Ethics of mental health research
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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

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Q1 ways in which mental health differs
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
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
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
Q2: capacity - discussion capacity

  • 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
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
Q4: Issues in developing / under-resourced countries capacity

  • 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
Q4 : measures to address issues in developing countries capacity

  • 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