Minimal risk studiesmay qualify for exemption or expedited review under45 CFR 46.101(b).
* 45 CFR 46.109(f):"Unless an IRB determines otherwise, continuing review of research is not required for research eligible for expedited review and determined to involve no more than minimal risk."
* ICH E6(R2) 3.1.4:Requires IRB review for clinical trials, but exemptions exist for minimal risk studies.
Therefore, once exempted, there isno requirement for continuing review, unless specifically required by the IRB. Submission at closure is optional depending on institutional policy but not a federal requirement.
Thus, the correct answer isD (No such requirement).
References:
45 CFR 46.109(f) (Exempt and expedited reviews).