CLINICAL HANDBOOK OF SCHIZOPHRENIA

628 VIII. SPECIAL TOPICSticipant regarding study participation. The conversation may take place over one or moresessions, during which time the investigator must disclose relevant information, answerquestions, 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 informationto be conveyed in the consent process. The mere provision of a consent form toa prospective participant does not constitute an adequate consent process. As may not infrequentlybe the case in schizophrenia research, when a prospective subject is incapableof providing free and informed consent, consent must be sought from the subject’s legallyauthorized representative in accord with State law (Dunn, 2006). Finally, both the consentprocess and the consent form must detail adequate protections for the research subject’sdata.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 administeredon the basis of therapeutic warrant, that is, on the basis of evidence thatmakes it reasonable to believe that they may benefit the research subject. Therapeuticprocedures in research must meet the standard of clinical equipoise; that is, they must beconsistent with competent medical care. Formally, clinical equipoise requires that thereexist a state of honest, professional disagreement in the community of expert practitionersas to the preferred treatment. Nontherapeutic procedures, such as additional bloodtests or questionnaires not a part of routine clinical practice, on the other hand, are notadministered with therapeutic warrant and are given solely to answer the scientific questionat hand. The risks of nontherapeutic procedures must be minimized by using proceduresthat are consistent with sound scientific design and reasonable in relation to theknowledge expected to be gained from the study. Only if ethical requirements for boththerapeutic and nontherapeutic procedures are fulfilled may one conclude legitimatelythat the benefits and harms of study participation are reasonable.Study selection procedures must be fair. Study eligibility criteria must be clearlystated and ought to be accompanied by a clear justification. Research subjects ought notto be wrongfully included in, or excluded from, research. It is generally accepted that researchought to be carried out on the least vulnerable study population possible, consistentwith the scientific goals of the study. Therefore, a study ought to include only subjectscapable of providing informed consent, unless the scientific ends of the study requirethe inclusion of incapable subjects. Having said this, it is also recognized that patientpopulations (e.g., women, children, and older adults) may be deprived of important benefitsif not included in clinical research. Thus, the exclusion of these groups requires adequatejustification.Schizophrenia research raises a considerable number of ethical questions for investigatorsand clinicians alike. Here we consider two of these briefly. First, what are the obligationsof the clinician to the patient in research? Second, when may placebo controls beused 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 ofcare. The duty of care requires that the clinician act and advise in the best medical interestsof 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 researchsubject. Beyond this, the study itself has been approved by the IRB as being scientificallyand ethically sound. Finally, changing the management of a patient in a clinical studymay interfere with the scientific ends of the study. What role is there then for clinicianjudgment in clinical research?