340 CH.1 Impaired Consent Capacity Checklist

Yale University Institutional Review Boards

340 CH 1 Impaired Consent Capacity Checklist

Points to Consider In accordance with 45 CFR §46.111(b) and 21 CFR §56.111(b), consideration of additional safeguards is required for certain subject populations likely to be vulnerable to coercion or undue influence, such as individuals with impaired consent capacity. Although each individual protocol must be reviewed within the context of its own unique intricacies, the following considerations should be thought about when involving individuals with impaired consent capacity in research.

1. ____(Y/N) Are there additional safeguards established to protect the rights and welfare of these subjects? If yes, indicate by checking applicable items below or adding additional safeguards not listed; if there are no additional safeguards that can or will be employed, please provide rationale on a continuation sheet or in your proposed protocol as to why additional safeguards are felt not to be necessary or useful in this study. ___ Consent monitor ___ Subject advocate ___ Medical monitor ___ DSMB ___ Education of family ___ Surrogate/Next of Kin/Legally Authorized Representative ___ Subject advance directive ___ Assessment of capacity to consent ___ Independent assessment of capacity to consent ___ Consent process waiting period ___ Consent information provided incrementally ___ Provisional/Affirmatory consent ___ Quizzes or summary sheets to assist subjects to understand: ___ Clinician vs. Investigator Roles ___ Risks (including withdrawal from existing therapy and/or from the study) ___ Benefits ___ Alternatives ___ Rationale for invitation ___Other (Please specify on a continuation sheet)

2. ____(Y/N) Does the protocol include a thorough justification of the research design, including a description of procedures to minimize risks and, if appropriate, a process for heightened scrutiny for studies designed to provoke symptoms, withdraw subjects rapidly from therapies, or expose subjects to the use of placebo controls when standard therapy is withheld? 340 CH.1 – Impaired Consent Capacity Checklist

3. ____(Y/N) Is it necessary to have a special representative to the IRB deliberations familiar with the disorder and capable of addressing concerns specific to the subject population? (45 CFR §46.107(a); 21 CFR §56.107(a))

4. ____(Y/N) Does participation provide access to an important potential benefit, particularly one that is not otherwise available? Is it necessary or important that this benefit be provided through this study?

5. ____(Y/N) Are the provisions for obtaining assent of the subject appropriate and adequately described in the protocol?

6. ____(Y/N) Are there provisions in the protocol to ensure that a subject's objection (dissent) to enrollment or to continued participation will be heeded?

7. ____(Y/N) If continuing or periodically renewed consent is necessary for continued involvement (e.g., when a procedure that as originally described in the consent process is not performed until a much later time), is there a process to re-evaluate capacity to consent and affirmation of the original consent?

The IRB will consider whether research involving greater than minimal risk with no prospect of direct benefit to individual subjects may be conducted if such research targets adult individuals with impaired capacity to consent. Approvals for this type of research will be granted on an extraordinary basis. As preparation for the IRB review, investigators should include in their protocol a discussion addressing the items listed below1 :  Are there any other means by which the investigator might obtain the information?  Does the intervention or procedure present experiences to subjects reasonably commensurate with those inherent in their actual or expected medical, psychological, social, or educational situations?  Is the study likely to yield generalizable knowledge about the subject's disorder or condition, which is of vital importance for the understanding or amelioration of the subject's disorder or condition?

The above points to consider derive, in part, from the findings of the National Bioethics Advisory Commission in its report Research Involving Persons with Mental Disorders That May Affect Decision Making Capacity (December, 1998), the National Institutes of Health's Research Involving Individuals with Questionable Capacity to Consent—Points to Consider (http://grants.nih.gov/grants/policy/questionablecapacity.htm ), and the federal regulations at 45 CFR Part 46 and 21 CFR Part 56.

1 45 CFR §46.406—adapted from Subpart D, Additional DHHS Protections for Children Involved as Subjects in Research

Last Revised 9/26/12 Page 2 of 2