Title
Research Involving the Vulnerable Sick
Document Type
Article
Publication Date
10-1999
Source
Accountability in Research
Volume
7
Issue
1
First Page
21
Last Page
36
URL with Digital Object Identifier
http://dx.doi.org/10.1080/08989629908573940
Abstract
Research involving the vulnerable sick raises difficult challenges for investigators and Institutional Review Boards. Exactly who among the ill counts as vulnerable is a matter of judgement, and involves consideration of susceptibility to harm and capacity to provide free and informed consent. A balanced approach is required when protections are considered, and the benefits as well as the risks of research participation must be carefully weighed. A variety of protections for the vulnerable sick in research are available, including enrolling subjects in a study only with a strong justification, ensuring that consent is free and comprehending, and setting limits on the risk to which they may be asked to endure. Discussion of three contemporary controversies, placebo-controlled trials in the psychiatric setting, phase I clinical trials and oncology patients, and emergency room research involving patients incapable of giving consent, highlights the little recognized prominence of risk-benefit issues in the clinical studies in the vulnerable sick.
Notes
Dr. Charles Weijer is currently a faculty member at The University of Western Ontario.