Conflicts of InterestWho they impact and why?Prepared byThe Office of Research Training & Compliance (ORT&C)March 27, 2008

Director, Jackie Bendall

Just In: Washington Post article Tobacco Cash in Lung Study Lung scans were proved effective Funds provided for research came from ACS,

DHHS 3.6 Million came from a parent company of

cigarette maker Liggett Group, Inc. Foundation was formed

Washington Post, cont.

Cornell Foundation

What is a COI? A COI can occur when there is an actual

or perceived divergence between a faculty member’s private interests and professional service to the University.

Conflicts Occur When a Faculty Member/PI Deprives GW of appropriate (compensated) time

and effort (conflict of commitment) due to other competing demands;

Makes substantial use of GW human or material resources for non-University purposes;

Has financial involvements that appear to affect his/her academic responsibilities (e.g., invention royalties outside of the University)

Examples of Actual COIs within Academia:

A Department Chair purchases a computer from company run by his son;

A research scientists gives a friend use of a GW lab and doesn’t disclose to anyone;

A GW researcher invents a new device using GW resources and fails to disclose to University;

A faculty member acts as the thesis or dissertation advisor to a graduate student for a research project, suggested by the faculty member, w/ expectation to enhance the value of the company in which the faculty has a significant interest;

Examples of Actual COIs within Academia:(Cont.)

A faculty member goes against the university policy and accepts the sponsor’s request to suppress publication due to undesirable results that could significantly affect the sponsor’s financial interests;

Submits proposals in which researcher has financial interest in the proposed sponsor, subcontractor, vendor, or collaborator;

A faculty member/clinician accepts a fee/vacation for the sake of influencing the financial status of company and himself/herself (e.g., writing prescriptions for a drug).

What does Perceived mean in this case?

Exist when an investigator’s significant financial interest could lead an independent observer to reasonably question whether the design, conduct, or reporting of research might be influenced by the possibility of personal gain.

- PI conducts federally or foundation sponsored non-clinical research on a product developed by a company for which he is a consultant;- A PI who participates on a scientific advisory board conducts non-clinical research sponsored by company

How is significant defined?GW policy defines Significant financial interest" as:

Stock or ownership interest of the lesser of $10,000 or 5% ownershipin the outside entity (excludes mutual funds);

Receipt, right or expectation of income in any form (e.g., consulting),salary, allowance, forbearance, forgiveness, interest in real orpersonal property, dividend, royalty derived from the licensing oftechnology or other processes or products, rent, capital gain, real orpersonal property, or any other form of compensation or > $10,000per 12 month period;

Serving as PI for or having a management position in the outsideentity;

Corrupted Science:Corporations view science not as a generator of truth but as one among many inputs into production

Drug Companies carefully choose and pay exorbitant fees to influence what is presented;

Ghost Writing (fees paid to Doctors who can be cited in journal articles, articles written by ghost writers);

Companies pay scientists fees to submit articles to open and peer reviewed journals so that their unbiased science could be cited in appeals;

Companies seek to repress publication that affect their bottom line and those of their shareholders;

Senator Grassley’s Common Themes with the FDA Suppression of Scientific Dissent Cozy Relationship with Industry Pressure to Alter or Exclude Information Pressure to Approve Products Atmosphere of Fear of Retaliation Organizational Challenges Lack of Leadership

Patient Safety and Efficacy of Drugs Teaching how to practice has been handed to

the Pharma companies; Dangerous side effects are rarely on the

curriculum; Half of all continuing medical education

courses are paid for by drug companies (up 1/3 from a decade ago). Promotion of sponsor’s product?

Proposed Legislation – Senator Grassley – Senate Finance Committee Requires drug makers to disclose payments

that they make to prescribers for services provided, including consulting, giving presentations, or attendance at seminars.

Create a federal registry of such payments similar to those registries in Maine, Vermont, and Minnesota.

Continuing education provided by Pharma Industry should not be accredited.

Conflicts in Research cannot be avoided in many cases The mere existence of a conflict does not necessarily

imply wrongdoing on anyone’s part;

Gov’t encourages collaboration, therefore start-ups are created; (STTRs, SBIRs);

The University encourages engagement and collaboration with the outside world;

Prevention Techniques Refer to your employer’s policy regarding

COI; Be wary of publication restrictions and the

loss of control to publish; Be wary of gifts, typically there are strings

attached; Always, Always, Always, read the fine print; Always Disclose your relationship;

Reporting of COI Report your concerns even if you are not completely

sure there is a problem; Speak to your supervisor first; Provide as many facts as possible; If you are uncomfortable contacting someone

directly, contact the University’s Regulatory Compliance Help and Referral Line at 1-888-508-5275;

Reports will be handled in strict confidence to the extent possible or permitted by law.

THE END, THANK YOU FOR LISTENING!

Questions?