An Important Step Forward

September 11, 2015

The Department of Health and Human Services’ proposed new rule making is an important step forward in the evolution of the oversight of research involving human subjects. Particularly noteworthy is broadening the reach of the regulations to now require that all clinical trials – not just those funded by the federal government – be subject to the same oversight as federally funded trials, assuming they are conducted by institutions that receive any federal funding for research. From an ethics standpoint, broadening oversight requirements to privately funded research can only be in participants’ interests.


The changes to informed consent requirements, whereby key elements will be emphasized and consent documents will likely be shorter, should improve what research participants around the country and around the world will understand about research. For decades many of us have criticized the practice of having extremely lengthy and highly detailed consent forms. This practice is counterproductive to the moral objective of genuinely informing potential research participants about studies. It is heartening to see the proposed changes addressing this important problem.


An important commitment of the proposed changes seems to be separating the oversight needs of higher vs. lower risk research. Unfortunately, however, the proposed changes fail to address that some clinical research also can be low-risk. Specifically, comparative effectiveness research often compares medicines and treatments that are already known to be safe, effective and widely prescribed to patients. Comparing these alternative treatments, in the context of a rigorous study, will often pose no or few additional risks to patients compared with the care they would otherwise have received. Streamlining oversight for this type of research is important not only so that lower risk trials evaluating existing and widely used therapies can move forward efficiently, but also, from an ethics perspective, to help communicate to patients which studies require more examination than others. We hope that the final regulations will expand their commitment of triaging oversight to risk into this domain as well.


Overall, these proposed changes are a welcome step forward, indicating that the federal government remains committed to careful oversight of human subjects research, to ensuring that oversight is responsive to changing research methods and norms, and to the idea that oversight is not a one-size fits-all model but should be appropriately calibrated to the type of research being conducted.



–          Ruth Faden, PhD, MPH, Director, Johns Hopkins Berman Institute of Bioethics

–          Nancy Kass, ScD, Deputy Director for Bioethics and Public Health, Johns Hopkins Berman Institute of Bioethics



(image: luckey_sun – CC BY-SA 2.0)

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