Ethics of clinical research in schizophrenia
The conversation may take place over one or more sessions, during which time the investigator must disclose relevant information, answer questions, and ensure that the prospective subject understands the information presented. The consent form is mandated by Federal regulation and is a written summary of the information to be conveyed in the consent process. The mere provision of a consent form to a prospective participant does not constitute an adequate consent process. As may not infrequently be the case in schizophrenia research, when a prospective subject is incapable of providing free and informed consent, consent must be sought from the subject’s legally authorized representative in accord with State law (Dunn, 2006). Finally, both the consent process and the consent form must detail adequate protections for the research subject’s data. The benefits and harms of research participation must stand in reasonable relation (Weijer & Miller, 2004). Clinical research often contains a mixture of study procedures. Therapeutic procedures are interventions, such as antipsychotic drugs or counseling administered on the basis of therapeutic warrant, that is, on the basis of evidence that makes it reasonable to believe that they may benefit the research subject. Therapeutic procedures in research must meet the standard of clinical equipoise; that is, they must be consistent with competent medical care. Formally, clinical equipoise requires that there exist a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Nontherapeutic procedures, such as additional blood tests or questionnaires not a part of routine clinical practice, on the other hand, are not administered with therapeutic warrant and are given solely to answer the scientific question at hand. The risks of nontherapeutic procedures must be minimized by using procedures that are consistent with sound scientific design and reasonable in relation to the knowledge expected to be gained from the study. Only if ethical requirements for both therapeutic and nontherapeutic procedures are fulfilled may one conclude legitimately that the benefits and harms of study participation are reasonable. Study selection procedures must be fair. Study eligibility criteria must be clearly stated and ought to be accompanied by a clear justification. Research subjects ought not to be wrongfully included in, or excluded from, research. It is generally accepted that research ought to be carried out on the least vulnerable study population possible, consistent with the scientific goals of the study. Therefore, a study ought to include only subjects capable of providing informed consent, unless the scientific ends of the study require the inclusion of incapable subjects. Having said this, it is also recognized that patient populations (e.g., women, children, and older adults) may be deprived of important benefits if not included in clinical research. Thus, the exclusion of these groups requires adequate justification. Schizophrenia research raises a considerable number of ethical questions for investigators and clinicians alike. Here we consider two of these briefly. First, what are the obligations of the clinician to the patient in research? Second, when may placebo controls be used ethically? What are the obligations of the clinician to the patient in research? In clinical practice, the clinician has a broad range of fiduciary duties to the patient, including a duty of care. The duty of care requires that the clinician act and advise in the best medical interests of the patient. But how can the clinician do this when the patient is a research subject? The research protocol may involve a detailed regimen for treatment of the research subject. Beyond this, the study itself has been approved by the IRB as being scientifically and ethically sound. Finally, changing the management of a patient in a clinical study may interfere with the scientific ends of the study. What role is there then for clinician judgment in clinical research?