TY - JOUR
T1 - Innovative approaches to obtain minors' consent for biomedical HIV prevention trials
T2 - Multi-site quasi-experimental study of adolescent and parent perspectives
AU - Knopf, Amelia
AU - Ott, Mary A.
AU - Draucker, Claire Burke
AU - Fortenberry, J. Dennis
AU - Reirden, Daniel H.
AU - Arrington-Sanders, Renata
AU - Schneider, John
AU - Straub, Diane
AU - Baker, Rebecca
AU - Bakoyannis, Giorgos
AU - Zimet, Gregory D.
N1 - Funding Information:
This protocol is supported by the ATN from the NIH (5U24HD089880-02) through the following institutes: National Institute on Minority Health and Health Disparities, NICHD, National Institute of Mental Health, and National Institute on Drug Abuse. Network operations are supported through the ATN coordinating center (University of North Carolina) with data management support and statistical analyses provided by the IU Department of Biostatistics (G Bakoyannis, S Ofner, and P Krombach). A Katz provides additional research assistance and helps in project coordination. The authors acknowledge the contribution of the staff at participating research sites, including the following: Johns Hopkins University, Baltimore (M Oliva, K Bailey, and Dr D Brooks); the University of Chicago (D Franklin, B Davis, S Nakasone, and S Ramani); the University of Colorado, School of Medicine, Aurora (A Katai, C Chambers, M Curry, M Glidden, and M Salerno); and the University of South Florida, Tampa (Dr J Hess). The authors would like to thank S Wilson, R Goolsby, L Holland, and Dr M Psioda, all of whom contributed to the initiation of this project, the adolescents and parents of the IU Adolescent Medicine Teen Advisory Board, and the University of South Florida Youth Advisory Board, who pilot tested early versions of study materials. Finally, the authors are grateful to all the youth and parents who participated in this project. They thank all of the aforementioned people for their time and effort.
Funding Information:
Here, we describe the protocol for our ongoing study researching consent for minors. The project is titled Consent 2.0 and is supported by the NIH-funded Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). Consent 2.0 examines the issue of minor consent to enrollment in biomedical HIV prevention trials from the perspective of the youth and parents. The study will expand the body of empirical evidence available to guide regulators, IRB members, researchers, and policy makers as they consider approaches to the ethical engagement of minor adolescents in biomedical research on stigmatized topics or with highly vulnerable populations. The purpose of the study is to examine how parental involvement in the consent process affects the acceptability of hypothetical participation in biomedical HIV prevention trials, from the perspective of minor adolescents and parents of minor adolescents. We use a simulated consent process, which emulates real consent processes for 2 different types of biomedical HIV prevention trials that have included minor adolescents.
Funding Information:
This protocol is supported by the ATN from the NIH (5U24HD089880-02) through the following institutes: National Institute on Minority Health and Health Disparities, NICHD, National Institute of Mental Health, and National Institute on Drug Abuse. Network operations are supported through the ATN coordinating center (University of North Carolina) with data management support and statistical analyses provided by the IU Department of Biostatistics (G Bakoyannis, S Ofner, and P Krombach). A Katz provides additional research assistance and helps in project coordination. The authors acknowledge the contribution of the staff at participating research sites, including the following: Johns Hopkins University, Baltimore (M Oliva, K Bailey, and Dr D Brooks); the University of Chicago (D Franklin, B Davis, S Nakasone, and S Ramani); the University of Colorado, School of Medicine, Aurora (A Katai, C Chambers, M Curry, M Glidden, and M Salerno); and the University of South Florida, Tampa (Dr J Hess). The authors would like to thank S Wilson, R Goolsby, L Holland, and Dr M Psioda, all of whom contributed to the initiation of this project, the adolescents and parents of the IU Adolescent Medicine Teen Advisory Board, and the University of South Florida Youth Advisory Board, who pilot tested early versions of study materials. Finally, the authors are grateful to all the youth and parents who participated in this project. They thank all of the aforementioned people for their time and effort. The content in this paper is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Publisher Copyright:
© Amelia Knopf, Mary A Ott, Claire Burke Draucker, J Dennis Fortenberry, Daniel H Reirden, Renata Arrington-Sanders, John Schneider, Diane Straub, Rebecca Baker, Giorgos Bakoyannis, Gregory D Zimet.
