Moral conflict and competing duties in the initiation of a biomedical HIV prevention trial with minor adolescents

Amy Knopf, Amy Lewis Gilbert, Gregory Zimet, Bill G. Kapogiannis, Sybil G. Hosek, J. Fortenberry, Mary Ott

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background: Biomedical HIV prevention research with minors is complicated by the requirement of parental consent, which may disclose sensitive information to parents. We examine the experience of principal investigators (PIs) and study personnel who faced this complex ethical issue in the first biomedical HIV prevention study that allowed minors to self-consent for enrollment. Methods: We conducted in-depth interviews with PIs and study personnel from 13 medical trial sites in cities across the United States. Data were analyzed using a conventional content analysis. Results: Participants experienced moral conflict as they struggled to fulfill conflicting duties in this trial involving minor adolescents with multiple vulnerabilities. Our participants experienced conflict between the two types of duties—protective and scientific—previously identified by Merritt. Protective duties were owed to the child, the parents, and the institution, and participants expressed tension between the actions that would protect these subgroups and the actions necessary to fulfill their scientific duties. Conclusions: Moral conflict was resolved in a variety of ways, including reflecting on the protocol's alignment with federal regulations, modifying consent language, considering each individual for enrollment carefully, and accepting institutional review board (IRB) decisions. Potential solutions for future studies are discussed, and include flexible protocol consent procedures and centralized IRB reviews.

Original languageEnglish (US)
Pages (from-to)1-8
Number of pages8
JournalAJOB Empirical Bioethics
DOIs
StateAccepted/In press - Nov 21 2016

Fingerprint

Minors
Research Ethics Committees
HIV
adolescent
personnel
parents
Parents
Parental Consent
Research Personnel
Ethics
content analysis
vulnerability
Language
Interviews
regulation
interview
language
Research
Conflict (Psychology)
Consent

Keywords

  • adolescents
  • clinical trial
  • HIV
  • moral conflict
  • parental consent
  • preexposure prophylaxis

ASJC Scopus subject areas

  • Health(social science)
  • Philosophy
  • Health Policy

Cite this

Moral conflict and competing duties in the initiation of a biomedical HIV prevention trial with minor adolescents. / Knopf, Amy; Gilbert, Amy Lewis; Zimet, Gregory; Kapogiannis, Bill G.; Hosek, Sybil G.; Fortenberry, J.; Ott, Mary.

In: AJOB Empirical Bioethics, 21.11.2016, p. 1-8.

Research output: Contribution to journalArticle

@article{036117fd2ab14e7789cb89c7bd630738,
title = "Moral conflict and competing duties in the initiation of a biomedical HIV prevention trial with minor adolescents",
abstract = "Background: Biomedical HIV prevention research with minors is complicated by the requirement of parental consent, which may disclose sensitive information to parents. We examine the experience of principal investigators (PIs) and study personnel who faced this complex ethical issue in the first biomedical HIV prevention study that allowed minors to self-consent for enrollment. Methods: We conducted in-depth interviews with PIs and study personnel from 13 medical trial sites in cities across the United States. Data were analyzed using a conventional content analysis. Results: Participants experienced moral conflict as they struggled to fulfill conflicting duties in this trial involving minor adolescents with multiple vulnerabilities. Our participants experienced conflict between the two types of duties—protective and scientific—previously identified by Merritt. Protective duties were owed to the child, the parents, and the institution, and participants expressed tension between the actions that would protect these subgroups and the actions necessary to fulfill their scientific duties. Conclusions: Moral conflict was resolved in a variety of ways, including reflecting on the protocol's alignment with federal regulations, modifying consent language, considering each individual for enrollment carefully, and accepting institutional review board (IRB) decisions. Potential solutions for future studies are discussed, and include flexible protocol consent procedures and centralized IRB reviews.",
keywords = "adolescents, clinical trial, HIV, moral conflict, parental consent, preexposure prophylaxis",
author = "Amy Knopf and Gilbert, {Amy Lewis} and Gregory Zimet and Kapogiannis, {Bill G.} and Hosek, {Sybil G.} and J. Fortenberry and Mary Ott",
year = "2016",
month = "11",
day = "21",
doi = "10.1080/23294515.2016.1251506",
language = "English (US)",
pages = "1--8",
journal = "AJOB Empirical Bioethics",
issn = "2329-4515",
publisher = "Taylor and Francis Ltd.",

}

TY - JOUR

T1 - Moral conflict and competing duties in the initiation of a biomedical HIV prevention trial with minor adolescents

AU - Knopf, Amy

AU - Gilbert, Amy Lewis

AU - Zimet, Gregory

AU - Kapogiannis, Bill G.

AU - Hosek, Sybil G.

AU - Fortenberry, J.

AU - Ott, Mary

PY - 2016/11/21

Y1 - 2016/11/21

N2 - Background: Biomedical HIV prevention research with minors is complicated by the requirement of parental consent, which may disclose sensitive information to parents. We examine the experience of principal investigators (PIs) and study personnel who faced this complex ethical issue in the first biomedical HIV prevention study that allowed minors to self-consent for enrollment. Methods: We conducted in-depth interviews with PIs and study personnel from 13 medical trial sites in cities across the United States. Data were analyzed using a conventional content analysis. Results: Participants experienced moral conflict as they struggled to fulfill conflicting duties in this trial involving minor adolescents with multiple vulnerabilities. Our participants experienced conflict between the two types of duties—protective and scientific—previously identified by Merritt. Protective duties were owed to the child, the parents, and the institution, and participants expressed tension between the actions that would protect these subgroups and the actions necessary to fulfill their scientific duties. Conclusions: Moral conflict was resolved in a variety of ways, including reflecting on the protocol's alignment with federal regulations, modifying consent language, considering each individual for enrollment carefully, and accepting institutional review board (IRB) decisions. Potential solutions for future studies are discussed, and include flexible protocol consent procedures and centralized IRB reviews.

AB - Background: Biomedical HIV prevention research with minors is complicated by the requirement of parental consent, which may disclose sensitive information to parents. We examine the experience of principal investigators (PIs) and study personnel who faced this complex ethical issue in the first biomedical HIV prevention study that allowed minors to self-consent for enrollment. Methods: We conducted in-depth interviews with PIs and study personnel from 13 medical trial sites in cities across the United States. Data were analyzed using a conventional content analysis. Results: Participants experienced moral conflict as they struggled to fulfill conflicting duties in this trial involving minor adolescents with multiple vulnerabilities. Our participants experienced conflict between the two types of duties—protective and scientific—previously identified by Merritt. Protective duties were owed to the child, the parents, and the institution, and participants expressed tension between the actions that would protect these subgroups and the actions necessary to fulfill their scientific duties. Conclusions: Moral conflict was resolved in a variety of ways, including reflecting on the protocol's alignment with federal regulations, modifying consent language, considering each individual for enrollment carefully, and accepting institutional review board (IRB) decisions. Potential solutions for future studies are discussed, and include flexible protocol consent procedures and centralized IRB reviews.

KW - adolescents

KW - clinical trial

KW - HIV

KW - moral conflict

KW - parental consent

KW - preexposure prophylaxis

UR - http://www.scopus.com/inward/record.url?scp=84999788896&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84999788896&partnerID=8YFLogxK

U2 - 10.1080/23294515.2016.1251506

DO - 10.1080/23294515.2016.1251506

M3 - Article

SP - 1

EP - 8

JO - AJOB Empirical Bioethics

JF - AJOB Empirical Bioethics

SN - 2329-4515

ER -