Can I obtain consent from a representative if the subject lacks capacity to provide their own consent (e.g. surrogate consent)?
If the potential subject lacks capacity to provide their own consent, permission may only be obtained from a legally-authorized representative (i.e., court appointed representative) or an individual who has such authority under a health care proxy if the research is determined by the IRB to provide potential therapeutic benefit and the health care proxy is not restrictive for research.The IRB must review and approve all recruitment and consent procedures for studies that may potentially enroll subjects who lack the capacity to consent.
If the potential subject lacks capacity to provide their own consent, permission may only be obtained from a legally-authorized representative (i.e., court appointed representative) or an individual who has such authority under a health care proxy if the research is determined by the IRB to provide potential therapeutic benefit and the health care proxy is not restrictive for research. The IRB must review and approve all recruitment and consent procedures for studies that may potentially enroll subjects who lack the capacity to consent.
Related Questions
- Is it acceptable to obtain consent over the telephone by a parent, legal guardian, or surrogate, when they are unable to come to the hospital?
- Can I obtain consent from a representative if the subject lacks capacity to provide their own consent (e.g. surrogate consent)?
- If an adviser appoints an independent representative for a client, must the adviser obtain the clients consent?