CLINICAL HANDBOOK OF SCHIZOPHRENIA

61. Ethics 629Despite these seeming obstacles, clinical judgment is a critical protection for researchsubjects (Miller & Weijer, 2006). IRB approval of a research study means that it has determinedthat the benefits and harms of study participation are acceptable. But in makingthis determination the IRB can appeal only to population-level evidence. The circumstancesof individual research subjects are not in view at the time of IRB approval; hence,such approval does not imply the acceptability of enrollment or continued participationof particular patients. It remains for the clinician to meet his or her obligations to theresearch subject through the exercise of clinical judgment that takes into account the circumstancesof the research subject. If the clinician judges study participation to be medicallyirresponsible based on evidence that ought to be convincing to colleagues, the clinicianis obliged to decline to offer enrollment or to recommend to the patient or to thelegal guardian withdrawal of the patient/subject from the study.When may placebo controls be used ethically? Placebo is a nonactive intervention,such as a sugar pill. In standard clinical trials, subjects (and clinicians) are blinded towhether they are receiving placebo or active treatment. The use of placebo controls inpsychiatric research has proven controversial. Proponents of the routine use of placebocontrols have argued that good science and ethics require their use (Temple & Ellenberg,2000). Scientifically, the placebo control provides a clinical trial with a “benchmark” accordingto which investigators may ensure that conclusions derived from study results aresound (i.e., that the new intervention/medication being studied is indeed beneficial). Proponentsargue that free and informed consent provides sufficient moral grounds for placebostudies, provided that research subjects are not exposed to a risk of death or permanentdisability. Critics of this view point out that the design of the study ought to dependon the scientific question, and not on unsubstantiated claims regarding the special propertiesof placebo controls (Weijer, 1999). Clinically relevant scientific questions usuallyregard the comparative effectiveness of treatments and require designs that employ astandard therapy control. Although often permissible ethically, the use of placebo controlsis problematic when therapeutic procedures in a study are not consistent with clinicalequipoise, as may be the case for schizophrenia, where there are evidence-based beneficialinterventions such as various antipsychotic medications.Given the contentious nature of placebo use in clinical research currently, how oughtthe clinician approach the issue? It is a well accepted maxim in research ethics that themedical care of a patient ought not to be disadvantaged by research participation. In consideringdecisions to refer, enroll, or continue a patient in a clinical trial, the clinicianought to act accordingly. The use of a placebo control is generally agreed to beunproblematic when there is no treatment for a condition, when nontreatment is consistentwith competent medical care, or when all patients receive standard care and thestudy is concerned with the efficacy of the addition of a treatment to the standard regimen.This may not be the case for clinical research on schizophrenia using placebo-onlycontrols. Hence, such research on subjects with schizophrenia may not be ethically justified.As discussed earlier, clinical judgment must also take into account the circumstancesof each patient.KEY POINTS• Bioethics addresses conflicts of values that arise in health care situations.• Mental health care such as psychiatric rehabilitation for individuals with schizophrenia is notethically and conceptually sound if it is (purely) client-centered at all costs.• A dialogical approach to the mental health care of individuals with schizophrenia may pro-