Navigating the Conflict of Interest Process

1. Navigating the Conflict of Interest Process Jo Ellen Sherow Ohio University Office of Research Compliance

2. In the News • Researchers’ Financial Disclosures in the Spotlight • Conflicts of interest, always an emotional topic, returned to the headlines this week as Sen. Charles Grassley, a longtime critic of the drug industry’s potential influence on research, released new evidence that prominent Harvard University scientists had failed to disclose much of their outside income from pharmaceutical companies over the past eight years. • http://www.insidehighered.com/news/2008/06/12/conflict January 15, 2008

3. Conflict of Interest Not Disclosed Initially in Smokeless Tobacco and Cancer Review; Correction Issued, But Issue is Still Largely Misunderstood • Wednesday, January 21, 2009 • In a review of the literature regarding the relationship between smokeless tobacco use and cancer, a conflict of interest of one of the article's authors was initially not disclosed (see: Boffetta P, Hecht S, Gray N, Gupta P, Straif K. Smokeless tobacco and cancer. Lancet Oncology 2008; 9:667-675). The original article was published in July, 2008. That article stated: "The authors declare no conflicts of interest." After the editor of the journal was notified by a researcher with knowledge of a potential conflict of interest of Dr. Stephen Hecht (one of the study authors), an erratum was published in September 2008, which noted: "During the immediate months preceding submission of the review SH was acting in the capacity of an expert witness for the plaintiff in a future court case against a smokeless tobacco company. SH declares his participation in this case in no way influenced his writing or involvement in the review." • http://tobaccoanalysis.blogspot.com/2009/01/conflict-of-interest-not.html

4. FDA Not Effectively Monitoring Investigator Conflicts of Interest, HHS Watchdog Says • January 16, 2009 — More than one third of new drug marketing applications approved by the US Food and Drug Administration (FDA) were missing information about potential conflicts of interest for clinical trial investigators, which could allow bias to creep into the approvals process, a government report released this week has found. The FDA has said that it agrees with most of the report's findings. • http://www.medscape.com/viewarticle/586980

5. ''Industrial/Academic Collaborations: Are These Examples of a Conflict of Interest?'' • Do collaborations between biotech companies and academic centers constitute a conflict of interest? • Biotechnology industry partnerships with universities and academic centers have been fruitful for both. So why is there so much concern about conflict of interest and is that concern appropriate? • http://www.redorbit.com/news/health/750100/genetic_engineering_news_posts_podcast_on_industrialacademic_collaborations_are_these/index.html

6. Introduction • Universities are responsible for use of public funds and therefore must maintain the public trust. • Identifying and mitigating situations that may have the potential for conflict maintains the integrity of the university. • Maintaining integrity allows the university to do credible academic research.

7. Objectives Today • To provide information on the purpose of the conflict of interest requirements. • To provide a basic overview of conflicts of interest • To introduce the disclosure process and the use of management plans • To provide information on the need for updates and annual renewals.

8. What is a Conflict of Interest? • Situations where financial considerations compromise your professional judgment. “Actual Conflict of Interest” • Not permitted • Situations where an independent observer might reasonably question whether your professional actions or decisions are determined by considerations of personal gain. “Perceived Conflict of Interest” • Managed

9. Types of Conflicts • Potential conflicts may be financial or may be a conflict of time, effort and/or commitment. • Potential conflicts can occur as a result of administrative, scientific, academic, fiduciary or familial situations. • They are situations that can be PERCEIVED to be conflicting, whether a “real” conflict exists or not.

10. Required Thresholds • Ohio University Policy has a mandatory disclosure policy if you: • Earn over $10,000 in a twelve month period from your outside activity OR • Have over 5% equity in the entity

11. Significant Financial Interest • Applies to members of your immediate family (spouse, domestic partner, dependent children) as well as yourself. • Anything of monetary value, including but not limited to: • Salary • Payments for services • Equity interests over 5% • Intellectual property rights • Excludes mutual, pension and other investments over which you have no control

12. Conflicts of Commitment: Faculty • Outside work during regular academic year should not exceed equivalent of 1 day per week. • Consulting work must avoid activities that involve a conflict of interest with assigned Ohio University activities and programs Faculty Handbook, section IV-D

13. Conflicts of Commitment: Faculty • Outside interests cannot interfere with primary loyalty to Ohio University and your academic role • Use of university resources must have prior approval of Chair, Dean and VPR. • Your outside interests should not be in direct competition with university interests

