 December 10, 2008
| Topic: |
Improving Informed Consent: Can we balance risk management with meaningful disclosure? |
| Presenter: |
Barton W. Palmer, Ph.D., Professor of Psychiatry, Associate Director UCSD Geriatric Psychiatry Advanced Center for Innovation in Services and Intervention Research |
| Location: |
SDSU Foundation: Sky Park |
| Discussion: |
A recent Cochran review by Ryan et al (2008) entitled “Audio-visual presentation of information for informed consent for participation in clinical trials” reflects ongoing ethical and empirical concern regarding the process of informed consent for research. It is often noted that informed consent is best conceived of as a process not a form, yet one suspects that in practice the printed consent documents may still represent the primary means of formal disclosure of information relevant to consent in many research studies. Yet printed consent forms have also evolved to serve two different purposes, which may at times be at odds: institutional or investigator risk management versus effective provision of relevant information to potential participants. In this journal club meeting we will consider the state of empirical data in regard to potential methods of improving the consent process and, hopefully, have a fruitful discussion to develop suggestions for fostering implementation of changes likely to be helpful in making the informed consent process more meaningful. |
| Readings: |
- Epstein, L.C., & Lasagna, L. (1969). Obtaining informed consent. Form or substance. Arch Intern Med, 123(6), 682-688.
- Lemaire, R. (2006). Informed consent - a contemporary myth? Journal of Bone and Joint Surgery in Health -British Volume, 88B(1), 2-7.
- Palmer, B.W., Cassidy, E.L., Dunn, L.B., Spira, A.P., & Sheikh, J.I. (2008). Effective use of consent forms and interactive questions in the consent process. IRB: Ethics & Human Research, 30(2), 8-12.
- Ryan R, Prictor M, McLaughlin KJ, Hill S. Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database of Systematic Reviews 2008, Issue 1. Art. No.: CD003717. DOI: 10.1002/14651858.CD003717.pub2.
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Note: For those Journal Club members at UCSD, readings will be available through electronic reserves in the UCSD Biomedical Library. Go to http://reserves.ucsd.edu, click "STUDENTS - Find your reserve materials here", select the "Pages by Instructor" tab, select instructor "Kalichman", and click "Search". On the Course Reserves page, click "SOM300", read and accept the copyright statement, open the Journal Club folder, and find the files in this month's file. For those not at UCSD, please e-mail us at ethics@ucsd.edu and we will send you a PDF attachment. |
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