Beth Taraban Director TTUHSC Research Integrity Office Some Definitions Financial interest Anything of monetary value whether or not the value is readily ascertainable Significant financial interest ID: 1033633
Download Presentation The PPT/PDF document "Financial Conflicts of Interest in Resea..." is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
1. Financial Conflicts of Interest in ResearchBeth TarabanDirectorTTUHSC Research Integrity Office
2. Some DefinitionsFinancial 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. Regulations are specific to PHS funding agencies. What is a PHS agency anyway? Agency for Healthcare Research and Quality (AHRQ)Agency for Toxic Substances and Disease Registry (ATSDR)Centers for Disease Control and Prevention (CDC)Food and Drug Administration (FDA)Health Resources and Services Administration (HRSA)Indian Health Service (IHS)National Institutes of Health (NIH)Substance Abuse and Mental Health Services Administration (SAMHSA)
4. NIH Agencies:National Cancer InstituteNational Eye InstituteNational Heart, Lung and Blood InstituteNational Human Genome Research InstituteNational Institute (NI) on AgingNI on Alcohol Abuse and AlcoholismNI of Allergy and Infectious DiseaseNI Arthritis and Musculoskeletal and Skin DiseaseNI Biomedical ImagingNI Child Health and Human DevelopmentNI on Deafness
5. More NIH AgenciesNI of Dental and Craniofacial ResearchNI Diabetes and Digestive and Kidney DiseaseNI Drug AbuseNI General Medical SciencesNI Mental Health NI Minority Health and Health DisparitiesNI Neurological Disorders and StrokeNI Nursing ResearchNational 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. Where we are now: More than half of research funding in the US is from non-government sourcesAcademic 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. Investigator responsibilities under new regulations1) 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. Investigator responsibilities—Training (PHS-Funded 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-Specific Policy on Training “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. Investigator responsibilities-DisclosureSignificant Financial Interests that must be disclosed): 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. Any payment from a non-public entity that exceeded $5K in the past 12 months.
12. Required Disclosures (con’t) Equity: Any amount of equity (stock, stock options, ownership interest ) in a non-publicly traded company, even if value of the equity is unknown. Intellectual property rights and interests upon receipt of income related to those rights. 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. What ISN’T A SFI? Money your employer pays you Intellectual property rights assigned to the institutionMutual funds or retirement accounts where you don’t control how the $$ are investedHonoraria 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. Investigator/Institutional Responsibilities: Conflict management planSome methods for mitigating a FCOI:Disclosing FCOI to research participantsDisclosing FCOI in publications/presentationsAppointing independent research monitor(s) to evaluate design, conduct, reporting of researchChanging personnel or responsibilities/ removing conflicted person from participation in all or a portion of the researchReduction or elimination of the financial interest
15. Institutional Responsibilities:Reporting to PHS: Send Conflict Management Plans to PHS funding agency for any FCOIs identified in a federally-funded research project. Public accessibility: 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 FCOIs!!!! Descriptive article about the Jesse Gelsinger case:http://www.sskrplaw.com/lawyer-attorney-1482386.htmlDescriptive article from Scientific American, 2009: http://www.scientificamerican.com/article.cfm?id=conflict-of-interest-disclosureCheck 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.htmlTTUHSC’s Financial Conflict of Interest in Research Policy (revised 7/31/2012): http://www.ttuhsc.edu/hsc/op/op73/op7309.pdfFDA Financial Disclosure regulation (21 CFR 54) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54&showFR=1