Research Conflict of Interest Procedures

Review by Policy Owner: November 15, 2007

Research Conflict of Interest Procedures

Introduction

Potential research conflicts of interest arise in a variety of circumstances in the academic medical center setting. Examples include but are not limited to the following:

1. Receipt of significant consulting fees, honoria, speakers’ bureaus fees and other payment or remuneration from commercial sponsors of research;
2. Payments related to recruiting or enrolling research subjects;
3. Financial interests in commercial sponsors of research;
4. Royalty interests resulting from publications, products or technology;
5. Philanthropic support from commercial sponsors of research;
6. Serving as a director of a company that sponsors research;
7. Employing research subcontractors in which a Covered Person or an immediate member of his/her family has a substantial financial interest.

Definitions

Covered Persons means all individuals engaged in research for or on behalf of UNMC. Any financial interest accruing to the immediate family, including parent(s), or spouse of a parent, spouse, dependent child of a Covered Person, or anyone that a Covered Person may claim as a dependent under the Internal Revenue Code; or any financial interest accruing to a business or other entity in which the Covered Person or his/her immediate family member owns a controlling interest, will be treated as a financial interest of the Covered Person.

Responsible Person means the principal investigator and any other person who, in the principal investigator’s professional judgment, is responsible for the design, conduct or reporting of the research, whether or not salary is requested. The term “Responsible Person” may include research coordinators and technicians.

Conflict of Interest (COI) refers to situations when the Covered Person’s personal financial interests or fiduciary duties owed to third parties may compromise, or have the appearance of compromising, a Covered Person’s professional judgment or behavior in carrying out his or her research obligations.

Significant Financial Interest means anything of monetary value that exceeds $10,000 received in the past twelve months, or anticipated to be received in the next twelve months, from sources that might reasonably appear to be affected by the Covered Person’s research activities. For equity holdings the limit is $2,000 (See D below). Significant financial interests include but are not limited to:

1. Salary, royalties, or a commitment for future royalties or other remuneration received outside of the University of Nebraska system, UNMC Physicians or University Dental Associates (UDA);
2. Other income or payments for services (e.g. consulting fees, speakers bureaus or honoraria) except for
3. income from seminars, lectures or teaching engagements sponsored by public or nonprofit entities; and
4. income from service on advisory committees or review panels for public or nonprofit entities;
5. Intellectual property rights (e.g. patents, copyrights and royalties from such rights);
6. Equity interests (e.g. stocks, stock options or other ownership interests, both direct and indirect, i.e. trusts, etc.) that when aggregated for the Covered Person and the Covered Person’s spouse, parent, spouse of parent, and dependent children, exceeds $2,000 in value as determined through reference to public prices or other reasonable measures of fair market value, or represents more than five percent ownership interest in a single entity. Equity interests in mutual funds are not included.

Institutional Conflict of Interest” (“Institutional COI”) may occur when UNMC, any of its senior management (chancellor, deans, associate deans, vice-chancellors, assistant and associate vice chancellors, Center and Institute directors, department/division chairs, and College of Medicine Section Chiefs) or a department, school, or other sub-unit, has an external relationship with or financial interest in a company that itself has a financial interest in the University, including a teaching, research or service project. Senior managers may also have conflicts when they serve on the board of (or otherwise have an official relationship with) organizations that have commercial transactions with UNMC.

An example of a potential Institutional COI is a proposed research project funded in whole or in part by an entity in which UNMC, an affiliated corporation, or other entity created to promote and facilitate technology transfer at UNMC (i.e., UNeMed), owns an equity interest or a future right to own an equity interest, the fair market value of which is greater than $2,000 or represents more than five percent ownership interest.

The following activity would not normally be considered an Institutional COI: an equity, royalty or other interest held in a University of Nebraska endowment or similar account, which is segregated from the decision making processes of research activities. For example, a stock interest held in an account managed by a University of Nebraska Office of Business and Finance would not trigger a reporting requirement.

