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Resources :: Guide :: Vulnerable and risk sensitive participants :: Vulnerable participants :: Diminished capacity to consent :: Consent

Consent

Which participants require surrogate consent?
If the participant is an adult, the researcher needs to determine if the participant has the legal ability to provide consent or if the participant already has a legally authorized representative. If an individual is found not competent to legally consent, then a legally authorized representative 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. Please see Assessing Capacity to Consent for more information. 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 and document your capacity assessment procedures.

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 consent 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.

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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