1. F INANCIAL C ONFLICTS OF I NTEREST IN R ESEARCH Beth Taraban Director TTUHSC Research Integrity Office

2. S OME D EFINITIONS Financial interest : Anything of monetary value, whether or not the value is readily ascertainable; Significant financial interest : More detail later, but, generally, enough of a financial interest to make it more likely that a COI might occur. Financial Conflicts of Interest (in Research ): A significant financial interest that could directly and significantly affect the design, conduct, or reporting of (PHS- funded) research.

3. R EGULATIONS ARE SPECIFIC TO PHS FUNDING AGENCIES. W HAT IS A PHS AGENCY ANYWAY ? Agency for Healthcare Research and QualityAgency for Healthcare Research and Quality (AHRQ) Agency for Toxic Substances and Disease Registry Agency for Toxic Substances and Disease Registry (ATSDR) Centers for Disease Control and PreventionCenters for Disease Control and Prevention (CDC) Food and Drug AdministrationFood and Drug Administration (FDA) Health Resources and Services AdministrationHealth Resources and Services Administration ( HRSA) Indian Health ServiceIndian Health Service (IHS) National Institutes of HealthNational Institutes of Health (NIH) Substance Abuse and Mental Health Services AdministrationSubstance Abuse and Mental Health Services Administration (SAMHSA)

4. NIH A GENCIES : National Cancer Institute National Eye Institute National Heart, Lung and Blood Institute National Human Genome Research Institute National Institute (NI) on Aging NI on Alcohol Abuse and Alcoholism NI of Allergy and Infectious Disease NI Arthritis and Musculoskeletal and Skin Disease NI Biomedical Imaging NI Child Health and Human Development NI on Deafness

5. M ORE NIH A GENCIES NI of Dental and Craniofacial Research NI Diabetes and Digestive and Kidney Disease NI Drug Abuse NI General Medical Sciences NI Mental Health NI Minority Health and Health Disparities NI Neurological Disorders and Stroke NI Nursing Research National Library of Medicine

6. WHERE WE CAME FROM : Jesse Gelsinger case (Penn, 1999): First time this issue came up in a court case. Since then, we have heard of many cases. Grassley/Sunshine Laws/Pharmaceutical companies, etc. DHHS has had regulations about COI in research since 1995, last revised in 2004.

7. W HERE WE ARE NOW : More than half of research funding in the US is from non-government sources Academic researchers are encouraged to develop and market their research. New PHS regulations for FCOI enacted 8/24/11 with focus of increased transparency went into effect in August, 2012.

8. I NVESTIGATOR RESPONSIBILITIES UNDER NEW REGULATIONS 1) Familiarity with regulations 2) Complete training on conflict of interest issues at a minimum of once every 4 years; 3)Disclose Significant Financial Interests to the institution at least annually and within 30 days of a new SFI; 4) If the SFI is determined to create a Conflict of Interest, accept and comply with a Conflict Management Plan; retain documentation of compliance with plan

9. I NVESTIGATOR RESPONSIBILITIES — T RAINING (PHS-F UNDED INVESTIGATORS ) Applies to all investigators and Senior/Key research personnel Complete institutional FCOI training at least once every 4 years (more frequently if there are changes, or if there is non-compliance)

10. TTUHSC-S PECIFIC P OLICY ON T RAINING “For investigators and study coordinators conducting non-exempt research with human subjects, regardless of funding, training is required. New research proposals submitted without up-to-date conflict of interest training may not receive final approval by the TTUHSC IRBs.” HSC OP 73.09 Section 4b(3) TTUHSC uses the CITI online COI training modules.

11. I NVESTIGATOR RESPONSIBILITIES -D ISCLOSURE Significant Financial Interests that must be disclosed) : o Income: Any salary, consulting fees, honoraria, paid authorship, royalties, stocks, stock options, etc. received from a public entity (other than employer) if, when aggregated exceed $5K in the past 12 months. o Any payment from a non-public entity that exceeded $5K in the past 12 months.

12. R EQUIRED D ISCLOSURES ( CON ’ T ) o Equity: Any amount of equity (stock, stock options, ownership interest ) in a non-publicly traded company, even if value of the equity is unknown. o Intellectual property rights and interests upon receipt of income related to those rights. o Sponsored Travel : Any reimbursed or sponsored travel related to institutional responsibilities (except travel paid by a government agency or institute of higher ed). (NIH has already allowed a bit of wiggle room on this)

13. W HAT ISN’T A SFI? Money your employer pays you Intellectual property rights assigned to the institution Mutual funds or retirement accounts where you don’t control how the $$ are invested Honoraria from a government agency(lecturing or peer review at a state university) Money from doing work for a government agency (NIH/NSF review panels)

14. I NVESTIGATOR /I NSTITUTIONAL R ESPONSIBILITIES : C ONFLICT MANAGEMENT PLAN Some methods for mitigating a FCOI: Disclosing FCOI to research participants Disclosing FCOI in publications/presentations Appointing independent research monitor(s) to evaluate design, conduct, reporting of research Changing personnel or responsibilities/ removing conflicted person from participation in all or a portion of the research Reduction or elimination of the financial interest

15. I NSTITUTIONAL R ESPONSIBILITIES : Reporting to PHS : o Send Conflict Management Plans to PHS funding agency for any FCOIs identified in a federally- funded research project. Public accessibility : o Must post FCOIs on publicly accessible website or respond to written requests for information within 5 days. This information will no longer be considered confidential.

16. FUN READINGS ABOUT FCOI S !!!! Descriptive article about the Jesse Gelsinger case: http://www.sskrplaw.com/lawyer-attorney-1482386.html Descriptive article from Scientific American, 2009: http://www.scientificamerican.com/article.cfm?id=conflict-of- interest-disclosure Check to see whether a particular physician is receiving money from a pharmaceutical company, and if so, how much: http://projects.propublica.org/docdollars/ Conflicts of interest in stem cell research in Texas, March, 2012: http://www.nature.com/nature/journal/v483/n7387/full/483005a.ht ml TTUHSC’s Financial Conflict of Interest in Research Policy (revised 7/31/2012): http://www.ttuhsc.edu/hsc/op/op73/op7309.pdfhttp://www.ttuhsc.edu/hsc/op/op73/op7309.pdf FDA Financial Disclosure regulation (21 CFR 54) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54&showFR=1 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54&showFR=1