BackgroundMany of the important elements of a valid informed consent – comprehension, voluntariness, and capacity – can be compromised or unmet in the context of psychiatric research. The inability to protect their own interests puts mentally ill subjects at an increased likelihood of being wronged or harmed and makes them particularly vulnerable in the context of clinical research. Therefore, they are due extra protection. Sometimes, these additional safeguards can significantly limit the possibilities for research involving subjects deemed unable to consent (...) due to their mental illness. Montenegro, a middle-income country in Southern-Eastern Europe, goes so far in their policy to protect these subjects from harms of research, as to ban all biomedical research on mentally ill persons who are unable to provide consent.Main bodyMental health research is often neglected and very low on the list of health research priorities, especially in low- and middle-income countries. Despite the fact that mental health disorders are among leading causes of disability, the need for evidence-based services and interventions for those affected remains unmet.To exclude all members of a certain group of subjects seems extremely restrictive and unnecessary. Such a policy is discriminatory and unethical, because it inflicts further harms and exclusion of those patients from participation in society. This unjust exclusion policy obstructs research of certain psychiatric disorders and implies that new treatments for conditions that directly affect these incapacitated subjects will not be developed.ConclusionsScientific and clinical development must not be precluded by overly restrictive, discriminatory and unjust practices, such as the normative ban on research on decisionally-impaired mentally ill subjects. Rather, there should be a regulative framework that ensures that those who cannot consent for themselves are respected and protected in research, the anticipated benefits maximized, risks minimized, their autonomy recognized and extended. These patient-subjects must be appropriately included unless there is a clear and compelling rationale and justification that inclusion is inappropriate with respect to the health of the participants or the purpose of the research. (shrink)

This article addresses two areas of continuing controversy about consent in clinical research: the question of when consent to low risk research is necessary, and the question of when consent to research is valid. The article identifies a number of considerations relevant to determining whether consent is necessary, chief of which is whether the study would involve subjects in ways that would (otherwise) infringe their rights. When consent is necessary, there is a further question of under what conditions consent is (...) valid or successful in waiving a right. The most influential account of validity conditions is non-moralized, in the sense that the conditions make no essential reference to whether the researcher soliciting consent has obtained it in a way that wrongs the subject. The article examines the implications of this account, and compares it with recent accounts that moralize some of the validity conditions. -/- . (shrink)