V. Conflict of Interest 

In accordance with the Code of Federal Regulations 42 CFR Part 50, all Principal Investigators must comply with the Public Health Service (PHS) and the National Science Foundation (NSF) financial Conflict of Interest (fCOI) regulations. Investigators applying for funding from the PHS (including the NIH, CDC, HRSA, and AHRQ), sponsors adopting the PHS regulations (including the American Heart Association, American Cancer Society, Arthritis Foundation, Susan G. Komen Foundation, and the Alliance for Lupus Research), or the National Science Foundation (NSF) must submit a Financial Interest Disclosure form to the Office of Grants and Sponsored Projects. Investigators (defined as "project director or Principal Investigator and any other person, who is responsible for the design, conduct, or reporting of research") for each proposal must be identified by the Principal Investigator early in the proposal preparation process.

 

University Investigators must submit their Financial Interest Disclosure forms to the Office of Grants and Sponsored Projects. Non-University Investigators must provide evidence of the subrecipient organization's fCOI policy that is compliant with the PHS regulations. If no fCOI policy is available at the Investigator's organization, the Investigator must submit a Lesley University Financial Disclosure Form. The guidelines below describe University policies and procedures regarding compliance.

For more detailed information, the NSF regulations can be found here.

NIH regulations can be found here.

A Conflict of Interest may exist when a significant financial interest could directly affect the design, conduct, or reporting of an investigator's research. "Investigator" includes the investigator's spouse or domestic partner, dependent children, or anyone related by blood, adoption or marriage.

 

"Significant financial interest" means, except as otherwise specified in this definition: "(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appear to be related to the Investigator's institutional responsibilities:

(i) With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition,

(ii) remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship, travel reimbursement); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value; "

(iii)With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or the Investigator (or the Investigator's spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or

(iv) Intellectual property rights (e.g., parents, copyrights), royalties from such rights, and agreements to share in royalties related to such rights. If an individual is debarred or suspended, she or he is ineligible to receive federal funds. Any individual meeting these conditions must immediately notify the OGSP and is precluded from receiving federally-funded grants or contracts or from being paid with federal funds.

 

All significant financial interests must be disclosed before a proposal is submitted, and disclosures must be updated annually or as new significant financial interests occur. The Associate Provost shall conduct an initial review to determine whether a potential conflict exists. If a potential conflict is revealed, then the disclosure and supporting materials will be referred to the Associate Provost of Academic Affairs. The Associate Provost will work with the investigator(s) to develop a written Conflict Management Plan that details steps to manage, reduce, or eliminate conflict of interest.

The Conflict Management Plan will be submitted to the Provost and upon approval by the Provost, signed by the investigator(s) and the Provost. Investigators dissatisfied with the Plan may appeal to the Provost, whose decision is final. The Conflict Management Plan shall be kept on file with the investigator's funding application materials. The Plan must be approved before any award funds can be expended. Violations, such as willful concealment of financial interests, may result in sanctions.

 Travel
 
The revised Public Health Service financial Conflict of Interest regulations now include a requirement for Investigators on PHS projects to disclose the occurrence of travel paid by outside entities, which can be done using the Financial Disclosure Form. Any Investigator receiving PHS funding must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. This disclosure does not apply to travel that is reimbursed through the University. The Investigator should disclose the occurrence of travel, not the cost of the trip, within 30 days of travel completion.

Records of financial disclosures and reimbursed or sponsored travel as well as actions taken to manage conflicts of interest shall be kept in strictest confidence and retained by the OGSP until seven years after the termination of the award, or the resolution of any government action involving those records. Records will not be provided to sponsors unless the agency requires it, the agency submits a written request, or there is a documented instance of research misconduct. The Associate Provost will be responsible for communicating with sponsors. The investigator will be notified any time such records are released.

The University assumes responsibility for resolving allegations and investigating misconduct in research and scholarship by its faculty, staff, and students. These responsibilities exist regardless of whether the activity is funded by federal, state, or private sources, or is the result of unfunded efforts. This document contains policy and procedures for addressing misconduct in original research and scholarship.