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Resources :: Guide :: Vulnerable and risk sensitive participants :: Vulnerable participants :: Diminished mental capacity :: Consent


Which participants require surrogate consent?
The issue of consent here is similar to that of parent consent/child assent.  If an individual is found not competent to legally consent, then a legally authorized individual can provide surrogate consent for the individual. A surrogate is usually a family member, though it could be a state appointed representative as well. If the participant does not have a legal representative and if there is a possibility that the cognitive capacity of the participants could be in question (i.e. elderly population with possibility of dementia), it may be necessary for the researcher to determine a participant’s competency to consent.  The Board will expect you to develop a procedure that is appropriate for the participants, and they will also expect that you (or a member of your research staff) will have the expertise to assess competency.  You will need to provide an instrument that you will use to determine competency. The Mini Mental State Examination, for example, could be used for appropriate participants.

What forms should I use?
The IRB does not have a specific template for a surrogate consent form, but the Parent Consent/ Child Assent template can act as guide.  In general the surrogate receives a surrogate version of the consent form, while the participant receives an assent form.  Both forms should be written to the reader’s comprehension level.  Some participants may not have the capacity to read and sign a form.  However, it is generally appropriate to explain to the participant what you are doing and ask if they want to participate.

In some studies, the surrogate may act as a participant in the study as well as allowing the adult with diminished cognitive capacity to participate.  If so, it may be necessary to provide a separate consent form document that more clearly explains what the surrogate will do as a participant in the study (although one consent document can usually provide adequate information).  Also, if the study requires that you provide additional forms (i.e. materials release forms, debriefing documents), you should provide a surrogate version as well as a participant version.

If you need to determine capacity to consent, please see the Capacity to Consent template.  This is a sample document that will help you to develop your capacity assessment procedures.

Enhancing Comprehension
For some participants, providing them with a written document does little to prepare them to give full consent. However, this does not mean that they are incapable of providing full consent, only that the approach is inefficient.  Taking the initiative to enhance the participant’s comprehension may make it possible for a participant to fully consent. For example, consider using other forms of media (i.e. video, photography) to convey the message of the consent form.  Involve family members and/or care takers in the process.  Talk to the participants and ask them open-ended questions to determine if they understand the consent information.  When the participant demonstrates that he or she understands the study, you can then proceed with documenting consent.

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