PY - 2020/3
Y1 - 2020/3
N2 - Background: Despite the high burden of new HIV infections in minor adolescents, they are often excluded from biomedical HIV prevention trials, largely owing to the ethical complexities of obtaining consent for enrollment. Researchers and ethics regulators have a duty to protect adolescents-as a special category of human subjects, they must have protection that extends beyond those afforded to all human subjects. Typically, additional protection includes parental consent for enrollment. However, parental consent can present a risk of harm for minor adolescents. Research involving minor adolescents indicate that they are unwilling to join biomedical trials for stigmatized health problems, such as HIV, when parental consent is required. This presents a significant barrier to progress in adolescent HIV prevention by creating delays in research and the translation of new scientific evidence generated in biomedical trials in adult populations. Objective: This protocol aims to examine how parental involvement in the consent process affects the acceptability of hypothetical participation in biomedical HIV prevention trials from the perspectives of minor adolescents and parents of minor adolescents. Methods: In this protocol, we use a quasi-experimental design that involves a simulated consent process for 2 different HIV prevention trials. The first trial is modeled after an open-label study of the use of tenofovir disoproxil fumarate and emtricitabine as preexposure prophylaxis for HIV. The second trial is modeled after a phase IIa trial of an injectable HIV integrase inhibitor. There are 2 groups in the study - minor adolescents aged 14 to 17 years, inclusive, and parents of minor adolescents in the same age range. The adolescent participants are randomized to 1 of 3 consent conditions with varying degrees of parental involvement. After undergoing a simulated consent process, they rate their willingness to participate (WTP) in each of the 2 trials if offered the opportunity. The primary outcome is WTP, given the consent condition. Parents undergo a similar process but are asked to rate the acceptability of each of the 3 consent conditions. The primary outcome is acceptability of the consent method for enrollment. The secondary outcomes include the following: capacity to consent among both participant groups, the prevalence of medical mistrust, and the effects of the study phase (eg, phase IIa vs the open-label study) and drug administration route (eg, oral vs injection) on WTP (adolescents) and acceptability (parents) of the consent method. Results: Enrollment began in April 2018 and ended mid-September 2019. Data are being analyzed and dissemination is expected in April 2020. Conclusions: The study will provide the needed empirical data about minor adolescents' and parents' perspectives on consent methods for minors. The evidence generated can be used to guide investigators and ethics regulators in the design of consent processes for biomedical HIV prevention trials.
AB - Background: Despite the high burden of new HIV infections in minor adolescents, they are often excluded from biomedical HIV prevention trials, largely owing to the ethical complexities of obtaining consent for enrollment. Researchers and ethics regulators have a duty to protect adolescents-as a special category of human subjects, they must have protection that extends beyond those afforded to all human subjects. Typically, additional protection includes parental consent for enrollment. However, parental consent can present a risk of harm for minor adolescents. Research involving minor adolescents indicate that they are unwilling to join biomedical trials for stigmatized health problems, such as HIV, when parental consent is required. This presents a significant barrier to progress in adolescent HIV prevention by creating delays in research and the translation of new scientific evidence generated in biomedical trials in adult populations. Objective: This protocol aims to examine how parental involvement in the consent process affects the acceptability of hypothetical participation in biomedical HIV prevention trials from the perspectives of minor adolescents and parents of minor adolescents. Methods: In this protocol, we use a quasi-experimental design that involves a simulated consent process for 2 different HIV prevention trials. The first trial is modeled after an open-label study of the use of tenofovir disoproxil fumarate and emtricitabine as preexposure prophylaxis for HIV. The second trial is modeled after a phase IIa trial of an injectable HIV integrase inhibitor. There are 2 groups in the study - minor adolescents aged 14 to 17 years, inclusive, and parents of minor adolescents in the same age range. The adolescent participants are randomized to 1 of 3 consent conditions with varying degrees of parental involvement. After undergoing a simulated consent process, they rate their willingness to participate (WTP) in each of the 2 trials if offered the opportunity. The primary outcome is WTP, given the consent condition. Parents undergo a similar process but are asked to rate the acceptability of each of the 3 consent conditions. The primary outcome is acceptability of the consent method for enrollment. The secondary outcomes include the following: capacity to consent among both participant groups, the prevalence of medical mistrust, and the effects of the study phase (eg, phase IIa vs the open-label study) and drug administration route (eg, oral vs injection) on WTP (adolescents) and acceptability (parents) of the consent method. Results: Enrollment began in April 2018 and ended mid-September 2019. Data are being analyzed and dissemination is expected in April 2020. Conclusions: The study will provide the needed empirical data about minor adolescents' and parents' perspectives on consent methods for minors. The evidence generated can be used to guide investigators and ethics regulators in the design of consent processes for biomedical HIV prevention trials.
KW - Adolescence
KW - Biomedical ethics
KW - HIV
KW - Parental consent
UR - http://www.scopus.com/inward/record.url?scp=85083364752&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85083364752&partnerID=8YFLogxK
U2 - 10.2196/16509
DO - 10.2196/16509
M3 - Review article
C2 - 32224493
AN - SCOPUS:85083364752
SN - 1929-0748
VL - 9
JO - JMIR Research Protocols
JF - JMIR Research Protocols
IS - 3
M1 - e16509
ER -