EFFECTIVELY IMPLEMENTING THE NIH SINGLE IRB POLICY AND REVISED COMMON RULE

Transcription

1 EFFECTIVELY IMPLEMENTING THE NIH SINGLE IRB POLICY AND REVISED COMMON RULE 2018 SRA MIDWEST/SOUTHERN SECTION MEETING ST. LOUIS, MO Wednesday, April 18, :30 AM - 11:45 AM 2018 HURON CONSULTING GROUP INC.

2 IMPLEMENTING THE NIH SIRB POLICY AND REVISED COMMON RULE 1 Introductions 5 Revised Common Rule Changes & Updates 2 Learning Objectives 6 Revised Common Rule Compliance Delay-What Can We Do Now? 3 4 NIH Single IRB (sirb) Policy 7 sirb Implementation Strategies 8 Q&A Future-Proofing IRB Operations HURON CONSULTING GROUP INC. AND AFFILIATES. ALL RIGHTS RESERVED.

3 1 INTRODUCTIONS 3

4 TODAY S PRESENTERS PHILIP COLA, PH.D. T E pac4@case.edu + Phil is an Associate Professor of Management and Adjunct Assistant Professor of Medicine at Case Western Reserve University (CWRU). He has more than 20 years of experience leading research administration in an Academic Medical Center where he was instrumental in designing and developing reliant IRB review mechanisms. Presently, he is also the Director of the Regulatory Knowledge and Support core of the CWRU Clinical Translational Science Award. MADELEINE WILLIAMS T E mwilliams@huronconsultinggroup.com + Maddie is a Senior Consultant in Huron s Research Enterprise Solutions practice. She has over 15 years of research experience and assists clients with institutional review board (IRB) operational support, regulatory compliance evaluations, human research protection program (HRPP) evaluation and accreditation, and biorepository assessments and infrastructure development HURON CONSULTING GROUP INC.

5 2 LEARNING OBJECTIVES 5

6 LEARNING OBJECTIVES 1. Identify 5 core strategies for implementing the NIH sirb policy and evaluate how your organization is handling the implementation. 2. List the major changes in the revised Common Rule and best practices when working within both sets of rules HURON CONSULTING GROUP INC.

7 REVISED COMMON RULE: DISCLAIMER The material presented today should be considered a work in progress, based upon our current understanding of the Revised Common Rule and the Interim Final Rule (IRF) HURON CONSULTING GROUP INC.

8 NIH SIRB AND REVISED COMMON RULE TERMINOLOGY Terms Current Rule; Pre-2018 Rule Final Rule; New Rule; 2018 Rule; Revised Rule; Revised Common Rule NPRM, Revision to the New Rule Definition Current set of Common Rule regulations that IRBs follow Updated Common Rule, effective January 19, 2018 (except for collaborative research, effective January 20, 2020) The request to delay the Final Rule, posted to the Office of Management and Budget (OMB) website on October 7, 2017 Interim Final Rule Formal rulemaking which delayed the 2018 Rule until July 19, 2018 (or possibly longer) NIH Single IRB (sirb) Policy Policy requiring Single IRB Review of multisite research, effective January 25, HURON CONSULTING GROUP INC.

9 3 NIH SINGLE IRB (SIRB) POLICY 9

10 NIH POLICY UPDATE: SINGLE IRB REVIEW The NIH Policy on the Use of a Single Institutional Review Board of Record for Multi- Site Research establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the National Institutes of Health (NIH) will use a single Institutional Review Board (sirb) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects. This policy applies to all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after January 25, The original compliance date was May 25, 2017, but NIH decided to extend the effective date to January 25, 2018 to provide additional time for implementation HURON CONSULTING GROUP INC AND AFFILIATES. ALL RIGHTS RESERVED.

11 POLICY BACKGROUND: MULTIPLE IRB REVIEWS + The traditional approach to ethical review of multi-site research has been for each participating site s (psite) IRB to review the research + Challenges associated with the traditional approach include: - Duplication of effort - Inconsistency of IRB determinations - Potential for methodological inconsistencies - Delays in study start-up - Multiple changes to a study that could impact study objectives HURON CONSULTING GROUP INC.

12 POLICY BACKGROUND: MULTIPLE IRB REVIEWS For the majority of multi-site studies, the IRB at each participating site continues to conduct an independent review. This review adds time, but generally does not meaningfully enhance protections for the participants. This new NIH policy seeks to end duplicative reviews that slow down the start of the research. - Francis Collins, NIH Director June 20, In the discussion of the policy, the NIH noted that there was not much evidence to support that multiple IRB reviews enhance protections for subjects involved in multisite research + The new NIH policy creates an expectation for a single IRB review arrangement that federal regulations have allowed on a voluntary basis + Reduces the likelihood to introduce unintended inconsistencies from multiple reviews while allowing for more effective resource utilization HURON CONSULTING GROUP INC.

