Research Interests

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There are few studies about the use of legally authorized represenatives or surrogate consent for research. This is surprising given the fundamental role that informed consent has in the protection of human subjects of research and the often impaired cognitive and physical functioning of persons who may serve as prospective research subjects. Under certain circumstances, such as in cases involving critical care or trauma patients, investigators may want to enroll as human subjects of research patients who are decisionally incapacitated and consequently unable to provide informed consent. In these circumstances, authorization to involve such patients as subjects might be obtained from patients’ legally authorized representatives, or surrogates. However, the precise parameters and permissibility of such consent, or what is often referred to as surrogate consent, is ambiguous owing to the application of both federal regulation and state laws. Indeed, the effectiveness of surrogate consent for research is poorly understood; recent studies suggest that legally authorized representatives do not always exercise consent decisions consistent with patients’ wishes. To help advance our understanding of some of these issues and help to ensure the appropriate involvement of decisionally incapacitated adults in research, we are interested in undertaking the following types of studies:

BASIC & INITIAL RESEARCH

Social Implications

There are some reports in the literature (check out our bibliography) that suggest that if offered the opportunity to participate as subjects in research, that patients and the persons to whom patients would likely designate as having decisional authority would differ on their consent. We are interested in exploring the reasons behind such differences, and identifying as well as studying the factors that may be associated with concordance between patients and their legally authorized representatives and surrogates in making what may be inherently difficult decisions.

Legal Issues

Federal HHS regulations defer to state or local laws with regard to what persons may serve as legally authorized representatives (or "LARs") to provide consent for research on behalf of adults who may be decisionally incapacitated. However, not many state or local laws explicitly address the issue, and these laws may differ. Given the absence of explicit state and local laws, we are interested in determining whether researchers and IRBs may rely upon state and locals laws on legally authorized representatives and surrogate consent to treatment as authority to permit research involving decisionally incapacitated adults.

Policies & Guidance

The HHS Office for Human Research Protections provides only limited guidance on legally authorized representatives and surrogate consent for research. Recently however, the HHS Secretary was provided by an advisory committee with a list of recommendations to improve clarity on the involvement of decisionally incapacitated persons as subjects of research. However, no action has yet been taken. Institutional policies may serve to fill the critical void. We would like to examine these policies as well as examine how researchers, IRBs and research institutions conform their research practices to current laws and ethical principles with regard to research involving decisionally incapacitated adults.

FUTURE RESEARCH

Given the profound concerns associated with decisionally incapacitated persons as subjects in research, under what circumstances, if any, should researchers, IRBs and research institutions involve decisionally incapacitated adults to take part in research? Would better guidance, explicit laws or policies, improving concordance between patients and their legally authorized representatives or surrogates, or other interventions adequately protect this vulnerable population? Our longer range plans would involve building upon our initial research and designing as well as testing different interventions that may help to answer these questions.