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 journalArticle

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

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Clinical Trials
Guidelines
Vulnerable Populations
Informed Consent

Keywords

  • Vulnerable subjects
  • clinical trials
  • decisional impairment

Cite this

Proposed guidelines for the protection of vulnerable subjects in clinical trials : Protections for decisionally impaired subjects. / MacFarlane, Gordon D.; Herzberg, Mark C; Campbell, Laure.

In: Clinical Ethics, Vol. 10, No. 3, 01.09.2015, p. 59-69.

Research output: Contribution to journalArticle

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