Research with Cognitively Impaired Persons

POLICY

In addition to the criteria for review listed in the policy and procedure Initial Review, in order to approve research in which some or all of the participants have cognitive impairment, the IRB must determine that all research is in compliance with this policy and procedure.

UTHealth will follow ‘Texas Health & Safety Code - Chapter 313 Consent to Medical Treatment Act’ for research consent matters unless clearly inapplicable because there is no applicable Texas law specific to research consent.  According to this act, if an adult patient of a home and community support services agency or in a hospital or nursing home is comatose, incapacitated, or otherwise mentally or physically incapable of communication, an adult surrogate from the following list, in order of priority, who has decision-making capacity, is available after a reasonably diligent inquiry, and is willing to consent to medical treatment on behalf of the patient may consent to medical treatment on behalf of the patient:

1. the patient's spouse;
2. an adult child of the patient who has the waiver and consent of all other qualified adult children of the patient to act as the sole decision-maker;
3. a majority of the patient's reasonably available adult children;
4. the patient's parents; or
5. the individual clearly identified to act for the patient by the patient before the patient became incapacitated, or the patient's nearest living relative.

Any dispute as to the right of a party to act as a surrogate decision-maker may be resolved only by a court of record having jurisdiction under Chapter V, Texas Probate Code. Any medical treatment consented to under this section must be based on knowledge of what the patient would desire, if known. Notwithstanding any other provision of this chapter, a surrogate decision-maker may not consent to:

1. voluntary inpatient mental health services;
2. electro-convulsive treatment; or
3. the appointment of another surrogate decision-maker.

When the research is being conducted outside Texas, The IRB will work with the local IRB to determine who can serve as a legally authorized representative under the applicable state law. If UTHealth is not relying on a local IRB to review the research being conducted outside of Texas, the investigator should submit documentation as to who is considered a legally authorized representative in the particular state.

Degree of Risk – Research that presents more than minimal risk should involve cognitively impaired persons only when the research holds prospects of direct benefit to these individuals. A minor increase over minimal risk may be permitted in research involving institutionalized individuals only where research is designed to evaluate an intervention of foreseeable benefit to their care. If a research study poses more than minimal risk and no prospect of direct benefit to the individuals, the IRB should obtain advice from experts regarding the appropriateness of the research study.

Key Terms

Cognitively Impaired – Having either a psychiatric disorder (e.g. psychosis, neurosis, personality or behavior disorders) an organic impairment (e.g. dementia) or a development disorder (e.g. mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.

Competence – The capacity to act on one’s own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Competence may fluctuate as a function of the natural course of a mental illness, response to training, effects of medication, general physical health, and other factors. Therefore, mental status should be re-evaluated periodically.

Incapacity – The inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Often used as a synonym for incompetence.

Incompetence – The inability to manage one’s own affairs. Often used as a synonym for incapacity.

Institution – A residential facility that provides food, shelter, and professional services (including treatment, skilled nursing, intermediate or long term care, and custodial or residential care).

PROCEDURE

Review Process – The IRB will review the proposed research and ensure that the conditions set forth in this policy and procedures are met. The research proposal may be reviewed by exempt, expedited or by the full committee process according to UTHealth policies and procedures. Research involving cognitively impaired persons shall be reviewed by an IRB member who is knowledgeable in ethical, clinical and psychosocial issues concerning research involving these subjects.  The IRB shall consider the appropriateness of enrolling cognitively impaired persons in research. Besides the usual criteria for review of research outlined in policy and procedure on Initial Review, the IRB shall also consider the following:

Selection of Subjects – Research involving persons whose autonomy is compromised by disability or restraints on their personal freedom should bear some direct relationship to their condition or circumstances. The researchers should not choose persons who are institutionalized as a convenient sample for studies that bear no relation to their situation.

Limiting Risks – The IRB should ensure the protocol includes a description of appropriate psychological or medical screening criteria to prevent or reduce adverse reactions to the therapeutic and research procedures. When appropriate the IRB might require other health care providers involved in the care of these patients to be consulted to ensure that the research will not be detrimental to ongoing therapeutic regimens.

Assessing Competence - As a general rule, all adults, regardless of their diagnosis or condition, should be presumed to be competent to consent unless there is evidence of a serious mental disability that would impair reasoning or judgment. Even those who do have a diagnosed mental disorder may be perfectly able to understand the concept of being a research volunteer, and capable of consenting to or refusing participation. Mental disability alone should not disqualify a person from consenting to participate in research; rather, there should be specific evidence of individuals’ incapacity to understand and to make a choice before they are deemed unable to consent.

Documenting Capacity – When a research study involves cognitively impaired persons, the IRB shall consider the need for independent assessment of capacity. The IRB may set qualifications for the person making assessment such as requiring a psychiatrist or geriatrician to make this assessment. The independent assessment should be documented by a formal note that is dated and signed.

Consent in Research Involving Cognitively Impaired Persons – In general, informed consent is required or waived according to the policy and procedure on informed consent. Consent may be sought from legally authorized representative with prior IRB approval.

The IRB shall consider whether investigators must solicit prospective subjects’ assent (i.e., the willing and, to the extent possible, knowledgeable participation of those unable to give legally valid consent) in addition to the permission by the legally authorized representative.

Persons who are Institutionalized – When the research poses more than minimal risk and has no prospect of direct benefit to the individuals -

1. Court appointed guardian may consent on behalf of the persons formally adjudged incompetent.
2. Officials of the institution in which incompetent patients reside (even if they are the patient’s legal guardian) are not generally considered appropriate, since their supervisory duties may give rise to conflicting interests and loyalties.
3. Investigators must assess if conflicting interests exist for the legally authorized representative due to financial pressures, emotional distancing, or other ambivalent feelings common in such circumstances.

Texas state law specifically addresses research in patients who were admitted involuntarily to a mental health facility, but who have requested voluntary status.  For these patients,   Sec.574.154 requires that the patient may not participate in a research program in the inpatient mental health facility unless:

1. the patient provides written consent to participate in the research program under a protocol that has been approved by the facility ’s institutional review board; and
2. the institutional review board specifically reviews the patient ’s consent under the approved protocol. Added by Acts 2001, 77th Leg., ch. 1309, Sec. 1, eff. June 16, 2001.

Exceptions - As a general principle, incapable persons should not be involved in research that can be conducted with capable subjects. Inclusion of cognitively impaired persons may be permitted by the IRB if such research provides societal benefit, particularly one that is not otherwise available outside of the research setting.

APPLICABLE REGULATIONS

1. 45 CFR 46 Protection of Human Subjects
2. 21 CFR 50 Protection of Human Subjects
3. 21 CFR 56 Institutional Review Board
4. SACHRP Recommendations Regarding Research Involving Individuals with Impaired Decision-making             

REFERENCE TO OTHER POLICIES

1. Initial Review

ATTACHMENTS

1. Initial Application Form Panel – Research Involving Cognitively Impaired Persons

If you find errors in this document, contact [email protected]

CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)

IRB OFFICE HOURS Thursdays from 1 to 4pm, via the Teams Room at this link

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