1. Research Policy: ORD & ORO Working Together Brenda Cuccherini, PhD Office of Research & Development & Tom Puglisi, PhD Office of Research Oversight

2. The Need for Policies Ensures consistent standards Implements statutes and regulations Defines specific required actions Serves as basis for procedures & functions Provides a framework for how an institution functions

3. Who “Owns” the Policy? Office of Research & Development (ORD) –General and specific policy governing: The VA Research Program The conduct and support of VA research Office of Research Oversight (ORO) –Policy specifically related to compliance with VA research policies Privacy, OI&T, etc

4. Receiving Conflicting Advise Contact ORO or ORD Both offices work together to ensure –Interpretation is consistent –Assessing compliance is based on appropriate understanding of policy ORO/ORD will contact other CO offices as needed

5. Policy Interpretation Only the office publishing the policy should interpret it Wording in policies carefully chosen Intent inferred from the: –Purpose on transmittal sheet –Scope paragraph –Background –Policy statement Look for guidance from ORD or ORO

6. The Need for Policies Response to an “event” –Loss of data –Untoward event –Findings during site visits Suggested by –Congressional inquiry –IG, GAO, FDA reports –Administration, staff, experts New statutes & regulations Changing standards of practice

7. The Process Evaluate existing policies and regulations –Determine if there is existing policy –Does currently existing policy need to be changed because of the new policy –Are there any policies or regulations that prohibit the new policy (example: privacy rule policy may conflict with the privacy act of 1974) Identifying the impacts of the policy

8. Process (continued) Outline the scope Brainstorm with experts Develop background information Consult & work closely with other CO offices –ORO, OI&T, Privacy Develop a small working group –Membership depends on reason for policy and content –Variable field involvement depending on who requires the policy development

9. Issues to Decide How proscriptive? Can facilities comply? Is there any impact on other entities? Can compliance be measured? Is there authority to develop it? (Statutory, regulatory) Unfunded mandate?

10. Draft, Draft, & Redraft Original draft incorporates suggestions Review by larger group Redrafted and sent around for comments multiple times Final draft placed into concurrence in CO Reviewed by CO program offices –Concur –Require changes to concur –Non-concur

11. Final Compromise & Publication Final policy may be very different from the first draft All approvals obtained Submit to VHA publications Sent to Under Secretary’s office Signed by USH Published Field notified

12. The Evolution of VHA Handbook 1058.01 What to Report to ORO (Guidance) Reporting Adverse Events in Research to the Office of Research Oversight (1058.1, Nov 19, 2004) What to Report to ORO (Guidance, 2005) Requirements for Reporting Research Events to Facility Oversight Committees and the Office of Research Oversight (1058.01, Feb 27, 2009) Research Compliance Reporting Requirements (currently in concurrence)

13. Evolution of VHA Handbook 1200.01 The role of the R&D Committee –M-1, Part II, Chapters 1-3 –1200.1 March 3, 2007 Administrative Review report Dec. 15, 2008 –ACOS work group –1200.01 April 9, 2009; June 16, 2009 tech. correction New draft will address issues and inconsistencies in current HB

14. Upcoming Policy Issues Redrafted policies New policies Guidance