14. Conflicts of Commitment: Administrative Employees • Full time administrative employees are expected to devote their full-time professional loyalty, time and energy to their position. • You must use non-work hours and no university resources

15. Who Requires Disclosure? • Federal Agencies • State Law • University Policies • Many Academic Publications

16. Public Health Service Requirements 45 CFR Part 50, Subpart F “Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought” Authority: 42 U.S.C. 216, 289b-1, 299c-3. Intent is to assure objectivity by establishing standards that preclude bias in design, conduct, or reporting of research

17. 45 CFR Part 50, Subpart F • Focuses on financial conflicts of interest (FCOI) • Regulations apply to investigators, including sub grantees, contractors, and collaborating investigators. • Does not apply to applications for support under Phase I of SBIR and STTR programs

18. NSF Grant Policy ManualChapter V – Grantee Standards • An institutional conflict of interest policy should require that each investigator disclose to a responsible representative of the institution all significant financial interests of the investigator (including those of the investigator’s spouse and dependent children) (i) that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by NSF; or (ii) in entities whose financial interests would reasonably appear to be affected by such activities.

19. Title 21 Food and Drugs Chapter 1 (Subchapter A) (Part 54) Financial Disclosure by Clinical Investigators • The Food and Drug Administration (FDA) regulations state that investigators that receive compensation in excess of $25,000 from a corporate sponsor of a trial in which the investigator is engaged must disclose to the FDA at the time of filing for a new drug application.

20. Ohio University Conflict Policies • 19.058, Conflict of Interest in Research, Educational, and Public Service Activities • 19.059, Employee Participation in Authorized Private Companies Commercializing Ohio University Research

21. Ohio University Policy and Procedure 19.058 “Conflict of Interest in Research, Educational, and Public Service Activities” • Most conflict disclosures fall within the parameters of this policy • States that faculty are primarily responsible for their academic, research and service obligations

22. Ohio University Policy and Procedure 19.059 “Employee Participation in Authorized Private Companies Commercializing Ohio University Research” • Applies to “employees, faculty, staff and students, who create intellectual property owned by the Ohio University and who desire to hold an equity interest in a firm, corporation, or other association to which Ohio University has assigned, licensed or transferred Ohio University’s interests…”

23. Potential Areas of Conflict • Consulting • Licensing University Technology • Clinical Studies • Procurement • Mentoring • Institutional

24. Disclosures are Unique • A disclosure is filed specific to the funding application. • If you have a potential conflict for one proposal, it does not automatically apply to all of your proposals.

25. How should you disclose? • Research conflicts of interest are usually disclosed using LEO as you apply for funding by completing the conflict of interest section of the electronic transmittal • If you are not using LEO, you can download the appropriate disclosure form from www.ohio.edu/research/compliance

26. The Electronic Disclosure Process on LEO • “A” is selected if you have no conflicts to disclose • “B” is selected if you have a potential conflict to disclose relative to the submission. (Requires a subsequent paper process) • “C” is selected if you have a current disclosure on file, but it is not relevant to the proposal you are submitting

27. Disclosure Paper Process • Still uses option A, B or C • Requires that you gather signatures on paper for all options, however • Generally used for personnel not listed on the grant proposal or “key personnel”

28. COI Forms are Revised • We have revised the COI forms to word forms • This should be easier to complete than the previous form • PDF versions are also available • Should be on the compliance web site soon, but we can e-mail them to you until then

29. Disclosure Form A – No Potential Conflicts of Interest • Use this form only if you are unable to use the LEO transmittal form to assure that no conflict of interest exists. A form must be completed for each proposal. • I assure that I have read Ohio University Policy 19.058, “Conflict of Interest in Research, Educational, and Public Service Activities” and declare that I have nothing that is, or could be perceived to be a conflict of interest with this proposal.

