Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
Reissue of PAR-18-732
None
93.989, 93.279, 93.242, 93.393, 93.394, 93.395, 93.399, 93.865
The purpose of this FOA is to stimulate research on interventions to reduce HIV/AIDS-associated stigma and its impact on the prevention and treatment of HIV/AIDS and on the quality of life of People Living with HIV/AIDS (PLWH). Specifically, this initiative will support intervention research on a) novel stigma reduction strategies 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 comorbidities/coinfections, d) reducing the effects of stigma on, and/or by, family members or caregivers of PLWH and e) development of innovative and improved stigma measurement in the context of implementation of a stigma-reduction intervention. The overall goals are to understand how to reduce stigma as a factor in HIV transmission, to eliminate or mitigate the aspects of stigma that limit beneficial health outcomes for the infected and at-risk individuals and communities, and to conduct exploratory studies to determine the feasibility of stigma-reduction interventions related to HIV prevention, treatment and/or care in Low and Middle-Income Countries (LMICs).
July 31, 2019
October 12, 2019; October 12, 2020
Only accepting applications for the AIDS Application Due Date(s) listed below
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
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.
This Funding Opportunity Announcement (FOA) issued by the Fogarty International Center (FIC) seeks to stimulate new and impactful research to develop 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). The FOA will support work to be done in Low and Middle-Income Countries (LMICs). Specifically, this initiative will support research on a) novel stigma-reduction and/or resilience building interventional strategies that link to increase in care-seeking behavior and/or promote decrease in transmission, b) reducing the impact of stigma on adolescent and/or youth health, c) strategies to address the complex burden of stigmatization due to HIV and/or one or more co-morbidities/co-infections/complications, d) reducing the effects of stigma on, and/or by, family members or caregivers of PLWH and e) development of innovative and improved stigma measurement in the context of intervention development or implementation of the proposed intervention. 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 lead to applications to 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 who are stigmatized. Stigma affects all PLWH, 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 to 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 to 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:
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 prevention and care continuum and improve biological and mental health outcomes for PLWH or their caregivers. In the context of an intervention, the areas of focus may include but are not limited to:
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 support exploratory studies to determine the 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 academic or research institution in the U.S. and one or more investigators from an academic or research institution in an LMIC are strongly encouraged to 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, and the plans for sustaining the research activity.
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.The United Nations AIDS Update Report 2018 -Miles to go: closing gaps, breaking barriers, righting injustices - https://www.unaids.org/sites/default/files/media_asset/miles-to-go_en.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.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Applicants may request a project period of up to two years.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Non-domestic entities are restricted to higher education and/or research 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.
Non-U.S. High Income Country Institutions are not eligible as the primary partner for a LMIC Institution, but may be included as consultants, especially if they present special opportunities for the proposed research. LMIC-U.S. or LMIC-LMIC partnerships between institutions are eligible.
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.
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.
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.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace 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.
Letter of Intent
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:
The letter of intent should be sent to:
Geetha P. Bansal, Ph.D.
Fogarty International Center
Telephone: 301-496-1492
Email:[email protected]
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.
Research Strategy: All applicants should incorporate the following elements while preparing the application:
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 will facilitate success in such collaboration, beyond the information stated on individual biosketches, should be clearly delineated. The role 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.
The following modifications also apply:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).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.
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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission 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 emphasize 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.
In addition, for applications involving clinical trials:
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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 HIV-related health outcome that would result from a successful intervention?
In addition, for applications involving clinical trials:
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological or psychological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical public health practice, community behaviors or healthcare policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
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?
In addition, for applications involving clinical trials:
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
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?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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? Is 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? 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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable?
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
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)?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Study Timeline
Specific to applications proposing clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of the 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 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 individuals of all ages (including children and older adults) 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.
Reviewers do not need to address this criterion because this program is also for applicants from foreign organizations and the work will only be conducted at foreign sites. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
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 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.
Applications will be assigned to the Fogarty International Center (FIC). 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 FIC Advisory Board. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available 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.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov)). NIH expects registration of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at https://grants.nih.gov/policy/humansubjects/policies-and-regulations/data-safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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.
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.
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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.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.
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.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Sonia Lee, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-594-4783
Email: [email protected]
Geetha P. Bansal, Ph.D.
Fogarty International Center
Telephone: 301-496-1492
Email:[email protected]
Gregory Greenwood, Ph.D., MPH
National Institute of Mental Health
Telephone: 240-669-5532
Email:[email protected]
Richard Jenkins, Ph.D.
National Institute on Drug Abuse
Telephone: 301-443-1923
Email: [email protected]
Geraldina Dominguez, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-781-3291
Email: [email protected]
Mark Rubert, PhD
Scientific Review Officer
Center for Scientific Review (CSR)
Telephone: 301-806-6596
Email: [email protected]
Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]
Mollie Shea
Fogarty International Center
Telephone: 301-451-6830
Email:[email protected]
Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: [email protected]