This Article Full Text (PDF) References Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Sugarman, J. Articles by Yeh, S. S. Search for Related Content PubMed PubMed Citation Articles by Sugarman, J. Articles by Yeh, S. S. Social Bookmarking                   What's this?

Evaluating the quality of informed consent

Phoebe R. Berman Bioethics Institute, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for the Study of Medical Ethics and Humanities, Departments of Medicine and Philosophy, Duke University Medical Center, Durham, NC, USA

Philip W. Lavori

VA Cooperative Studies Program Coordinating Center, Palo Alto, California, USA; VA Palo Alto Health Care System, Palo Alto, California, USA; Stanford University School of Medicine, Stanford, California, USA

Maryann Boeger

VA Cooperative Studies Program Coordinating Center, Palo Alto, California, USA; VA Palo Alto Health Care System, Palo Alto, California, USA

Carole Cain

Center for the Study of Medical Ethics and Humanities, Departments of Medicine and Philosophy, Duke University Medical Center, Durham, NC, USA

Robert Edson

VA Cooperative Studies Program Coordinating Center, Palo Alto, California, USA; VA Palo Alto Health Care System, Palo Alto, California, USA

Vicki Morrison

Minneapolis VAMC, Minneapolis, Minnesota, USA

Shing Shing Yeh

Northport VAMC, Northport, New York, USA

Context Although informed consent is a critical means of protecting the rights and interests of participants in clinical research, effective and efficient means of evaluating the quality of consent are needed. Having such means will be important to monitoring consent and testing potential improvements in the consent process. Objective To develop and test a practical and general means of evaluating the quality of informed consent for clinical research.

Methods We developed and tested the Brief Informed Consent Evaluation Protocol (BICEP), a short telephone-based assessment of informed consent. As soon as patient-participants completed the informed consent process for a participating VA Cooperative Studies Program clinical trial they called an interviewer who administered the BICEP.

Results 632 participants completed BICEP, representing eight ongoing studies from 14 VA and one non-VA medical centers across the country. Site coordinators reported little to no difficulty implementing BICEP. The average duration of BICEP was 8.8 minutes (SD 3.6). Overall, patient-participants evaluated the informed consent process positively. A reliable coding system was then developed to analyze the verbatim responses of the final 191 participants. An Informed Consent Aggregate Score (ICAS) had a mean score of 8.23 (SD 1.17) with a range of 0–10, with 10 a perfect score; and a Therapeutic Misconception Aggregate Score (TMAS) had a mean of 1.62 (SD 0.93) with a range of 0–5, with 5 a perfect score.

Conclusions The BICEP is an efficient means of evaluating informed consent that is acceptable to research participants and research personnel. While participants tend to be satisfied with the informed consent process, the BICEP indicates there is room for improvement in the informed consent process for research.

Clinical Trials, Vol. 2, No. 1, 34-41 (2005)
DOI: 10.1191/1740774505cn066oa


CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

This article has been cited by other articles:

				S. E. Kasner, A. Del Giudice, S. Rosenberg, M. Sheen, J. M. Luciano, B. L. Cucchiara, S. R. Messe, L. H. Sansing, and J. M. Baren Who will participate in acute stroke trials? Neurology, May 12, 2009; 72(19): 1682 - 1688. [Abstract] [Full Text] [PDF]

				I S Durand-Zaleski, C Alberti, P Durieux, X Duval, S Gottot, P. Ravaud, S Gainotti, C Vincent-Genod, D Moreau, and P Amiel Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception J. Med. Ethics, September 1, 2008; 34(9): e16 - e16. [Abstract] [Full Text] [PDF]

				R. M Califf Clinical trials bureaucracy: unintended consequences of well-intentioned policy Clinical Trials, December 1, 2006; 3(6): 496 - 502. [Abstract] [PDF]