1. Financial Conflicts of Interest in Biomedical Research Project Findings Josephine Johnston The Hastings Center Garrison, New York

2. Project Purpose Review nature and extent of financial conflicts of interestReview nature and extent of financial conflicts of interest Consider existing rules and guidelinesConsider existing rules and guidelines Compare with other professionsCompare with other professions Isolate areas of concern in present managementIsolate areas of concern in present management Recommend changesRecommend changes

3. Prevalence Financial interests are pervasive Individual researchersIndividual researchers –1/3 have ties to industry Research InstitutionsResearch Institutions –Equity in companies sponsoring research

4. Benefits of Financial Interests Benefits – knowledge transfer, additional finances.Benefits – knowledge transfer, additional finances. We focused on the risks Financial interests can conflict with other interests or dutiesFinancial interests can conflict with other interests or duties

5. Conflicting Interests Conflict of primary and secondary interests – actual or apparentConflict of primary and secondary interests – actual or apparent Term = description of situationTerm = description of situation ≠ moral judgment ≠ moral judgment “Yellow flag”“Yellow flag”

6. Risks “Human nature” creates risks: BiasBias CarelessnessCarelessness SecrecySecrecy Delay in publicationDelay in publication Loss of public interest scientistsLoss of public interest scientists Loss of public trustLoss of public trust

7. Questions What do about these situations?What do about these situations? What must be preserved and protected?What must be preserved and protected? Which mechanisms already work well?Which mechanisms already work well? What new measures are necessary?What new measures are necessary?

8. Existing Rules and Guidelines Institutions, professional societies, federal regulations, journals.Institutions, professional societies, federal regulations, journals. Complex, variable, misunderstood, resented, avoided, relaxed, not enforced.Complex, variable, misunderstood, resented, avoided, relaxed, not enforced. Over-reliance on disclosure.Over-reliance on disclosure.

9. Recommendation Changes to existing rules SimplificationSimplification UnificationUnification EducationEducation EnforcementEnforcement

10. Existing Culture Lack of understanding of risks of financial interestsLack of understanding of risks of financial interests Lack of support for rulesLack of support for rules ResentmentResentment Comparison with other professionsComparison with other professions

11. Recommendation Promote recognition of the problem through: EducationEducation Professional discussionProfessional discussion Aim for: “Buy in”“Buy in” Culture of embarrassmentCulture of embarrassment

12. Other Recommendations Firewalls to separate research and finance.Firewalls to separate research and finance. Support public clinical trials registry.Support public clinical trials registry. Presumption against conflicted investigators in human subject research (AAMC).Presumption against conflicted investigators in human subject research (AAMC). Reduce reliance on disclosure.Reduce reliance on disclosure. Publicize best practices.Publicize best practices. Continue public discussion.Continue public discussion.