1.  Tracy L. LeGrow, Psy.D. Associate Professor Department of Psychiatry and Behavioral Medicine

2.  Know the definition of “Conflicts of Interest”  Understand the various types of conflicts of interest including: o Personal-Individual o Professional-Institutional o Financial  Gain knowledge of ways to manage potential conflicts of interest

3.  “A conflict of interest involves the abuse, apparent, or potential, of the trust that people have in professionals.”  “A situation in which financial or personal considerations have the potential to compromise or bias professional judgment or objectivity.”  http://ori.hhs.gov http://ori.hhs.gov

4.  Standard of relates to what a “reasonable” person might infer about the professional’s judgment.  Potential for bias, even if no decisions are made that impact the research  Can involve both tangible gain such as financial or more intangible which tends to focus more on academic gain/scholarship

5.  Bias based on our own judgment o Selective in-attendance o Interference with peer review process o Delaying /withholding results o Recruitment of participants o Attribution of adverse events Tuskegee Study of Syphilis (1932-1972)

6.  Time spent on other activities vs. research  Time devoted to own research versus those of supervisees  Nepotism

7.  Related to functioning of IRB o Pressure to or desire to protect the institution o Concern for institutional reputation/prestige o Research versus subject protection o Undervaluation of IRB role o Potential liability o Institutional/community values o Pressure for speedy reviews o Institutional equity or ownership o Review fees

8.  IRB members as researchers o Member/investigator-dual role o Members hold financial interest o Loyalty to colleagues being reviewed o Knowledge of subject area-too much/too little o Impact of decisions on one’s own work o Personal agendas/beliefs o Non-IRB roles MERC Legal Counsel

9.  Conflicts can occur between department within an institution  Conflicts can occur between institutions and outside parties  Jesse Gelsinger o University of Pennsylvania and Institute of Human Gene Therapy had financial conflict of interest o Death of 18 year old Gelsinger

10.  Commercial development of scientific discoveries o Processes o Drugs  Bayh-Dole Act (1980) o Essentially, allows investigators to retain rights to their discoveries and to transfer this knowledge to the public sector, even when receiving federal funding o Unfortunately, has allowed for more undue influence on publication practices, assignment of student time to potentially lucrative projects and prescribing practices of physicians/investigators

11.  Researchers not only getting academic credit but also stand to make significant amounts of money, as do their institutions

12.  1995-US Public Health Service (NIH, NSF)  “Responsibility of Applicants for Promoting Objectivity in Research” o Institution must develop internal policies and procedures, designate way to review disclosures and manage potential conflict of interest o Investigators must disclose “significant financial interest” o Institution must report to federal funders any situation where it believes there may be a financial situation that could compromise the research

13.  Anything of monetary value that could include salary or payment for services from an outside institution, any equity (stock) interests, and any intellectual property rights. o Does not include salary, royalties or remuneration from the home institution, income from seminars, lectures or teaching sponsored by public or nonprofit entities, or income from service on advisory committees or review panels for public or nonprofit entities o $10,000 or 5% ownership is common threshold but that varies

14.  Must be aware of and follow institutional guidelines  Professional Societies and Associations are also developing guidelines  Best approach is to have no financial relationships with sponsors at all o Zero tolerance

15.  Full disclosure  Altering research plan o Change location of trial o Use of independent reviewers o Divest financial interests o Sever potential problematic relationships o Disqualify researcher from all or part of the project

16.  Encourage transparency include trustees, boards of companies etc.  Limit faculty involvement in outside companies  Caution should be taken when remuneration is directly tied to stock values  Use independent sources and external reviewers  Build organizational firewalls, safeguards  Anticipate areas of potential problem

17.  What types of conflicts of interest can you identify in this case?  Who carries the greatest responsibility?  How could better oversight been provided?

18.  http://www.circare.org/submit/jintent.pdf http://www.circare.org/submit/jintent.pdf  http://ori.hhs.gov http://ori.hhs.gov