Ethics of Mental Health Research

1. Ethics of Mental Health Research

2. 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

3. 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

4. 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.

5. 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

6. 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

7. 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

8. 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