Human Subject Research Protections: The Revised Common Rule

1. Human Subject Research Protections: The Revised Common Rule Office for Human Research Studies Emily Eldh, CIP January 2019

2. The (Forever Changing) Regulatory Landscape • Introductions • How did we get here? • Health and Human Services (HHS) Final Common Rule • 21st Century Cures Act • What’s next? • Questions

3. Introductions – OHRS Senior Staff • Emily Eldh, CIP – emily_eldh@dfci.harvard.edu Director • Liz Bowie, JD, MPH, MSc – elizabeth_bowie@dfci.Harvard.edu Associate Director • Daniel Kronish, MD – danielp_kronish@dfci.harvard.edu Associate Director of Medical Review • Casey Rich, CIP – casey_rich@dfci.harvard.edu Research Review Manager: Activation, Meeting Management, Policy Documentation • Elizabeth Mutti – elizabeth_mutti@dfci.harvard.edu Operations Manager: Intake, Online Communications, and OHRS Systems • Polly Goodman, CIP – polly_goodman@dfci.harvard.edu Senior Human Research Coordinator • Nicole Burbul – nicole_burbul@dfci.harvard.edu Senior Human Research Coordinator • Sean Murphy, CIP – sean_murphy@dfci.harvard.edu Senior Human Research Coordinator

4. OHRS Organization Chart – January 2019

5. How Did We Get Here?

6. How did we get here? Health and Human Services (HHS) Common Rule & Food and Drug Administration (FDA) regulations governing Human Subjects Research detail: • What an Institutional Review Board (IRB) is charged with reviewing; • How an IRB should be organized; and • The Criteria for Approval of IRB reviewed research. Note: HHS & FDA regulations are currently aligned (pre-1/21/2019). Health Insurance Portability & Accountability Act (HIPAA) • The DFCI IRB also serves as the Privacy Board and determines whether waivers or alterations to the HIPAA Privacy Rule are appropriate in the context of human subjects research.

7. How did we get here?

8. How did we get here?

9. How did we get here?

10. What didn’t happen? Revised Final Rule - Notable Deviations from the NPRM: • Regulations do not cover clinical trials that are not federally funded. • Biospecimens – What did not Happen? • No Broad Consent Requirement(Optional “Regulatory Broad Consent” added). • The definition of “human subject” was not expanded to include deidentified biospecimens or the requirements to obtain informed consent from the originating human source for the retention and future use of such specimens. • Eliminated proposed standardized privacy safeguards for identifiable private information and identifiable biospecimens. • The restrictive proposed criteria for obtaining a waiver of consent requirements relating to research with identifiable biospecimens were not adopted. • Informed Consent Presentation Requirements more flexible than originally proposed. • Exempt / NHSR Determinations will NOT be made by investigators - No Decision Tool

11. Final Revised Common Rule What is changing? • Definitions (Scope) • IRB Operations • Informed Consent Content • New Guidelines for Exemptions • Other Major Changes for Investigators are noted with an asterisk.

12. Final Revised Common Rule: Definitions

13. Final Revised Common Rule: IRB Operations

14. Final Revised Common Rule: IRB Operations

15. Final Revised Common Rule: Informed Consent

16. Final Revised Common Rule: Informed Consent

17. Final Revised Common Rule: Informed Consent

18. Final Revised Common Rule: Informed Consent

19. Final Revised Common Rule: Exemptions

20. Final Revised Common Rule: Other Considerations

21. Other Requirements: 21st Century Cures Act Aims to minimize administrative burden on researchers Highlights include: • HHS Secretary to Harmonize FDA regulations and the revised Common Rule (Note: They will not be aligned when the Final Rule is implemented) • Requires Drug Manufacturers to publicly post their expanded access policies and provide points of contacts for requests. • Removes Local IRB oversight requirement for device (IDE) studies • Requires NIH to ensure that centers and institutes collaborate on projects collecting similar data • Requests Guidance from HHS on HIPAA Privacy Rule and future uses of specimens and data • Consent alteration or waivers for minimal risk FDA-governed research

22. What’s needed to prepare and implement?

23. What’s next? Keeping Track

24. What’s needed to prepare and implement? 1. Update and Require use of Revised Consent Form Template (done) http://www.dfhcc.harvard.edu/research/clinical-research-support/office-for-human-research-studies/2019-common-rule/ 2. Revise and Finalize DFCI IRB Policies and Procedures and Guidance Documents (ongoing) 3. Update Systems and IRB Documentation including Forms to accommodate Rule Change (ongoing) 4. Train Research Community (ongoing): • Revised Consent Form Training: November 9th and 28th 2018 • IRB Member Consent Form Training: December 10th – December 20th 2018 • OHRS Staff Rule Change Training: December 19th 2018 • IRB Chair Rule Change Training: December 20th 2018 • Rule Change Training: January 4h and 10th 2019

25. What’s still needed to prepare and implement? • Guidance from OHRP • Read the text of the revised Common RuleRead about the revised Common RuleRevised Common Rule Q&As • Activities Deemed Not to be Research: Public Health Surveillance, 2018 Requirements • Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements • When Continuing Review Is Not Required During the 6-Month Delay Period • Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements • Guidance from SACHRP • https://www.hhs.gov/ohrp/sachrp-committee/recommendations/sachrp-recommendations/index.html • Guidance from FDA • Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations (10/2018) https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM623211.pdf • Guidance from NIH • NIH Implementation of the Burden-Reducing Provisions of the 2018 Common Rule: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-211.html • NIH Implementation of the Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule): https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-050.html

26. Additional Recommended Training on the Revised Common Rule: The CITI program has a new optional training module on the Common Rule changes.  Please keep in mind CITI will not describe specific plans for implementing this new rule at DF/HCC.  Additional information on implementation plans will be communicated separately. CITI program:  http://www.dfhcc.harvard.edu/research/clinical-research-support/office-of-data-quality/services-support/education-citi/

27. More Info to Come! 2019 Common Rule Webpage: OHRS has created a new page on the OHRS website where updates concerning the revised common rule will be placed.

28. Thank you! OHRS Common Rule Website: http://www.dfhcc.harvard.edu/research/clinical-research-support/office-for-human-research-studies/2019-common-rule/ Office for Human Research Studies (OHRS) Dana-Farber Cancer Institute 450 Brookline Avenue, OS229Boston, MA 02215Phone: 617 632-3029Fax: 617 632-2686http://www.dfhcc.harvard.edu/research/clinical-research-support/