Ethics of Mental Health Research

Q1: ways in which mental health differs Definition of mental illness is problematic. Terminology is very broad and inconsistent Diagnosis is difficult and can be a socio- or political- construction Awareness of possible cultural factors Patients are potentially more vulnerable These factors lead to… –Greater need for clear inclusion/exclusion criteria –Special attention to assess diagnostic criteria that have been used? –..need Psychiatrist on REC or trust Psych investigator? Possible lack of awareness of patient of illness and implications of intervention

Q1: discussion - vulnerability NB assumption of extra vulnerability – is this function of mental illness, or of loss of capacity. Ie why does mental illness necessarily imply vulnerability where patient has capacity. –Vulnerability arising from representation by a third party –Vulnerability function of dependency –Vulnerability arising from poor judgement

Q2: Ethical implications for research of lack/loss of capacity Research has to be directly relevant to that population and not be possible with patients with capacity, so… Special justification needed for studies that are not specifically targetted at the condition leading to incapacity, but… Should incapacitated patients be excluded from research that could benefit all sectors of population – eg treatment of heart disease / patients with Downs Syndrome This group is different to general population, but take care not to over-protect Lack of capacity should not be assumed in patients with even severe mental illness – capacity can be variable and should be assessed independently of the illness Need clear understanding of legal definition of competence and implications for assessing capacity How can we be confident that the legal representative can know wishes or represent best interests of the patient? Consider issues of confidentiality in respect of legal rep.

Q2: capacity - discussion If a court has declared a person incompetent, but we consider that they have capacity for this purpose, can they enter trial? REC needs to examine protocols to consider inclusion/exclusion criteria in terms of capacity / competence / representation Particular questions about use of placebo? Questions of conflicts of interest: –Role of pharmaceutical sponsor, payments –Especially where there may be a dependent relationship with clinician

Q3: Special precautions where people have diminished capacity Important for legal representative to be independent of researcher / sponsor REC to examine protocol for how best interests will be considered Is there a greater need for ongoing inspection / audit / monitoring / scrutiny? How to monitor practice of decision-making rather than just the SOP What if legal rep consents, but patient is resistant

Q4: Issues in developing / under- resourced countries Sponsor of research – what is their role / interest. More vulnerable population – needs extra attention. Poor quality of local standard of care in – entry in any trial could be seen as a benefit – ie always in best interests to enter study! Attention to risk of inducement in view of poverty Post-trial position if drugs are successful or addictive [Not unique to mental health, but issues might be more sensitive, especially as MH provision is particularly badly served in developing countries] Identifying decision-maker(s) and cultural factors in considering individual/family interests Competence of local doctors to participate

Q4 : measures to address issues in developing countries Capacity (ie resource) to manage issues is limited, so take extra cautionary approach as default, despite potential risk of exclusion from beneficial research? Dedicated training modules to mental health research Specialised committee for MH research proposals – if possible and workable