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?
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))
340 CH.1 – Impaired Consent Capacity Checklist
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
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