Enhancing the Responsible Conduct of Sexual Health Prevention Research Across Global and Local Contexts: Training for Evidence-Based Research Ethics

Abstract

The HIV/AIDS pandemic has brought global attention to the ethical challenges of conducting research involving socially vulnerable participants. Such challenges require not only ethical deliberation but also an empirical evidentiary basis for research ethics policies and practices. This need has been addressed through the Fordham University HIV and Drug Abuse Prevention Research Ethics Institute, a National Institute on Drug Abuse–funded program that trains and funds early career scientists in conducting research on HIV/drug abuse research ethics. This article describes the ethical framework guiding Institute training and introduces readers to six empirical articles in this special issue that illuminate and help foster the responsible conduct of research.

Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth

“…The purpose of this study was to provide empirical data on SGMY self-consent that can assist investigators and IRBs in strategies to increase their research participation in ways that best protect their rights and welfare. Our method was grounded in the premise that integrating SGMY perspectives into the fabric of ethical planning is critical to enhancing the responsible conduct of research and for reducing IRB barriers to HIV prevention research (Fisher, 1999, 2004, 2015). SGMY responses provide a preliminary empirical basis for approving self-consent for PrEP prevention trials, and the method we used provides groundwork for gathering similar data for other biomedical and behavioral HIV prevention approaches as they continue to develop.…”

“…CDC recommendations for providing PrEP to HIV-risk populations underscore the urgent need for age- and population-targeted research to avoid the use of treatments tested in adult populations that may be ill-suited for SGMY (Center for Disease Control, 2014; Rudy et al, 2010). Instead of classifying SGMY as a vulnerable population based solely on age or social characteristics viewed as disadvantageous (DiClemente et al, 2010; Fisher, 1999, 2015; Masty & Fisher, 2008; Ott, 2014; Steinberg, 2013), we hope the data from this study encourages IRBs to approve self-consent procedures that draw on empirical data to build on youth consent strengths, to ensure SGMY have opportunities to participate in research critical to their health.…”

“…To reduce barriers to SGMY participation in research necessary to ensure their health and wellbeing requires equipping investigators with the knowledge and skills to conduct empirical research on these critical research ethics questions. To date, although there is an increasing number of U.S. and international research ethics programs (Glass, 2013; Matar, Garner, Millum, Sina, & Silverman, 2014), most doctoral and postdoctoral programs in public health and the social and medical sciences do not provide specific training in the investigative skills needed to understand the attitudes and perspectives of marginalized youth toward the goals and methods of research practices that may not be readily discerned simply through professional logic or inference (Fisher, 2014, 2015; Fisher & Yuko, in press). We hope this research encourages health science training programs to include instruction in generating systematic and generalizable knowledge on key ethical and regulatory issues that can assist investigators and IRBs in constructing age-appropriate human subjects protections for HIV prevention research.…”

“…Protecting the rights and welfare of minors requires applying empirical data on participant consent strengths and vulnerabilities to design procedures that reflect a “fit” between participant characteristics and the unique demands of the research context (Fisher, 2015; Masty & Fisher, 2008). Despite empirical data demonstrating that by age 14, most adolescents approach adult understanding of components of informed consent, there is a paucity of research on SGMY’s ability to self-consent to biomedical HIV prevention in general and PrEP studies specifically (Alexander et al, 2015; Corneli et al, 2015; Field & Behrman, 2004; Gilbert et al, 2015; Hosek & Zimet, 2010; Lally et al, 2014; Ott et al, 2013).…”

HIV Rates Are Increasing in Gay/Bisexual Teens

“…16 Ethics research in the form of qualitative interviews and quantitative surveys that elicit youth and parent perspectives and experiments that compare the effectiveness of different procedures can help empirically identify consent techniques that maximize youth understanding of procedures and minimize potential risks. In the absence of such empirical data, IRB decisions denying AMSM the right to self-consent to HIV prevention research will continue to be based on untested opinions about youth’s consent abilities, naïve assumptions that guardian permission is always in a child’s best interest, personal or institutional biases, or anecdotal evidence.…”