by Susie A. Han and Valerie Gutmann Koch
Susie A. Han, MA, MA, is the deputy director and principal policy analyst of the New York State Task Force on Life and the Law. Valerie Gutmann Koch, JD, 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 senior attorney and consultant to the Task Force.
First-person informed consent—a central tenet of ethical human subjects research (HSR)—is challenging, if not impossible, to secure for individuals who lack consent capacity. Due to concerns about exploitation and the dearth of federal and New York State guidelines on how to ethically conduct research involving adults who are cognitively impaired, this group has been (perhaps overly) protected in biomedical research, sometimes to the point of exclusion, which may prevent the discovery of cures and treatment for conditions that cause decisional incapacity. The New York State Task Force on Life and the Law (Task Force) recently released a publication titled “Report and Recommendations for Research with Human Subjects who Lack Consent Capacity,” which analyzes the legal and ethical implications of proceeding with research with this population and provides recommendations for additional protections and safeguards.
While the report examines a wide variety of issues—such as the legal landscape governing HSR involving participants who lack consent capacity, the principles and values underlying HSR, the role of institutional review boards (IRBs), acceptable risk-benefit ratios when reviewing research protocols, capacity assessments of participants, informed consent and assent requirements, and additional safeguards (i.e., independent consent monitors to oversee the informed consent process, medically responsible clinicians to attend to the safety of participants, and reporting requirements of adverse and unanticipated events)—we will focus here on the role of the legally authorized representative (LAR) in providing surrogate consent to enroll a cognitively impaired adult in research.
When researchers are unable to obtain first-person informed consent from a potential participant, a surrogate may, through the appointment of an LAR, consent to enroll that individual depending on the nature of the study and its risk-benefit ratio. Like many states, New York has no legally defined hierarchy for identifying an LAR for research. In such cases, IRBs and researchers can look to the surrogate hierarchy for health care treatment decisions, if one exists. In New York, the Family Health Care Decisions Act (FHCDA), passed in 2010, established a hierarchy of surrogate decision-makers for health care decisions (with court-appointed guardians at the top of the list, followed by spouses and domestic partners, children, parents, siblings, and close friends).
In its report, the Task Force recommended that, because classes of LARs listed in a surrogate hierarchy for treatment purposes often will have varying degrees of understanding of the wishes of impaired individuals regarding research participation, IRBs and researchers should consider limiting the classes of LAR(s) who are authorized to provide surrogate consent. The riskier the research protocol and the more remote the prospect of benefit, the closer (by kinship or intimacy level) the LAR should be to an individual to provide surrogate consent. For example, while all classes of LARs might be allowed to consent to research that involves minimal risk and offers the prospect of direct benefit, IRBs might only permit a certain LAR class to consent to research that involves no prospect of direct benefit and that involves an increased level of risk. The Task Force also recommended that procedures be developed for addressing objections to the choice of LAR or to a surrogate decision.
When determining whether an individual should participate in research, the Task Force recommended that an LAR should follow a research advance directive, if one exists; or the participant’s prior expressed wishes and preferences about research, if known. However, in most instances the views on research participation of a cognitively impaired individual are unknown. In such cases, the Task Force recommends that an LAR use either the “best interest” or “substituted judgment” decision-making standards.
The best interest standard is often used in the health care treatment context; it requires a surrogate to choose the option that will both respect the patient and provide the most benefit to him or her. However, this standard is often difficult to apply in the research setting because although some research protocols may offer a prospect of direct benefit to the participant, the benefit is not guaranteed. Furthermore, some studies may not offer a prospect of direct benefit, and therefore research participation would never be in the best interest of the individual. For such research, it may be more appropriate to employ the substituted judgment standard, which relies on the known and/or presumed values and beliefs about medical research of the cognitively impaired individual. In considering these factors, an LAR can make a reasonably assured estimate of whether the individual would choose to enroll in research.
The Task Force also emphasized that LARs should understand the difference between the goals of research (i.e., generalizable knowledge) and the goals of clinical care (i.e., improving the health of an individual), as well as the risks and benefits to participating in the specific research protocol to help dispel the therapeutic misconception. The Task Force underscored the utility of a neutral discloser’s role in explaining the research protocol. Relying on a person who is not a member of the individual’s health care treatment and research team may help eliminate the possibility that the credentials and authority of the researcher or the health care provider may inappropriately influence the LAR.
Finally, the Task Force recommended that LARs should never be the true beneficiary of any financial compensation offered to prevent undue inducement to consent to research. LARs should understand their continued role and responsibilities associated with the research protocol and should serve as an advocate for the participant.
For more information about the role of LARs in surrogate decision-making and other recommendations on HSR involving adults who lack consent capacity, we encourage you to read the Task Force’s full report.