Human Research Protection Program: Policy

Research with Adult Subjects Lacking Capacity to Consent

Adopted by: All Campus IRB

Adopted Date: June 8, 2004

Revised: June 7, 2007

Revised: July 10, 2008

I. Purpose of this Policy

This document is a guide for your determination of who may consent to participation in research on behalf of adult subjects who lack the capacity to consent.[1]

II. Definitions

Please refer to Appendix A (below) for definitions.

III. Conditions for the Application of this Guidance Document

This guidance does not apply under the following conditions:

Ÿ         If the subjects lacking capacity to consent are at performance sites outside of Wisconsin, the law of the state where the subjects are located will prevail.

Ÿ         If the research involves patients with a psychiatric diagnosis, special considerations may apply to such research, including additional required protections for subjects.

If either of the above conditions applies to the research being reviewed, please consult with an attorney in the UW-Madison Office of Administrative Legal Services at 608-263-7400.

IV. Research Risks and Subject Protections

The risks and benefits of the research should fall into one of the categories below:

Ÿ         The research intervention involves minimal risk.

Ÿ         The research intervention involves more than minimal risk but holds out the prospect of direct benefit to the individual subject.

Ÿ         The research intervention involves more than minimal risk and does not hold out the prospect of direct benefit, but the potential subject has previously, while having capacity to do so, executed an advance directive and/or research power of attorney or there exists other clear and convincing evidence that s/he wants to participate in such research.

A subject’s preference not to participate in the research should operate as a veto to the subject’s participation, even if a representative of the subject consents.  Because an individual’s capacity to consent may be variable, respect for a potential subject’s preferences often is an important safeguard of individual autonomy.  Nevertheless, for some research, unconditional respect for subject preferences about participation may not be required because of superseding considerations.

An appropriate official at each performance site should acknowledge and agree in writing to consent by representatives of potential subjects prior to the initiation of the research.

The research protocol should include a contingency plan in the event that a dispute occurs among possible representatives about a potential subject’s participation in research (for example, an adult child objects to a subject’s participation, although another adult child has consented to that participation).  It may be prudent for the investigator to plan to exclude the potential subject from enrollment in this situation, depending on the nature of the possible benefit from research participation.  Nonetheless, it is not necessary to solicit the opinions of every possible representative of the potential subject, especially if a person with decision-making priority (see paragraph VI of this policy, below) or a clearly designated decision maker, such as a research or healthcare agent, is available.  If no research or healthcare agent is available and family members are in dispute, contact an attorney in the UW-Madison Office of Administrative Legal Services at 608-263-7400 for advice.

V. Health Care Agent’s Authority

The justification for recognizing the authority of a health care agent, designated under a power of attorney for health care, to make research participation decisions is based on the prospect for the research to directly benefit the subject involved.

VI. Priority of Decision Makers

 

The following individuals may consent to research participation on their own behalf or on behalf of a subject who lacks capacity to do so.  The research risks must fall into the categories described in Section IV, above.  The individuals below are in order of priority for consent purposes under Wisconsin law.  Consult them in the order they appear.

A. Subject with Capacity.  If a potential subjects has capacity to consent to the research, informed consent must be obtained from him or her.  If the subject with capacity has an activated research or healthcare power of attorney or a court-appointed guardian, please contact the UW-Madison Office of Administrative Legal Services at 608-263-7400.  Capacity to consent is presumed to exist unless there is evidence to the contrary.

B. Subject with Variable Capacity.  A potential subject who has variable capacity may consent during a period of capacity.  When the lack of capacity is temporary and likely to end in a short period of time, the investigator should wait, if possible, until the subject regains capacity to seek consent to research participation.

C. Subject with a Research Power of Attorney.  A research agent may consent to a potential subject’s participation in research to the extent that the agent’s decision is not inconsistent with the wishes and preferences of the potential subject as expressed in the power of attorney instrument.

D. Subject with a Guardian.  A court-appointed guardian of the person, but not a guardian of the estate or guardian ad litem, may consent to a ward’s research participation.  Under Wisconsin law, a guardian of the person may consent to research on behalf of the ward, if the research is minimal risk or the research holds out the prospect of direct benefit to the ward.  The guardian of the person may consent to research on behalf of the ward that is more than minimal risk with no prospect of direct benefit only if the guardian can show by clear and convincing evidence that the ward would have elected to participate in such research (see Section IV, above).

E. Subject with a Power of Attorney for Healthcare Decisions.  A healthcare agent designated in a power of attorney for healthcare may consent to a potential subject’s participation in research to the extent that the agent’s decision is not inconsistent with the wishes and preferences of the potential subject as expressed in the power of attorney for health care instrument.  Under Wisconsin law, a healthcare power of attorney is activated when two physicians or one physician and one licensed psychologist determine that the subject lacks capacity.  Such determination must be documented in writing.

F. Subject with no Research Power of Attorney, no Guardian, and no Healthcare Power of Attorney.  If the potential subject is found to lack capacity, then the potential subjects “next of kin” may consent on behalf of the potential subject.  Any “next of kin” representative of the potential subject should be actively involved in the care of the subject.  In the following order of priority, “next of kin” include: the spouse, adult child, parent, adult sibling, grandparent, adult grandchild, or a close friend of the potential subject.

 

There may be circumstances in which the order of priority for next of kin should not be followed as written above.  Contact an attorney in the UW-Madison Office of Administrative Legal Services at 608-263-7400 if you have an instance in which you think a different order of priority should apply to next of kin.

 

Importantly, the researcher should instruct the subject’s representative that he or she should make a decision about research participation based on (1) what the subject would have decided if capable of consenting or (2) what is in the best interest of the potential subject.

