Scientific investigation may sometimes be hindered by rigidly applied rules of informed consent and institutional review boards, according to a recent article published in the New England Journal of Medicine.
David A. Asch, MD, MBA, from the Center for Health Care Innovation, Philadelphia, Pennsylvania, and colleagues argue for more flexibility in the interpretation of “the Common Rule” of the Code of Federal Regulations, which dictates when informed consent may be waived.
According to the authors, conventional thinking about low-risk research results in misdirections that ultimately compromise the validity of some research.
Informed consent regulations are needed to ensure not only that the safety and risk of the subject are accounted for but also the subject’s right to volunteer or opt out. But in some cases, the validity of a trial’s results relies on the contingency that participants are not prejudiced or subject to selection bias by filling out consent forms. Consent is essential in drug trials, especially where there is the potential for harm. However, in studies evaluating behaviors, requiring informed consent can invalidate some trial results.
Although drug trials are based mostly on human biology, trials of cancer screening, medication adherence, weight loss, or tobacco cessation are largely based on forming new habits or enhancing motivation, behaviors that might come more easily to those who would be motivated to sign a consent form. In studies researching patient behavior where no risk is involved, requiring signed consent may result in a cohort of subjects who are more motivated. This approach tends to select a population that is not reflective of the general patient population, compromising the results of the study.
The authors suggest that institutional review boards could improve scientific research, and ultimately innovation, in the healthcare field by addressing misconceptions of conventional thinking of informed consent in low-risk research.
Asch DA, Ziolek TA, Mehta SJ. Misdirections in informed consent—impediments to health care innovation. N Engl J Med. 2017;377(15):1412-1413.