THE REVISED COMMON RULE: WHAT S NEXT?

Transcription

1 THE REVISED COMMON RULE: WHAT S NEXT? November 15, HURON CONSULTING GROUP INC.

2 THE REVISED COMMON RULE: WHAT S NEXT? 2 1 Introductions & Information 4 Proposal to Delay the Final Rule 2 General Notes 5 Planning Ahead 3 Key Takeaways from Previous Webinars 6 Q&A 2017 HURON CONSULTING GROUP INC. AND AFFILIATES. ALL RIGHTS RESERVED.

3 1 INTRODUCTIONS & INFORMATION HURON CONSULTING GROUP INC.

4 TODAY S MODERATOR + GARY WHITNEY + Managing Director + Huron s Education Practice Experience: Gary has 30+ years experience in software and technology products. He assists clients with automation and deployment strategies in the areas of research compliance, grants and contracts administration and clinical trials management. Prior to joining Huron, Gary served as the VP of sales and marketing for Click Commerce. He cofounded Click Commerce s.com predecessor, Webridge, an enterprise web-based solutions startup HURON CONSULTING GROUP INC. AND AFFILIATES. ALL RIGHTS RESERVED.

5 TODAY S PRESENTERS FRANK CONTE T E fconte@huronconsultinggroup.com + Frank is a Director in Huron s Research Enterprise Solutions practice. He has more than fifteen years of project management experience in higher education. He focuses on assisting higher education and healthcare organizations with research administration initiatives including human research protection program and institutional review board (IRB) evaluation and process improvement, research administration system software selection, design and implementation and clinical research program evaluations. Frank is on the Huron IRB product advisory committee. 5 JONATHAN HUNTER T E jhunter@huronconsultinggroup.com 2017 HURON CONSULTING GROUP INC. AND AFFILIATES. ALL RIGHTS RESERVED. + Jonathan is a Manager in Huron s Research Enterprise Solutions practice. His work focuses on institutional review board (IRB) structure and function and human research protection program (HRPP) evaluation and accreditation. He has worked directly for or partnered with a wide range of institutions to implement policies and procedures designed to improve the efficiency and effectiveness of the IRB review process. Jonathan is also on the Huron IRB software solution product advisory committee, serves as the IRB Solution Lead for that product, and is part of the team responsible for maintaining Huron s HRPP Toolkit.

6 ASK US YOUR QUESTIONS: LEVEL 3 CHAT PANEL Enter a question in this dialog area at any time.

7 WHO IS ATTENDING THE WEBINAR TODAY? Primary job function: Sponsored Programs 5 % Other 28% Compliance 48.1% IT 9.9% Executive Leaders 9%

8 WHO IS ATTENDING THE WEBINAR TODAY? Level of research expenditures last year: $100 - $200M 17.8% $200 - $500M 17.8% Under $100M 53% $500M+ 11.4%

9 WHO IS ATTENDING THE WEBINAR TODAY? Where are you in the planning process for the revised Common Rule? Not started 7.3% Put on hold 2.6% Beginning Implementation 9.9% Developing revised policies and procedures 51.6% Reviewing the revised Common Rule 28.6%

10 POLLING QUESTION 1

11 2 GENERAL NOTES HURON CONSULTING GROUP INC.

12 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. We will continue to update our approach as guidance and other official information is released HURON CONSULTING GROUP INC.

13 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 NIH Single IRB Policy 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 Policy requiring Single IRB Review of multi-site research, effective January 25, HURON CONSULTING GROUP INC.

14 POLLING QUESTION 2

15 3 KEY TAKEAWAYS: PREVIOUS WEBINARS HURON CONSULTING GROUP INC.

16 KEY TAKEAWAYS +July 19, 2017: Prepare Your IRB Operations for Your IRB Operations for The Revised Common Rule - Making the switch Considerations for moving studies from the Current Rule to the New Rule - Broad Consent - Continuing Review for expedited projects - Planning ahead and timeline for implementation +September 20, 2017: Achieve IRB Operations Success for The Revised Common Rule - System-related considerations - Further discussion on Broad Consent - Benign behavioral interventions - Planning ahead and timeline for implementation HURON CONSULTING GROUP INC.

17 REVISED COMMON RULE TIMELINE 1/19/17 Release of the Final Rule from OHRP First major update to the Common Rule since the 90s 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 1/?/19 Proposed delay to the Final Rule (General Implementation Date) 1/20/20 Compliance Date for the Final Rule Single IRB of Record Requirement HURON CONSULTING GROUP INC.

18 4 PROPOSAL TO DELAY THE FINAL RULE HURON CONSULTING GROUP INC.

