary in dissecting out the relative contribution of layered or intersecting stigma either due to HIV/AIDS comorbidities and coinfections, or HIV compounded by other factors such as racism, sexism, religious intolerance, and sexual orientation among others.

For the purposes of this FOA:

• HIV-related health outcomes include any change in the health status of the affected person, group or community that result from an intervention, including but not limited to: employing preventative methods for protection from infection, undergoing HIV testing, adhering to medications, and retention in and maintaining linkage to HIV care. Care seeking behaviors can also be assessed by biological outcomes such as decrease in viral load, among others.
• Interventions may employ biomedical, behavioral or structural approaches that are designed to produce a decrease in stigma. Processes that address individual (for example self-stigma), interpersonal, intersectional, or structural (for example cultural norms, institutional practices, and other) stigma for which an intervention can be developed would be considered an appropriate focus for the application.

Objectives:

The objective of this FOA is to lay the groundwork for, or pilot, stigma-reduction interventions to improve HIV health seeking behavior across the HIV care continuum and improve biological and mental outcomes for PLWH or their caregivers. In the context of an intervention, the areas of focus may include but are not limited to:

• Adapting, developing, validating or implementing stigma reduction interventions in PLWH. Target populations may include adolescents and/or youth, caregivers, and other key populations such as sex workers, people who inject drugs, transgender people, prisoners, and men who have sex with men, among others.
• Adapting, developing, or validating measurement instruments to assess the success of the intervention in reducing stigma and in improving health outcomes.
• Formative research on novel stigma reduction interventions to understand the obstacles to seeking care.
• Formative research to assess the complexities in layered or intersecting stigma that might lead to strategies to address the synergistic burden.
• Studies to assess stigma reduction interventions in specific social groups (for example, unmarried pregnant women); or across multiple groups (for example PLWH and their health care workers) linking to a health outcome such as decrease in transmission.
• Studies to assess the association of structural level stigma reduction interventions with better health outcomes; for example, modifiable structural factors such as health policy and its impact on health outcomes.
• Tools for addressing stigma awareness in HIV+ adolescents, young children and orphans and increase their participation in care seeking and prevention strategies.

Applications proposing studies that do not address a stigma reduction intervention strategy linked to measurement of a beneficial health outcome would not be supported under this FOA.

Through this FOA, FIC seeks to initiate exploratory studies to determine feasibility of implementable and ultimately scalable approaches to understand and reduce stigma as a factor in HIV transmission. Applicants should assemble teams with the appropriate range of expertise required to accomplish the aims of the study, which may include a collaborative team with multi-disciplinary expertise.

The proposed collaborative exploratory research is expected to help build the capacity for full research programs by improving the research environment and strengthening LMIC individual and institutional research capabilities in the proposed research areas. The proposed work and follow up research are expected to contribute to the long-term goals of building sustainable capacity for stigma research in LMICs. One or more investigators from an institution in the U.S. and one or more investigators from an institution in an LMIC must collaborate as key personnel on the application. Applicants should explicitly address the needs of collaborating LMIC institutions to develop capacity for carrying out research in this field.

Proposed studies must be consistent with the NIH Office of AIDS Research high and medium priorities for HIV research (NOT-OD-15-137: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html ).

References:

1. https://www.cdc.gov/nchhstp/newsroom/2017/croi-hiv-incidence-press-release.html

2. http://www.unaids.org/sites/default/files/media_asset/WAD2015_report_en_part01.pdf

3. http://www.unwomen.org/en/what-we-do/hiv-and-aids/facts-and-figures

4. On the fast track to end AIDS by 2030: Focus on location and population. UNAIDS World AIDS Day 2015 Report.

See Section VIII. Other Information for award authorities and regulations.

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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)

Other

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

Non-domestic entities are restricted to higher education institutions and other non-profit organizations in LMICs, which are defined by The World Bank as low-, lower-middle-, or upper-middle-income economies - http://data.worldbank.org/about/country-classifications/country-and-lending-groups Hong Kong-based institutions are not eligible as applicant or primary LMIC -partner institutions. If Hong Kong is included, a second institution in mainland China must be involved as the primary collaborating LMIC institution.

At least one institution in the U.S. and at least one institution in an LMIC must be involved as partners in the grant application.