Conflict of Interest Officer/Conflict of Interest Committee

The Vice Chancellor of Academic Affairs shall appoint a Conflict of Interest Officer (“COI Officer”) who shall be responsible for and is authorized to oversee and monitor implementation and compliance with these Procedures. The COI Officer shall also be responsible to provide guidance and interpretation to Covered Persons seeking to comply with these Procedures, and to carry out the duties associated with reporting conflicts of interest.

The Vice Chancellor for Academic Affairs shall appoint a Conflict of Interest Committee (“COI Committee”) comprised of faculty, research staff, academic administrators, business operations personnel, at least one member of the Institutional Review Board (“IRB”) and at least one community member to fulfill the duties outlined in these Procedures. The COI Committee shall be a standing committee that operates in accordance with the guidelines at Appendix A, and shall be chaired by the COI Officer.

Reporting Potential Conflicts

Conflicts of Interest

1. Initial disclosure. All faculty members, directors, administrators and department heads (or equivalents) shall complete a UNMC Disclosure of Potential Conflict of Interest Form (Appendix B) within 90 days of initial appointment/hire. The unit Personnel Action Form (PAF) coordinators are responsible for ensuring forms are completed in a timely manner. (Paragraph under construction; will be implemented at later date)
2. New potential conflicts. Covered Persons who propose to engage in an activity that would create a situation defined as a COI shall complete a Disclosure of Potential Conflict of Interest form (Appendix B) and submit it to the COI Officer.
3. Grant Applications and Sponsored Programs Agreements. Covered Persons who are principal investigators on grant applications or who submit a sponsored program agreement shall submit a current UNMC Disclosure of Potential Conflict of Interest Form(Appendix B) to Sponsored Programs Administration as a part of the application process. All other Responsible Persons (individuals who are responsible for the conduct, design, or reporting of the research, whether or not salaries are requested) shall submit a current Disclosure of Potential Conflict of Interest form to Sponsored Programs Administration at the time the grant is awarded. Sponsored Programs Administration shall report the existence of a COI and the management plan to federal grant administering agencies when required by federal regulation or the terms of the research grant.
4. IRB Applications. Covered Persons listed in Section I of the IRB application shall submit a conflict of interest disclosure form as a part of the application process to the Office of Regulatory Affairs pursuant to UNMC Human Research Protection Program Policy 1.11
5. Changes in Existing COI. Any $5,000 or more increase in the amount of COI must be reported to the COI Officer on a Disclosure of Potential Conflict of Interest form within 60 days of the increase.

Institutional Conflict of Interest

In order to avoid real and perceived favoritism in long-term or repeated dealings with research sponsors, each/every potential Institutional COI shall be reported. Any Covered Person that has knowledge of potential Institutional COI shall complete a UNMC Disclosure of Potential Institutional Conflict of Interest Form (Appendix C) and send it to the COI Officer for review. The COI Officer shall convene a group of senior UNMC officials appointed by the Chancellor to review the disclosure and implement a management plan if appropriate. Sponsored Programs Administration shall report the significant Institutional COI to federal grant administering agencies when required by federal regulation or the terms of the research grant.

COI Officer Action.

The COI Officer shall review all conflict of interest disclosure forms and determine in his/her professional judgment whether any action should be taken in response to potential conflicts. If the COI Officer determines that management of the COI beyond mere disclosure is warranted, he/she shall coordinate with the Covered Person to create a proposed management plan. For significant financial interests, the COI Officer shall submit the COI disclosure and the proposed management plan to the COI Committee for review, approval or modification.

COI Committee Action.

