Research Policy: ORD & ORO Working Together

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