Should it be mandated that an HEC review a physician's decision not to honor a patient's or surrogate's refusal of treatment?
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Biomedical subjects
Publications and source records attributed to E G DeRenzo.
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In response to public concern over abuses in human medical experimentation, the dominant approach to the ethics of clinical research during the past 30 years has been regulation, particularly via institutional review board review and approval of scientific protocols and written consent forms. However, the effectiveness of regulatory mechanisms in ensuring the ethical conduct of clinical research is limited. Little attention has been devoted to the nature and role of professional integrity of physician investigators, a conscientious framework for guiding investigators in the socially important but morally complex activity of clinical research. Professional integrity is vital in forging an ethically sound relationship between investigators and patient volunteers, a relationship that differs in important ways from the patient-physician relationship in standard clinical practice. We examine critically 2 models of the moral identity of physician investigators, the investigator as clinician and the investigator as scientist; in neither of these 2 models can the physician investigator eliminate completely the moral conflicts posed by clinical research. The professional integrity of physician investigators depends on a coherent moral identity that is proper to the enterprise of clinical research. The roles of clinician and scientist must be integrated to manage conscientiously the ethical complexity, ambiguity, and tensions between the potentially competing loyalties of science and care of volunteer patients.
As increasing attention is paid to the ethical concerns raised by human subject research, more needs to be focused on issues usually not discussed in the research ethics literature. No longer is it sufficient to talk only about the conflicting goals of clinical care and clinical research. We need to delve more deeply into how human subjects studies are performed and examine the feminist ethics issues of power differentials, context, relationships, and emotions. The source of much of our moral discomfort with clinical trials frequently is in these components of the clinical research settings that are discussed less often.
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An outreach program to deliver mental health services to mentally ill older adults has been developed in Baltimore County, Maryland. Incorporating prevention and early intervention strategies, this program targets persons aged 60 and over with late-onset or previously undiagnosed psychiatric histories. Services are provided through a novel one-third/one-third/one-third delivery schedule in senior centers, in community mental health centers, and in seniors' homes.
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Amid the ethical debate about consent to research involving cognitively impaired subjects, author cautions against creating barriers to acceptable research and provides criteria by which guidelines should be developed.
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