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. 2015 Dec;12(6):692-5.
doi: 10.1177/1740774515594362. Epub 2015 Jul 15.

Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel

Beverly H Lorell  1 , J Stephen Mikita  2 , Annick Anderson  3 , Zachary P Hallinan  3 , Annemarie Forrest  4
Affiliations

Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel

Beverly H Lorell et al. Clin Trials. 2015 Dec.

Abstract

Background: Informed consent is the cornerstone for protection of human subjects in clinical trials. However, a growing body of evidence suggests that reform of the informed consent process in the United States is needed.

Methods: The Clinical Trials Transformation Initiative conducted interviews with 25 experienced observers of the informed consent process to identify limitations and actionable recommendations for change.

Results: There was broad consensus that current practices often fail to meet the ethical obligation to inform potential research participants during the informed consent process. The most frequent single recommendation, which would affect all participants in federally regulated clinical research, was reform of the informed consent document. The interviews also identified the need for reform of clinical research review by institutional review boards, including transitioning to a single institutional review board for multi-site trials.

Conclusion: The consensus recommendations from the interviewees provide a framework for meaningful change in the informed consent process. Although some proposed changes are feasible for rapid implementation, others such as substantive reform of the informed consent document may require change in federal regulations.

Keywords: Informed consent; clinical research; decision-making; health policy; institutional review board; research ethics.

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Conflict of interest statement

Declaration of conflicting interests: The authors have no potential conflicts of interest to disclose.

Figures

Figure 1.
Figure 1.
Enhancing research participant understanding of a clinical trial. Derived from authors’ analysis of results from 25 interview transcripts.
See this image and copyright information in PMC

References

    1. Protection of human subjects: see 21 C.F.R. Part 50 and 45 C.F.R. Part 46.
    1. Flory J, Emanuel E. Interventions to improve research participants’ understanding in informed consent for research: a systematic review. JAMA 2004; 292: 1593–1601. - PubMed
    1. Meade CD. Improving understanding of the informed consent process and document. Semin Oncol Nurs 1999; 15: 124–137. - PubMed
    1. Nishimura A, Carey J, Erwin PJ, et al. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Med Ethics 2013; 14: 28. - PMC - PubMed
    1. The Center for Information and Study on Clinical Research Participation (CISCRP). 2013 perceptions & insights study: report on the informed consent process, https://www.ciscrp.org/wp-content/uploads/2014/01/2013-CISCRP-Study-the-... (2013, accessed 9 March 2015).

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