Informed Consent: Impaired Decision-Making Capacity
Informed Consent: Impaired Decision-Making Capacity
For Campus Policy, see Research with Adult Participants Lacking Capacity to Consent
In regards to ED/SBS studies involving those with impaired decision-making capacity, consider the following:
- Outline how the study team will determine capacity to consent.
- Note that not just any caregiver can give consent for those with impaired decision-making. This must also be the appropriate Legally Authorized Representative (LAR)
- When the court appoints a legal guardian, there is a box that can be checked to allow the legal guardian to consent to research for the impaired decision-making individual. The study team should outline in the application the plan in place to document that this box was checked.
- Assent should be obtained from the person with impaired decision-making, even when the LAR gives consent.