Ever since the horrors of Nazi human experimentation were revealed following World War II, the clinical research community has been continuously re-examining and strengthening ethical control measures employed in medical experimentation. Human subjects committees, informed consent procedures employing easily understood language, local and national clinical research review entities, and considerable media attention have all led to a safer, more enlightened, and more equitable clinical research environment. Having been personally involved in many of these processes, I can attest to the serious nature with which these experimental protocols are planned and implemented.
The remarkable advances in clinical therapeutics seen over the last 50 years are largely the result of such carefully designed and carefully performed clinical trials. In the world of human experimentation, every clinical investigator with whom I have ever worked accepted the premise that physicians should encourage their patients to enter clinical research protocols as volunteers when the correct therapeutic intervention in a particular setting was unknown. In addition, there has always been universal agreement that physician-investigators should be completely forthright with patients recruited into clinical trials concerning potential financial and non-financial conflicts of the investigator. For example, does the doctor stand to profit personally from the patient’s participation in the trial that has been suggested?
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— Joseph S. Alpert, MD
This article was originally published in the June 2008 issue of the American Journal of Medicine.
