CENTRALIZED INSTITUTIONAL REVIEW BOARD TO REVIEW MINIMAL RISK REGISTRY LINKAGE STUDIES "CIRB"

NIH RePORTER · NIH · N02 · $12,315 · view on reporter.nih.gov ↗

Abstract

Over the past 15 years, unprecedented capacity and opportunity for large scale epidemiologic research has emerged, but a significant barrier still exists. Researchers who seek to efficiently perform a linkage with multiple state cancer registries must submit applications to each individual registry resulting in significant expenditure of time and fiscal resources. This is compounded by the fact that there is no consistency among states in the application, approval and linkage procedures. To address this barrier and continue to improve the opportunities for linkages, NCI and NAACCR are working together to develop and implement a Virtual Pooled Registry Cancer Linkage System (VPR-CLS). VPR-CLS will provide a streamlined and efficient process for multi-state cancer linkages and IRB approval. Implementation of such an integrated system to link and provide cancer registry data would benefit the NCI with potential cost savings and enhanced efficiency of current linkage processes for cohort studies and follow-up on NCI sponsored clinical trials. Currently NCI DCCPS funds cohorts that annually follow more than 1.2 million individuals. For most of those, follow up information on the development of cancer, as well as survival and cause of death are essential components. In addition to DCCPS, DCP and DCEG also have large cohort studies that would benefit from cost-efficient methods to acquire follow up information. Establishing use of a CIRB is a key component of the VPR-CLS approach. It is bolstered by the NIH policy, effective May 25, 2017 (Notice Number NOT-OD-16-094), which set the expectation that a single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects research protocols funded by the NIH that are carried on at more than one site in the United States. While the minimal risk studies that will be submitted will initially be through the VPR-CLS workflow, it is expected that the CIRB will also be used for other DCCPS funded studies utilizing or linking or requesting SEER data where there may be some risk of re-identifiability. These studies will also meet the definition of minimal risk and multi-site research, so the NIH policy is applicable regardless of sponsor. The CIRB will not only streamline and speed up the review process but will also eliminate duplicative local IRB review, minimize locally driven modifications to the study protocol, and ensure a standard high-quality patient protection review.

Key facts

NIH application ID
10619488
Project number
75N91021P00419-P00002-0-1
Recipient
Principal Investigator
RAFFAELLA HART
Activity code
N02
Funding institute
NIH
Fiscal year
2022
Award amount
$12,315
Award type
Project period
2021-05-07 → 2023-05-06