In his ruling, Judge John T. Nixon, stated that "none of the exposed women were ever informed of the type of experimental project in which they were involved." Therefore, on the foundation of lack of informed consent, these women may claim medical negligence.
Well, hold on to your hats ladies and gentleman. A September 26, 1996 press release by the United States Department of Health and Human Services, stated that the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have issued final rules to allow promising experimental drugs and medical devices to be studied in persons who are in life-threatening situations and unable to give informed consent for their use.
Under considerable pressure to relax restrictions on medical research from the Republican led Congress, the FDA and NIH have altered one of the most basic and fundamental premises of contemporary medical research, that of informed consent.
This sacred principle of informed consent arose during the Nuremberg trials following the defeat of Nazi Germany, where it was learned that thousands of humans underwent incredible scientific experiments without their consent. The first sentence of the Nuremberg code therefore, states that nothing should be done to human beings without their consent. With these new government rules, it seems an exception is now being made.
Knowing the dedication to human rights of the FDA's Executive Director, David Kessler, I hoped there was a plausible explanation, and called a friend in Washington who is a FDA spokesperson. He explained the reasoning behind this monumental change in the conduct of medical research and he also sent me information.
What I received somewhat reassured me. "FDA and NIH have produced a coherent approach to protecting patients who may be helped by an experimental procedure, but who cannot give consent on their own," said HHS Secretary, Donna E. Shalala. "These rules address a difficult, ethical situation and they apply fair, common sense tests to allowing the use of experimental treatment in life-threatening emergencies." According to HHS, these new guidelines will offer the best hope in cases when critically ill, unconscious persons with no readily available legal representative to give consent, cannot be successfully treated in conventional ways.
Other safety guidelines include that the risks and benefits of the experimental procedures are reasonable compared to those associated with the patient's medical condition and standard therapy. Also, that there had to be approval of the study by the medical institution, and the FDA. In addition, there had to be public disclosure of the study design and risks.
Supporters of this new regulation believe such steps are needed to benefit patients and that harm would actually be greater in the long-run if these patients were kept out of these studies, merely because they could not give their consent. An advocate for these new guidelines is Dr. Norman Fost, Director of the Center for Clinical Ethics of the University of Wisconsin. Dr. Fost claims "that if the choice for a patient with a severe head injury was to receive standard treatment which is of little help, or to be part of a study testing a drug that seems to have virtually no side-effects that have saved the brains of animals, seems to me that a reasonable person would very much want to be in that study."
Not everyone agrees. George Annas, a lawyer and ethicist at Boston University, stated that most people would not want a doctor to flip a coin when they come to an emergency room for treatment. He also is critical of the premise that this type of research is an opportunity for patients. "For most people research is not an opportunity. The average person wants treatment not an opportunity to be researched on." Others are concerned that after all has been said and done on this matter, the enrollment of critically ill patients into a randomized study without their consent is a violation of basic human rights.
Protection of human subjects during medical research is paramount and must be vigorously sustained by our society. I hope that as we now embark on this new journey in medical research that the benefits of this new regulation will outweigh the risks. Still, I wonder even if it is, will it be worth it?
(Frank H. Boehm, MD is a professor of OB/GYN and Director of OB at Vanderbilt Medical Center in Nashville, TN. He can be reached at his web site http://dr-boehm.com. Dr. Boehm resides in Boca).