TY - JOUR
T1 - Whether to Waive Parental Permission in HIV Prevention Research Among Adolescents
T2 - Ethical and Legal Considerations
AU - Bauman, Laurie J.
AU - Mellins, Claude Ann
AU - Klitzman, Robert
N1 - Funding Information:
This work was supported by a center grant from the National Institute Mental Health to the HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University (P30MH43520; Center PI: Robert H Remien, Ph.D.). Specifically, this grant funded the invitational meeting, “Obtaining Parental Permission in HIV Prevention Research with Adolescent Minors: Whose Risk, Whose Benefit, Whose Judgment?” held June 15, 2017 at The HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, New York, NY. We acknowledge the participants at the meeting, listed alphabetical order: Susannah Allison, Ph.D., Program Officer, Division of AIDS Research, NIMH; Laurie Bauman, Ph.D., Professor of Pediatrics, Director of the Prevention Intervention Research Center and Professor of Pediatrics and Psychiatry and Behavioral Sciences, Science Core of Einstein-Rockefeller-CUNY-CFAR at the Albert Einstein College of Medicine, Director of the Biomedical Core, HIV Center for Clinical and Behavioral Studies; Melissa Epstein, Ph.D., M.B.E., C.I.P., Director, Office of Human Research Affairs, Albert Einstein College of Medicine/Montefiore Medical Center; Robert E. Fullilove, Ed.D., Associate Dean for Community and Minority Affairs, Professor of Clinical Sociomedical Sciences, Mailman School of Public Health, Columbia University; Donna Futterman, M.D., Professor of Pediatrics, Albert Einstein College of Medicine, Director, Adolescent AIDS Program, Montefiore; Adrian Guzman, J.D., M.P.H., Acting Director of External Affairs/Policy Analyst, Bureau of HIV/AIDS Prevention and Control (BHIV), NYC Health Department; Robert Klitzman, M.D., Professor of Psychiatry in the Vagelos College of Physicians and Surgeons and Mailman School of Public Health and Director of the Masters of Bioethics Program, Columbia University; Sonia Lee, Ph.D., Program Officer, Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH; Carol Levine, M.A., Director, Families and Health Care Project, United Hospital Fund; Claude Ann Mellins, Ph.D., Professor of Medical Psychology (in Psychiatry and Sociomedical Sciences), Co-Director, HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality, and Health, Co-Director, Office of Clinical Psychology, New York State Psychiatric Institute and Columbia University; Susan L. Rosenthal, Ph.D., A.B.P.P., Professor of Medical Psychology (in Pediatrics and Psychiatry), Vice Chair for Faculty Development, Department of Pediatrics, Director, Division of Child and Adolescent Health, Department of Pediatrics at Columbia University Irving Medical Center – Vagelos College of Physicians and Surgeons, New York Presbyterian Morgan Stanley Children's Hospital; John Santelli, M.D., Professor, Population and Family Health and Pediatrics, Columbia University Mailman School of Public Health; Michele Ybarra, M.P.H., Ph.D., Center for Innovative Public Health Research (CiPHR).
Funding Information:
Funding was provided by the National Institute of Mental Health (NIMH) to the HIV Center for Clinical and Behavioral Studies (#P30-MH45320; PI: Robert H. Remien, Ph.D.). Acknowledgements
Publisher Copyright:
© 2020 American Society of Law, Medicine & Ethics.
PY - 2020/3/1
Y1 - 2020/3/1
N2 - Critical ethical questions arise concerning whether studies among adolescents of new behavioral and biomedical HIV preventive interventions such as Pre-Exposure Prophylaxis (PrEP) 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 (IRB) 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.
AB - Critical ethical questions arise concerning whether studies among adolescents of new behavioral and biomedical HIV preventive interventions such as Pre-Exposure Prophylaxis (PrEP) 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 (IRB) 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.
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U2 - 10.1177/1073110520917010
DO - 10.1177/1073110520917010
M3 - Article
C2 - 32342775
AN - SCOPUS:85084169369
SN - 1073-1105
VL - 48
SP - 188
EP - 201
JO - Journal of Law, Medicine and Ethics
JF - Journal of Law, Medicine and Ethics
IS - 1
ER -