13 POLICY IMPLICATIONS: PARADIGM SHIFT IN IRB REVIEW +The NIH acknowledges that there may be short-lived challenges associated with the new policy + Examples of implementation challenges include: - How costs associated with sirb review may be charged as direct versus indirect costs - How the sirb is selected - Equal qualifications of the sirb to serve in that role - How IRB operations and electronic systems are adapted to facilitate the review process HURON CONSULTING GROUP INC.

14 4 SIRB IMPLEMENTATION STRATEGIES 14

15 IMPLEMENTATION STRATEGY #1: CONDUCT A PORTFOLIO REVIEW + Important to know volume of NIH funded research to determine impact - How many multi-site studies you are/may need to serve as sirb - How many multi-site studies you are/will be a participating site +Small volume may = small number of changes +Helps with decision or whether to serve as sirb or outsource HURON CONSULTING GROUP INC.

16 IMPLEMENTATION STRATEGY #1: CONDUCT A PORTFOLIO REVIEW + Example portfolio assessment questions: - How many NIH funded multi-site studies do you currently review? - Of those, how many are you the IRB of record for or the lead site? - How many NIH multi-site studies will be up for renewal, revision or resubmission in 2017? 2018? - How many new multi-site grant applications do you anticipate submitting to the NIH in the upcoming year? - How many NIH-funded multi-site studies do you foresee participating as a performance site? - Does the institution have a strategy to grow its research portfolio significantly in the next five years? +In preparation for the revised Common Rule, ask the same questions for all Federally funded multi-site studies HURON CONSULTING GROUP INC.

17 IMPLEMENTATION STRATEGY #2: DETERMINE WHO WILL SERVE AS THE SIRB +The sirb of record will be required to coordinate IRB review processes on behalf of all sites participating in the study - The sirb institution will need the right resources to process an increased volume of information + How is the sirb determined? - Pre-determined by the study sponsor or grant - Established by prior arrangement (e.g., network central IRB) - IRB from Lead Principal Investigator s institution - Selected based on expertise in the study area (e.g., type of procedures to be performed or subject population) HURON CONSULTING GROUP INC.

18 IMPLEMENTATION STRATEGY #2: DETERMINE WHO WILL SERVE AS THE SIRB +Most often, the IRB from the Lead PI s institution will serve as the sirb or the IRB of record +Use of commercial/independent IRBs as sirb is allowed under Policy and via SMART IRB +Lead institution s IRB often has first right of refusal or the choice to use a commercial/independent IRB HURON CONSULTING GROUP INC.

19 IMPLEMENTATION STRATEGY #3: DETERMINE ASSOCIATED COST +The NIH has provided costing guidance for the new policy for 12 scenarios* +If your institution is the prime awardee and serving as the sirb: - IRB review activities for your institution (site) = indirect cost - IRB review activities for all participating sites = direct cost +If your institution is the prime awardee and a different participating site is serving as the sirb: - IRB review activities for your institution (site) = direct cost - IRB review activities for participating site serving as sirb = indirect cost - IRB review activities for all participating sites = direct cost +If your institution is the prime awardee and a commercial IRB is serving as the sirb: - IRB review activities for your institution (site) = direct cost - IRB review activities for all participating sites = direct cost *Source: Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research HURON CONSULTING GROUP INC.

20 IMPLEMENTATION STRATEGY #3: DETERMINE ASSOCIATED COST +Considerations in determining direct costs associated with sirb review of participating sites: - Can develop your own fee structures for sirb costs but have to follow the requirements for a specialized service facility - May choose to remove all IRB costs from indirect cost pool thereby charging all IRB costs, including sirb costs, as direct costs - Basis for determination of sirb direct costs +Commercial IRB costs may be charged as a direct cost when they are serving as the sirb HURON CONSULTING GROUP INC.

21 IMPLEMENTATION STRATEGY #4: IDENTIFY BUSINESS PROCESSES THAT NEED TO BE CREATED/UPDATED +Identify and document processes and agreements between the sirb and participating sites that need to either be updated or created to ensure continuity of information, including: - Authorization agreements - Turnaround time commitments - Communication processes - Documentation requirements +Authorization agreements should clearly define the responsibilities of the sirb and participating sites HURON CONSULTING GROUP INC.

