Research Involving Adults with Decisional Impairment

Complete and submit Appendix E.Research Involving Adults with Decisional Impairments with the protocol application. Include the appendix as a separate file labeled LASTNAME.Decisional.DATE.

Persons with decisional impairments often have a diminished capacity to understand potential risks and benefits of a research study and thus may have limited ability to provide autonomous informed consent. Decisional impairment could result from a psychiatric, organic, developmental or other disorder that affects cognitive or emotional functions, or may result from the effect of drugs or alcohol. The impairment may be temporary, permanent or may fluctuate.

For research studies involving persons with decisional impairment (whether permanent or temporary), each individual's legally authorized representative (LAR) must provide permission for the individual to participate in the research project. An LAR is an individual or judicial or other body authorized by law to consent on behalf of a potential subject to the subject's participation in the research.

IRB Requirements

Although federal regulations do not specifically designate individuals with decisional impairments as a "vulnerable population," the SU IRB includes these individuals among those who require special consideration and protections when recruited for a research study. The IRB will approve research with individuals with decisional impairment under the following circumstances:

  1. the research has a direct relationship to the decisionally impaired subject’s condition or circumstance;
  2. the research meets one of the following criteria:
    • presents no greater than minimal risk to participants;
    • presents slightly greater than minimal risk to participants, but offers the potential for direct individual benefit;
    • presents slightly greater than minimal risk to participants, and while it will not directly benefit the individual, the potential knowledge has direct relevance for understanding or eventually alleviating the subjects' disorder or condition.

In reviewing protocols involving adults with decisional impairment, the IRB may require additional protections, such as:

  • assessment of the potential participant's decisional capacity by an experienced individual independent of the investigator;
  • use of standardized assessment of cognition and/or decisional capacity;
  • including further informational or educational techniques;
  • consent process monitoring by an independent person other than the researcher;
  • including waiting periods to allow for additional consideration time before consent to participate;
  • use of proxy consent by an individual's LAR;
  • obtaining assent in addition to proxy consent to respect the autonomy of individuals with decisional impairment;
  • witness observation of the consent process

Consent

Generally, all adults should be presumed able to consent to participate in research unless an evident disability would impair reasoning or judgment. In deciding whether proxy consent is appropriate for a given study, the IRB will consider:

  • whether the provided rationale for proxy consent is justified;
  • what criteria are used to determine whether the use of proxy consent is warranted, including any use of standardized assessment tools;
  • what additional methods could improve a potential participant's ability to consent to participation (e.g., reading simple consent forms aloud or using videos or graphics to help potential subjects understand what the research will involve);
  • the process by which proxy consent will be obtained.

Special considerations with proxy consent include:

  • If individuals have been determined legally incapacitated by a court decision and may be considered for enrollment in a research study, only the court-appointed guardian may provide proxy consent and only if the court order appointing that person guardian specifically states he/she has the authority to enroll the incapacitated person in a research protocol. A copy of the court order stipulating these conditions must be attached to the protocol.
  • Persons may also, through a health care proxy appointed by a power of attorney, designate a person to make decisions for them in the event they are subsequently incapacitated. This person may give proxy consent for enrollment of a subject in research.
  • If a potential subject has neither a guardian, nor a health care proxy designated, the investigator may obtain the informed consent of the subject’s legally authorized representative (LAR). Where neither a court-appointed guardian, nor a health care proxy exists, investigators may seek informed consent from the following individuals, in the order listed below:
    • Spouse;
    • natural or adoptive parent;
    • adult child;
    • adult brother or sister;
    • any other available adult relative related through blood or marriage known and documented to have made decisions for the subject in prior health care settings.

The person giving proxy consent should base the decision, if possible, on views that the subject expressed while decisionally capable. The proxy should be fully informed on the risks, benefits and alternatives to the research. If the subject's values are not known with respect to a proposed research study, the proxy should act in the best interest of the subject.

If a person with decisional impairment is capable of exercising some judgment concerning the nature of the research and participation in it, the investigator should obtain the subject’s assent in addition to the permission of his/her legally authorized representative.

Any verbal objection by an adult with decisional impairment to participation in the research must be binding. If the participant, at any time, objects to continuing in the research study, the objection must be respected.

If the subject’s decisional impairment is temporary or fluctuates, the informed consent process should include a mechanism for obtaining the subject’s subsequent direct informed consent to participate in the research. If a subject regains decision making-capacity and declines to continue in the research, the decision must be respected.

Documentation of Consent and Assent

For adult persons with decisional impairment, the investigator should document the following before obtaining the consent and signature of the subject’s LAR or guardian and the signature of the unbiased witness to this consent, if required by the IRB:

  • the conclusion that the subject is incapable of understanding the information presented regarding the research, to appreciate the consequences of acting (or not acting) on that information, and to make a choice;
  • the information provided to the subject’s LAR regarding the cognitive and health status of the subject, the risks and benefits of the research, and the role of the proxy.

To document obtaining the assent of a subject with decisional impairment, the investigator should add a Verification of Explanation statement to the consent document. This verification should be signed and dated by the investigator, listed co-investigators, or other research staff, if authorized by the IRB.

Documentation of Consent and Assent: Research Record

In studies in which some or all participants may have decisional impairment, the investigator should document (in notes) the following during the consent process:

  • whether the subject demonstrated the ability to understand the nature of the research procedures, the potential risks and benefits, the voluntary nature of the participation and to make a personal judgment about participation;
  • use of any supplemental methods to enhance or evaluate decisional capacity;
  • a summary of the matters discussed with the subject’s legally authorized representative.