VII. Assessment of Incapacity and Need for Surrogate Decision Maker

An assessment of a potential research participant’s capacity to consent must be made before deciding whether there is a need for a surrogate decision-maker.  See, Section VIII of this policy, below, for information on who may make this determination.

Situations in which individuals may have impaired decision-making capacity:

Ÿ         Adults and emancipated minors who have a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders), an organic impairment (e.g., dementia), or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished.

Ÿ         Individuals who are under the influence of or dependent on drugs or alcohol, suffering from degenerative diseases affecting the brain, are unconscious, in a coma, confused, in pain, suffering from a terminal illness or emotional trauma or have severely disabling physical handicaps.

Not all persons with the above conditions will lack decision making capacity.

The IRB may consider situations and factors other than those identified above in determining whether an individual has impaired decision-making capacity.

In ongoing research studies, investigators should be prepared to re-assess the decision making capacity of a participant if a participant’s physical or mental status changes.  As a general rule, UW-Madison IRBs consider individuals who are unable to consent for their own clinical care to be unable to consent to research participation.  Tools or instruments such as the Mini Mental Exam may be used to determine capacity to consent to research participation.

VIII. Who May Determine Incapacity and Need for Surrogate Decision Maker

If the research is minimal risk or more than minimal risk but holds out the prospect of direct benefit, an appropriate member of the research team may assess capacity.  Such persons include physicians, licensed psychologists, or other individuals with experience and training in assessing capacity.  If the research is more than minimal risk and does not hold out the prospect of direct benefit, the subject’s lack of capacity must be confirmed by a physician or licensed psychologist not connected with the research before a surrogate may be consulted.  Such determination should be in writing and provided to the research team.

There may be circumstances in which the person assessing capacity from the research team determines that a potential subject has capacity to consent, but a healthcare provider, family member, or other interested party raises a question about the subject’s capacity.  If the research is more than minimal risk and does not hold out the prospect of direct benefit, it is strongly recommended that the subject’s capacity to consent on his or her own behalf be confirmed by a physician or licensed psychologist not connected with the research.

Note that under Wisconsin law, a healthcare power of attorney can be activated only after two physicians or one physician and one licensed psychologist determine, in writing, that the subject lacks capacity to consent.

IX. Additional Safeguards for Adults with Impaired Decision-Making Capacity

Federal regulations require an IRB to determine whether additional safeguards have been included in a research study to protect the rights and welfare of subjects who are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons [45 CFR 46.111(b)].

UW-Madison IRBs review protocols involving individuals with impaired decision making capacity to assure compliance with this federal regulation as well as applicable ethical principles, state law and institutional policies.

In addition to the criteria set forth above, the IRB will consider the following when reviewing research involving participants with impaired decision-making capacity:

Ÿ         Whether a plan for obtaining assent from participants is required and, if so, whether the proposed plan is adequate.

Ÿ         Whether a participant is receiving protective services or treatment for mental illness, substance abuse or alcohol dependency in Wisconsin and whether state law requirements have been satisfied.  Wisconsin Mental Health Code, WSA 51.61(1)(j), 51.61(4); Wisconsin Protective Services statute, WSA 55.07; Applying State Law in Human Subjects Research Policy.

Ÿ         Whether any applicable Veterans Affairs (VA) research requirements have been adequately addressed.  See Section X of this policy.

X. Veterans Affairs (VA) research involving adults unable to consent

Department of Veterans Affairs (VA) research is all research that is conducted completely or partially in VA facilities, conducted in approved off-site locations, facilities, and/or conducted by VA researchers while on official VA duty time. The research may be VA funded, funded from extra-VA sources, or conducted without direct funding.

VA research involving adults who lack the capacity to consent to research participation must also comply with provisions of the VA Handbook 1200.5 relating to surrogate consent and vulnerable groups.  See, VA Handbook 1200.5, paragraph 11 and Appendix D.  These provisions of the VA Handbook 1200.5 establish requirements for determining who may consent to participation in research on behalf of adult subjects who lack the capacity to consent:

Ÿ         Obtaining consent from a legally authorized representative is limited to situations where the prospective participant is incompetent or has impaired decision-making capacity, as determined and documented in the person’s medical record in a signed and dated progress note.

Ÿ         The determination that a participant is incompetent or has an impaired decision-making capacity must be made by a legal determination or a determination by the practitioner, in consultation with the chief of service, after appropriate medical evaluation that the prospective participant lacks decision-making capacity and is unlikely to regain it within a reasonable period of time.

Ÿ         Consultation with a psychiatrist or licensed psychologist must be obtained if the determination that the prospective participant lacks decision-making capacity is based on a diagnosis of mental illness.

Ÿ         Whenever feasible, the practitioner is required to explain the proposed research to the prospective participant even when the surrogate gives consent.

Ÿ         Adults unable to consent may not be forced or coerced to participate in a VAMC research study.

 

Appendix A

Ÿ         Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy people.  45 CFR §46.102(i).

Ÿ         Legally authorized representative means an individual or judicial or other body authorized under applicable law or institutional policy, to consent to research participation on behalf of a subject who lacks capacity to consent.

Ÿ         Research agent is the person designated within a research power of attorney instrument to act as an agent for the proposed research subject with respect to research participation decisions.  The research power of attorney becomes effective upon a finding of incapacity of the subject by a physician or licensed psychologist.

Ÿ         Healthcare agent is the person designated within a healthcare power of attorney instrument to act as an agent for the proposed subject with respect to healthcare decisions.  The healthcare power of attorney becomes effective upon a finding of incapacity of the subject by two physicians or one physician and one licensed psychologist.  Wisconsin Statutes §155.01(4).

Ÿ         Incapacity means the inability of an individual effectively to receive and evaluate information or to make or communicate a decision with respect to the exercise of a right or power, including the management of his or her research participation decisions.  Wisconsin Statutes §54.01(15).