The COI Committee shall consider the nature of the activity, the magnitude of the COI and its relation to the Covered Person’s research, the potential impact the COI might have on the integrity of the Covered Person’s decisions, and such other considerations as the COI Committee shall deem relevant in order to make a decision. The COI Committee shall then determine whether the proposed management plan will adequately reduce or eliminate the COI and state its determination on the Conflict of Interest Committee Management Plan Form (Appendix D). In rare instances, the COI Committee may determine that no management plan could adequately reduce the COI, and therefore prohibit the Covered Person from participating in the activity. The COI committee chair shall forward a copy of the approved management plan to the Covered Person, the Covered Person’s supervisor, Sponsored Programs Administration, and also to the IRB for review and further modification if human subjects research is involved.

Management of COI.

The following is a non-exhaustive list of Management Plan strategies provided to serve as guidance to the COI Officer and the COI Committee.

1. Take no action beyond disclosure of the COI to UNMC and/or the research sponsor.
2. Disclose the COI to the academic and professional communities in presentations and publications; the research sponsor through written notification; and research participants through informed consent documents when human subjects are involved.
3. Require independent monitoring of the research or other academic project.
4. Require modification of the research protocol to manage potential bias through means such as blinding; modifying the scope of the project; and setting timetables for delivery of the product.
5. Designate a peer or supervising co-investigator with no COI in the project to assume the lead investigative role.
6. Require divestiture or appropriate reduction of the financial interest giving rise to the COI with restrictions on re-investment for an appropriate period to provide for publication and critique of the completed project.
7. Require severance of relationships existing between the Covered Person and the company or other entity that is the source of the COI.
8. Require removal of contract terms which create the COI. For example, under no circumstances shall UNMC engage in projects where payment is defined by the outcome of the research.
9. After careful consideration of less prohibitive alternatives, the Covered Person may be disqualified from participation in all or a portion of the research or other project when a COI exists (e.g. may not enroll human research subjects, obtain informed consent, or analyze data).

Institutional Review Board (IRB) Management Plan Review.

When the COI Committee develops management plans for COI involving human subjects research, the IRB shall review the management plan and may require more stringent management of the COI within the scope of authority given to the IRB by federal regulations for the protection of human subjects. However, the IRB may not adopt less stringent management than the COI Committee plan. The IRB shall notify the COI officer of its decision. The IRB shall incorporate and require implementation of the approved management plan strategies applicable to the research into the approved protocol.

See UNMC Human Research Protection Program Policy 1.11 for further information.

Corrective Action

Covered Persons who do not disclose potential conflicts of interest they have pursuant to these Procedures, or who choose not to comply with COI Officer or COI Committee determination and recommendations, may be reassigned to an activity in which he/she has no COI. Further, such failure or refusal to comply shall be cause for disciplinary consideration and grounds for employment or academic action.

Sponsored Programs Administration shall notify the Public Health Service Awarding Component when the COI Committee has determined that the failure of the Covered Person to comply with this policy has biased the design, conduct, or reporting of the PHS-funded research in accordance with 42 CFR Part 50 Subpart F.

Recordkeeping

The COI Officer shall retain the forms, records and COI Committee minutes processed pursuant to this policy for purposes of documenting the existence and/or identification of conflicts of interest and commitment and their resolution. Records shall be retained for no less than seven years following the cessation of the outside activity to which they relate.

Audits

Management of the research conflict of interest program may be audited as a part of the UNMC compliance program.

Open Meetings and Public Records Concerns

No proceedings under this Policy, including those of the COI Committee, are subject to the public meetings laws of the State of Nebraska, Neb. Rev. Stat. §84-1408 et. seq. as amended. The records generated pursuant to this policy are confidential except to the extent they are required to be disclosed pursuant to the Public Records laws found at Neb. Rev. Stat. §84-712 et. seq. as amended, or other law requiring disclosure.

Conflict of Interest Policy /

Appendix A - Conflict of Interest Committee (COIC) Governance / Appendix B - UNMC Disclosure of Potential Conflict of Interest / Appendix C - UNMC Disclosure of Potential Institutional Conflict of Interest / Appendix D - Conflict of Interest Committee Management Plan

This page updated on Wednesday, November 15, 2007, by dkp.