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.

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!

IRB Membership and Reviewer Qualifications All IRBs 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.

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.

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.

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

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.

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.