Ethical, Legal and Policy Issues in HIV Research with Key Populations (R21)

Ethical, Legal and Policy Issues in HIV Research with Key Populations (R21)
Department of Health and Human Services – National Institutes of Health


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

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

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

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


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

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

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

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

Topics of interest

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

Minimizing and Managing Risk  

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

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

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

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Mental Health (NIMH)

Funding Opportunity Title

Ethical, Legal and Policy Issues in HIV Research with Key Populations (R21)

Activity Code

R21 Exploratory/Developmental Research Grant

Announcement Type


Related Notices


Funding Opportunity Announcement (FOA) Number


Companion Funding Opportunity

PAR-15-328 R01 Research Project Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.855, 93.856; 93.242

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages applications to analyze and address ethical, legal, or policy challenges specific to work with key populations in HIV research or health care.

Proposed projects should be focused on ethical, legal or policy challenges in relation to research studies or program implementation for HIV or associated co-morbidities, affecting one or more of the following key populations: (1) men who have sex with men; (2) people who inject drugs; (3) people in prisons and other closed settings; (4) sex workers; (5) transgender people or (6) adolescent girls and young women at high risk of HIV acquisition or who are living with HIV.  This FOA encourages both empirical and conceptual research projects addressing these topics.

Key Dates

Posted Date

August 7, 2015

Open Date (Earliest Submission Date)

December 7, 2015

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

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.

AIDS Application Due Date(s)

January 7, 2016; September 7, 2016; January 7, 2017; September 7, 2017; January 8, 2018; September 7, 2018, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

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.

Scientific Merit Review

February 2016; October 2016; February 2017; October 2017; February 2018; October 2018

Advisory Council Review

May 2016; January 2017; May 2017; January 2018; May 2018; January 2019

Earliest Start Date

July 2016; April 2017; July 2017; April 2018; July 2018; April 2019

Expiration Date

September 8, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options to submit your application to the agency through You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from, complete the forms offline, submit the completed forms to and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to and track your application in eRA Commons.