51��������

Disclosure

Investigators must certify by signature on the Routing for Proposal Approval & Submission (RPAS) Form that s/he has read and understands the University’s policy on Conflict of Interest in Sponsored Programs and that all required financial disclosures have been made as part of the proposal preparation and submission process.

Prior to submission of a proposal for sponsored research or programmatic activities, each investigator must disclose to the OGCA Director any significant financial interest that would reasonably appear to be affected by the activities funded or proposed for funding. Investigators shall use the Significant Financial Interests Disclosure Form to make the disclosure. During the period of an award, investigators must update financial disclosures as new reportable financial interests are obtained. This is separate and distinct from the "Ethics Disclosure Form" required to be completed annually under AS 39.52.170, which by statute must be reviewed by the General Counsel.

Training

All Investigators engaged in research related to any PHS-funded grant or contract must complete COI training prior to engaging in research and at least every four years. Training is available from 51��������'s Office of Research Integrity.

Designation of Official to Review Disclosures and Resolve Problems

The Office of Research Integrity is designated to review financial disclosures, determine whether a conflict of interest exists, and determine what conditions or restrictions, if any, should be imposed by the University to manage, reduce or eliminate such conflict of interest.

A conflict of interest exists when the reviewer determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of the research or educational activity.

Possible conditions or restrictions that might be imposed to manage, reduce, or eliminate conflicts of interest include but are not limited to:

• Public disclosure of significant financial interests;
• Monitoring of research by independent reviewers;
• Modification of the research plan;
• Disqualification from participation in the portion of research that would be affected by significant financial interests;
• Divestiture of significant financial interests; and
• Severance of relationships that create conflicts.

The approved conditions or restrictions imposed upon the investigator in the conduct of the project shall be incorporated into a management plan between the University and the investigator.

All identified conflicts of interest will have been satisfactorily managed, reduced, or eliminated prior to expenditure of any funds under the award.

If the reviewer determines that imposing conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the reviewer may allow the research to go forward without imposing such conditions or restrictions.

Definitions

For a summary of these definitions, please see the table above.

The term "investigator" means the project director or principal investigator, co-investigators, and any person regardless of title or position who is responsible for the design, conduct, or reporting of the proposed or funded research or educational activity , which may include for example, collaborators or consultants.

The term "financial interest" means anything of monetary value, whether or not the value is readily ascertainable, including, but not limited to:

1.  Salary or other payment for services (e.g., consulting fees or honoraria , paid authorship for other than scholarly works );
2. Equity interests (e.g., stocks, stock options or other ownership interests); and
3. Intellectual property rights and interests (e.g., patents, trademarks, service marks and copyrights ) upon receipt of royalties or other income related to such intellectual property rights and interests ).

The term does not include:

1. Salary, royalties or other remuneration from the institution;
2. Income from seminars, lectures, or teaching engagements sponsored by and service on advisory or review panels for a federal, state or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an aca demic teaching hospital, medical center or research institute that is affiliated with an Institution of higher education ;
3. Income from authorship of academic or scholarly works;
4. An equity interest that, when aggregated for the investigator and investigator’s spouse and dependent children, meets both of the following tests: does not exceed $5,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a 5% ownership interest in any single entity; or
5. Salary, royalties or other payments that when aggregated for the investigator and the investigator’s spouse and dependent children, are not expected to exceed $5,000 during the next twelve month period
6. Equity interests or income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in these vehicles.

A “significant financial interest” means a financial interest that reasonably appears to be related to the Investigator ’s institutional responsibilities, and:

1. if with a publicly traded entity, the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure, and the value of any equity interest during the 12 month period preceding or as of the date of disclosure, exceeds $5,000; or
2. if with a non-publicly traded entity, the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure exceeds $5,000; or
3. if with a non-publicly-traded company, is an equity interest of any value during the 12 month period preceding or as of the date of disclosure; or
4. is income related to intellectual property rights and interests not reimbursed through the Institution.

A “financial conflict of interest” means a Significant Financial Interest (or, where the Institutional official requires disclosure of other Financial Interests, a Financial Interest) that the Institution reasonably determines could directly and significantly affect the design, conduct or reporting of Institutional research.

Disclosure, Resolution, and MOU Forms

• Investigators must use the 51�������� Significant Financial Interest Disclosure Form to disclose significant financial interests.
• Investigators must also complete the Resolution Plan Questionnaire.
• Investigators must also complete the Memorandum of Understanding.

Disclosure Timing

Investigators must provide all required financial disclosures by the time of proposal submission. Disclosures must be updated during the period of the award as new significant financial interests are obtained.

Disclosure to NSF and PHS

For National Science Foundation proposals, prior to expenditure of any funds under the award, the University reviewer (Vice Chancellor for Research) will report to the NSF Office of General Counsel any conflicts of interest that cannot be satisfactorily managed, reduced or eliminated, but not the nature of the conflicting interest or other details.

For Public Health Service proposals, prior to expenditure of any funds under the award, the University reviewer will report the existence of a conflicting interest to the PHS awarding component, but not the nature of the interest or other details and assure that the interest has been managed reduced or eliminated.

Enforcement

When an investigator violates this policy or the terms of the management plan the Vice Chancellor shall recommend sanctions that shall be consistent with the applicable personnel policies.

Records

The University shall retain records of all financial disclosures and of all actions taken to resolve conflicts of interest for at least three years beyond the termination or completion of the grant to which they relate, or until resolution of any sponsor action involving those records, whichever is longer.