Conflicts of Interest in Research

1. Conflicts of Interest in Research School of Pharmacy October 13, 2009 Joe Giffels Research Integrity Office jgiff001@umaryland.edu www.umaryland.edu/research_integrity

2. Some Things to Think About • Which aspects of a given situation constitute CoI? Which are directly financial and which are not? • How can CoI affect the conduct of research? Of the scientific record? • What are the ramifications of CoI for scientists as researchers? As consumers of scientific information?

3. Some More Things to Think About • What can scientists do to avoid the ramifications of CoI? • What regulations apply to CoI in research? • How is CoI in research routinely managed? • How shouldCoI in research be managed?

4. FTC: Bloggers must disclose payments for reviews By DEBORAH YAO, AP Business Writer - Mon Oct 5, 2009 2:47PM EDT The Federal Trade Commission will try to regulate blogging for the first time, requiring writers on the Web to clearly disclose any freebies or payments they get from companies for reviewing their products. The FTC said Monday its commissioners voted 4-0 to approve the final Web guidelines, which had been expected. Violating the rules, which take effect Dec. 1, could bring fines up to $11,000 per violation. Bloggers or advertisers also could face injunctions and be ordered to reimburse consumers for financial losses stemming from inappropriate product reviews. The commission stopped short of specifying how bloggers must disclose conflicts of interest. Rich Cleland, assistant director of the FTC's advertising practices division, said the disclosure must be "clear and conspicuous," no matter what form it will take.

5. Conflict of Interest Situation in which the integrity of academic activity, especially research, may be, or may be perceived to be, compromised by financial or other interests.

6. Conflicts of Interest • Most are financially based • Some are just accepted • Owning an hypothesis • Research results as proprietary information pending publication • Continuing research support • Developing intellectual property

8. Similarities Scientist Entrepreneur Reputation is a key asset It’s all about gaining acceptance of a new idea Passion for the enterprise is essential

9. Differences Entrepreneur Scientist Produces data which may be built upon Uses the scientific method Rules out alternatives to an idea Avoids risky approaches to a problem Produces something marketable Uses business development models Develops support for an idea Is comfortable accepting and managing risk

10. Sources of Potential Conflict • Consultant • Speaker • Stock or Other Equity • Management Position • Income from Royalties or Licensing Fees • Board or Scientific Advisory Board Member • Gift • Relationship with Competitor • Loans (To or From) • Family Member has Relationship Institutional vs Invididual CoI

11. Does conflict of interestpresent a legitimate concern? Financial interests steer the academic activity to the point where it is compromised Financial interest gives the appearance that the academic activity may be compromised

12. Jesse Gelsinger

13. Examples of What We are Guarding Against Deciding not to publish research results which would be harmful to the entity Agreeing to develop a research protocol to the entity’s specifications Falsifying or fabricating research results which would be beneficial to the entity Conducting research which poses significant risk in order to develop a technology licensed by the University

14. Relationship betweenFunding Source and Conclusion amongNutrition-Related Scientific Articles • 111 of 206 articles declared financial sponsorship • 22% had all industry funding • 47% had no industry funding • 32% had mixed funding • Funding source was significantly related to conclusions for all article types (p=0.037) • Odds ratio of favorable to unfavorable conclusions for all industry funding vs no industry funding was 7.61 • Interventional studies • 0% unfavorable conclusions for all industry funding • 37% unfavorable conclusions for no industry funding Data from Lesser, et al. PLoS Medicine, Jan 2007, pp 0001-0006

15. Exemption Provisions/Conditions(examples) Conflict of Commitment Insider Trading

16. Maryland Public Ethics Law Code of Maryland Regulations 15-501 and 15-523

17. Applicable Policies and Procedures USM Policy On Conflicts of Interest In Research or Development www.umaryland.edu/hrpolicies/section3/t30111sa.html UMB Procedures Implementing Board of Regents Policy on COI… www.ord.umaryland.edu/researchers/policies/umproceed.php

18. Applicable Policies and Procedures(cont’d) UMB IRB Policies and Procedures 6c: Investigator and Study Personnel Conflicts of Interest http://medschool.umaryland.edu/orags/hrpo/HRPP_Policies.pdf

19. NIH Objectivity In Science http://grants1.nih.gov/grants/compliance/42_CFR_50_subpart_F.htm

20. Case Study Alice Pharmer is a SOP faculty member whose research involves predictors of the extent to which a generic drug will be substituted for an established product. Over the years, she has published regularly in the scientific literature. She is known for having developed “Pharmer’s Almanac,” a list of predictors and their relative contributions to a utilization algorithm.

21. Questions • Does this line of research have intrinsic academic value? • Does this line of research have value outside of academe? To whom?

22. Case Study (cont’d) • Kamal Singh joins Dr Pharmer’s lab as a graduate student. Kamal wants to land a top management position in a pharmaceutical firm when he grows up. He is bright and something of an entrepreneur. He finds peer-reviewed research grant writing to be a tedious task and, in his case, a waste of time.

23. Case Study (cont’d) • Kamal and Dr Pharmer agree that, for Kamal’s dissertation, he will develop a utilization algorithm for a specific drug. The chosen drug has been a blockbuster for Nofartis Pharmaceuticals, but will be coming off patent in 3 years. Kamal suggests to Dr Pharmer that they approach Nofartis for funding for Kamal’s dissertation research.

24. Questions • Would Nofartis be interested enough in this research project to provide funding? • If so, what conditions might Nofartis try to impose on Dr Pharma and Kamal? • What conditions should Kamal and Dr Pharma insist upon if they are going to accept funding from Nofartis?

25. Case Study (cont’d) • A Research Agreement between the University and Nofartis is executed. Excellent progress is being made as evidenced by periodic reports prepared for Nofartis. At the end of 18 months, Dr Pharmer encourages Kamal to submit his utilization algorithm for this drug for publication and for presentation at an international conference.

26. Questions • What CoI issues might arise if: • Nofartis asks Dr Pharmer to be a paid consultant? • Dr Pharmer gets married and her new spouse owns 10,000 shares of Nofartis stock? • Nofartis suggests there will be a management trainee position waiting for Kamal when he graduates? • How might each of these financial conflicts of interest be managed?

27. Conflicts of Interest in Research School of Pharmacy October 13, 2009 Joe Giffels Research Integrity Office jgiff001@umaryland.edu www.umaryland.edu/research_integrity