1. Office for Human Research Protections 1 Updating the Common Rule Governing Human Subjects Research Protections Jerry Menikoff

2. Office for Human Research Protections 22 Disclaimer The views expressed in this presentation and those of the presenter and do not necessarily represent the views of the Department of Health and Human Services or any subdivision thereof.

3. Office for Human Research Protections 333 I. Background Twenty years have passed since the Common Rule was adopted Nature of research activities has changed dramatically. Multi-site studies; genomics; internet and information technology Time to update the Common Rule: goal of improving protections for subjects, while making the rules function more effectively Thus, an Advance Notice of Proposed Rulemaking

4. Office for Human Research Protections 444 I. Background Current rules on secondary use of data: If stripped of identifiers, no human subject, thus not subject to these rules. Can even keep one-way link to original data source, and collect new information Genomic data is not per se identifiable No consent needed under those scenarios Even if a study uses human subjects, it can still be found exempt from needing to follow these rules.

5. Office for Human Research Protections II. Ensuring Risk-Based Protections 5

6. Office for Human Research Protections 6666 II. Ensuring Risk-Based Protections Goal is to better target time and effort spent on reviewing a study to the risk of the study.

7. Office for Human Research Protections 777 II. Ensuring Risk-Based Protections Current framework has tiers of review: Review by a convened IRB Studies with greater than minimal risk Expedited review –commonly single IRB reviewer Exempt --six categories exempted from IRB review altogether

8. Office for Human Research Protections 88888 II. Ensuring Risk-Based Protections Currently, no specific standards for protecting privacy and confidentiality IRBs currently must, where appropriate, determine that there are adequate protections New standards for data security and information protection that would apply to appropriate studies IRB would no longer be responsible for reviewing this aspect of protocols

9. Office for Human Research Protections 99999 II. Ensuring Risk-Based Protections Convened IRB Review Only change: continuing review not required if only analyzing data or collecting new data from standard clinical follow-up

10. Office for Human Research Protections 10 II. Ensuring Risk-Based Protections Eligibility for Expedited Review: Regular updates to list of research activities that qualify for expedited review Presumption that a study which includes only activities on the list is a minimal risk study and should receive expedited review (reviewer option to send to convened IRB) Considering whether a study eligible for expedited review should be required to meet all of the current criteria for IRB approval

11. Office for Human Research Protections 11 II. Ensuring Risk-Based Protections Eliminating Continuing Review of Expedited Studies Default -- no continuing review for studies that qualify for expedited review Reviewer could make a specific determination (with justification) that continuing review is appropriate for a study

12. Office for Human Research Protections 12 II. Ensuring Risk-Based Protections Streamlining Documentation Requirements for Expedited Studies Templates for protocols and consent forms

13. Office for Human Research Protections 13 II. Ensuring Risk-Based Protections Revising and expanding current exempt category: No longer fully exemptadhere to data security rules, some consent rules Requiring brief registration form to be filed with institution Research could generally begin immediately after filing Eliminate current routine review of almost all exempt studies; audit some to verify qualification

14. Office for Human Research Protections 14 II. Ensuring Risk-Based Protections Expansions of exempt categories: Surveys conducted with competent adults would qualify, even if risky identifiable data Perhaps a new category for social and behavioral research involving specified types of benign interventions that are known to involve virtually no risk to subjects Secondary research with existing biospecimens and data would qualify, even if identifiers retained; consent rules

15. Office for Human Research Protections III. Streamlining IRB Review of Multi-site Studies 15

16. Office for Human Research Protections 16 III. Streamlining IRB Review of Multi-site Studies Mandating that all domestic sites in a multi- site study rely upon a single IRB as their IRB of record for that study.

17. Office for Human Research Protections IV. Improving Informed Consent 17

18. Office for Human Research Protections 18 IV. Improving Informed Consent Goal is to produce consent forms that do a much better job in informing prospective subjects by: Prescribing how information should be presented in consent forms Providing more specifics about content that should be in the forms, and about what should not be in them (vs. in appendix) Reducing institutional boilerplate

19. Office for Human Research Protections 19 IV. Improving Informed Consent Written consent for biospecimens collected after effective date Open-ended standard consent form for giving consent to broad future use

20. Office for Human Research Protections V. Strengthening Data Protections To Minimize Information Risks 20

21. Office for Human Research Protections 21 V. Strengthening Data Protections To Minimize Information Risks As mentioned earlier: new data security protections that would apply to research involving identifiable information

22. Office for Human Research Protections 22 V. Strengthening Data Protections to Minimize Information Risks Common Rule definition of when data is identifiable would be harmonized with definition in HIPAA Privacy Rule

23. Office for Human Research Protections VI. Data Collection To Enhance System Oversight 23

24. Office for Human Research Protections 24 VI. Data Collection To Enhance System Oversight Create a web-based portal for investigators to submit safety data and automatically have it delivered to appropriate agencies Harmonize safety reporting guidance across all Federal agencies Central repository

25. Office for Human Research Protections VII. Extension of Federal Regulations 25

26. Office for Human Research Protections 26 VII. Extension of Federal Regulations Require domestic institutions that receive some Federal funding from a Common Rule agency for research with human subjects to extend the Common Rule protections to all research studies conducted at their institution.

27. Office for Human Research Protections VIII. Clarifying and Harmonizing Regulatory Requirements and Agency Guidance 27

28. Office for Human Research Protections 28 VIII. Clarifying and Harmonizing Regulatory Requirements and Agency Guidance Request for Comments How do differences in guidance from different agencies either strengthen or weaken protections for human subjects or the ability to conduct research? Should these differences be reduced?

29. Office for Human Research Protections How to find the Advance Notice of Proposed Rulemaking: www.hhs.gov/ohrp Click the big blue button! Check out the 1,100 comments! www.hhs.gov/ohrp 29