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Ethical Challenges Related to Financial Conflicts of Interest in Research

Ethical Challenges Related to Financial Conflicts of Interest in Research. Jeremy Sugarman, MD, MPH, MA Berman Bioethics Institute Johns Hopkins University Baltimore, Maryland USA. At the Newsstand. “Safeguards Get Trampled in Rush for Research Cash” Chicago Tribune , 9/5/99

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Ethical Challenges Related to Financial Conflicts of Interest in Research

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  1. Ethical Challenges Related to Financial Conflicts of Interest in Research Jeremy Sugarman, MD, MPH, MA Berman Bioethics Institute Johns Hopkins University Baltimore, Maryland USA

  2. At the Newsstand • “Safeguards Get Trampled in Rush for Research Cash” • Chicago Tribune, 9/5/99 • “Senators Ask Drug Giant to Explain Grants to Doctors” • New York Times, 7/06/05 • “How Tightly Do Ties Between Doctor and Drug Company Bind” • New York Times, 7/27/05

  3. At the Bookstore • Science in the Private Interest : Has the Lure of Profits Corrupted Biomedical Research? • Krimsky, 2003 • The Truth About the Drug Companies: How They Deceive Us and What to Do About It • Angell, 2004 • On The Take: How Medicine's Complicity with Big Business Can Endanger Your Health • Kassirer, 2004

  4. At the Medical Library • “Handling conflicts of interest between industry and academia” • JAMA 2003; 3240-1 • "Regulating academic-industrial research relationships--solving problems or stifling progress?" • NEJM 2005; 1060-5 • "Reporting Conflicts of Interest, Financial Aspects of Research, and Role of Sponsors in Funded Studies" • JAMA 2005; 110-111

  5. In the Beltway • Institutional Review Boards: A Time for Reform • OIG, June 1998 • Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research • OIG, June 2000

  6. Conflict of Interest Timeline

  7. Ethical Foundations • Scandals, codes, regulations and principles • Fiduciary obligations • Reservoir of trust

  8. Fiduciary • “a person holding the character of trustee, in respect of the trust and confidence involved in it and scrupulous good faith and candor which it requires.” • a “person having duty, created by his undertaking, to act primarily for another’s benefit in matters connected with such understanding.” Black’s Law Dictionary

  9. Fiduciary Obligations • Put aside self-interest • Focus primarily on the interests of the person for whom he or she serves as fiduciary • Act to promote that individual’s interest and so earn the trust of that individual McCullough, et al 1998

  10. Reservoir of Trust • Individual physicians and investigators • Specific institutions • The research enterprise as a whole

  11. Trust and Trustworthiness “Not all things that thrive when there is trust between people…are things that should be encouraged to thrive…There are immoral as well as moral trust relationships.” Baier A, 1986

  12. Spectrum of Conflicts • Initial considerations • Research design • Prospective review • In process • Recruitment • Informed consent • Integrity of the data • Reporting

  13. Selected Types of Financial Interests • Per capita payments • Money received outside the study • Investigator holds equity • Institution holds equity

  14. Potential Solutions • Divest • Minimize • Disclose

  15. Important Empirical Questions Regarding Disclosures of COI • Who, What, When, Where, and How? • How will these data be used? • What are the effects on trust? • What are the effects on the research enterprise?

  16. COINSConflict of Interest Notification Study • Johns Hopkins • Jeremy Sugarman • Duke • Kevin Weinfurt • Rob Califf • Kevin Schulman • Joelle Friedman • Jennifer Allsbrook • Michaela Dinan • Wake Forest • Mark Hall NHLBI Grant: 1 R01 HL075538-01

  17. COINS Overview Institutional Policies Effects of Disclosure Officials/ Investigators Models for Disclosure Potential Research Participants

  18. Policy Review • Online and written policies of US academic medical centers (AMCs) • February-August, 2004 • Identified materials for 98% of 123 AMCs Weinfurt et al, Academic Medicine 2006; 81: 113-118.

  19. Policy Review • Online and written policies of US academic medical centers (AMCs) • February-August, 2004 • Identified materials for 98% of 123 AMCs • 48% mentioned disclosure to subjects as an option • 58% of those contained required or suggested verbatim language • Few suggested more than disclosure of sponsor Weinfurt et al, Academic Medicine 2006; 81: 113-118.

  20. Interviews With Officials and Investigators • Types of Institutions Sampled • Academic Medical Centers • Independent Hospitals • Independent IRBs • Non- Affiliated Research Entities • Participation • 23 IRB Chairs • 14 COIC Chairs or similar official • 7 investigators Weinfurt et al, J Law Med Ethics 2006; 581-591.