22 IMPLEMENTATION STRATEGY #4: IDENTIFY BUSINESS PROCESSES THAT NEED TO BE CREATED/UPDATED + Considerations if serving as sirb: - Need additional staff? Full or part-time depending on portfolio review - Need to create specialized positions (e.g., reliance coordinator)? - What other ancillary reviews are required for multi-site studies? How does that affect timing? - What turnaround time commitments is the sirb prepared to make? - How does the sirb communicate with sites? + Considerations if a participating site: - What information is needed to track for reporting and monitoring purposes? - What responsibilities are retained (e.g., COI management, other ancillary reviews)? - How will different requirements for different sirbs be managed? - How will you communicate to the sirb? HURON CONSULTING GROUP INC.

23 IMPLEMENTATION STRATEGY #5: EVALUATE TECHNOLOGY OPTIONS +Employ a manual process - May save budget in the short-term by avoiding a technology investment, need to evaluate the expense of human resources (and risk of human error) +Modify an existing eirb system - May take significant effort and time - Additional complexity if you allow sites to access to the sirb system +Outsource oversight to a commercial IRB - Institutions running industry-sponsored studies using commercial IRBs may choose to use the same IRB for NIH-funded multi-site studies as well increasing their ROIs and centralizing resources +Move to a new eirb system - The process of moving over to a new solution that supports sirb functionality poses short-term challenges and added expenses, but could provide the infrastructure needed to ensure long-term success and cost savings HURON CONSULTING GROUP INC.

24 4 REVISED COMMON RULE CHANGES AND UPDATES 24

25 REVISED COMMON RULE BACKGROUND +The U.S. Department of Health and Human Services and 15 other federal agencies have issued a final rule to update the Common Rule regulations that safeguard individuals who participate in research +This update to the Common Rule follows the September 2015 publication of the Notice of Proposed Rulemaking (NPRM). In response to concerns raised during the public comment period and extensive subsequent review processes, the final rule contains a number of significant changes from the originally-proposed rule +Original effective and compliance date was January 19, 2018; was delayed and effective and compliance date is now July 19, HURON CONSULTING GROUP INC.

26 REVISED COMMON RULE SUMMARY OF CHANGES + Key changes to existing Common Rule regulations include: - Required additional content in informed consent documents - Required use of a single IRB for most multi-institution research studies - New options for the use of broad consent documents for research involving identifiable data or identifiable bio-specimens - New categories of exempt human research - Elimination of continuing review requirements for certain human research studies - Required posting of consent documents for certain federally-funded trials to a public website - Elimination of grant congruency review by the IRB - New criteria for limited IRB review required for certain exempt categories HURON CONSULTING GROUP INC.

27 COMMON RULE DELAY IT S OFFICIAL! HURON CONSULTING GROUP INC.

28 COMMON RULE DELAY TIMELINE 1/4/2018 New Delay Proposal 1/19/2018 Original Effective and Compliance Date 7/19/2018 New Effective and Compliance Date 1/19/2018-7/19/2018 Only Those Provisions that Do Not Confliect with the Pre-2018 Common Rule 1/1/2018 4/1/2018 7/1/ /7/2017 Official Delay Announcement 7/19/2018 1/17/2018 Original Delay Proposal 10/7/ HURON CONSULTING GROUP INC.

29 COMMON RULE DELAY NEXT STEPS Before July 19, 2018, institutions may implement only those provisions of the Revised Common Rule that do not conflict with the Pre-2018 Common Rule. The Interim Final Rule does not delay the compliance date for the cooperative research provision of the 2018 Requirements ( _.114(b)), which remains January 20, The Interim Final Rule indicates that the Common Rule agencies are developing a Notice of Proposed Rulemaking in order to fully engage regulated entities and the public regarding further delay of the 2018 Requirements until January 21, The Comment Period for the Interim Final Rule is open until March 31, HURON CONSULTING GROUP INC.

30 REVISED COMMON RULE TIMELINE 1/19/17 Release of the Final Rule from OHRP First major update to the Common Rule since the 1990s 1/19/18 Effective and Compliance date for the Final Rule All research approved on or after this date must follow the Final Rule 1/25/18 Effective Date for the NIH Single IRB of Record Policy 7/19/19 Revised Effective and Compliance date for the Final Rule All research approved on or after this date must follow the Final Rule 1/20/20 Compliance Date for the Final Rule Single IRB of Record Requirement HURON CONSULTING GROUP INC.

31 5 REVISED COMMON RULE COMPLIANCE DELAY- WHAT CAN WE DO NOW? 31

32 WHAT CAN WE DO NOW? EXAMPLES +The delay announcement from HHS states the following: institutions may only begin implementing provisions of the revised Common Rule that do not conflict with the pre Common Rule. What does this mean? +HHS provided two examples: - Example 1: Permissible. Incorporation of new elements of consent at.116(b)(9), (c)(7)-(9). - Example 2. Not permissible. Elimination of Continuing Review at.109(f) HURON CONSULTING GROUP INC.

