Advanced Notice of Proposed Rule Making ITHS Town Hall 8/26/2011

1. Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators Advanced Notice of Proposed Rule Making ITHS Town Hall 8/26/2011

2. Agenda • Brief overview of the ANRPM • Process for modification to the Common Rule • Proposal • Details of proposals affecting the consent for and use of biospecimens • Intent and implications of proposed changes • Discussion

3. Process

4. Why • 45CFR46 Subpart A – the “Common Rule” was adopted 20 years ago • Recognition that research has changed significantly since that time • Increase in volume • More multicenter trials • New informational risks due to use of genetic information • Concern that current process requires a lot of time and resources without the attendant protection of subjects for which the rules were intended

5. Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators • Proposing agencies: Office of the Secretary, HHS and the FDA • http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html • Each proposed change is presented followed by a set of questions • There are 74 questions to direct the feedback being requested.

6. Structure of the ANPRM • Section I • Background –why and why now • Sections II –VIII • Details of the proposed changes • Section IX • Request for information and comment • How to submit comments

7. Summary of Proposed changes 1. Refinement of the existing risk-based regulatory framework (Section II); 2. Utilization of a single IRB review of record for domestic sites of multi-site studies(Section III); 3. Improvement of consent forms and the consent process (Section IV); 4. Establishment of mandatory data security and information protection standardsfor all studies that involve identifiable or potentially identifiable data (Section V); 5. Establishment of an improved, more systematic approach for the collection and analysis of data on unanticipated problems and adverse events (Section VI); 6. Extension of Federal regulatory protections toall research, regardless of funding source, conducted at institutions in the U.S. that receive some Federal funding from a Common Rule agency for research with human subjects (Section VII); and 7. Improvement in the harmonization of regulations and related agency guidance (Section VIII).

8. Section II – ensuring risk-based protections • Set mandatory standards for data security and information protection based on HIPAA – IRBs would not then be responsible for assessing adequacy of protection of informational risks • Default to expedited continuing review even if original application required full board review when remaining activities are minimal risk • Updating list of what qualifies for expedited initial review and eliminating continuing review for these studies.

9. Section II • Converting “exempt” category to “excused” category • Would be subject to the new data security and information protection standards • Expand category • Clarify the definition of “existing” to mean collected for purposes other than the research and not that the data and specimens have to exist when the study starts • Written consent would be required for use of existing biospecimens

10. Section II • New excused category • Written consent would be required for use of pre-existing data if collected for research purposes • if collected for non-research purposes, consent only if identifiable • Require registration of excused research, not review of application • Add a tracking and audit requirement of excused research

11. Section III – streamlining IRB review of multi-site research • Mandating that all multi-site domestic trials rely on a single-site IRB • Would not apply to international research • Would not apply to FDA regulated device trials

12. Section IV – improving informed consent • Changes to the consent forms • Specifying required content • Restricting inappropriate content • Limiting length • Reducing institutional “boilerplate” language • Providing standardized consent form templates

13. Section IV • Changes to informed consent process • Clarification of the waiver criteria • Allowing more oral consent • Requiring consent for use of pre-existing biospecimens regardless of identifiability

14. Section V – strengthening data protections • Aligning Common Rule and HIPAA standards for de-identified data • Classifying all biospecimens as identifiable and requiring consent for use • Enhancing data security standards • Data can still be considered de-identified if investigators see the identifiers but don’t record them • Require periodic random audits for enforcement

15. Section VI – data collection to enhance oversight • Standardize data elements for reporting • Implementing a web-based Federal-wide portal for safety reporting • Harmonize safety reporting guidance across all federal agencies

16. Section VII – extension of Federal Regulations • Extend common rule protections to all research conducted at institutions that receive any federal funding for research and VIII – clarifying and harmonizing agency guidance • Reconciling the advantage of consistency across Federal departments and agencies providing guidance with need for flexibility and timeliness of issuance of guidance.

17. Summary of proposed changes Emanuel and Menikoff: 10.1056/NEJMsb1106942 published July 25, 2011 at NEJM.org - taken from PRIM&R webinar – Pearl O’Rourke

18. Ways to comment • www.regulations.gov - HHS-OPHS-2011-0005 • Mail/Courier to: Jerry Menikoff, M.D., J.D., OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852 • UW HSD discussion board - https://catalyst.uw.edu/gopost/board/sherrye/22982/ • E-mail Karen Moe by 9/10 at kemoe@uw.edu • Send comments to the ITHS discussion board https://catalyst.uw.edu/gopost/board/lalithas/23060/

19. Future ITHS Town Hall Discussions • September 2 – Seattle Children’s Hospital – Wright Auditorium 9-10:30am • changes to minimal risk and exempt research (excused); proposed changes to informed consent • Moderator - Doug Diekema, MD, MPH, Prof. Pediatric Bioethics, Chair, Children's IRB • September 9 – FHCRC, Thomas Building D1-084 • data security requirements and information protection standards; central IRB review for multi-site studies • Moderator - TBD