An issue of ongoing concern to clinical investigators, medical ethicists, and institutional review board members is the problem of obtaining informed consent in research that involves people with mental illness as research participants. Although the presence of a mental disorder per se does not render a person incapable of giving informed consent, some individuals afflicted with significant cognitive impairment, formal thought disorder, substantial anxiety or depression, or a variety of other symptoms may be impaired in their capacity to comprehend consent (...) disclosures and therefore to exercise consent to research participation in a competent manner.The stakes surrounding this informed consent issue are significant. On the one hand, the inclusion in research of participants who are not capable of giving informed consent may result in their exposure to unwarranted risks and significant harm. These concerns may be exacerbated in certain clinical trials in which patients are required to discontinue their medications during “washout periods” at the onset of a study, or are randomly assigned to a placebo treatment and remain off medication for extended periods. (shrink)

The mission of the Indian Health Service affects what research is done and how It is reviewed and managed and in turn affects the forms and process used to obtain informed consent. Consent forms must be Informative and understandable to American Indian and Alaska Native potential volunteers; the process used to obtain informed consent must minimize any institutional pressure to participate. The IHS Institutional Review Boards developed seven research Model Volunteer Consent Forms.

Traditional disciplinary guidelines are inadequate to address some of the ethical dilemmas that emerge when conducting research on violence against women and girls. This article is organized according to the ethical principles of respect for persons, privacy and confidentiality, justice, beneficence, and nonmaleficence. In the article, I describe dilemmas involved in cross-cultural research, research on children, informed consent, voluntariness, coercion, deception, safety, mandated reporting, and dissemination. In the article, I include examples from qualitative and quantitative studies in many nations. I (...) also offer suggestions for researchers and institutional review boards. (shrink)

The application of human right frameworks is an increasingly important part of efforts to accelerate progress in global mental health. Much of this has been driven by several influential legal and policy instruments, most notably the United Nations’ Convention on the Rights of Persons with Disabilities, as well as the World Health Organization’s QualityRights Tool Kit and Mental Health Action Plan. Despite these significant developments, however, much more needs to be done to prevent human rights violations. This chapter focuses on (...) a critical component of this broader challenge, which is the question of how best to regulate and reduce the use of coercive measures. The recent literature on coercion in psychiatry – which addresses involuntary commitment, seclusion, restraint, and forced medication – represents a useful resource that can help guide tractable solutions in global mental health. These issues are evaluated from the perspective of global health governance, and several general recommendations are made in order to improve monitoring and enforcement, provide guidance for domestic legislative reform, and strengthen health systems. (shrink)