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.