Environmental Factor, July 2008, National Institute of Environmental Health Sciences
NIH Ethicist Tackles "Cutting Edge Consent"
By Eddy Ball
As part of a daylong Institutional Review Board Retreat June 12, NIH ethicist Jerry Menikoff, M.D., J.D., explored the implications of informed consent during a lecture in Rodbell Auditorium. Menikoff's talk was titled "Cutting Edge Consent: What Law and Ethics May Require Beyond Current Practice." The event was hosted by David Resnik, Ph.D., J.D., bioethicist in the NIEHS Division of Intramural Research.
Menikoff(http://www3.kumc.edu/historyofmed/staff.html) , who currently serves as the director of the NIH Office of Human Subjects Research, is on leave from his position as a University of Kansas associate professor of Law, Ethics & Medicine in the School of Medicine and associate professor of Law in the School of Law there. He is the author of several books on ethics and the regulation of research with human subjects, including What the Doctor Didn't Say: The Hidden Truth about Medical Research.
"It [informed consent] ties into what NIEHS is doing now, particularly in your move toward doing clinical research," Menikoff said as he began his talk. "It is especially applicable to research relating to people who have a clinical problem."
According to Menikoff, participants need to understand that the primary goal of research is to answer a research question. He said patients often enter clinical trials specifically to get treatment they think they could not get otherwise, and they may have unrealistic expectations about the benefits of participating.
"We have all these rules to protect research subjects," Menikoff continued, "because research subjects are actually under weaker protections than patients.... Research regulations are designed to make sure that the goal of answering the research question does not inappropriately override the patient's interest."
Menikoff maintained that the research community should feel an obligation to give subjects a much more complete and candid explanation about what participating in a study means - and does not mean - for an individual. Invoking the Nuremberg Code(http://ohsr.od.nih.gov/guidelines/nuremberg.html) of bioethics, he said that "a person should have 'sufficient knowledge... to make an understanding and enlightened decision' about participation."
For Menikoff, that knowledge includes an understanding of the benefits and risks of participation, as well as appropriate alternatives available elsewhere that could be just as advantageous as anything participants might be able to get in the study. To illustrate his point, Menikoff pointed to the five-year randomized, double-blind Study of Tamoxifen and Raloxifene (STAR), which sought to determine which of the drugs is most effective at preventing breast cancer.
STAR was an example of a situation when getting a "new" therapy outside the study, Raloxifene, would in most cases involve no greater risk than getting it in the study, Menikoff explained. By getting a non-standard treatment that is widely available off-label, the patients who wanted the therapy would also have a 100 percent chance of actually getting it, rather than the 50 percent chance they would have in a randomized study.
Menikoff argued for looking at informed consent as a medical research version of the Miranda warning, which he describes as "making more sense [in the context of clinical research] than it does in a criminal context." Research subjects deserve to be clearly informed of anything about a study that a "reasonable person" would want to know before enrolling.
As he illustrated with several examples from informed consent forms from clinical studies, that level of disclosure is far from being a common practice. "I'm not saying the studies shouldn't be conducted," he concluded, "but patients should be told what they need to know."