Use of a Central IRB (CIRB) for Minimal Risk Study Reviews. Steve Friedman Surveillance Research Program, NCI NAACCR Annual Conference

Transcription

1 Use of a Central IRB (CIRB) for Minimal Risk Study Reviews Steve Friedman Surveillance Research Program, NCI NAACCR Annual Conference June 12, 2018

2 Background Linkage of patient information from research studies (such as cohorts) currently require each registry s IRB to review and approve the submitted study. The time and effort involved may serve as dis-incentive to PIs seeking to do multi-site linkage studies. Office of Human Research Protections (OHRP) through 45 CFR 46 has determined that such linkages are considered minimal risk studies and can be reviewed via an expedited process. NIH policy, effective 1/20/20, stipulates that a Single IRB (sirb) of record will be used for multi-site studies funded by the NIH. Common Rule NIH has a more conservative position, additional impact may take years.!2

3 Evolution of Centralized IRB Support OHRP Alternative IRB Models workshops November 2005 sponsored by NIH, OHRP, AAMC, ASCO and VA o Suggested by HHS SACHRP in 2004 report o Described 10 models of IRB review including CIRB o Listed division of responsibilities between Institution and IRB o Encourage accreditation of HRPs November 2006 sponsored by NIH, OHRP, AAMC, ASCO, VA, AAU, COGR, COSSA, DOD, NACUA, PRIM&R, and FDA o Participants agreed that multi-site research related to situations that require rapid response, research involving special populations and research accomplished through practice-based or regional networks. o Led to recommendation of use of external, centralized IRBs b/c of efficiencies!3

4 Evolution of Central IRB Support (con t) OHRP article in 10/21/2010 NEJM The Paradoxical Problem with Multiple-IRB Review The result is that a great deal of resources are devoted to the ethics review of multi-site studies Another approach to reducing the number of IRB reviews would be to have sponsors require the use of a central IRB as a condition for participating in a study. Follows notice in federal register to make rule change improving ability to oversee non-compliant IRB and IORGs. Common theme with workshops amend Common Rule Final rule published Jan and then delayed to Jan 2020 start date July 2017 OIG Investigation in response to Congress questions on OHRP independence. Commented on need to strengthen independence as research community adjusts to amended Common Rule!4

5 Division of Responsibilities!5

6 Common Rule Change!6

7 Background (con t) NAACCR conducted two pilots in Fall 2015 with favorable results towards use of enhancing linkage efforts. Led to VPR-CLS. NAACCR survey (55 of 60 registries) indicated experience and support for a single IRB for linkage studies.!7

8 Background (con t) Decision made for NCI to pursue procurement of a commercial IRB to serve as a CIRB. Requirement Have and Maintain AAHRPP Accreditation Focus of this CIRB will be on minimal risk registry linkages Objective of establishing a CIRB: Provide a central IRB for the review of minimal risk, multi-site studies to help alleviate the burden on both the registries and the investigators in review of multiple IRBs Provide access to IRB review for those registries who do not hold an IRB!8

9 Association for the Accreditation of Human Research Protection Programs (AAHRRP) Formed in 2001 through collaborative efforts of seven non-profits representing health care education and research. Established as leader in human research protection program accreditation, AAHRPP has accredited 251 organizations with 49 outside of the U.S. Benefits of accreditation helps organization adhere to OHRP and FDA requirements, part of organizational quality efforts.!9

10 Benefits of a 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 rereview by institutional IRB Decrease administrative burden on research and registry staff Reduce timeline for approval and release of data!10

11 CIRB Contract Tasks Major Tasks for the CIRB Contractor Include: Have process and SOPs for the review and adjudication of expedited reviews of minimal risk studies Identify reviewers 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 Integrated into the VPR process!11

12 DRAFT CIRB Workflow PI receives institutional IRB approval PI submits completed application to CIRB CIRB reviews application If no changes CIRB notifies PI or nonparticipating IRB of approval If CIRB recommends changes PI modifies application and resubmits!12

13 Current Status of CIRB Contract 2017 Solicitation went out with AAHRRP accreditation as a mandatory technical requirement Response did not yield a qualified IRB Working with NCI Office of Acquisitions to review aspects of SOW, market research efforts, solicitation mechanism!13

14 Next Steps Resolve outstanding issues discussions underway internally to resolve. SOW, budget and acquisition plan with contracts all major elements in place. May modify SOW based on new market research efforts. Develop additional technical requirements for review of responses and elements for both the technical and business proposals as needed. Contracts will put this out for solicitation. Mechanisms in addition to fedbizopps.gov?!14

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