Clinical trial design, ethical issues, research

Finally, regulatory and policy bioethics is concerned with ethical issues such as clinical trial design, drug approval ethics, use of embryonic tissue in research and clinical treatment, human cloning, organ procurement for transplantation, xenotransplantation, assisted suicide, euthanasia, formulation of brain death policy, allocation of scarce healthcare resources, and so on. 

A basic ethical issue in several areas of psychiatric research is whether participants are able to provide informed consent, particularly for protocols entailing medication washout and/or placebo treatment. The majority of psychiatric patients who are asked to participate in clinical trials have adequate capacity to provide consent. Thus, in a study specifically designed to examine the capacity of schizophrenic patients to give informed consent, cognitive dysfunction and negative symptoms (apathy and avolition). but not psychotic symptoms (hallucinations, delusions), were found to be associated with impaired decisional capacity (Moser et al., 2002). These features are probably not unique to schizophrenia but are likely to apply to many other forms of illness. 

Each study component has an ethical aspect. The ethical aspects of a clinical trial cannot be separated from the scientific objectives. Segregation of ethical issues from the full range of study design components demonstrates a flaw in understanding the fundamental nature of research involving human subjects. Compartmentalization of ethical issues is inconsistent with a well-run trial. Ethical and scientific considerations are intertwined (p. 4). 

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