1. Emerging SACHRP Issues K. Lynn Cates, MD Assistant Chief Research & Development Officer Director, PRIDE Office of Research & Development Department of Veterans Affairs October 17, 2005

2. SACHRP Secretary’s Advisory Committee on Human Research Protection, HHS* Purpose To provide expert advice & recommendations to the Secretary of HHS & the Assistant Secretary for Health on issues and topics pertaining to or associated with the protection of human research subjects. *Authority: 42 U.S.C. 217a, section 222, PHS Act

3. Emerging SACHRP Issues Federal Adverse Events Taskforce (FAET) IRB Workshop

4. Federal Adverse Event Taskforce Charge Propose specific means for promoting harmonized and streamlined federal requirements for reporting, analyzing, and communicating adverse events in clinical research.

5. Federal Adverse Event Taskforce Member Agencies AHRQ CDC DoD FDA OHRP NIH VA

6. Federal Adverse Events Taskforce Objectives 1.Common terms & definitions 2.Common AE report forms 3.Common workflow patterns 4.Communications

7. 1. Common Terms & Definitions Reduce variability in language e.g., “unanticipated problem” vs. “adverse event” or “unanticipated” vs. “unexpected” Align federal agencies’ policies & guidance

8. 2. Common AE Report Forms Basal Adverse Event Report (BAER) Develop a baseline set of core information adopted by all agencies Address individual agency needs by adding extra fields

9. 3. Common Workflow Patterns Develop a best practices blue print for reporting, analyzing, and applying AE data

10. AE Reporting in Multi-Center Clinical Trials: Trans-Federal Guidance Clarify regulatory requirements for reporting and reviewing adverse events from multi-center trials Outline criteria for when AE reports should be forwarded to other sites Work with industry and academia

11. 4. Communication Effective communication Enhance subjects’ safety Further scientific knowledge Earn public trust

12. FAET Focus Groups Examine current practices at the local level What safety information does an IRB receive and when? How is the safety information analyzed? How and to whom is it communicated? Identify Problem Areas Does government contribute? Define what needs to be done

13. VA Local Management of Adverse Events: Mission Ensure that local management of unanticipated problems in research, including adverse events, assures maximal protection for VA research participants, and complies fully with all laws, regulations, and standards.

14. VA Local Management of Adverse Events: Charge Identifying/Reporting What should be reported? When should it be reported? Where should it be reported? Monitoring Who monitors? What is monitored? What trends/patterns require further action?

15. VA Local Management of Adverse Events: Charge Research v. Patient Safety Corrective Action Who takes action? What are appropriate actions? When does it become research misconduct?

16. Alternatives to Current IRBs IRB Workshop VA Central IRB “What is Research?” Panel

17. IRB Workshop Steering Group OHRP NIH AAMC ASCO VA November 17-18, 2005, Washington, DC

18. IRB Workshop Invitational, exploratory meeting Diverse perspectives IRBs Academic and community-based investigators Attorneys Patients Ethicists Industry officials Senior university and medical school research administrators

19. IRB Workshop Topics Institutional responsibilities Ways to reduce burdens (especially for multi-site trials) Costs and other barriers The federal policy framework relevant to new IRB arrangements

20. IRB Workshop: Follow-on Activities Report for SACHRP on The suitability of alternative models of IRB review for different research contexts Strategies to address barriers Public meeting

21. VA Central IRB Review multi-site VA studies Assure quality by ensuring appropriate representation (scientific, ethical, “community”) Enhance efficiency

22. VA Central IRB: Timeline Fall 2005 Implementation strategies Policies & procedures Begin recruitment process for IRB Administrator Site visits to NCI CIRB, Western & Chesapeake Winter 2005-6 IRB Chair and field input Summer & Fall 2006 Training – local accountability

23. Alternatives to Current IRB System “What is Research?” Panel Responsibilities Review multi-site projects to determine whether or not they are “research” Develop guidance for the field on “What is Research?” (vs. Quality) High level representatives from ORD, ORO, Ethics, Patient Services, Quality