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2. ASU Prospective Office of Research Integrity and Assurance – provides resources to assist faculty & administrators to facilitate, achieve & maintain ethical principles and comply with federal, state and university regulations governing research. Areas supported include research policy development, human subjects, animal care, conflict of interest, biosafety, research misconduct, export controls, & the responsible conduct of research. 2

3. Objectives for Today Together we will explore options and identify best practices for developing and growing a research compliance program within a culture of compliance in a atmosphere of shared responsibility and partnership. 3

4. Areas Supported – Native Americans – Conflict of Interest – Export Control including screening for visa eligibility and visitors – Animal Care & Use (IACUC) – Biosafety – Human Subjects Protections (IRB) – 2 Committees – – RCR – Publication Waivers (>90 day delays; RSP 406) – Proprietary Research/Security – Misconduct in Science 4

5. Institution-wide Federal Regulations Program needs/regs Award Specific Terms and Conditions Copyright 2002 Atlantic Information Services Inc. The Compliance Pyramid

6. Definitions 6

7. Compliance Black’s Law Dictionary » Submission » Obedience » Conformance 7

8. Compliance Webster’s Dictionary – The act or process of complying to a desire, demand, or proposal or to coercion – Conformity in fulfilling official requirements; – The ability of an object to yield elastically when a force is applied: FLEXIBILITY

9. Culture - set of values, conventions or social practices associated with a particular field, activity, or societal characteristic - shared attitudes, values, goals, and practices that characterizes an institution or organization 9

10. Partnership - a legal relation existing between two or more persons contractually associated as joint principals in a business - the persons joined together in a partnership 10

11. Responsibility for Institutional Culture Begins at the Top 11

12. Who are the Players? - Institutional Officials (VP, Deans, Chairs) - Principal Investigators - Research Integrity Office - Sponsored Programs Central Administration - Departmental Administrators 12

13. Who are the Players? Don’t forget the external players - State Regulators - Sponsor Representatives - Enforcement Partners (OBA, OHRP, FDA, FBI, Local Law Enforcement) 13

14. Shared Responsibility Researcher InstitutionRegulators Culture of Compliance The three legged stool approach – each leg is required for success 14

15. What are the Federally Imposed Requirements & Programs – Animal Use & Care Programs – Human Subjects Protection Programs – Conflict of Interest -- institutional and individual – Scientific Misconduct – Whistleblower policies & procedures – Environmental Health and Safety Programs (Biosafety, Select Agents, Occupational Health) – Export Controls

16. Program Areas to Remember – Agency Regulations – Federal Demonstration Partnership – University Policies & Guidelines – National concerns and impact of research since 9/11 (Select Agents, Foreign Nationals, Publication restrictions, Sensitive but not classified export controls.

17. Designing Collaborative Programs that Work

18. One Size May Not Fit All Considerations for local environments Immerging versus Enterprise Research Programs Centralized Compliance Models Decentralized Compliance Models Find a program that meets your structure and culture 18

19. Building Shared Resources Biggest Headaches for Research Administrators How to collaboratively solve challenges 19

20. Planning for Success Involve all necessary members of the University community in the decision making – Ensure that faculty and principal investigators are involved in every phase of the reviews, the development of the new policies and procedures, and the practices – Make sure that upper management is on board with each step and is supportive – Involve the department staff and the grants administrators – By-in by all parties makes compliance programs work

21. Thinking Ahead Time to do a policy review – Are policies & procedures adequate for today’s climate? – Are policies well known by those who need to know them through the institution? – Are they followed? – How are they communicated ?

22. Develop Outreach Programs to Education & Train --everyone from faculty to secretary -- and don’t forget the senior administration!! – Web-based training – Formal in-class workshops – Brochures and “Topics of Interest” – Video taped programs to loan out – Conferences Sharing What you Learn

23. Is it Working Monitor --develop an appropriate way to tell. Plan to continue this for as long as the program lasts Require formal reviews from outside & inside the institution. Consider an advisory review system

24. Age of Enforcement Consider the Risk of Non-Compliance - You Name it 24

25. Age of Enforcement Consider the Risk of Non-Compliance Negative Publicity (It’s your name – your reputation Loss of Reputation Civil and Criminal Penalties Harm to participants Suspension or Debarment 25

26. Age of Enforcement USDA inspection models fCOI revisions from PHS – anticipated (Congressional Interest RCR – NSF plans to implement site reviews OBA Site Visits OHRP and FDA IRB reviews (cause and not for cause) Presidential Commission on International Human Subjects rights 26

27. Enforcement is Essential Develop appropriate sanctions Make sure they are well known and well documented Apply the sanctions consistently and consciously Make sure senior management will support the enforcement activities Be reasonable and just

28. 28 “BE FLEXIBLE AND DEVELOP A PRINCIPLED BASED PROGRAM NOT A RULE BASED ONE”

29. Credits My appreciation to colleagues a the National Council of University Research Administrators, the Federal Demonstration Project, the National Institutes of Health, and the National Science Foundation for the wonderful web based and shared resources they have made available. Much of this presentation is from them… 29

30. Questions? Contacts: Debra Murphy, Director, ASU debra.murphy@asu.edudebra.murphy@asu.edu; 965-2179 30

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