It is UAB policy that research will not include human subjects without the prospective informed consent of the subject or the subject’s legally authorized representative unless a recognized exception or waiver applies under federal regulations. An investigator will seek informed consent in accordance with federal regulations at 45 CFR §46.116, and, if applicable, 21 CFR 50.20, §§50.25, and any applicable regulations of the sponsor (e.g., DOE GUI338, DoD GUI339, DOJ/NIJ and BOP GUI341). The IRB may grant a waiver of informed consent in accordance with 45 CFR 46.116(e), 46.116(f) and, if applicable, 21 CFR §§50.23(d), 50.23(e), 50.24 and DHHS waiver for emergency research at 61 FR 51531, or any applicable regulations of the sponsor. Also an investigator will document informed consent in accordance with 45 CFR §46.117 and, if applicable, 21 CFR §50.27 or other applicable regulations of the sponsor unless the IRB waives documentation of informed consent in accordance with 45 CFR §46.117, and, if applicable, 21 CFR §56.109 (c), (d) or other regulations of the sponsor. The principal investigator is responsible for ensuring informed consent is obtained from each subject before the subject participates in a research study. Although the principal investigator may delegate duties for obtaining informed consent to other members of the research team, (s)he remains ultimately responsible for the informed consent process.

If consent or documentation of consent has not been waived by the IRB, in order to approve research the IRB will determine that informed consent will be sought from each prospective subject or the subject’s legally authorized representative and appropriately documented in accordance with and to the extent required by federal regulations at 45 CFR §§46.111, 46.116, and 46.117; and 21 CFR §§50.20, 50.25, 50.27, and 56.111, if applicable; and any applicable regulations of the sponsoring agency. The IRB will determine whether additional information to that required by federal regulations should be included in the informed consent process in accordance with 45 CFR 46.109(b), and whether any other disclosures should be included in the informed consent process as required by other federal, state, or local laws or regulations for the informed consent process to be legally effective. All IRB determinations under this policy will be made at the time of initial review, continuing review, and review of modifications to research.

Additional Safeguards for the Informed Consent Process in Vulnerable Groups
In addition to the other responsibilities described in this policy, the IRB and investigators will employ additional safeguards to preserve the informed consent process when some or all subjects are likely to be vulnerable to coercion or undue influence. The IRB will systematically evaluate, at the time of initial review, continuing review, and review of modifications to research, whether the research involves subjects likely to be vulnerable to coercion or undue influence and will consider appropriate additional safeguards for the informed consent process. Research will incorporate safeguards for pregnant women, fetuses, and neonates; prisoners; and children in accordance with 45 CFR Part 46 subparts B, C, and D, respectively, and 21 CFR Part 50 Subpart D if applicable, and any applicable regulations of sponsoring agencies.

When ICH-GCP guidelines apply, the IRB, investigators, and research staff will provide all the disclosures and follow the guidelines pertaining to consent (see GUI342).

Where no federal regulations or guidance exist to provide standards for safeguards to preserve the informed consent process for subjects vulnerable to coercion or undue influence, such safeguards will conform to specific institutional policy and procedure or, when no institutional policy and procedure exists, written procedures developed by the IRB. IRB procedures developed for the informed consent process in vulnerable groups will take into account the decision-making capacity of subjects; likely circumstances producing coercion or undue influence; the magnitude of the effect on subjects’ ability to knowingly and voluntarily consent; appropriate options to neutralize coercive or undue effects; and, if subjects are unable to give legally effective consent, that adequate provisions are made for soliciting the assent of the subjects and the permission of their legally authorized representatives.

POLICY STATEMENT