Evidence map›Paper›PMID 28949893›Full record

ArticleAJOB empirical bioethics

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

Amelia S Knopf, Amy Lewis Gilbert, Gregory D Zimet, Bill G Kapogiannis, Sybil G Hosek, J Dennis Fortenberry, Mary A Ott, Adolescent Medicine Trials Network for HIV/AIDS Interventions

Abstract read
In one paragraph

Article in AJOB empirical bioethics. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

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  14. Whether to Waive Parental Permission in HIV Prevention Research Among Adolescents: Ethical and Legal Considerations.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 2 countries.

Amelia S Knopfa Indiana University School of Nursing.ORCID 0000-0003-2557-4556
Amy Lewis Gilbertb Department of Pediatrics , Indiana University School of Medicine.ORCID 0000-0003-2492-178X
Gregory D Zimetb Department of Pediatrics , Indiana University School of Medicine.
Bill G Kapogiannisc Maternal and Pediatric Infectious Disease Branch, National Institute of Child Health and Human Development.
Sybil G Hosekd Department of Psychiatry, Stroger Hospital of Cook County.
J Dennis Fortenberryb Department of Pediatrics , Indiana University School of Medicine.
Mary A Ottb Department of Pediatrics , Indiana University School of Medicine.
Adolescent Medicine Trials Network for HIV/AIDS Interventionse ATN Coordinating Center, Department of Epidemiology , University of Alabama Birmingham School of Public Health.
Indiana University School of MedicineHealth and Human Development (2HD) Research Network · CMJohn H. Stroger, Jr. Hospital of Cook County · USUniversity School · US

Funding

Adol. Medicine Trials Network for HIV/AIDS InterventionsU01HD040474 · NICHD · WESTAT, INC. · PI HARRIS, DONALD ROBERT · 2001 to 2016
$114.4M
LEADERSHIP GROUP FOR ADOLESCENT MEDICINE TRIALS NETWORKU01HD040533 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI WILSON, CRAIG M · 2001 to 2016
$76.4M
INDIANA UNIVERSITY: TRAINING IN BEHAVIORAL NURSINGT32NR007066 · NINR · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI RAWL, SUSAN M · 1990 to 2017
$4.2M
NICHD NIH HHS U01 HD040474NICHD NIH HHS U01 HD040533NINR NIH HHS T32 NR007066
6 · The paper itself

Abstract

backgroundBiomedical 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.

methodsWe 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.

resultsParticipants 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.

conclusionsMoral 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.

Indexed as

ConfidentialityConflict, PsychologicalInformed Consent By MinorsParentsAdolescentBiomedical ResearchDisclosureEthics, ResearchHIV InfectionsHumansMoral ObligationsMoralsParental ConsentPatient RightsResearch Personneladolescentsclinical trialHIVmoral conflictparental consentpreexposure prophylaxis

Identifiers

PMID28949893
PMCPMC5618718
OpenAlexW2537853811

What OpenQuestion holds

Textmetadata
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Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.