Research with Decisionally Incapacitated Human Subjects: An Argument for a Systemic Approach to Risk-Benefit Assessment

The amount of medical research with persons who lack decision-making capacity is rapidly increasing, but in most states it takes place without clear legal authority. In addition to creating significant liability risks for researchers and persons who provide consent on behalf of incapacitated subjects, the lack of explicit legal standards means that few, if any, safeguards exist to protect incapacitated persons\u27 rights and welfare. Previous efforts to close the gap between clinical reality and legal requirements have failed in part because they have not provided a coherent or persuasive ethical justification for permitting this research. This Article seeks to fill that void by proposing a new way of thinking about the ethics of research with incapacitated persons, grounded in a long-term, systemic approach to risk-benefit assessment. This approach explains why it is ultimately in incapacitated persons\u27 best interests to be governed by a policy that permits them to be enrolled in research without their personal authorization--even if such a policy puts them at risk of participating in studies that, when viewed in isolation, may involve more burdens than benefits. Unlike other approaches, the framework developed here does not depend on false analogies between participating in research and receiving medical treatment, or dubious claims about family members\u27 inherent authority or incapacitated persons\u27 obligations to society. Because the proposed framework directly responds to the criticism that research with incapacitated persons is a form of exploitation, it may increase the likelihood that proposals to authorize this research will actually be adopted. It also has important implications for both how laws governing research with incapacitated persons should be structured, and the roles and responsibilities of surrogate decision makers

Research with Decisionally Incapacitated Human Subjects: An Argument for a Systemic Approach to Risk-Benefit Assessment

The amount of medical research with persons who lack decision-making capacity is rapidly increasing, but in most states it takes place without clear legal authority. In addition to creating significant liability risks for researchers and persons who provide consent on behalf of incapacitated subjects, the lack of explicit legal standards means that few, if any, safeguards exist to protect incapacitated persons\u27 rights and welfare. Previous efforts to close the gap between clinical reality and legal requirements have failed in part because they have not provided a coherent or persuasive ethical justification for permitting this research. This Article seeks to fill that void by proposing a new way of thinking about the ethics of research with incapacitated persons, grounded in a long-term, systemic approach to risk-benefit assessment. This approach explains why it is ultimately in incapacitated persons\u27 best interests to be governed by a policy that permits them to be enrolled in research without their personal authorization--even if such a policy puts them at risk of participating in studies that, when viewed in isolation, may involve more burdens than benefits. Unlike other approaches, the framework developed here does not depend on false analogies between participating in research and receiving medical treatment, or dubious claims about family members\u27 inherent authority or incapacitated persons\u27 obligations to society. Because the proposed framework directly responds to the criticism that research with incapacitated persons is a form of exploitation, it may increase the likelihood that proposals to authorize this research will actually be adopted. It also has important implications for both how laws governing research with incapacitated persons should be structured, and the roles and responsibilities of surrogate decision makers

Duties to Subjects in Clinical Research

Physicians who conduct clinical research with human subjects face a profound conflict in professional roles. As physicians, they are committed to promoting the best interests of current patients. As researchers, however, their goal is to produce generalizable knowledge by studying the effects of interventions in broad cohorts of subjects.\u27 Because producing generalizable knowledge often requires actions that are inconsistent with the best interests of the individuals enrolled in a study, these dual objectives often come into conflict. In such situations, where should the physician-researcher\u27s loyalties lie? While this question has long been of interest to physicians and bioethicists, it has largely escaped the attention of lawyers. A recent wave of lawsuits against clinical researchers, however, is likely to change this situation. In evaluating these claims, courts will have to determine whether researchers owe subjects the same duty of care that physicians owe to their patients, or whether the researcher- subject relationship involves a different set of legal obligations-and, if it does, how those obligations should be defined