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