For the last few years, Professor Valerie Gutmann Koch has worked as Special Advisor to the New York State Task Force on Life & the Law, the state’s bioethics commission. The Task Force has recently released a report offering recommendations for research with human subjects who lack consent capacity. Last week, Koch—along with Susie A. Han, deputy director and principal policy analyst to the Task Force—detailed the contents of the report on a blog run by The Hastings Center, an independent bioethics research institute. Read an excerpt below:
The New York State Task Force on Life and the Law released its Report and Recommendations for Research with Human Subjects Who Lack Consent Capacity today, which analyzes the ethical and legal implications of involving cognitively impaired adults to participate in human subjects research (HSR). The report provides recommendations and guidance to institutional review boards, researchers, and legal authorized representatives to ensure the ethical conduct of research subject to New York State oversight involving adults who lack the capacity to provide consent as a result of dementia, developmental disabilities, or other conditions.
Although New York State law provides mechanisms for ensuring voluntary informed consent for participants and IRB review, it does not provide any oversight of research involving adults who lack consent capacity. Similarly, federal regulations do not provide safeguards or special protections for research involving this vulnerable population, despite calls to do so.
Without safeguards that are adequate and robust but not overly burdensome, the conduct of ethical research with this population is ethically and legally challenging. While some institutions and investigators are conducting research with this group without guidance—risking exploitation of this vulnerable population—others are taking an extremely conservative approach and are excluding these individuals from research. Excluding them could mean a dearth of important research into the broad range of diseases that impair cognition.
To address the gap in oversight, the Task Force drafted a set of legal and ethical guidance regarding the conduct of research in New York State involving individuals who lack consent capacity. An underlying goal of the work is to ensure that research protocols are available to all individuals so that they may experience the benefits of research and share its risks and burdens like people who are not cognitively impaired while also ensuring the appropriate level of protections.
To see a full list of the Task Force’s recommendations, continue reading here.
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