19 WHAT WE KNOW: OMB REVIEW +Posted to the Office of Management and Budget (OMB) website on October 7: - Federal Policy for the Protection of Human Subjects: Proposed 1-Year Delay of the General Implementation Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Year HURON CONSULTING GROUP INC.

20 WHAT WE KNOW: TITLE OF THE PROPOSAL Federal Policy for the Protection of Human Subjects: Proposed 1-Year Delay of the General Implementation Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Year HURON CONSULTING GROUP INC.

21 WHAT WE DON T KNOW: A LOT! +What does General Implementation Date refer to? - This term does not appear anywhere in the Preamble or the text of the Final Rule itself. - This has a different meaning if OHRP is referring to the Effective Date or the Compliance Date (currently the same date). +What are the three burden-reducing provisions? - Are these the provisions requested by the AAMC, AAU, APLU, and COGR? HURON CONSULTING GROUP INC.

22 WHAT WE DON T KNOW: EFFECTIVE VS. COMPLIANCE DATE We understand there to be three possible scenarios depending on what General Implementation Date means: Possible Scenario 1: The Effective Date and Compliance Date are kept together and both are delayed by 1 year. The only provisions of the Final Rule that can be implemented prior to the new Effective and Compliance Date would be the three burden-reducing provisions. Possible Scenario 2: The Effective Date and Compliance Date are separated and the Compliance date is delayed by 1 year. But what is allowed is the same as in Possible Scenario 1. Possible Scenario 3: The Effective Date and Compliance Date are separated and the Compliance Date is delayed by 1 year. If an institution is ready, it may implement the entire Final Rule on of after 1/19/2018. Otherwise, an institution would be allowed to implement only the three burden-reducing provisions until ready to implement the entire Final Rule HURON CONSULTING GROUP INC.

23 WHAT WE DON T KNOW: POSSIBLE SCENARIO 1 11/15/2017 Revised Common Rule Webinar Possible Scenario 1 1/19/2018-1/21/ Burden-Reducing Provisions Only, All-In Only After New Date 1/21/2019 Proposed Effective and Compliance Date* 1/1/2018 4/1/2018 7/1/ /1/2018 1/1/ /15/2017 Current Effective and Compliance Date 1/21/2019 1/19/2018 *We selected 1/21/2019 because it is a Monday HURON CONSULTING GROUP INC.

24 WHAT WE DON T KNOW: POSSIBLE SCENARIO 2 11/15/2017 Revised Common Rule Webinar 1/19/2018 Proposed Effective Date Possible Scenario 2 1/19/2018-1/21/ Burden-Reducing Provisions Only, All-In Only After New Date 1/21/2019 Proposed Compliance Date* 1/1/2018 4/1/2018 7/1/ /1/2018 1/1/ /15/2017 Current Effective and Compliance Date 1/21/2019 1/19/2018 *We selected 1/21/2019 because it is a Monday HURON CONSULTING GROUP INC.

25 WHAT WE DON T KNOW: POSSIBLE SCENARIO 3 11/15/2017 Revised Common Rule Webinar 1/19/2018 Proposed Effective Date Possible Scenario 3 1/19/2018-1/21/2019 All-In If Ready, or 3 Burden-Reducing Provisions Only Until Ready 1/21/2019 Proposed Compliance Date* 1/1/2018 4/1/2018 7/1/ /1/2018 1/1/ /15/2017 Current Effective and Compliance Date 1/21/2019 1/19/2018 *We selected 1/21/2019 because it is a Monday HURON CONSULTING GROUP INC.

26 WHAT WE DON T KNOW: BURDEN-REDUCING PROVISIONS? In June 2017, the AAMC, AAU, APLU, and COGR requested to move forward with the following prior to the Effective Date (meaning, before January 19, 2018): - Certain exclusions and exemptions. - Elimination of the continuing review requirement for certain types or stages of research. - Elimination of IRB review of grant applications. What are the consequences of moving forward with any of the above provisions without implementing the entire Final Rule? - For example, certain exclusions and exemptions depend on other provisions in the Final Rule, e.g., Limited IRB Review. If the delay included the ability to move forward with certain exclusions and exemptions, how to move forward would need to be clarified. Our assumption, considering the complexity of the Final Rule, is that any provisions allowed during a delay period would need to be able to stand alone HURON CONSULTING GROUP INC.

