 October 8, 2008
| Topic: |
The Least Advantaged When They Are the Most Vulnerable: Clinical Trials in the Emergency Context |
| Presenter: |
Robert A. Bohrer, Professor of Law, California Western School of Law |
| Location: |
SDSU Foundation: Sky Park |
| Discussion: |
The ethical foundation of clinical research is deeply Kantian; the voluntary, and fully informed, consent of the trial participants is an absolute requirement. However, there is one clinical trial context in which such informed consent is clearly not possible. When the trial study is aimed at treatments for emergency conditions, such as severe head trauma, or wounds which have caused severe blood loss, it is likely that trial subjects will be unable to consent and it is unlikely that their legally authorized representative would be available. Certainly it is important to develop effective interventions for these conditions and it would seem impossible to develop them without testing them in patients whose circumstances preclude consent. While the FDA and NIH have long acknowledged the problem and provided exceptions to the normal informed consent requirements for such trials, the current guidelines essentially delegate the problem to the IRBs overseeing such trials, with provisions for community involvement. The discussion will center on the question of the normative foundation for IRB decision-making for clinical trials of emergency treatments where informed consent is not possible. |
| Readings: |
- LEXSTAT CA HEALTH SAF 24177.5, DEERING'S CALIFORNIA CODES ANNOTATED, Copyright (c) 2008 by Matthew Bender & Company, Inc. a member of the LexisNexis Group. All rights reserved. (PDF - 2 pages)
- Waived Consent for Emergency Research. Copyright (c) 1998 Boston University School of Law, American Journal of Law & Medicine, 1998, 24 Am. J. L. and Med. 163 (PDF - 37 pages)
- ANALYZING THE LAWS, REGULATIONS, AND POLICIES AFFECTING FDA-REGULATED PRODUCTS: FDA's Emergency Research Rule: An Inch Given, a Yard Taken. Copyright (c) 2008 The Food and Drug Law Institute Food and Drug Law Journal, 2008, 63 Food Drug L.J. 217 (PDF - 58 pages)
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