Other Changes to the Common Rule - effective Jan. 22, 2019

Limited IRB review

Limited IRB review is a process that is required only for certain exemptions, and does not require an IRB to consider all of the IRB approval criteria in §46.111. In limited IRB review, the IRB must determine that certain conditions, which are specified in the regulations, are met. Limited IRB review may be done via the expedited review mechanism, that is, by the Chair or an experienced IRB member designated by the Chair (although it can also be conducted by the full IRB). Continuing review is not required.

[Refer to sections 45 CFR 46.109(a)and 46.109(f)(1)(ii) of the revised Common Rule.]

NOTE: The limited review changes have very little impact on the KSU IRB. Most reviews in the past have been subject to limited review.

Broad Consent in the Revised Common Rule

Broad consent is a new type of informed consent provided under the revised Common Rule pertaining to storage, maintenance, and secondary research with identifiable private information or identifiable biospecimens. Secondary research refers to research use of materials that are collected for either research studies distinct from the current secondary research proposal, or for materials that are collected for non-research purposes, such as materials that are left over from routine clinical diagnosis or treatments. Broad consent does not apply to research that collects information or biospecimens from individuals through direct interaction or intervention specifically for the purpose of the research.

[Refer to 45 CFR 46.116(d) of the revised Common Rule.]

NOTE: Broad consent is for identifiable private information or identifiable biospecimens from secondary sources. The KSU IRB has not dealt with requests for approval for this kind of information in the past but is fully prepared to review applications involving broad consent.

 

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