Critical ethical questions arise concerning whether studies among adolescents of new behavioral and biomedical HIV preventive interventions such as Pre-Exposure Prophylaxis should obtain parental permission. This paper examines the relevant regulations and ethical guidance concerning waivers of parental permission, and arguments for and against such waivers. Opponents of such waivers may argue that adolescent decision-making is “too immature” and that parents always have rights to decide how to protect their children. Yet requiring parental permission may put adolescents at risk, and/or (...) limit adolescent participation, jeopardizing study findings’ validity. This paper presents recommendations on when researchers and Institutional Review Boards should waive parental permission, and what special protections should be adopted for adolescents who consent for themselves, e.g., assuring adolescent privacy and confidentiality, screening for capacity to consent, and identifying adolescents who are at elevated risk from study participation. We also present a series of specific areas for future research to design tools to help make these assessments, and to inform researcher and IRB decisions. These recommendations can help ensure that research is conducted that can aid adolescents at risk for HIV, while minimizing risks and protecting these individuals' rights as much as possible. (shrink)

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. (shrink)

ABSTRACT Online research has become a critical recruitment modality for understanding and reducing health disparities among hidden populations most at risk for HIV infection. There is a lack of consensus and guidelines for the responsible conduct of online recruitment for HIV risk populations. Using semi-structured phone interviews, this study drew on the experiences of principal investigators engaged in online HIV research to illuminate scientific and ethical benefits and challenges of social media recruitment. Using Thematic Analysis five major themes emerged: sampling (...) advantages and disadvantages; challenges of data integrity; control of privacy protections; researcher competence and responsibility; and resources. (shrink)

Young men who have sex with men younger than 18 years are often excluded from HIV prevention research in Thailand due to cultural attitudes toward youth sexuality, social stigma, and difficulties obtaining guardian permission. Culturally sensitive focus group discussions conducted with parents and YMSM in Bangkok, Thailand, identified barriers and facilitators related to minors’ participation in HIV prevention research. Although gender and class differences emerged, mothers and fathers were generally accepting of research to reduce HIV risk but not in favor (...) of waiver. Youth’s positive attitude toward parental permission was tempered by concerns about harms posed by disclosing same-sex attraction through permission forms. (shrink)