The Food and Drug Administration has issued guidance related to FDA-regulated studies that are also subject to the Revised Common Rule.
As you may already know, the Revised Common Rule (RCR) is to take effect in January 2019 (the 22nd here, to be specific; the first workday after the rule’s implementation date). The RCR will apply to federally funded research, some of which involves FDA-regulated products. Key takeaways from the guidance include:
–A study subject to both the RCR and the FDA regs will have to comply with both sets of regulations, even though they differ somewhat.
–The RCR contains some new informed consent provisions related to the content, organization, and presentation of information. FDA says these changes are “not inconsistent” with FDA requirements. This language means sponsor and investigators will not have to draft to two sets of consent materials for protocols subject to both sets of rules.
–The RCR refers to the types studies that must be reviewed using expedited procedures, unless a reviewer determines and documents that it must be reviewed by the full board. The FDA last published its list of expeditable studies in 1998, and this list is unchanged. FDA-regulated research must continue to follow the FDA regs regarding when expedited status review is allowed.
–The RCR eliminates the requirement for annual continuing review for expeditable studies, or studies that no longer involve subject interactions. The FDA, however, has not, and will require continuing review for the studies it regulates at least annually.