The paper by Lisa Eyler and Dilip Jeste on ''Enhancing the informed consent process: A conceptual overview'' is a thoughtful and comprehensive review of the literature on informed consent and mental disorders. It includes a variety of perspectives on the elements of informed consent, a useful review of the relevant literature, and a discussion of approaches that have shown promise in improving consent capacity in individuals with severe mental disorders.
We want to take this opportunity to discuss the issues from somewhat different perspectives. There has been a long history of concern about the protection of vulnerable populations. Historically, people with mental disorders have been described as a potentially vulnerable population due to questions about their capacity to make decisions, and thus to provide voluntary informed consent. This is reflected in documents such as the ''Common Rule'' (45 CFR 46), and deliberations by a number of federal committees including the National Bioethics Advisory Committee (NBAC), the National Human Research Protections Advisory Committee (NHRPAC), and others. The HHS Secretary's Advisory Committee on Human Research Protections (SACHRP) has discussed upcoming OHRP efforts to further address the issue of questionable capacity. Given that serious concerns have been raised about prior attempts to further regulate research involving people with mental disorders, new efforts should be followed carefully by those with an interest in facilitating research on the causes and treatments of severe mental disorders.
In the past, NBAC and NHRPAC have proposed restricting people with mental disorders that may affect decision-making capacity from participating in entire categories of research. Some proposals have sought to apply concepts based on subpart D regulations, which govern the protection of children in research, to studies involving adults with mental disorders that may impair decision-making capacity. These efforts would allow for adults with mental disorders to participate in treatment research studies that offer the prospect of direct benefit. However, the