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Assent - Diminished Capacity

Diminished Capacity

The PI should identify the intent to enroll vulnerable participants during the initial protocol submission and provide justification for including participants with diminished capacity. The justification should include a description of how mental capacity will be assessed.

  • If the research involves adults unable to consent, the IRB evaluates the proposed plan for the consent of legally authorized representatives.
  • The IRB evaluates and approves the proposed plan for the assent of participants. 
  • If mental capacity is over 7 years of age, Assent is required along with Parental\LAR consent.
  • The IRB evaluates the research to determine the need for additional protections and considers the use of a data and safety monitoring board or data monitoring committee as appropriate.
  • The PI should provide appropriate safeguards to protect the participant’s rights and welfare, which may include the addition of an Independent Monitor. The Independent Monitor is a qualified individual not involved in the research project who will determine the participant's capacity to provide voluntary informed consent.
    • An example of a research project that warrants independent monitoring includes:
      • Research involving schizophrenic patients who will be exposed to a placebo, and/or drug washout, and/or treatment with agents that are not approved by the Food and Drug Administration (FDA).

    • Examples of populations requiring independent monitoring include:
      • Individuals with schizophrenia, other psychotic disorders or conditions characterized by a lack of reality testing (i.e., psychosis).
      • Populations not usually requiring independent monitoring would include those with substance use disorders.