Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa.

Full Abstract

BACKGROUND:
South Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial. Adolescents may be enrolled in late 2007. In the development and review of adolescent HIV vaccine trial protocols there are many complexities to consider, and much work to be done if these important trials are to become a reality.

DISCUSSION:
This article sets out essential requirements for the lawful conduct of adolescent research in South Africa including compliance with consent requirements, child protection laws, and processes for the ethical and regulatory approval of research.

SUMMARY:
This article outlines likely complexities for researchers and research ethics committees, including determining that trial interventions meet current risk standards for child research. Explicit recommendations are made for role-players in other jurisdictions who may also be planning such trials. This article concludes with concrete steps for implementing these important trials in South Africa and other jurisdictions, including planning for consent processes; delineating privacy rights; compiling information necessary for ethics committees to assess risks to child participants; training trial site staff to recognize when disclosures trig mandatory reporting response; networking among relevant ethics committees; and lobbying the National Regulatory Authority for guidance.

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Author information

Author/s: Slack, Catherine (C); Strode, Ann (A); Fleischer, Theodore (T); Gray, Glenda (G); Ranchod, Chitra (C);

Affiliation: HIV AIDS Vaccines Ethics Group, School of Psychology, University of KwaZulu-Natal, Private Bag X01, Scottsville, 3209, Pietermaritzburg, South Africa. slackca(-atsign-)ukzn.ac.za

Journal and publication information

Publication Type: Journal Article; Research Support, Non-U.S. Gov't

Journal: BMC medical ethics (BMC Med Ethics), published in England. (Language: eng)

Reference: 2007-; vol 8 (issue ) : pp 5

Dates: Created 2007/05/30; Completed 2007/08/27; Revised 2008/11/20;

PMID: 17498316, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

AIDS Vaccines
Adolescent
Child Advocacy - ethics; legislation & jurisprudence
Clinical Trials, Phase I as Topic - ethics
Clinical Trials, Phase II as Topic - ethics
Ethics Committees, Research
Ethics, Research

Humans
Informed Consent - ethics; legislation & jurisprudence
Legal Guardians
Nontherapeutic Human Experimentation - ethics; legislation & jurisprudence
Parental Consent
Privacy - legislation & jurisprudence
South Africa

Associated Chemicals: AIDS Vaccines (0)

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