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.