Breaking Barriers for Central Cancer Registry Based Research: The New NIH Policy on Use of a Single Institutional Review Board for Multi-Site Research

Transcription

1 Breaking Barriers for Central Cancer Registry Based Research: The New NIH Policy on Use of a Single Institutional Review Board for Multi-Site Research DENNIS DEAPEN, DRPH LOS ANGELES CANCER SURVEILLANCE PROGRAM UNIVERSITY OF SOUTHERN CALIFORNIA NAACCR ANNUAL MEETING, ALBUQUERQUE, NM, JUNE 22,

2 OUTLINE 1. What is the Common Rule? 2. What has changed? 3. Why was this changed? 4. What is a single IRB? 5. How does this impact cancer registries? 6. What is being done to assist? 2

3 WHAT IS THE COMMON RULE? The Common Rule is a 1981 rule of ethics (revised in 1991) in the US regarding biomedical and behavioral research involving human subjects. It governs Institutional Review Boards for oversight of human research and is included in US Department of Health and Human Services (HHS) regulations. The Common Rule is the baseline standard of ethics by which any government-funded research in the US is held; nearly all US academic institutions hold their researchers to these statements of rights regardless of funding. 3

4 WHAT HAS CHANGED? 12/14 NIH issued a request for public comments in a draft policy to promote the use of a single IRB for multi-site studies funded by NIH 1 September 2015, US Health and Human Services and other Common Rule agencies published a Notice of Proposed Rulemaking (NPRM) Received >2100 comments Provided responses and changes Final Rule issue 1/18/17 (included other Common Rule changes) 4

5 FINAL RULE Several changes (but focus here on single IRB) ll.114 Cooperative Research (b)(1) Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research. 2 Compliance date 1/20/20 5

6 WHY WAS THIS CHANGE MADE? Both HHS and FDA already allowed multi-site studies to use joint review or rely on the view of another IRB 3-5. HHS believes too few institutions are using this option. 6

7 NIH STATEMENT Accelerating clinical research studies benefits researchers, research participants, and all who stand to gain from research results. Today, the time it takes to go from a sound research idea to the launch of a new, multi-site clinical research study is too long. A major contributor to the delay is that too many institutional review boards (IRBs) are reviewing the protocol and consent documents for the same study, often with no added benefit in terms of the protections for research participants. To address this bottleneck, NIH has issued a new policy to streamline the review process for NIH-funded, multi-site clinical research studies in the United States. The NIH Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research sets the expectation that multi-site studies conducting the same protocol use a single IRB to carry out the ethical review of the proposed research. 6 Francis S. Collins, M.D., Ph.D. Director, National Institutes of Health June 20,

8 WHAT IS A SINGLE IRB? The selection of one IRB to conduct review and approval of a research proposal on which other organizations participating in the same research may rely. May also be called a central IRB. 8

9 WHY USE A SINGLE IRB? Review of a multi-site study by the IRB of each participating site involves significant administrative burden. When each participating institution s IRB conducts a review, the process can take many months and significantly delay the initiation of research projects and recruitment of human subjects into research studies. Use of single IRBs in multi-site studies has been shown to decrease approval times for clinical protocols and may be more cost effective than local IRB review. 7 There is no evidence that multiple IRB reviews enhance protections for human subjects. In fact, the use of single IRBs may lead to enhanced protections for research participants by eliminating the problem of distributed accountability, minimizing institutional conflicts of interest, and refocusing IRB time and resources toward review of other studies. 8,9 9

10 NCI HAS LONG USED CENTRAL IRBs Adult CIRB Late Phase Emphasis (reviews CTEP-sponsored Phase 3 adult clinical trials) Adult CIRB Early Phase Emphasis Pediatric CIRB reviews CTEP-sponsored Pilot, Phase 2, and Phase 3 pediatric clinical trials Cancer Prevention and Control CIRB reviews cancer prevention and control studies 10

