Why is it different?• Disease of the mind affecting understanding and mental ability of

the human being - disorder of attention concentration cognition affect & reality testing – all impair ability to consent

• All declarations question ability to consent• Roumania – negative perception of mentally ill patient- STIGMA• Lack of integration in the community• Different degrees of mental illness

• IRB members don’t get to see patients – very subjective• Advanced directive for research participation?• What are the significant harms toxic treament vs benefit of doing

nothing?• Is the harm significant enough to exclude them entirely?• Any measures we could take to protect as well as include?

Problem with semantics?

• Legal terms vs philosophical terms?

• Autnomy,capacity etc all mean the same thing – difference is jurisdiction

• Definitions of mental illness

• Social perspectives to mental illness – cultural relevance eg Nigeria – won’t believe there is a cure

Protections?

• Informed consent to allow inclusion?• More dynamic procedures to measure capacity?• Eg alzheimers – continuous evaluation• Study with no direct benefit eg to see progess if

disease, so no benefit to individual - Talk about enrolment, not access

• We HAVE to do research into mental health

Criteria for defining mental illness

• Brain scans – physical measures?

• cf competence defined by ability to name presidents of US

• Does IRB have technical knowledge to critique the methodology? Do they know which scoring systems are scientifically valid – how many scales do we have?

• Hard measures of function or ability to participate in social life?

• Somatic disorders, mental retardation• Need to bottom out the concept of mental

disorders?• Eg does arachnophobia mean you can’t make a

decision? Would it disqualify you from taking part because you have a mental illness

• In theory everyone has some sort of mental illness and therefore a ‘vulnerable’ person

• If you can’t define mental illness or agree your criteria you can’t define your research question

• Mental illness covers a huge range of conditions• Double blind randomised control trials – already

diagnosed with a mental health condition, so is it ethical to withhold treatment in the control group? Study could show that doing nothing is better than medication and control group would be monitored.

• Somatic basis to mental health• Why is there a difference between malaria and

mental health?• Lack of biomedical marker for mental illness • Various scales & criteria for measuring mental

health – can be a wide as ‘something that adversely affects their day to day lives’

• Is there enough expertise on IRB to be able to recognise a well regulated research project?

• Scientific review separate from ethical review?• Scientific review first?

Implications for research –Consent issues

• Competence varies over time

• Capacity affected by medication – competent to give consent when on medication?

• What if research needs for subjects to be at their ‘worst’? Is their consent still valid?

Implications for research

• Diminished capacity causes the person to change their mind

• Deterioration

• Impaired capacity affects ability to make informed decision

• Medication can affect mood/abilities

Special precautions?

• Any special precautions in developing countries?

• What is IRB looking for to protect the subject?

• Special monitoring of subjects for their own and others protection – even to holding a person in secure place?

• Exclusion of most vulnerable subsets of the group under research?

Problems for developing countries?

• IRBs couldn’t allow certain people to stop medication so that they could take part in a placebo trial – current rules wouldn’t allow, but is this an exclusion too far?

• Sophisticated facilities in the West eg CFRs where people can be treated while in a trial – but not in developing countries.

• Health care systems and provision of facilities worse for mental health eg Kenya – have to think of a different name to describe facilities

Solutions

• Advanced directive to appoint proxy for future consent – a solution? Ulysses & the sirens

• Or advanced directive to withdraw consent under certain circumstances

• Surrogate to take precedence over advanced directive