2012 conflict of interest guidlelines
DESCRIPTION
Presentation by Kacey Strickland at Mississippi State University on new COI guidelines for 2012TRANSCRIPT
Conflict of Interest:
a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity.
Source: Office of Research Integrity, Department of Health and Human Services, RCR Courses Portal (http://ori.hhs.gov/education/products/columbia_wbt/index.html)
2 Categories
Intangible• Those involving academic
activities and scholarship– Pressure to publish– Pressure to get funding– Academic appointments– Promotions and tenure– Glory
Tangible• Those involving financial
relationships• Equity (stock) interests• Intellectual property rights
2 CategoriesIntangible
Those involving academic activities and scholarship-Pressure to publish-Pressure to get funding-Academic appointments-Promotions and tenure-Glory-Personal bias/beliefs
TangibleThose involving financial relationships-Equity (stock) interests-Intellectual property rights-Travel-Consulting fees-Honoraria
“Try this – I just bought a hundred shares.”
Clinical Research Stats
• In 2002, PhRMA companies spent more on pharmaceutical R&D than the total NIH operating budget of $24 billion.
• Private practice physicians involved in drug studies increased by 60% over a five-year span.
• Over the same time period, the proportion of trials conducted in academic medical centers dropped from 80% to 40%.
Source: Nelson DK. Conflict of Interest: Researchers in Amdur and Bankert ed. Institutional Review Board: Management and Function: Sudbury, MA, 2002, pp.197-203.
Bayh-Dole Act (1980)
Pre-1980• Federal gov’t retained rights
to research and discoveries of investigators it funded.
• Biotech companies were having difficulty obtaining licenses to manufacture and market.
• The research enterprise was not thriving.
Post-1980• Recipients of federal funds
can obtain title to their inventions and transfer the technology to the private sector.
• Universities encourage their faculty to apply for patents because they benefit from the shared royalties.
MS University Research Authority
• State ethics laws prohibit state employees from maintaining a material financial interest in a company that contracts or licenses technology from MSU, except when the arrangement is approved by the Mississippi University Research Authority (MURA).
Mississippi Code 37-147-3
NCURA Peer Review
• Recommendation: The campus should make faculty and staff aware that the MURA approval process does not relieve investigators from completing financial disclosures required by federal sponsors. The Review Team was advised of problems due to this misunderstanding.
Excerpt from Final Report dated November 29, 2011
1995 FCOI Regulations
• Public Health Service (PHS) and National Science Foundation (NSF) require grantees to adopt and enforce written policies regarding conflicts of interest.
The Grassley Effect“I’m working to shed light on financial
relationships between drug companies and doctors. I’ve conducted oversight, and I’m working for passage of legislation that would require public reporting by drug companies of the money they give to doctors for consulting, travel, speeches, meals and other activities.”
Source: http://www.grassley.senate.gov/about/Disclosure-of-Drug-Company-Payments-to-Doctors.cfm
2011 Revised FCOI Regulations
• August 25, 2011: New PHS regulations published in the Federal Register
• Headline reads: “FCOI Reg Means Big Changes, Even For Those With Strong Policies in Place” Source: Report on Research Compliance, Volume 8, Number 10, October 2011
MSU’s Written Policy
• Mississippi State’s OP 70.09, “Conflict of Interest in Federally Sponsored Programs” was updated.
Major Changes in PHS Regulations
• Definition of Significant Financial Interest (SFI)• Extent of Investigator Disclosure• Reporting to sponsor• Information available to the public• Investigator training• Effective August 24, 2012!
Significant Financial Interest
• Value of remuneration (received by the investigator,
investigator’s spouse, or dependent children) from any publicly traded entity (in the previous 12 months)
and the value of the equity interest (at the time of
disclosure) exceeds $5,000– Remuneration includes salary, consulting fees,
honoraria, paid authorship, etc.– Equity interest includes stock, stock option,
ownership interest, etc.
