Assessing and communicating the risks and benefits of gene transfer clinical trials.

Full Abstract

The two most important ethical requirements for clinical studies of gene transfer are to ensure that:
(i) a protocol's risks are minimized and acceptable in light of the potential benefit to society and to research participants; and that (ii) a valid, informed consent process takes place. The history of gene transfer studies in humans shows that the probability of harm or benefit to participating individuals is extremely low. However, because the risks and benefits of gene transfer remain unpredictable, and because increasing the potential for benefits to individuals is likely to be accompanied by increases in potential for adverse events, close monitoring of human gene transfer research will continue. Recent research on informed consent for phase I studies of serious illnesses has revealed an evolving discussion on the proper standards for disclosure; one important conclusion is that disclosures regarding potential benefits to individuals need to be less ambiguous than they currently are.

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Author information

Author/s: Kim, Scott Y H (SY);

Affiliation: Bioethics Program, University of Michigan Medical School, 300 North Ingalls Street, Ann Arbor, MI 48109-0429, USA. scottkim(-atsign-)med.umich.edu

Journal and publication information

Publication Type: Journal Article; Review

Journal: Current opinion in molecular therapeutics (Curr Opin Mol Ther), published in England. (Language: eng)

Reference: 2006-Oct; vol 8 (issue 5) : pp 384-9

Dates: Created 2006/11/02; Completed 2007/01/09; Revised 2007/11/15;

PMID: 17078380, 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.

Clinical Trials as Topic - ethics; standards
Gene Therapy - adverse effects; ethics; standards
Humans

Humans
Informed Consent - ethics
Risk Assessment

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