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 provides an avenue for investigators in the U.S. and LMICs, with shared interests in stigma research in HIV/AIDS affected populations, to establish collaborative research and strengthen and sustain research capacity activities. Therefore, one or more investigators from an institution in the U.S. and one or more from an institution in an LMIC (see definitions above, in the Eligible Institutions section) must collaborate on the application. PLEASE NOTE: Use of the multiple PD/PI format is encouraged but not required. Where there are multiple PD/PIs, the contact PD/PI may be from the LMIC institution or from the U.S. but the collaborators are expected to prepare the application jointly.

Non-U.S. based High Income Country investigators are not eligible as PD/PIs but may be included as consultants, especially if they present special opportunities for furthering research programs.

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).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) 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.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Geetha P. Bansal, Ph.D.
Telephone: 301-496-1492
Fax: 301-402-0779
Email: [email protected]

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. At least one LMIC researcher and at least one U.S. researcher must be identified as key personnel.

All instructions in the SF424 (R&R) Application Guide must be followed. Applicant should budget funds for at least one PD/PI to attend the annual program network meeting in Bethesda, MD.

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:

Research Strategy: All applicants should incorporate the following elements while preparing the application:

• Succinctly define the stigma associated problem and describe the magnitude of, and factors involved in, the problem to be addressed in the LMIC population
• Identify the needs of the affected group targeted for the appropriate stigma reduction intervention
• Clearly articulate research questions to be addressed and the methodological approach that will be used to answer the questions
• Justify the relevance of the proposed research to the health outcomes of people in the LMIC setting
• Discuss briefly how the proposed exploratory research will prepare for or test an intervention to reduce stigma and increase the health of stigmatized individuals or populations
• Describe the resources including research capabilities that will be needed to develop the intervention and how they will be implemented
• Discuss the outcome measures that will be utilized to determine whether the intervention is successful in increasing the health of the target population, including biological and psychological endpoints in addition to potential behavioral changes; and any formative research required to develop these instruments, measures, and interventions
• Integrate strategies for research capacity strengthening at the LMIC institution into the proposed research program

Collaboration

The purpose of this grant is to foster initial development of collaborative work focused on HIV-associated stigma relevant to LMICs; accordingly, investigators are not required to demonstrate in the application any history of prior collaboration. However, those factors in the investigators' background and/or institutional circumstances that would facilitate success in such collaboration should be clearly delineated, beyond the information stated on individual biosketches. The roles of each key personnel and institution and the plans for the coordination of the research activities should be noted.

Letters of Support: Letters of support should be provided by each collaborator and collaborating institution.

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.

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 PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

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 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 the policy.

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.

For this announcement, note the following:

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? Is there a strong scientific premise for the project? 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?Does the proposed study address the relevance of stigma to the target population in the LMIC, and identify the health outcome that would result from a successful intervention?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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? Do the PD(s)/PI(s) have the scientific background, expertise, and LMIC experience to provide strong leadership, direction, management, and administration of the proposed research? Based on the investigators' background and/or institutional circumstances, is there potential for successful collaboration within the research team?

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? Will the proposed study have sufficient influence on strengthening and sustaining HIV-associated stigma research capabilities at the LMIC institution?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? Is a specific subject population identified for this research along with the particular type of stigma specifically faced by this population? Do the applicants propose stigma reduction interventions for the specific type of stigma and propose to study the effects on one or more relevant health outcomes as \ HIV-related health outcomes include any change in the health status of the affected person, group or community that result from an intervention, including but not limited to: employing preventative methods for protection from infection, undergoing HIV testing, adhering to medications, and retention in and maintaining linkage to HIV care. Care seeking behaviors can also be assessed by biological outcomes such as decrease in viral load, among others.

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? Do the Institutional environment and commitment convey support for sustaining stigma research at the Institution(s)?

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.

Research Capacity Strengthening

Does the proposed exploratory research strategy contain appropriate plans to develop stigma related research capacity at the LMIC institution(s) as needed through research methodology training, professional development, mentoring and other models? Are there appropriate and feasible plans to help the LMIC institution(s) sustain and continue to strengthen their stigma research capabilities, including the capability to apply for externally funded initiatives as appropriate?

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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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.

Applications from Foreign Organizations

Not applicable

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 Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, 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 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 Councils or Boards. 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.
• Geographic balance of projects
• Scientific content for programmatic balance.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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 Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Geetha P. Bansal, Ph.D.
Fogarty International Center
Telephone: 301-496-1492
Email: [email protected]

Vidya Vedham, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7272
Email: [email protected]

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

Mollie Shea
Fogarty International Center
Telephone: 301-451-6830
Email: [email protected]

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
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.