Significant Financial Interest
• Any equity interest ($0 threshold) in non-publicly traded entities
• Any intellectual property rights and interests (e.g., patents, copyrights)
• Any reimbursed or sponsored travel related to investigators institutional responsibilities
Zero threshold
Consulting fees
Salary
Advisory committee
income
Seminar income
Retirement accounts
Mutual funds
Sponsored travel
Reimbursed travel
CopyrightPatent
Ownership interest
Stock optionsStock
Paid authorshipHonoraria
SFI Exclusions
• Income from government agencies, institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with an institution of higher education (domestic only)
• Income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions
• Remuneration paid by MSU• Income not related to your “institutional
responsibilities”
Consulting fees
Salary
Advisory committee
income
Seminar income
Retirement accounts
Mutual funds
Sponsored travel
Reimbursed travel
CopyrightPatent
Ownership interest
Stock optionsStock
Paid authorshipHonoraria
Investigator Disclosure
• All SFIs related to the investigators institutional responsibilities for PHS-funded
• Only SFIs related to the proposed research for all other sponsors
Consulting fees
Salary
Advisory committee
income
Seminar income
Retirement accounts
Mutual funds
Sponsored travel
Reimbursed travel
CopyrightPatent
Ownership interest
Stock optionsStock
Paid authorshipHonoraria
Consulting fees
Stock Ownership interest
Honoraria
Sponsored travel
Stock options
Salary
Investigator
• Project director or principal investigator• Any other person regardless of title or position
who is responsible for the:– Design – Conduct– Reporting
• Includes subgrantees, contractors, consortium participants, collaborators, or consultants.
When to Submit?
• Prior to PHS proposal submission• Within 30 days of new SFI (through purchase,
marriage, or inheritance)• At least annually as long as PHS project is
active
FCOI Determination
• The institution is responsible for determining whether SFIs relate to PHS-funded research and are financial conflicts of interest (FCOI)– The investigator may be involved in the
determination– In 1995 regs, the investigator was responsible
NIH Oversight
• NIH may inquire at any time before, during,or after award into any Investigator’s disclosure of financial interests.—If NIH decides that a particular FCOI will bias the
objectivity of research, NIH may impose special award conditions, suspend funding, or impose other enforcement mechanisms until the matter is resolved.
Source: grants.nih.gov/grants/policy/coi/FCOI_presentation_201204.ppt
Consulting fees
Stock Ownership interest
Honoraria
Sponsored travel
Stock options
Salary
Ownership interest
Stock options
Conflict of Interest Committee
• Charged with ensuring that a researcher’s interest in entities outside the University does not compromise his/her objectivity
• Develops the management plan• Not a punitive body• Recommends action to VP when unable to
appropriately manage the FCOI
FCOI Management Plan
• Although each case is treated individually, features are often common to many cases and over time, as set of standard clauses has emerged that forms at least part of most plans.
• Unusual features in a particular case can be specifically addressed by appropriate clauses.
Management Strategies• Public disclosure of financial conflicts of interests (e.g., when
presenting or publishing the research; to staff members working on the project; to Institution’s Institutional Review Board(s);
• For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;
• Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the Financial Conflict of Interest;
• Modification of the research plan; • Change of personnel or personnel responsibilities, or
disqualifications of personnel from participation in all or a portion of the research;
• Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
• Severance of relationships that create financial conflictsSource: Frequently Asked Questions to 2011 Revised Regulations -
http://grants.nih.gov/grants/policy/coi/coi_faqs.htm#3222
Reporting to Sponsor
• Name of investigator• Name of entity • Value of the financial interest• Nature of the financial conflict of interest• Description of determinations• Key elements of the management plan
Public Accessibility
• Policy must be on publicly accessible website• Identified financial conflicts of interest for
senior/key personnel– Post on a publicly accessible website or provide
the information within five business days of written request
• Name and title and role on the research project• Name of the entity• Nature of the financial conflict of interest• Approximate dollar value
Training
• Financial Conflict of Interest training is required for investigators before engaging in PHS-funded research, every four years thereafter, and immediately under designated circumstances.
Someone needs to let Chuck know he can’ t represent those HE injured. I’ll wait here, you tell him. Any questions?
CONFLICT OF INTEREST