- Frank J. Leavitt, Ph.D.
Chairman, The Centre for International Bioethics
Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheva, Israel
Eubios Journal of Asian and International Bioethics 14 (2004), 57.
Asai and Itai discuss at length the complications of the approach to the institutional review board (IRB). But I doubt that ethics require turning to an IRB in such a case. The World Medical Association Declaration of Helsinki [http://www.wma.net/e/policy/b3.htm] is God's Revealed Word about ethics. It can certainly be wrong. But their guidelines for medical experimentation on human subjects are extremely useful and often show a good deal of wisdom. Paragraph 32 of the most recent version says:
"In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods do not exist or have been ineffective, the physician, with informed consent from the patient, must be free to use unproven or new prophylactic, diagnostic and therapeutic measures, if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, these measures should be made the object of research, designed to evaluate their safety and efficacy. In all cases, new information should be recorded and, where appropriate, published. The other relevant guidelines of this Declaration should be followed. "
I think that whoever wrote this guideline showed a great deal of wisdom in recognizing that when the alternative is certain failure, ethical restrictions should be liberalized.