CONFLICTS OF INTEREST: RECOGNITION AND

MANAGEMENT

Judith L. CurryAssociate General Counsel

NC State University

February 27, 2014

Conflict of Interest Defined

Financial or personal interests that may compromise (or have the appearance of compromising) one’s objectivity in meeting university duties or responsibilities

NC State REG 01.25.01(Conflict of Interest and Conflict of Commitment)

UNC Policy Manual 300.2.2

Significant Financial Interest

SFI: Any monetary interest, including consulting fees, stock, stock options, and IP rights

Appears to be related to institutional responsibilities

Publicly Traded Entity– >$10,000* or >5% Equity

Non-Publicly Traded Entity– >$10,000 or Any Equity Interest

• SFI excludes: • Phase I SBIR’s • Income rom certain non-profit

activities• Equity interests valued at less

than $10K and less than 5% ownership interest and

• Salary or other payments not exceeding $10K per year

Conflicts of Interest in the academic

community may arise in:– Conduct of Research– Entrepreneurial Activity – Consulting and Other External Activities for

Pay – Personal Relationships – Student Supervision– Contract Management

NC Gen. Stat. §14-234

“No …employee who is involved in making or administering a contract on behalf of a public agency may derive a direct benefit from the contract”

“Administers” = oversees performance, or make decisions about the contract

“Direct Benefit” = >10% ownership in other party, or derives income directly

Compliance

– RECOGNIZE– DISCLOSE

AnnuallyPrior to engaging in EPAP Within 30 days of new SFI (New Rule)

– MANAGE, reduce or eliminate

Managing Conflict Develop Plan

Modification of Research Plan

Fully disclose COI in any Publication

Strict Adherence to Data Retention

Alternate Supervision of Students

Full Disclosure to Students

Why Should you Care?

– Loss of funding– Researchers who fail to disclose may be

subject to liability under the False Claims Act (31 U.S.C. 3729 et seq.) (Treble damages plus up to $11,000 for each false claim)

– University may also be subject to liability for failure to disclose known conflicts (See, e.g.Gelsinger v U Penn)

Public Perception

“The public trust in what we do is just essential, and we cannot afford to take any chances with the integrity of the research process.”

Dr. Francis Collins, Director, NIH

Additional Resources

OGC Consulting FAQ’s http://www.ncsu.edu/general_counsel/legal_topics/consulting-faqs.php

PHS Regulations 42 CFR Part 50, Subpart F

SPARCS http://research.ncsu.edu/sparcs/systems-

portal/coi/coi-plan-help/