When researching vulnerable populations, researchers should incorporate a safety plan, especially when populations may have diminished capacity to consent. Researchers must consider if it is possible to answer the proposed research questions and a justification for working with the vulnerable population. IRB reviewers will assess the risk and benefit ratio to make suggestions on how to protect vulnerable populations.
Researchers must clearly convey their qualifications for working with vulnerable populations including their understanding of risks and safeguards on the IRB application.
Researchers can utilize resources like MacArthur’s Competence Assessment Tool, Assessing Potential Research Participant’s Capacity to Consent, and ways to adapt study designs to the setting, context, and situation of their population of interest.
If a study participant portrays a diminished capacity for consent, or their cognitive capacity is compromised, researchers should reassess the situation, check-in with the individual, and initiate a safety plan to protect the rights and welfare of the individual.
For more information on the protocol submission process, please see the following page https://www.tc.columbia.edu/institutional-review-board/how-to-submit/.