  21. Disclose the Amount of the Financial Interest? • “No!” according to investigators • Complexity of the disclosure • Amount “might detract from what really needs to be decided” • No consensus among officials • PRPs overestimate value and the power to influence • Do not disclose amount • Investigators underestimate the power to influence, lay people do not • Do disclose

  22. We have not ever asked anyone to express the amount of money involved, really thinking that $1000 may be as bad as $20,000. --IRB Chair

  23. Describe Possible Implications of Financial Interest? • No, let them draw their own conclusions. • Yes, warn them like we do on cigarette ads. • Difficult balance

  24. I think that that is sort of leading the subject to where they might think that this is what is going to happen. I think that if the relationship between the risk and the study was not clear, you might need to spell that out. But, to some degree I think you are just informing the subject. You are not trying to tell them what they should think about it. --COIC Chair

  25. PRP Focus Groups • 16 groups (6-8 people each) • Healthy adults (6 Groups) • Mildly/Chronically ill adults (6 Groups) • Severely ill adults (2 Groups) • Parents with healthy children (1 Group) • Parents of children with illnesses (1 Group) • Stratified by race/ethnicity • Conducted in New York, Chicago, and Durham, NC Weinfurt et al, J Gen Intern Med 2006; 21: 901-6.

  26. PRPs on Disclosure and Trust • Might decrease trust • Might increase trust • Transparency • Perception that financial interest is good • Need to maintain image of physician

  27. Evolution of PRPs’ Thoughts • Few had considered financial interests and their implications in clinical research • Opportunity to ask questions during consent process • Prior to focus group, would not have known what to ask

  28. COINS Overview Institutional Policies Effects of Disclosure Officials/ Investigators Models for Disclosure Potential Research Participants

  29. Models for Disclosure • Expert Panel • Mark Barnes, JD, LLM (Ropes & Gray), Becky Coleman, PharmD (Theravance, Inc.), Joseph DiCesare, MPH, RPh (Novartis Pharmaceuticals Corporation), John M. Falletta, MD (Duke University Medical Center), Robert Gatter, JD, MA (Penn State University), Julie Gottlieb, MA (Johns Hopkins University), Jeffrey Kahn, PhD, MPH (University of Minnesota), Mary Faith Marshall, Ph.D. (University of Minnesota), S. Van McCrary, Ph.D., J.D., M.P.H. (State University of New York at Stony Brook), Erica Rose, JD (GlaxoSmithKline), Michael B. Waitzkin, JD (FoxKiser) • Focus Groups • Cognitive Pre-testing Weinfurt, et al. IRB 2007; 29:1-5

  30. COINS Overview Institutional Policies Effects of Disclosure Officials/ Investigators Models for Disclosure Potential Research Participants

  31. Assessing Effects of Disclosure • Online survey of 3,520 participants • Diabetics and asthmatics • Hypothetical clinical trial • 1 of 5 financial interests disclosed • Per capita payments • Money received outside the study • Investigator holds equity • Institution holds equity • Generic

  32. Willingness to Participate

  33. Change in Trust Due to Disclosure

  34. Self-Rated Understanding of Disclosed Financial Benefit

  35. Surprise Over Disclosed Information

  36. Perceived Effect on Scientific Quality

  37. Does the Type of Interest Matter? • Greater concern over investigator holding equity compared to per capita payment • Other types of financial interest did not differ substantially in their effects on participants

  38. Before leaving it up to the PRP to assess risk . . . • Understanding of implications • Some feel financial interest increases chance that investigators are committed, ethical, and confident that the experimental therapy will work • Invitation to ask questions during consent process • People might not know what to ask • With greater medical risk, some people may not pay attention to financial disclosure, but it is still important to them.

  39. The Process of Disclosure • Study of 300 clinical research coordinators to understand their role in disclosing financial interests in research, and possible barriers to such disclosures • Survey domains • Awareness of financial interests in research • Experience and comfort with disclosure of such interests • Barriers to disclosure

  40. Results • Experience • 41% reported disclosing financial interests to PRPs • 28% reported being asked about financial interests • 28% somewhat or not at all comfortable with answering questions about financial interests • Barriers • Lack of information • PRPs wont understand • Investigator privacy

  41. Suggestions • More education and training would facilitate the disclosure of financial interests in research to PRPs during the informed consent process • Failure to provide such training could result in discomfort that might discourage the effective communication of financial disclosures in research to PRPs

  42. Next Steps • Vignette study with patients with coronary artery disease • Provided with a copy of an informed consent document for a hypothetical trial • Three disclosure arms (per capita, equity, none) • Telephone review to simulate the informed consent process • Survey regarding willingness to participate, trust, etc • Conflict of interest management study • Determine how and when disclosure is selected as a management strategy

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