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Screening adult populations for capacity to consent

Adult subjects are routinely assumed to be able to weigh the potential risks and benefits of joining a research study. However, functional abilities can vary depending upon the population, and can even fluctuate in a particular individual, due to mental or physical health changes. So what kind of things does the IRB look for when reviewing a protocol and considering whether subjects can provide their own consent?

As mentioned above, most adults can typically provide their own consent. So if you are going to assess the ability to consent, please make sure your protocol describes a rationale for doing so. Other considerations include:

  • Describe what kind of assessment you plan to do. Will you use an instrument such as the Mini Mental State Exam? If so, will the person administering and scoring the MMSE have the appropriate training and expertise to do so?
  • Does the person who will first approach potential subjects have any experience with this type of population? Will they know the best way to interact with this group?
  • Is there any preexisting relationship between the study team and the potential participants? If this study will enroll subjects from the patients the PI has been treating for years, the PI may know these people well enough that she can tell without doing an assessment that they can, or cannot, consent for themselves.

In your submission, if there is a likelihood that your subjects’ ability to provide their own consent may be questionable, please be sure to describe the situation in your protocol’s Ethical Considerations questions. You’ll want to either indicate why you think there is no need to do a specific assessment of capacity to consent, or describe in detail how the capacity to consent will be determined. If you will use any written tools during the assessment, please provide them to the IRB for review.