ADARUQ Conference October 18, 2006

1. ADARUQ Conference October 18, 2006 Timothy L. Quigg, Associate Chair of Computer Science University of North Carolina at Chapel Hill

2. Overview of Current Research Administration Issues in the United States (Compared with Quebec!)

3. Influences on Development of U.S. Approach to Conducting and Managing Research History of External Support Key Cultural Values Research Management General Trends in Management Increasing Funding Complexity Research System

4. Outline • Money • Staffing (Central-Departmental) • Compliance – Unified Institutional Response • Misconduct in Science • Human Subject Testing • Intellectual Property Management • Technology Transfer • Conflict of Interest (Individual-Institutional)

5. Current State of Research Administration in the United States

6. “In the real world, Research Administrators strive to provide quality support to the research enterprise while following all of the applicable policies and rules. It’s not always as easy as it sounds!” Department Chair Purchasing Office Sponsored Programs Office Funding Agencies Students Dean’s Office

7. Outline • Money • Staffing (Central-Departmental)

12. History & Projections of U.S. Research Funding • Increase in National R&D Funding • Increase in Federal Health Funding • R&D at Colleges Increasing Most of Increase is in Life Science

17. Conclusions - National • Funding increased significantly over last 50 years • Health funding increased • NIH tripling • Flattening in next 5 years

18. Awards in Millionsat UNC-CH

19. Trends of Federally Sponsored Awards at UNC-CH

20. Sponsored awards vs state appropriations at UNC-CH

21. 2006 Funding by School

22. 2006 Funding by Source

23. Research Dollars vs Staffing at UNC-CH

24. Conclusions: UNC-Chapel Hill • From zero to $600M in 45 years • % from federal sources decreasing • Sponsored research exceeds state appropriations • Staff size constant • Need for new paradigms • Central – department cooperation • Delegation of responsibility

25. Outline • Money • Staffing (Central-Departmental) • Compliance – Unified Institutional Response • Misconduct in Science • Human Subject Testing • Intellectual Property Management • Technology Transfer • Conflict of Interest (Individual-Institutional)

26. “The only ethical principle which has made science possible is that the truth shall be told all the time…” C.P. Snow “The Search” 1959 Quoted in “Honor in Science”

27. “The right to search for truth implies also a duty; one must not conceal any part of what one has recognized to be true.” - Albert Einstein

28. Scientific Fraud and Misconduct Frequency Over the Past 10 Years

29. Institutional Compliance is: • A commitment to obey federal and state laws and sponsor policies, and follow internal policies and procedures • An ongoing operational program to prevent, detect, and correct wrongdoing • A system of internal control and procedures to evaluate operational practices, minimize legal and business risk and implement corrective action

30. Expectations of high standards of conduct in science: • Protection of human and animal research subjects • Proper fiscal management of public funds • Proper use and disposal of hazardous materials • Adherence to scientific method to produce valid knowledge

31. Federal Definition - Research Misconduct: Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting research results. Research misconduct does not include honest error or differences of opinion.

32. Fabrication: making up data or results and recording or reporting them • Falsification: manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record • Plagiarism: the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit

33. Whistleblowers • A good faith allegation is made with the honest belief that research misconduct may have occurred. An allegation is not in good faith if it is made with reckless disregard for or willful ignorance of facts that would disprove the allegation

34. Qui Tam provisions of the False Claims Act • Allows private parties to sue entities and individuals that have submitted false claims to the federal government • Can receive a portion of the settlement if the government receives a monetary agreement with the defendant

35. Recent Settlements Revealed via Qui Tam (Whistleblower): • University 1- $5.5 M (Feb, 2003) • University 2 - $2.6 M (Feb, 2004) • University 3- $3.4 M (Apr, 2005) • University 4- $4.4 M (Jun, 2005) Revealed via voluntary disclosure: • University 5- $2.4 M (June 2004) All involved overstatement of effort on NIH grants

36. Human Subject Testing: Tuskegee Syphilis Experiments From 1932 to 1972, the US Public Health Service conducted an experiment in Macon County, Alabama, to determine the natural course of untreated latent syphilis in black males. Treatment was withheld even after the onset of penicillin therapies became commonplace around 1940.

37. Recent Cases • Jesse Gelsinger Case (University of Pennsylvania, Institute for Gene Therapy) – September 1999 • An 18 year old volunteer in a gene therapy clinical trial for Ornithine Transcarbamylase (OTC) Deficiency, died four days after being injected with corrective genetic material. It was determined that the death was research-related. • The university held equity in the company developing the drug, and the lead doctor held one-third of its shares of stock

38. Conflicts of Interest It’s About Public Trust “Is the situation likely to interfere or appear to interfere with the independent judgment one is supposed to show as a professional performing official duties?

39. Conflicts of InterestFinancial Ties between Researchersand Industry • Grants and Contracts • Consultants • Advisory Boards • Speaker’s Bureaus • Patent/Royalty Arrangements • Expensive Gifts/Trips • Equity Interest

40. Conflict of Interest It’s About Public Trust • Longstanding interest in objectivity in research and financial conflict of interest. • Key Question: “Is the situation likely to interfere or appear to interfere with the independent judgment one is supposed to show as a professional performing official duties?”

41. Conflict of Interest • Institutional policy must ensure that investigators have provided all required financial disclosures at the time the proposal is submitted to NSF or NIH. • It must also require that those financial disclosures are updated during the period of the award, either on an annual basis, or as new reportable significant financial interests are obtained.

42. Technology Transfer: Bayh-Dole Act • Enacted December 1980; tech transfer born • Encouraged universities and research institutions to collaborate with industry, to commercialize successes • Institutions may elect to retain IP title • Institutions must file patents if ownership is desired • Government retains nonexclusive licenseplusmarch-in rights • Preference provided to small businesses

43. Research EthicsConclusions • Science is a community of trust. When this trust is violated, it tends to be on the front page of the paper. • You cannot teach ethics, but you can watch for it • Conflicts of interest and commitment are natural. They cannot be eliminated, but they can (and should) be managed.