Ron Honberg, JD, M.Ed. Director of Policy and Legal Affairs, NAMI October 28, 2008

1. Achieving the Right Balance?NAMI’s Perspectives on Research Involving Individuals with Impaired Decision-Making Capacity Ron Honberg, JD, M.Ed. Director of Policy and Legal Affairs, NAMI October 28, 2008 SACHRP meeting, Arlington VA.

2. Threshold Considerations • Human subjects research is critically important in finding effective treatments and ultimately a cure for mental illnesses. • Individuals with serious mental illnesses frequently participate in research for altruistic reasons. • Distinctions between “research” and “treatment” may not always be clear for individuals or families. • Capacity may fluctuate over the course of a research protocol, particularly for certain types of research. • Regulations governing research on persons who may lack capacity are needed!

3. IRB Membership and Reviewer Qualifications • AllIRBs that regularly review research on serious mental illness should include consumers and/or family members. • Members of IRBs that review research on mental illness should receive specialized training. • Training should include information about medical issues, life experiences, and legal, regulatory and ethical requirements. • IRBs should include as many members from outside of the research institution or facility as possible.

4. Risk-Benefit Analysis • Experience of “risk” in research is subjective. • Risk assessment should include multiple factors including: • Psychological as well as medical factors • Long-term as well as short-term risks • Possibility that research subject will incur risk as a consequence of research participation. • When questions about potential capacity of subjects exist, determination that research is beneficial should be based solely on potential benefits to subject, not to field.

5. A Suggested Framework • If minimal risk, regular IRB approval guidelines should be followed. • If greater than minimal risk, prospect of direct benefit to research subject, consent by an LAR is permissible when: • LAR has been specifically authorized by subject or a Court to consent to research • LAR has been personally informed of potential risks and benefits. • Surrogate consent by institutional or government body should not be permitted.

6. Suggested Framework, cont. • If greater than minimal risk, no prospect of direct benefit, participation in research by subject who lacks capacity should not be permitted unless: • Surrogate consent by LAR plus • Advance directive with explicit instructions consenting to particular type of research. • Generalized consent to participate in research should not be enough

7. Research Advance Directives (RADs) • Should be encouraged whenever there is a reason to anticipate potential lack or loss of capacity during research. • With RAD, identity of surrogate and explicit wishes of subject would be known. • Ideally, RAD should be written independently, to protect against undue influence or coercion. • SACHRP could develop a model RAD or recommend model language.

8. Related Issues • Capacity assessment should be conducted by someone other than principal investigator or others involved with research. • Verbal or non-verbal expression of dissent should always serve as basis for discontinuing individual’s participation in research. • When individual discontinues participation, efforts should be made to link with needed services. • Individuals who benefit from experimental medications should be provided with continued access until medication is approved or a third party source of payment is found.