Informed Consent for Psychiatric Research: The Case of Medication-Free Research
Author(s)Berghmans, Ron L.P.
Informed Consent or Human Experimentation
Research on Mentally Disabled Persons
Third Party Consent
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AbstractInformed consent for research in psychiatry raises a number of ethical and legal issues. To illustrate some of the ethical problems involved, in particular issues of patient competence and proxy consent, as well as the motives of patients to become research participants, as an example the case of so-called medication-free research in schizophrenia is discussed. It is argued that an assessment of the competence of potential research subjects to consent to participation, based on explicit criteria, is necessary. In case of substituted consent it is shown that proxy decision makers may fail to protect the interests of incompetent patients in research. Finally, researchers ought to be aware that research subjects may be motivated to participate in research because they may mistakenly believe that the research project is designed to benefit them directly.
Medicine and Law: World Association for Medical Law 1999; 18(4): 515-524
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Updating Protections for Human Subjects Involved in ResearchMoreno, Jonathan; Caplan, Arthur L.; Wolpe, Paul Root (Project on Informed Consent, Human Research Ethics Group (University of Pennsylvania Health System, Center for Bioethics), 2015-05-05)For decades, all federally funded research involving human subjects has been subject to regulations that require the informed consent of the subject and oversight by the local institution. These regulations last underwent major revision in 1981 and have remained unchanged despite significant changes in the nature of clinical science, the financial sources of research support, and the institutional environment in which clinical research is conducted. In the intervening years, doubt has evolved as to whether the regulations currently in place adequately protect the welfare and rights of research subjects in today's clinical research environment and whether the costs, in terms of time, bureaucracy, and delay, are justified by the level of protection afforded. The Human Research Ethics Group, administered by the Center for Bioethics at the University of Pennsylvania Health System, extensively reviewed the status of existing human subjects protections with the aim of making recommendations to improve and reform the regulations. Here, we present recommendations constituting a consensus of the group members for reform in 3 key areas: protecting subject populations with special needs and vulnerabilities, oversight by institutional review boards, and regulatory policy.