Spring 2021 NAACCR Narrative Leave a comment

The Revised Common Rule Reduces IRB Requirements for Some Registry Activities Supporting Research
Dennis Deapen, DrPH

Much of the research supported by population-based cancer registries is considered minimal risk in terms of federal guidelines for protection of research participants. Since 1991, the guidelines have been managed by the federal Office for Human Research Protection’s “Common Rule”.

In 2018, several modifications were made to the Common Rule, now often referred to as the Revised Common Rule, with meaningful reductions in some requirements that impact registry-based research.

Since the Common Rule was initially promulgated in 1991, the volume and landscape of research involving study participants have grown in scale and become more diverse. Revisions to the Common Rule took effect in 2018 that address this changing landscape. This 2018 version of the Common Rule is “intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the previous system of oversight.” https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html

NAACCR has prepared three fact sheets addressing how some of these changes can benefit cancer registries and researchers (https://www.naaccr.org/irb-information-for-cina/). Topics include use of a single (Central) IRB to minimize IRB reviews for multi-institutional research, identifying circumstances in which IRB monitoring was previously expected but are now exempt or not human subjects research, and elimination of Continuing Review of some studies.

Additionally, in collaboration with NAACCR, the Office for Human Research Protection provided a webinar entitled “Considerations for Registries and Data Centers under the Revised Common Rule” on August 14, 2020 (https://www.naaccr.org/irb-information-for-cina/). The webinar was geared toward central cancer registries and their affiliated IRBs. The webinar provided information on the Common Rule requirements for IRB oversight, which activities require IRB approval, how to determine if activities involve research, and whether IRB continuing review is required. A significant portion of the webinar focused on various examples of downstream research involving registry data and whether IRB review is required. Content from this webinar was also translated into one of the NAACCR fact sheets.

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