Fall 2022 NAACCR Narrative Leave a comment


Castine Clerkin, MS, CTR

NAACCR Program Manager of Virtual Pooled Registry
[email protected]

 

 

Happy Fall Everyone!

This quarter’s VPR update focuses on the successful implementation and use of the Central IRB. Last year NCI contracted with the Biomedical Research Alliance of New York (BRANY) to serve as the Central IRB (CIRB) for review of VPR linkage requests that qualify for expedited review. This is a significant step toward a more standardized and efficient IRB review process and supports the revised Common Rule requirement for use of a single IRB for multi-site studies. Use of a CIRB for review of VPR requests provides the following benefits:

  • Eliminates duplicative IRB review (beyond initial institutional IRB approval)
  • Ensures consistency of IRB reviews
  • Allows local/state IRBs to concentrate more time on other reviews
  • Reduces local/state requests for protocol changes that necessitate re-review by institutional IRB
  • Decreases administrative burden on research and registry staff
  • Reduces timeline for approval and release of data

BRANY, accredited by the Association for the Accreditation of Human Research Protections Program (AAHRRP), has been in existence since 1998 and provides IRB services to academic medical centers, community hospitals, independent research sites, and government agencies in the United States. Over the past year, BRANY, NCI, and NAACCR staff have held calls with individual registries and their IRBs to: (1) describe the CIRB review process, (2) understand the local review process, and (3) recruit registry IRBs to delegate review to the BRANY CIRB through a reliance agreement.

We are excited to report that the following eleven registry IRBs have delegated local review to BRANY CIRB: Georgia, Hawaii, Maine, Michigan, New Jersey, New Mexico, Oklahoma, Oregon, Puerto Rico, Rhode Island, and Tennessee. To date, BRANY has reviewed VPR linkage requests from the following studies:

  • Study on the Incidence of Cancer Diagnosis and Mortality among Military Aviators and Aviator Support Personnel (Defense Health Agency/Armed Forces Health Surveillance Division)
  • The Effects of Education on Cancer in High School and Beyond (University of Minnesota)
  • Sister Study (National Institute of Environmental Health Sciences)

While two registry IRBs are not able to cede review, five other registries have determined that IRB review is not needed for VPR linkage studies because the registry is not engaged in the research, according to the Common Rule, and does not require any local IRB review. BRANY will continue to work with the remaining twelve local IRBs that have yet to determine their ability to rely on the BRANY CIRB.

I’d like to thank all the registry and IRB staff who have been supportive of the CIRB initiative and helped advance this important initiative! We look forward to bringing on additional registry IRBs in the coming months.

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