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.
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