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IRB. 2017 Nov-Dec;39(6):10-15.

Reaping the Bounty of Publicly Available Clinical Trial Consent Forms.

Author information

1
(As of September 5, 2017), Assistant Professor and Assistant Faculty Director of Online Education, Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Blockley Hall, 14 Floor, 423 Guardian Drive, Philadelphia, PA 19104-4884.
2
(As of September 5, 2017), Assistant Professor, Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania.
3
Director, ClinicalTrials.gov, Assistant Director, Clinical Research Projects, National Library of Medicine, National Center for Biotechnology Information.

Abstract

Public access to clinical trial consent forms, beyond those individuals involved in reviewing, conducting, or participating in a trial, has been notoriously poor, resulting in missed opportunities for empirical analysis and improvement, among other benefits. However, recent changes to the Common Rule and policies governing ClinicalTrials.gov promise to make trial consent forms more accessible to the public, including prospective trial participants, other trialists and IRBs, and those seeking to study research consent. Analysis of publicly available consent forms can facilitate development of best practices, make the process of drafting consent forms more efficient, and provide insight into how well consent forms are satisfying their mission of protecting and promoting the autonomy of trial participants. Gaps in public access will remain even under the new policies, but we are on the cusp of an exciting new dataset that can contribute to addressing a perpetual challenge in research ethics: optimal informed consent.

KEYWORDS:

ClinicalTrials.gov; Common Rule; informed consent form (ICF); public posting; transparency

PMID:
29881132
PMCID:
PMC5985974

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