30. Ohio University Potential Conflict of Interest Disclosure Form B • Use this form to disclose a potential conflict of interest situation. • A separate disclosure form must be used for each entity with which you conduct business • Conflict includes any member of your immediate family (spouse, domestic partner or children)

31. “B” Disclosures • Require that you complete an option “B” disclosure statement in addition to completing the LEO transmittal form. • Require you to obtain signatures from Center or Institute (if applicable), Chair and Dean on the additional disclosure statement!! • The B disclosure form is available at www.ohio.edu/research/compliance

32. Disclosure Form C – Disclosed Conflict not Relevant to this Proposal • Use this form only if you are unable to use the LEO transmittal form. Complete this form if you have a current conflict of interest disclosure on file with the Office of Research Compliance, but that disclosure is not applicable to this proposal. • *New Option for 2008*

33. Management Plans • A management plan is developed for some disclosures to mitigate the potential conflict • Management plans are specific to each disclosure • May require submission of additional pieces, such as a student employment plan

34. Management Plan Strategies • Reduce or remove the financial interest creating the conflict • Place safeguards that mitigate the conflict potential, such having some decisions made by an independent entity • Limit participation in portions of the proposed research likely to create a conflict • Require that the researcher disclose his or her conflicting financial interests to all collaborators and any proposed trainees; • Disclose the conflict in publications • Work to remove students from being directly advised or taught by faculty where a conflict exists • Assure publication rights for student participants

35. What Types of Elements are Included in a Management Plan? • Student Use • Nepotism and Cronyism • Intellectual Property • Use of University Resources • Publication provisions • Use of Human Subjects • Oversight Requirements • Reporting and Annual Reviews

36. Annual Renewal Required • You must submit an annual renewal for your disclosure • If the potential conflict no longer exists you must notify us • If significant changes occur during the year you should submit an update to your disclosure as they occur

37. Can you disclose potential conflicts that are under the threshold? • Yes. We encourage employees to disclose potential conflicts that do not meet the financial threshold, but may still be problematic, such as student employment. • This allows you to be transparent with respect to outside interests.

38. Conflict Disclosure Categories • Allowable situations • Situations that require disclosure but may not need an extensive management plan • Situations that require disclosure and have problematic elements that will require mitigation and/or a management plan • Situations that are not permitted

39. Allowable Situations • Receipt of royalties or honoraria for published scholarly works, seminars, teaching, etc. • Honoraria for serving as a special reviewer or work on review panels • Royalties under our intellectual property policies if no other relationship with entity • Clinical income at OUCOM

40. Situations not requiring extensive management elements • You participate in research developed in whole or part by you, and you or your family receive royalties from an existing agreement with the business, but have no other significant financial interest • You assign students, etc. to research projects where you are entitled to receive royalties, but have no other significant financial interest

41. Situations requiring management • You assign students, etc. to projects supported by the business through an SRA, and have a significant financial interest other than royalty income • You receive research support from a business in which you serve on the board of directors, or other advisory board, even if you are not compensated. • You hold an executive position in a business engaged in commercial or research activities directly related to your Ohio University responsibilities.

42. Not Permitted • Any situation in which an actual conflict exists is not permitted. • The only “exceptions” are those handled under Ohio University Policy and Procedure 19.059 where faculty entrepreneurship is addressed.

43. Situations that are rarely, if ever, permitted • Participation in clinical trials or evaluation of other research in which you have a significant financial interest other than royalty income. • In the context of your position at Ohio University, you make professional referrals to a business in which you have a significant financial interest.

44. Possible Non-Compliance Sanctions • Letter of admonition • Ineligibility to submit grant applications • Withholding of IRB or IACUC approvals • Suspension • Non-Renewal • Loss of Tenure

45. Potential Conflict Situations • Consulting • Procurement • Mentoring • Clinical Studies

46. Consulting Tips • Avoid consulting relationships that have the potential to divert time and effort from your responsibilities to Ohio University. • Do not use students. • Be wary of situations that limit publication. • Do not use university stationary, etc. that could create an impression the university is involved with the activities.

47. Tips when Licensing University Technology is Involved • Make sure you are devoting sufficient time to your university obligations. • Be cautious that the potential financial gain cannot be perceived to influence your university mentoring relationships.

48. Tips Regarding Procurement • Disclose any personal or familial financial interest or equity in a company that is doing business with Ohio University. • If you make purchases using public funds, you should not use companies which will benefit you or your family. If there is no alternative you must seek and receive permission prior to purchasing.

49. Tips Regarding Mentoring • Any relationship in which there is a real or perceived power or influence imbalance has the potential for conflict. (Faculty:Student) • Isolating these relationships with respect to areas of personal financial gain is best. • If they cannot be isolated, then safeguards must be created.

50. Tips Regarding Clinical Studies • If you have a financial interest, it is best to isolate yourself from the study. • At a minimum, expect a more intense review and a robust management plan if you have a financial interest. • If both the institution and you have financial interests the clinical study should be conducted elsewhere.