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Resources :: Guide :: Vulnerable and risk sensitive participants :: Vulnerable participants :: Diminshed mental capacity :: Participating in a study

Can an Individual with Diminshed Mental Capacity Participate in My Study?

The following rules mirror those used for minors and assume that the individual participating requires surrogate consent.  For adults with diminished mental capacity, these rules may not always be appropriate and the Board will grant flexibility where justifiable.

  • Research is not greater than minimal risk. You are required to obtain permission from the legally authorized representative and assent from the participant.
  • Research is greater than minimal risk but presents direct benefit to participant. In order for the Board to approve this study, you must demonstrate that the risk is justified by the anticipated benefit to the participant and the relation of the anticipated benefit to the risk is at least as favorable to the participant as another approach. You are required to obtain permission from the legally authorized representative and assent from the participant.
  • Research is greater than minimal risk but will yield generalizable knowledge about disorders or conditions affecting the participant. In order for the Board to approve this study, you must demonstrate that the risk is only a minor increase over minimal risk, the procedure could reasonably occur in the participant’s normal care (i.e. medical, dental, psychological, social, or education situation), and the information gathered from the study will provide valuable information for the participant’s condition or disorder. You are required to obtain permission from the legally authorized representative and assent from the participant.
  • Research not otherwise approvable but presents opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of participants with similar disorders or conditions. In order for the Board to approve this study, you must justify that this study presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of participants with similar disorders and the research will be conducted in accordance with sound ethical principles. You are required to obtain permission from the legally authorized representative and assent from the participant.  

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