NUMBER / DATE / PAGE
HRP-422 / 7/13/12 / 1 of 2
Study #: / Reviewer: / Date:
The purpose of this checklist is to provide support for IRB members or the Designated Reviewer following the WORKSHEET: Criteria for Approval and Additional Considerations when research involves cognitively impaired adults as subjects. This checklist must be used for all reviews (initial, continuing, modification, review by the convened IRB, and review using the expedited procedure.)
- For initial review using the expedited procedure and modifications and continuing reviews where the determinations relevant to this checklist made on the previous review have changed, the Designated Reviewer completes this checklist to document determinations required by the regulations along with protocol specific findings justifying those determinations. The Designated Reviewer attaches this checklist to CHECKLIST: Non-Committee Review and the IRB office retains this checklist in the protocol file.
- For initial review using the convened IRB and for modifications and continuing reviews where the determinations relevant to this checklist made on the previous review have changed, one of the following two options may be used:
- The convened IRB completes the corresponding section of the TEMPLATE MINUTES to document determinations required by the regulations, in which case this checklist does not need to be completed or retained.
- The convened IRB completes this checklist to document determinations required by the regulations and the IRB office retains this checklist in the protocol file.
The research must meet one of the following two sets of criteria
1Research Involving Cognitively Impaired Adults in Which There is Anticipated Direct Benefit to the Subject (All items must be “Yes”)
YesNo / One of the following is true. (Check box that is true)
The risk to the subjects is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject.
More than minimal risk to subjects is presented by a monitoring procedure that is likely to contribute to the subject’s well-being.
YesNo / The risk is justified by the anticipated benefit to the subjects.
YesNo / The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches.
YesNo / The proposed plan for the assessment of the capacity to consent is adequate (and the PI states he/she will comply with institutional policies A3-113.9 and A3-113).
YesNo / The assessment of the capacity to consent will be performed by a qualified attending physician with appropriate training, licensing and certification, with special attention paid to qualifications re: assessing incapacity due to mental illness, mental retardation or developmental disability
YesNo / The proposed plan for the assessment of capacity includes the assessment of the cause and extent of the incapacity and likelihood that the subject will regain capacity.
YesNo / The PI has indicated that he/she will document this determination with the above details of the assessment appropriately (eg. In the medical record when applicable and in research record).
YesNo / Assent is required of: (One of the following must be “Yes”)
One of the following is true: (Check box that is true)
All subjects.
All subjects capable of being consulted.
None of the subjects
YesNo / The consent document includes a signature line for a legally authorized representative.
Research Involving Cognitively Impaired Adults in Which There is NO Anticipated Direct Benefit to the Subject (All items must be “Yes”)
Yes / The proposed plan for the assessment of the capacity to consent is adequate
Yes / The objectives of the trial cannot be met by means of study of subjects who can give consent personally.
Yes / The foreseeable risks to the subjects are low.
Yes / The negative impact on the subject’s well-being is minimized and low.
Yes / The trial is not prohibited by law.
Yes / Subjects have a disease or condition for which the procedures involved in the research are intended.
Yes / Subjects will be particularly closely monitored.
Yes / Subjects will be withdrawn if they appear to be unduly distressed.
Yes / The proposed plan for the assessment of the capacity to consent is adequate (and complies with institutional policies A3-113.9 and A3-113).
Yes / The assessment of the capacity to consent will be performed by a qualified attending physician with appropriate training, licensing and certification, with special attention paid to qualifications re: assessing incapacity due to mental illness, mental retardation or developmental disability
Yes / The proposed plan for the assessment of capacity includes the assessment of the cause and extent of the incapacity and likelihood that the subject will regain capacity.
Yes / The PI has indicated that he/she will document this determination with the above details of the assessment appropriately (eg. In the medical record when applicable and in research record).
Yes / Assent is required of: (One of the following must be “Yes”)
One of the following is true: (Check box that is true)
All subjects.
All subjects capable of being consulted.
None of the subjects
Yes / The consent document includes a signature line for a legally authorized representative.