Research with Adult Participants Lacking Capacity to Consent

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Policy Number:
UW-4068
Responsible Office:
Office of Research Compliance

University Policy

Rationale/​Purpose:

This policy outlines when participants with impaired decision-making capacity may be enrolled in research and who may consent to participation in research on behalf of adult participants who lack the capacity to consent. Different requirements apply to Veterans Affairs research. Researchers conducting VA research should follow the HS IRBs’ VA Research Policy.

Policy:
  1. Types of Research Permissible with Adult Participants Lacking Capacity to Consent
    1. Adult participants lacking capacity to consent may be enrolled in research when one of the following three conditions is met:
      1. The research presents minimal risk to participants.
      2. The research presents more than minimal risk but holds out the prospect of direct benefit to individual participants.
      3. The research presents more than minimal risk and no prospect of direct benefit to individual participants, but is likely to yield important generalizable knowledge about the participant’s disorder or condition provided:
        1. The IRB determines that the research cannot be performed solely with persons who possess decision-making capacity and:
          1. The focus of the research is the disorder leading to the participant’s lack of decision-making capacity, whether or not the lack of decision-making itself is being evaluated or
          2. The focus of the research is not directly related to the participant’s lack of decision-making capacity but the investigator has presented a compelling argument for including such subjects.
    2. Additionally, under Wisconsin law, if a participant has a court appointed guardian, the guardian must have authority, via the court order appointing the guardian, to enroll the ward in research.
      1. If the research presents more than minimal risk and no prospect of direct benefit to individual participants, the guardian must establish by clear and convincing evidence that the potential participant would have agreed to participate in such research if s/he had capacity.
    3. If a UW IRB is the IRB of record for study sites outside of Wisconsin, the UW IRB may be required to apply other laws.
  2. Assessment of Incapacity and Need for a Legally Authorized Representative
    1. Capacity to consent is presumed to exist unless there is evidence to the contrary.
      1. If a potential participant has the capacity to consent to the research, informed consent must be obtained from him or her unless the IRB has waived informed consent.
      2. The desires of a participant who has capacity supersede the effect of his or her power of attorney for health care at all times.
      3. Participants with variable capacity can consent to research participation during a period of capacity.
    2. The method of establishing capacity to consent is determined by the UW-Madison IRB reviewing the study based on information provided in the application by the study team.
    3. An assessment of a potential research participant’s capacity to consent must be made before deciding whether there is a need for a legally authorized representative. The capacity determination may be made by a physician, a psychologist, or an appropriate member of the research team with expertise in making capacity assessments.
    4. If the individual is deemed to lack decision-making capacity at the time of their participation in the study, a legally authorized representative must provide surrogate informed consent.
      1. If the participant regains decision-making capacity during the course of their participation in the study, the IRB may require that the informed consent process be repeated with the participant.
  3. Legally Authorized Representative Defined
    1. A.“legally authorized representative” means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, “legally authorized representative” means an individual recognized by institutional policy as acceptable for providing consent in the nonresearch context on behalf of the prospective subject to the subject’s participation in the procedure(s) involved in the research.
  4. Authority of Legally Authorized Representatives
    1. If there is a need for a legally authorized representative to consent to participation, the representative’s decisions must be consistent with the criteria outlined in I.A and I.B above. The individuals listed below may serve as legally authorized representatives under the circumstances described below.
    2. Research Powers of Attorney (POA)/Agents
      1. A participant with capacity may designate a research POA/agent to make decisions for the participant if s/he loses capacity through a research power of attorney instrument (link) or through some other document (such as within a research consent form). The agent’s decision must be consistent with the wishes and preferences of the potential participant as expressed in the power of attorney instrument or other document.
        1. A research agent designated within a research study consent form would be applicable to that specific study and its sub-studies only.
        2. Because some therapeutic research may overlap with medical treatment, it is advisable for a participant to delegate their healthcare POA, if any, as their research POA/agent.
        3. In the event that the person named as the research POA/agent is different than the guardian with authority to make research decisions or the activated healthcare POA (as further discussed below), consult the UW Office of Legal Affairs.
    3. Guardians and Healthcare POAs
      1. A court-appointed guardian of the person may consent to a ward’s participation in research if the court order includes the power to consent to research. NOTE: A guardian of the estate or guardian ad litem cannot provide surrogate consent.
      2. A power of attorney for healthcare may consent to a potential participant's participation in research, if the agent’s decision is consistent with the wishes and preferences of the potential participant as expressed in the power of attorney for health care instrument, and the research involves the types of procedures for which the healthcare POA has authority to consent for nonresearch purposes (e.g., biomedical research).
        1. Under state law, the person delegated as the healthcare POA by an individual is likely to be the person appointed that individual’s guardian by a court.
        2. If a guardian has been given authority by a court to make research participation decisions and that person is different than the healthcare POA, the guardian is the appropriate surrogate to consult.
    4. Next of Kin
      1. If the potential participant has no research power of attorney, guardian, or healthcare power of attorney, then the potential participant's “next of kin” may consent on behalf of the potential participant.
        1. "Next of kin” can provide surrogate consent in the following order: the spouse or registered domestic partner, adult child, parent, adult sibling, grandparent, adult grandchild, or a close friend of the potential participant.
        2. Under some circumstances, an exception to the above order of priority may be appropriate. In this case, consult with the UW Office of Legal Affairs.
  5.  Respect for Dissent and Maximization of Assent
    1. If feasible, the investigator must explain the proposed research to the prospective research participant even when the legally authorized representative gives consent.
    2. A participant's preference not to participate in the research should operate as a veto to the participant’s participation, even if a legally authorized representative of the participant consents.
    3. Nevertheless, for some research, unconditional respect for participant preferences about participation may be inappropriate because of superseding considerations.
Related UW-Madison Documents:

Policy Administration

Approval Authority:
Institutional Official, Associate Vice Chancellor for Research Policy and Compliance
Policy Manager:
Institutional Official
Contact:
Post Approval Monitor -- Travis Doran, travis.doran@wisc.edu, (608) 890-4399
Date Issued:
06-08-2004
Revised Dates:

6/7/2007, 7/10/2008, 3/1/2012, 3/26/2015, 4/7/2016, 2/5/2018, 5/3/2019, 7/2/2020

Retrieved:
05-15-2021 20:41:06