Transcript Financial Conflicts of Interest in Research

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 (PHSfunded) 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.
o Any payment from a non-public entity that
exceeded $5K in the past 12 months.
o
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.
o
oIntellectual
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
o
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 federallyfunded research project.
o
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.
o
FUN READINGS ABOUT FCOIS!!!!
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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-ofinterest-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.pdf
FDA Financial Disclosure regulation (21 CFR 54)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch
.cfm?CFRPart=54&showFR=1