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

Assessing Capacity to Consent

For some studies, the Board may require that you have a procedure in place to assess the capacity of your participants to consent.  In the consent section of the protocol, you will need to describe your procedure for assessing capacity to consent.  Depending on the level of risk in the study, the Board may require an independent assessment of capacity.  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. 

Assessing capacity may vary depending on the participants.  Often, the participant is questioned or given an examination to determine competency. Capacity can be documented by the participant’s signature on the consent form, or if there is an independent assessment of the participant, a formal note should be included with the participant’s consent form. 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.

The following list outlines various standards that a participant must meet in order to consent for him or herself. 

  1. The participant has the ability to communicate a yes or no decision. This standard is applicable to all risk/benefit levels.
  2. The participant has the ability to understand relevant information; the person can tell you what the research procedures involve and what the consent information includes.  This standard applies to all risk/benefit levels.
  3. The participant has the ability to appreciate the situation and its likely consequences. This standard applies to all research involving more than minimal risk.
  4. The participant has the ability to manipulate information rationally. This standard focuses on process, not outcome. For example, are decisions consistent with the religious, moral, and other beliefs of the person? This standard is critical for the most unfavorable risk/benefit levels.

If the participant does not meet the standard of capacity required for the level of risk in your study, the Board asks that you seek consent from the appropriate legally authorized representative. You will also need to document the assessment as part of your consent procedure. See the Capacity to Consent template in the Consent Forms section.

Please note that there is additional guidance for abused adults with diminished mental capacity.  

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