11 HOW DOES THIS IMPACT CANCER REGISTRY LINKAGE STUDIES? Cancer epidemiology cohort studies are either nationwide or members may reside in different states during follow up Linkage with cancer registries offers researchers complete, high quality, detailed, and standardized cancer information While national linkages are the ideal for some studies, no study has successfully linked with all population-based cancer registries 11

12 HOW DOES THIS IMPACT CANCER REGISTRY LINKAGE STUDIES? Each registry and IRB has a different application process Requesting linkages with 50 registries can take significant time Each registry and IRB dedicates time to reviewing the same study IRB/registry review time can take a few weeks to 18+ months Once approved, researcher must submit renewal applications Due to varying approval timeframes, data from registries is released to researcher sporadically, over extended period Long timeframe to complete studies 12

13 HOW DOES THIS IMPACT CANCER REGISTRY LINKAGE STUDIES? Minimize number of forms researcher must complete Decrease time/resources for completing application Reduce administrative burden of duplicative registry/irb review Speed up approval time and release of data Contribute to more timely science and discovery OHSRP through 45 CFR 46 has determined that cohort linkages are considered minimal risk studies and can be reviewed via expedited process. Opportunities to streamline IRB/registry review process for minimal risk linkage studies using the VPR-CLS: Templated IRB/Registry Applications Central IRB 13

14 WHAT IS BEING DONE? NCI is creating a central IRB to support VPR and other minimal risk studies 14

15 NCI CREATING CENTRAL IRB TO SUPPORT VPR AND OTHER MINIMAL RISK STUDIES Decision made to pursue procurement of a commercial IRB to serve as a CIRB Have and maintain AAHRPP* Accreditation Focus of this CIRB will be on minimal risk registry linkages Objective of establishing a CIRB is to provide a central IRB for the review of minimal risk, multi-site studies to help alleviate the burden of review of multiple local/state IRBs *Association for the Accreditation of Human Research Protection Program 15

16 CIRB TASKS Major Tasks for Contractor Include: Have process and procedures for the review and adjudication of expedited reviews of minimal risk studies Identify review personnel for expedited reviews (Chair/Reviewers); Handle communications with PIs regarding reviews Ability to adjust to increased capacity based upon demand Store and manage all review related materials Promote/provide information on CIRB website Educate those involved on CIRB process to enhance submission/review effort 16

17 BENEFITS OF CIRB Eliminate duplicative IRB review (beyond initial institutional IRB approval) Ensure consistency of IRB reviews Allow local/state IRBs to concentrate more time on other reviews Reduce local/state requests for protocol changes that necessitate re-review by institutional IRB Decrease administrative burden on research staff Reduce timeline for approval and release of data 17

18 ISSUES/QUESTIONS TO RESOLVE Local Context Issues issues from a particular IRB/state that must be factored into the review process by CIRB Use of templated application for use as the CIRB application Identify any state/federal/tribal laws or regulations regarding use of CIRB 18

19 NEXT STEPS/TIMELINE Resolve outstanding issues Prepare SOW, budget and acquisition plan Develop additional technical requirements for review of responses Once outstanding issues resolved, contracts will begin solicitation process Anticipated award date is second quarter

20 ACKNOWLEDGEMENTS Steve Friedman Castine Clerkin Lynne Penberthy Betsy Kohler Rob McGlaughlin 20

21 FOR MORE INFORMATION McLaughlin RH, Gomez SL, Deapen D, Induni M. Human subjects protection and cancer surveillance research: revised regulations, expanded opportunities. Cancer Res; 77(12); 1 4, Fact sheet for IRBs and registries in preparation. 21

22 CITATIONS CFR part and 21 CFR part Wagner TH, et al. Costs and benefits of the National Cancer Institute Central Institutional Review Board. J Clin Oncol. 2010; 28: Emanuel EJ, et al. Oversight of human participants research: identifying problems to evaluate reform proposals. Ann Intern Med. 2004; 141(4): Menikoff J. The paradoxical problem with multiple-irb review. N Engl J Med. 2010; 367:

23 Final NIH Policy on the Use of a Single Institutional Review Board for Multisite Research Clinical and Translational Science Volume 10, Issue 3, pages , 2 MAR 2017 DOI: /cts