Surrogate Assent

Surrogate Assent 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 Assent 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 Assent for participation in a research study.

• Surrogate assent 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 Assent is a protocol-specific request of the investigator, and must be reviewed and approved accordingly by the IRB.
• Surrogate Assent 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 Assent is implemented.
• The IRB protocol/modification form should detail the criteria under which surrogate assent may be sought.

In order to allow surrogate assent the following criteria must be met:

• As in all protocols, the IRB must carefully review the risks and benefits for the participants.
• Surrogate assent 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 assent along with a line explaining the relationship to the participant.
• 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 Assent; 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 Assent by word or gesture, the subject shall be excluded from the research study.

Guidance to Investigators Concerning Who May Act as a Surrogate or Legally Authorized Representatives (LAR)

In studies where surrogate assent is approved, the assent should be obtained from a decision maker using the following hierarchy per Code of Virginia Section32.1-162.16:

1. The agent previously appointed by the prospective subject when competent, in an advance directive that specifically authorized decisions about participation in research;
2. Legal guardian of the prospective subject;
3. Spouse of the prospective subject, except where a suit for divorce has been filed and the divorce decree is not yet final;
4. Adult child of the prospective subject;
5. Parent of the prospective subject when the subject is an adult;
6. Adult brother or sister of the prospective subject;

Potential LARs must be advised that if a higher-ranking LAR is identified at any time, the investigator will defer to the higher-ranking LAR's decision regarding the subject's participation in the research.

For non-emergency room environment research only, if the potential LAR identifies a person of a higher degree of surrogacy, the investigator is responsible to contact such individuals to determine if they want to serve as LAR.

*Taken from UVa IRB-HSR Research Guidance