27 POLLING QUESTION 3

28 POLLING QUESTION 4

29 FEDERAL RULE MAKING PROCESS WHERE ARE WE TODAY? HURON CONSULTING GROUP INC. Source: Office of Management and Budget,

30 FEDERAL RULE MAKING PROCESS NEXT STEPS HURON CONSULTING GROUP INC. Source: Office of Management and Budget,

31 EXAMPLE REGULATORY TIMELINE TODAY Nov. 16 Dec. 16 Jan. 16 Jan. 19 OMB Approves Posting of NPRM NPRM Published Comment Period Opens Comment Period Closes OHRP Compiles Comments OHRP Finalizes Rule and Obtains Signatures Delay to Final Rule Posted to Federal Register Assumptions: +Rule gets approved for posting by OMB today +30-day comment period +The OHRP is able to compile and respond to all comments within 30 days +Common Rule Agencies quickly sign-off on Final Rule +Final Rule gets posted to the Federal Register within 3 days of completing review and responding to comments +Not factoring in holidays or other potential delay factors HURON CONSULTING GROUP INC.

32 DON T FORGET OTHER INFLUENCING FACTORS +Thanksgiving, Christmas and New Year federal holidays all occur in our proposed timeline. +Other governmental factors, including timeline for the OMB review and sign-off from Common Rule Agencies. +Potential for a government shutdown in December HURON CONSULTING GROUP INC.

33 PROPOSED DELAY WHERE DOES THAT LEAVE US TODAY? Given the extremely aggressive timeline to post an official delay to the Final Rule before the Effective and Compliance date, it is not likely that the delay will go into effect by January 19. This leaves organizations with 2 options: - Option 1: Continue preparing to follow the Final Rule as it is currently posted in the Federal Register. - Option 2: Do nothing and expect that the Final Rule will be delayed HURON CONSULTING GROUP INC.

34 5 PLANNING AHEAD HURON CONSULTING GROUP INC.

35 PLANNING AHEAD HRPP PROCESS CHANGE HRPP Future State SOPs and Tools eirb Training Develop an approach to updating your SOPs and other tools to accommodate the 2018 requirements. Create a project plan for updating your IRB system; secure SME input and IT resources. Determine which groups need what training, and who will develop the curriculum and lead it HURON CONSULTING GROUP INC.

36 PLANNING AHEAD EXAMPLE TIMELINE - JULY WEBINAR 7/19/2017 Huron Revised Common Rule Webinar 1/19/2018 Revised Common Rule Effective Date 8/19/ /19/2017 Revise SOPs and other review tools 10/19/2017-1/19/2018 Train IRB staff, IRB members, and investigators 8/1/2017 9/1/ /1/ /1/ /1/2017 1/1/2018 7/19/2017 1/19/2018 8/19/ /19/ /19/2017-1/19/2018 7/19/2017-8/19/2017 Develop broad consent approach Revise investigator-facing materials and update IRB system Engage stakeholders/create comprehensive plan HURON CONSULTING GROUP INC.

37 PLANNING AHEAD NEW EXAMPLE TIMELINE (NO DELAY) 7/19/2017 Huron Revised Common Rule Webinar 9/20/2017 Huron Revised Common Rule Webinar 2 11/15/2017 Huron Revised Common Rule Webinar 3 12/17/2017-1/19/2018 Train IRB staff, IRB members, and investigators 11/15/ /16/2017 Revise SOPs and other review tools 8/1/2017 9/1/ /1/ /1/ /1/2017 1/1/2018 7/19/2017 1/19/ /17/2017-1/19/2018 Revise investigator-facing materials and update IRB system Don t panic. Prepare! Our goal throughout this series has been to help you prepare according to what we know. While a delay would ease the immediate burden, we still encourage you to be ready as soon as possible. Revised Common Rule Effective Date 11/15/ /2/2017 1/19/2018 Engage stakeholders/create comprehensive plan HURON CONSULTING GROUP INC.

38 POLLING QUESTION 5

39 Q&A HURON CONSULTING GROUP INC.

40 RESOURCES: + IRB Transformation Services & Product Information: + Huron NIH Single IRB Policy Thought Leadership: + Final revisions to the Common Rule: + The (R)evolution Can Wait: Implementation of Common Rule Updates May Be Delayed : - An article published on October 26, 2017 which discusses the possible delay. + SACHRP recommendations for broad consent, and draft template: Subscribe to our list for the most up-to-date webinars, news alerts and thought leadership on this topic: HURON CONSULTING GROUP INC.

41 CONTACT US FRANK CONTE DIRECTOR T E fconte@huronconsultinggroup.com JONATHAN HUNTER MANAGER T E jhunter@huronconsultinggroup.com GARY WHITNEY MANAGING DIRECTOR T E gwhitney@huronconsultinggroup.com HURON CONSULTING GROUP INC. AND AFFILIATES. ALL RIGHTS RESERVED.

42 THANK YOU!