2012 conflict of interest guidlelines

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