33 WHAT CAN WE DO NOW? ANALYSIS +Institutions can use those examples to determine what other provisions are permissible or not permissible +For the incorporation of new elements of consent, consider the following: - The new elements of consent at.116(b)(9), (c)(7)-(9) do not replace previously existing elements of consent in the Pre-2018 Common Rule - Institutions have always been allowed to incorporate local elements of consent that do not conflict with the Pre-2018 Common Rule, e.g., subject injury language, state-specific requirements +For the elimination of Continuing Review, consider the following: - That provision at (f) of the Revised Common Rule conflicts with the requirement to conduct Continuing Review for non-exempt Human Research at (e) precisely because the elimination of Continuing Review depends on an accompanying revision to.109(e) that is also being delayed: An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, not less than once per year, except as described in (f) (emphasis Huron s) HURON CONSULTING GROUP INC.

34 WHAT CAN WE DO NOW? MAINTAIN PRE-2018 POLICIES +Analyze the changes that you made to your policies, systems, and other tools using the HHS examples as guidance, to determine what you cannot do during the delay period +Some examples are: - Human Subject Definition - Revised Exempt Categories - Broad Consent - Limited IRB Review - Default unchecking the box for projects that do not have Common Rule oversight - Eliminating grant congruency review - Eliminating continuing review for expedited projects, or projects that have reached certain milestones HURON CONSULTING GROUP INC.

35 6 FUTURE PROOFING IRB OPERATIONS 35

36 FUTURE-PROOFING WHAT DOES IT MEAN? +In an uncertain environment, it is critical that organizations are prepared for upcoming changes and challenges, especially in these areas: - Regulatory and Guidance Landscape - Accreditation - Business Process - Staffing - Technology Assess/ Reassess the Landscape Monitor Success and Progress Develop Strategy Implement Strategy HURON CONSULTING GROUP INC.

37 FUTURE-PROOFING IRB OPERATIONS LEARNING FROM THE DELAY +Consider how you prepared for the Revised Common Rule and what you have to unwind or roll back as a result of the delay. +Do you have to undo any of the functionality you developed to get your IRB system ready? - How can you create additional IRB system flexibility moving forward? +Are there any policies or procedures that you need to adjust for the delay? - As you make adjustments, can you utilize decision trees to stage New Rule considerations for future determinations rather than removing them altogether? HURON CONSULTING GROUP INC.

38 FUTURE-PROOFING GENERAL SUGGESTIONS Be vigilant: - Talk to colleagues at other institutions - Review available resources: Huron Webinars PRIM&R website and conferences IRB Forum Prepare to be responsive: - Update policies, procedures and review tools as guidance is released - Plan ongoing trainings with IRB staff and reviewers to incorporate revisions HURON CONSULTING GROUP INC.

39 FUTURE-PROOFING SPECIFIC EXAMPLES Process: - Ensure SOPs, review tools, etc. are updated and maintained in a way that they can be easily adjusted - Have a plan in place for if there is a need to revert, or partially revert Technology: - Utilize smart technology to ensure that work done during technology design and implementation will not need to be re-done Add date setting for the Compliance date, that drives what and when users see Final Rule options throughout the system HURON CONSULTING GROUP INC.

40 PLANNING AHEAD EXAMPLE 1/19/2018 Original Revised Common Rule Effective Date 7/19/2018 New Revised Common Rule Effective Date 2/19/2018-4/20/2018 Revise SOPs and other review tools Train IRB staff, IRB members, and investigators 4/23/2018-7/18/2018 Possible Additional Delay Period 7/19/2018-1/21/2019 2/1/2018 3/1/2018 4/1/2018 5/1/2018 6/1/2018 7/1/2018 8/1/2018 9/1/ /1/ /1/ /1/2018 1/1/2019 1/19/2018 3/19/2018-5/18/2018 1/21/2019 Revise investigator-facing materials and update IRB system Engage stakeholders/create comprehensive plan 1/19/2018-3/16/2018 Other recommendations: 1. Add standing check-ins with IRB staff, Chairs, and key stakeholders. 2. Use IRB meeting time for training. Possible Revised Common Rule Effective Date 1/21/ HURON CONSULTING GROUP INC.

41 41 Q&A

42 THANK YOU! This presentation was in part made possible by the Clinical and Translational Science Collaborative of Cleveland, UL1TR000439, from the National Center for Advancing Translational Sciences (NCATS) component of the National Institutes of Health and NIH roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.