Research with Adult Participants Lacking Capacity to Consent
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.
- Types of Research Permissible with Adult Participants Lacking Capacity to Consent
- Adult participants lacking capacity to consent may be enrolled in research when one of the following three conditions is met:
- The research presents minimal risk to participants.
- The research presents more than minimal risk but holds out the prospect of direct benefit to individual participants.
- 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:
- The IRB determines that the research cannot be performed solely with persons who possess decision-making capacity and:
- 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
- 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.
- 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.
- 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.
- 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.
- Assessment of Incapacity and Need for a Legally Authorized Representative
- Capacity to consent is presumed to exist unless there is evidence to the contrary.
- 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.
- If a potential participant has an activated power of attorney but has regained capacity, the participant’s decision controls.
- Participants with variable capacity can consent to research participation during a period of capacity.
- 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.
- 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.
- 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.
- 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.
- Legally Authorized Representative
- 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.
- Priority of Legally Authorized Representatives
- If there is a need for a legally authorized representative to consent to participation, the representatives 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 and should be used in the following order of priority.
- A research power of attorney may consent to a potential participant's participation in research, if the agent’s decision is not inconsistent with the wishes and preferences of the potential participant expressed in the power of attorney instrument.
- 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.
- A power of attorney for healthcare may consent to a potential participant's participation in research, if the agent’s decision is not inconsistent with the wishes and preferences of the potential participant expressed in the power of attorney for health care instrument.
- 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.
- "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.
- 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.
- Respect for Dissent and Maximization of Assent
- If feasible, the investigator must explain the proposed research to the prospective research participant even when the legally authorized representative gives consent.
- 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.
- Nevertheless, for some research, unconditional respect for participant preferences about participation may be inappropriate because of superseding considerations.
Adopted by: All Campus IRB
Adopted Date: June 8, 2004
Revised by: Human Research Protection Program Advisory Committee
Revised: June 7, 2007
Revised: July 10, 2008
Revised: March 1, 2012
Revised By: Cross-Campus Human Research Protection Program (HRPP) Advisory Committee
Revised: March 26, 2015
Revised: April 7, 2016
Revised: February 5, 2018
Revised: May 3, 2019
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