New Recommendations for Research with Human Subjects Who Lack Consent Capacity
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.
The Task Force made a number of important and – in some cases – unique recommendations, including:
- Adults who lack consent capacity should be allowed to participate in research subject to New York State oversight only when researchers and IRBs can adequately justify their involvement in a study. Participation should be allowed only for individuals who have explored all available treatment and research options, and for those without any other known treatment or research options.
- For research involving adults who lack consent capacity, the IRB should establish a lower ceiling for allowable risk or require a more favorable risk-benefit ratio than it would for less vulnerable participants. Specific protections and safeguards should be implemented based on the level of risk and the prospect of benefit.
- If a potential research subject is unable to give consent, the researcher(s) can defer to an individual’s research advance directive, if one exists. In addition, it is possible to enroll an adult who lacks consent capacity if consent can be obtained from a legal authorized representative. However, IRBs and researchers should consider limiting the classes of such representatives who are authorized in New York State to provide surrogate consent for research. The riskier the research protocol and more remote the prospect of benefit, the closer (by kinship or intimacy level) the legal authorized representative should be to an individual.
- In rare circumstances, adults who lack consent capacity may be enrolled in research that presents more than a minor increase over minimal risk that offers no prospect of direct benefit. The Task Force recommends that IRBs may approve such studies in only two circumscribed situations: where the potential participants have a research advance directive or in special situations with notification to the Department of Health and use of a special review panel.
- A potential research participant should be notified and allowed the opportunity for review of all decisions to involve him or her in research, including assessments of capacity. These procedural steps are integral to the protection of all research participants.
The number and scope of additional safeguards depend on the level of risk and the likelihood of direct benefit that the research protocol offers to the participant. The higher the risk or the lower the prospect of direct benefit, the more protections are recommended. In addition to IRB review and approval, these special safeguards may include, but are not limited to independent consent monitors, medically responsible clinicians, and additional reporting requirements.
The report may serve as a model for research in other states and at the federal level, and provides guidance to investigators and IRBs. For entities that previously did not pursue research with adults lacking consent capacity, the report provides the foundation to enable them to pursue research protocols that will lead to a better understanding of conditions that impair cognition. For those who already enroll adults who lack consent capacity in research protocols, the report will help them ensure that consistent and appropriate safeguards are in place to protect the welfare of these vulnerable individuals.
Valerie Gutmann Koch, J.D., is a visiting assistant professor at Chicago-Kent College of Law, lecturer at the MacLean Center for Clinical Medical Ethics, and special advisor to the New York State Task Force on Life and the Law; she is the former consultant and senior attorney to the Task Force. Susie A. Han, M.A., M.A., is the deputy director and principal policy analyst to the Task Force.
Posted by Susan Gilbert at 01/13/2014 05:14:05 PM |
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