Have WCG IRBs adopted the 2018 revisions to the Common Rule for the Protection of Human Subjects?

Question: 

Have WCG IRBs adopted the 2018 revisions to the Common Rule/Federal Policy for the Protection of Human Subjects?
- Clinical research associate, CRO

Response: 

In January 2019 the 2018 Common Rule went into effect, and is applicable to all new research funded or supported by the U.S. Department of Health and Human Services (HHS) as well as any of the other 19 federal departments or agencies that have signed on to the Common Rule

Institutional Review Boards (IRBs) and institutions conducting research were given the discretion to decide whether research subject to the Common Rule and approved prior to the effective date of the 2018 Common Rule would be transitioned to the revised rule or remain on the pre-2018 Common Rule.  The U.S. Food and Drug Administration (FDA) regulations governing human subjects protections at 21 CFR Parts 50 and 56 are unchanged.

The WCG IRBs apply the applicable regulations.  Research with funding by a Common Rule department or agency is reviewed under the 2018 Common Rule. Clinical investigations of drugs or devices are reviewed under the applicable FDA regulations.  And FDA-regulated research with funding by a Common Rule department or agency follows the revised Common Rule with respect to informed consent requirements, but any new Common Rue requirements that conflict with FDA requirements, such as relaxed continuing review requirements or the use of Broad Consent, would not be permitted.

When research is otherwise unregulated – no federal funding and not FDA regulated – the WCG IRBs follow a hybrid approach, maximizing flexibility by applying a combination of the pre-2018 Common Rule and 2018 Common Rule.  The WCG IRBs can apply the 2018 Common Rule to all research at the request of the submitting body.

About the Author

David Borasky, MPH, CIP | VP of IRB Compliance

In addition to his compliance oversight responsibilities at WCG, Mr. Borasky also serves as Co-Chair of the Subpart A Subcommittee of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) former member of the board of directors of Public Responsibility in Medicine and Research (PRIM&R).

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