Research Involving "Edge" Populations: Ethical and Regulatory Considerations


There are many ethical considerations for research studies involving “edge” populations, and this program provided an investigator perspective as well as the regulatory angle on research with subjects who are homeless, substance abusers, and/or HIV-positive.

Cynthia Gómez, PhD, discussed a multi-site study with HIV-positive participants and the work of the research team to ensure protection and sensitivity to issues. This part of the webinar focused on the investigator’s responsibility in the design and conduct of a study involving “edge” populations, including:

  • Applying certain protocols from recruitment to engagement of “edge” populations
  • Ensuring informed consent and confidentiality, including the need for certificates of confidentiality (CoCs)
  • Maintaining contact and following up with research subjects
  • Special considerations to be addressed by study teams when designing a study and by institutional review boards (IRBs) when reviewing these studies, such as payment and undue influence.

The second half of the presentation featured Julia Gorey, JD, with the regulatory perspective on research involving “edge” populations:

  • Options for handling institutional engagement
  • Recruitment issues
  • Informed consent and confidentiality issues 
  • Appropriate incentives
  • An overview of protections for research involving prisoners, 45 CFR 46 Subpart C

Who should attend?

This intermediate-level webinar was of interest to investigators, individuals working with HRPPs and IRBs, and regulatory professionals.


Cynthia A. Gómez , PhD is the founding director of Health Equity Institute at San Francisco State University where she leads efforts to enhance and integrate campus research, curricula, community service, and training programs that address health disparities and/or promote health equity in the United States. She previously served as co-director of the Center for AIDS Prevention Studies (CAPS) at the University of California at San Francisco, where she was also an associate professor in the Department of Medicine since 1991. She received her master’s degree in counseling psychology from Harvard University and her PhD in Clinical Psychology from Boston University. Prior to her work with CAPS, Dr Gómez spent 12 years working in community health settings, including five years as director of a child and family mental health center in Boston. Dr. Gómez is considered a pioneer in the areas of cultural determinants in sexual behaviors among Latinos, in the role of power dynamics in sexual risk among women, and in the development of HIV prevention interventions, including interventions for people living with HIV. Dr. Gómez is a nationally renowned speaker and an expert in the field of HIV prevention and sexual health.  She has served on several national committees, including the Center for Disease Control’s HIV and STD Advisory Council, National Institute on Drug Abuse’s National Hispanic Science Network, and the Substance Abuse and Mental Health Services Administration’s Advisory Committee on Women’s Services. She is a member and past chair of the board of directors of the Guttmacher Institute. Dr Gómez was also an appointed member to the Presidential Advisory Council on HIV/AIDS under both WJ Clinton and GW Bush administrations.

Julia Gorey, JD serves as a public health analyst in the Division of Policy and Assurances, Office for Human Research Protections (OHRP), Department of Health and Human Services (DHHS). Ms. Gorey assists in the formulation of policy and guidance affecting 45 CFR 46, and since 2008 has served as executive director of the Secretary’s Advisory Committee on Human Research Protections (SACHRP). SACHRP’s mission is to provide expert advice and recommendations to the Secretary on the conduct of research involving human subjects, with particular emphasis on special populations. Julia moved to OHRP in 2003 from the National Institutes of Health (NIH), where she served as radiation safety officer of the NIH Neuroscience Center at St. Elizabeths, and managed the Single Positron Emission Computerized Tomography (SPECT) Laboratory, at the National Institutes of Mental Health, Clinical Brain Disorders Branch. Her experience with psychiatric patients and human subject research led her into the field of research bioethics. Ms. Gorey holds a JD with a certificate in health law and policy from the University of Maryland School of Law.


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