Proposed guidelines for the protection of vulnerable subjects in clinical trials: Protections for decisionally impaired subjects

Gordon D. MacFarlane, Mark C. Herzberg, Laure Campbell

Research output: Contribution to journalArticlepeer-review

Abstract

Current regulations and guidelines identify specific subject populations as vulnerable. Regulations and guidelines generally stipulate protections with regard to the process of informed consent. Recent clinical trials suggest that satisfying the legal requirements for additional safeguards may not protect subjects to the extent we may desire. We present proposed guidelines for the protection of decisionally impaired subjects throughout the course of the trial.

Original languageEnglish (US)
Pages (from-to)59-69
Number of pages11
JournalClinical Ethics
Volume10
Issue number3
DOIs
StatePublished - Sep 1 2015

Bibliographical note

Funding Information:
Existing guidelines and guidance come from a variety of sources. For clinical trials funded by the Department of Health and Human Services, which includes the National Institutes of Health, vulnerable subjects and the required additional safeguards are described in what is known as the “Common Rule.” Eighteen Federal departments and agencies are required to adhere to the Common Rule in the conduct of clinical trials. Fifteen have included the Common Rule text into their chapters of the Code of Federal Regulations (). Three other agencies have incorporated the Common Rule either by legislation or Executive Order. The Food and Drug Administration (FDA) also has the Common Rule protections with some modifications written into the regulations covered by their jurisdiction. ,

Publisher Copyright:
© 2015, © The Author(s) 2015.

Copyright:
Copyright 2016 Elsevier B.V., All rights reserved.

Keywords

  • Vulnerable subjects
  • clinical trials
  • decisional impairment

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