The Office of Human Research Protections (OHRP) within the Department of Health and Human Services (HHS) has released draft guidance for transitioning studies to the revised Common Rule. The Common Rule is the set of regulations governing research involving human participants. After a lengthy revision process (see COSSA’s previous coverage), changes to the Common Rule updating a number of its provisions took effect on January 21, 2019. The draft guidance released by OHRP gives details on how an institution may voluntarily transition a study initiated before the implementation date to the new regulations. The complete draft guidance can be accessed on the OHRP website. Comments on the guidance are requested by February 11, 2019 and may be submitted via regulations.gov.
In light of the new requirements taking effect, OHRP has also released more details on how institutional review boards (IRBs) should approach continuing review for studies eligible for expedited review under the new Common Rule on its website.