Surrogate Consent
Surrogate Consent
Surrogate Consent Guidelines
Prior IRB approval is necessary before utilizing a surrogate.
Investigator Responsibilities
- Must apply to the IRB for use of surrogate consent
- Once approved by the IRB, surrogate consent is used on a case-by-case basis within that protocol
- Whenever possible and when the subject is no longer incapable or incapacitated, investigators will obtain informed consent directly from the subject
- Advance healthcare directives of the subject or subject has indicated prior to incapacitation or incapability of decision-making that the subject does not wish or want to participate in a research study, the subject is not included in the research study
- An attending physician, not associated with the research study or will not derive any benefits from the research study, documents their determination that the subject is unable to consent
- For subject that lacks decision-making capacity, investigator shall inform the subject about the study and intention to seek a surrogate to provide consent
- For subjects that lack decision-making capacity, if subjects express resistance or dissent to participation or use of a surrogate for consent, that subject is excluded from the research study
- Investigators must make a good faith effort to contact individuals at the highest priority of the Surrogate Authorized Representative list below, document those efforts, and advise potential surrogates of a higher-ranking surrogate is identified at any time and investigator will defer to the higher-ranking Surrogate Authorized Representative decision regarding the subject's participation in the research study
- If one of two or more available surrogates in the same order of priority expresses oppostion for subject to participate in the research study, then the subject is excluded from the study
- If and when two or more available surrogates are in different orders of priority, refusal to consent by a surrogate of a higher priority is followed and consent by a surrogate of a lower priority is not followed and will not supersede the surrogate of higher priority refusal to consent/participate
Surrogate Authorized Representative Priority Hierarchy (Descending order of Priority - Highest to Lowest)
Surrogates must be an authorized representative with reasonable knowledge of the subject.
- Guardian of Subject with Authority to make health care decisions
- Healthcare representative pursuant to an advance directive for health care
- Spouse or civil union partner
- Domestic partner
- Adult son or daughter
- Custodial parent
- Adult brother or sister
- Adult grandchild
- Available adult relative with the closest degree of kinship
Obtaining Surrogate Consent
- Surrogates cannot receive financial compensation
- Surrogates must review, sign and date Surrogate Self Certification form and IRB-approved Surrogate Consent form
- Investigator or designee must orally review each element included in the Surrogate Consent form
- Investigator must provide a copy of the Surrogate Consent form to the surrogate
Subject Regains Cognitive Ability
Subjects that regain cognitive ability are promptly consented using standard consenting procedures
Documentation
- IRB-approved Surrogate Consent form must be used
- Investigator or designee signs and dates the Surrogate Consent form
- Subjects' surrogate signs and dates the Surrogate Consent form
- A witness signs and dates the Surrogate Consent form
- A completed Surrogate Consent form is filed and retained in both the medical and research records
- An attending physician, not associated with the research study nor will derive any benefits from the research study, make the determination of incapacitation and that is documented and retained in both the medical and research records