Surrogate Consent for participation in a research study should be employed only to the extent that it is consistent with the intent of 45 CFR 46.116, 45 CFR 46 and 21 CFR 50.20 and all other federal and state laws and regulations pertaining to protecting human subjects participating in research.
This would be necessary when an adult is not able to provide consent for themselves to participate in research due to:
- cognitive impairment,
- lacking capacity, or
- suffering from a serious or life-threatening disease
While no specific set of criteria can encompass all conceivable situations in which the use of Surrogate Consent complies with the intent of 45 CFR 46.116 and 21 CFR 50.20, the following criteria should be viewed as fundamental guidelines to be used by the UVa IRBs when determining whether to permit the use of Surrogate Consent for participation in a research study.
- Surrogate Consent should be considered only in research studies relating to the cognitive impairment, lack of capacity, or serious or life-threatening diseases and conditions of research subject.
- Surrogate Consent is a protocol-specific request of the investigator, and must be reviewed and approved accordingly by the IRB.
- Surrogate Consent is requested through the protocol for new research studies or through the modification process for an existing protocol.
- As in all human subject's research, the IRB must consider carefully the risk/benefit ratio of the particular study for the targeted population.
- As with all mental health research conducted by the University, subject confidentiality and privacy must be protected.
- The IRB may consider whether the frequency of a specific protocol's review cycle should be reasonably modified when Surrogate Consent is implemented.
- The IRB protocol/modification form should detail the criteria under which Surrogate Consent may be sought.
In order to allow surrogate consent the following criteria must be met:
The investigator shall include a specific plan for the assessment of the decision-making capacity of the subject in the protocol or modification request. If the investigator determines that the subject lacks decision-making capacity, the investigator shall, consistent with the standard consent process describe the research to the subject and the investigator's intent to obtain Surrogate Consent ; and document this communication in the research file confirming that the research protocol was described to the subject. However, if the investigator determines that the subject is non-responsive, the investigator shall document that observation in the research file. If the subject expresses resistance or dissent to participation or to the use of Surrogate Consent by word or gesture, the subject shall be excluded from the research study.
- As in all protocols, the IRB must carefully review the risks and benefits for the participants.
- Surrogate Consent will only be appropriate when it is clear that individuals cannot give informed consent.
- Where appropriate, animal and other pre-clinical studies must have been conducted which suggest that there is reason to believe that the proposed investigation may have potential for therapeutic benefit to the participant and/or that the study meets exempt or expedited approval criteria. The requirement for potential therapeutic benefit need not apply to any control group.
- A line must be added to the consent form for the signature of the person giving Surrogate Consent along with a line explaining the relationship to the participant.
Guidance to Investigators Concerning Who May Act as a Surrogate or Legally Authorized Representatives (LAR)
In studies where Surrogate Consent is approved, the consent should be obtained from a decision maker using the hierarchy below. Surrogate consent should be obtained from the person highest on the list who is available, willing and capable.
- The agent previously appointed by the prospective subject when competent, in an advance directive that specifically authorized decisions about participation in research;
- Legal guardian of the prospective subject;
- Spouse of the prospective subject, except where a suit for divorce has been filed and the divorce decree is not yet final;
- Adult child of the prospective subject;
- Parent of the prospective subject when the subject is an adult;
- Adult brother or sister of the prospective subject;
Potential LARs in emergency circumstances must be advised that if a higher-ranking LAR is identified and able to be consulted at a later time, the investigator will defer to the higher-ranking LAR’s decision regarding the subject’s participation in the research.
If a higher ranking LAR is identified after consent has been obtained, the higher ranking LAR must be contacted and informed of the study. He/she should be given a copy of the signed consent form and any communications with him/her should be documented in a note to file. A decision by a higher-ranking LAR to withdraw the subject from the research should be handled the same way one would handle a decision by the subject to withdraw if he/she becomes able to give consent for themselves. LARs and subjects considering withdrawal from a study should be fully informed about any clinical risks of withdrawing, such as feasibility, risks of removing inserted devices.
*Taken from UVa IRB-HSR Research Guidance