- The protocol must include a plan, that it is appropriate given the population and setting of the research, for how investigators will determine when a legally authorized representative will be required to provide informed consent. In general, the research staff must perform or obtain and document a clinical assessment of decision-making capacity for any subject suspected of lacking decision-making capacity.
- When the potential subject is determined to lack decision-making capacity, investigators must obtain consent from the LAR of the subject (i.e., surrogate consent). NOTE: Investigators and IRBs have a responsibility to consult with the Office of General Counsel (OGC) regarding state or local requirements for surrogate consent for research that may supersede VA requirements.
- The following persons are authorized to consent on behalf of persons who lack decision-making capacity in the following order of priority:
- Health care agent (i.e., an individual named by the subject in a Durable Power of Attorney for Health Care);
- Legal guardian or special guardian;
- Next of kin: a close relative of the patient 18 years of age or older, in the following priority: spouse, child, parent, sibling, grandparent, or grandchild; or
- Close friend.
- If feasible, the investigator must explain the proposed research to the prospective research subject even when the legally authorized representative gives consent. Although unable to provide informed consent, some persons may resist participating in a research protocol approved by their representatives. Under no circumstances may a subject be forced or coerced to participate in a research study even if the LAR has provided consent.
- Legally authorized representatives must be told that their obligation is to try to determine what the subjects would do if able to make an informed decision. If the potential subjects’ wishes cannot be determined, the legally authorized representatives must be told they are responsible for determining what is in the subjects’ best interest.