SECTION 925.8. Informed Consent

Requirements for approval of proposed research. Investigators shall ensure:

(1) procedures for obtaining and documenting informed consent meet the requirements in 45 Code of Federal Regulations (CFR) §46.116 and 45 CFR §46.117 and address:

(A) any extension of the subject's length of stay because of participation in the research;

(B) the subject's ability to receive the medication or device after the research has concluded if the research involves an investigational medication or device;

(C) whether the research involves the use of a placebo and the likelihood of assignment to the placebo condition;

(D) whether the research involves medication or doses of medication which are known to be ineffective for the targeted disorder or condition and the likelihood of assignment to such medication or doses of medication; and

(E) any risk of deterioration in the subject's condition and the potential consequences of such deterioration (e.g., an extension in the length of stay, or the use of interventions, such as restraint, seclusion, or emergency medications);

(2) there are procedures to ensure prospective human subjects are assessed for capacity to consent for research protocols that present greater than minimal risk, and:

(A) provide for a qualified professional to assess prospective human subjects for capacity to consent;

(B) identify and document who will conduct the assessments; and

(C) describe the nature of the assessment and justification if less formal procedures to assess capacity will be used;

(3) the requirements in 45 CFR §46.408 are met if children are the proposed human subjects;

(4) there are procedures that:

(A) each prospective human subject or the subject's legally authorized representative (LAR) understands the information provided before obtaining consent to research participation; and

(B) if consent is obtained from the subject's LAR, attempts are made, to the extent possible given the prospective subject's capacity, to obtain the human subject's assent to participation. Assent is an affirmative agreement of a prospective human subject to participate in research, which is obtained when the subject does not have the capacity or legal authority to consent;

(5) there are adequate safeguards to minimize the possibility of coercion or undue influence. For example, the possible advantages of the subject's participation in the research may not be so valuable as to impair the subject's ability to weigh the risks of the research against those advantages. Possible advantages within the limited choice environment may include enhancement of general living conditions, medical care, quality of food, or amenities; opportunity for earnings; or a change in commitment status;

(6) there are procedures for ensuring a prospective human subject's objection to enrollment in research or a human subject's objection to continued participation in a research protocol is heeded in all circumstances, regardless of whether the subject or the subject's LAR has given consent. Objection may be conveyed verbally, in writing, behaviorally, or by other indications or means; and

(7) procedures to ensure, throughout the course of the research study, human subjects' comprehension and capacity are assessed and enhanced since informed consent is an ongoing process. The procedures must take into consideration a prospective human subject's preferred method of communication for consent or objection.

Source Note: The provisions of this §925.8 adopted to be effective November 27, 2022, 47 TexReg 7731