Lead Researcher:
Study Title:
HS #:
APPENDIX E
COGNITIVELY IMPAIRED/MEDICALLY INCAPACITATED SUBJECTS
AND USE OF SURROGATE CONSENT
University of California, Irvine
Institutional Review Board
Please read the applicable HRP webpage on the use of surrogate consent before completing this appendix.
The mere presence of a cognitive impairment should not lead to a presumption that a person is incapable of making a
decision regarding participation in research. All adults are presumed competent unless determined to be incompetent.
Cognitively impaired and medically incapacitated persons are considered vulnerable research populations because their
mental or medical disability may compromise their capacity to make a reasoned decision about participation in research.
When competency of the subject is in question, a decision-making capacity assessment should be performed. When
surrogate consent will be used, investigators must attempt to obtain informed consent directly from the subject
whenever possible. If the subject expresses resistance or dissent to participation or to use of surrogate consent (by word
or gesture) the individual shall be excluded from the study. In addition, a subject who regains the cognitive ability to
consent must be re-consented using standard consenting procedures.
Surrogate consent to participate is not permitted for persons in a State of California mental health facility inpatient
psychiatric ward, or persons on psychiatric hold.
Note: If surrogate consent is approved by the IRB, the surrogate of each subject must complete the following form: SelfCertification of Surrogate Decision Makers for Participation in Research. Details of how to obtain consent from a surrogate
are provided on the Use of Surrogate Consent in Research webpage.
1. Check the population to be enrolled:
Cognitively Impaired
Medically Incapacitated
2. Provide a compelling and scientifically sound rationale for inclusion of cognitively impaired or medically incapacitated
subjects.
3. Describe in detail the plan for assessing the decision-making capacity of each subject in order to determine whether
the individual is capable of providing informed consent. A decision-making capacity assessment tool is available for
use on the Use of Surrogate Consent in Research webpage.
4. Specify who will be performing the decision-making capacity evaluation. Provide the credentials, experience, and
expertise of the individual(s) performing the evaluation.
Evaluator(s):
5. Is it reasonable to expect that during the course of the study subjects may lose their capacity to consent or their ability
to withdraw consent (e.g., research involving administration of or withdrawal of antipsychotic drug)?
Yes. Explain why. Also what provisions will be put in place to protect the subject’s rights (e.g., ongoing informed
consent; use of surrogate consent)?
Appendix “E” - Vulnerable Populations: Cog Impaired/Med Incap.
Revision Date: 9/30/09
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Lead Researcher:
Study Title:
HS #:
No. Explain why.
6. Are you requesting IRB approval to seek surrogate consent from a legally authorized representative?
If no, you are not required to complete questions 7-10.
Yes
No - You are not required to complete Questions 7 - 10.
7. Surrogate consent may be considered only in research studies relating to the cognitive impairment, lack of capacity or
serious or life-threatening disease and conditions of the research subjects. Check the condition(s) that apply to the
research study:
Cognitive Impairment
Lack of capacity
Serious or life-threatening diseases or conditions
8. Develop a plan that outlines the sequence of steps that will be employed by the study team to acquire and document
surrogate consent provided by a legally authorized representative. A sample plan is available on the Use of Surrogate
Consent in Research webpage.
9. Explain how you will solicit the assent of the cognitively impaired individual.
10. Describe how you will evaluate the subject's resistance or dissent to participate or to the use of surrogate consent.
Appendix “E” - Vulnerable Populations: Cog Impaired/Med Incap.
Revision Date: 9/30/09
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