Financial Conflicts of Interest in Research 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: 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.
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)
NIH Agencies: • 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
More NIH Agencies • 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
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.
Where 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.
Investigator 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
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)
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.
Investigator responsibilities-Disclosure Significant 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.
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)
What 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)
Investigator/Institutional Responsibilities: Conflict 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
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.
FUNreadingsaboutFCOIs!!!! • 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.html • TTUHSC’s Financial Conflict of Interest in Research Policy (revised 7/31/2012): http://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