In response to federal regulations codified at 42 CFR 50.601 et seq. and 45 CFR 94.1 et seq., Davidson College has established standards and procedures to be followed by investigators applying for federal funding to ensure that the design, conduct, or reporting of research; educational activities; and cooperative agreements or contracts will not be biased by any conflicting financial interest of those investigators responsible for the proposed activity.
A potential conflict of interest occurs when there is a divergence between an investigator's private interests and his/her professional obligations such that an independent observer might reasonably question whether the investigator's professional actions or decisions are determined by considerations of personal gain, financial or otherwise. An actual conflict of interest depends on the situation and not on the character or actions of the investigator. This policy seeks to maintain a reasonable balance between competing interests, give the College the ability to identify and manage financial interests that may bias the activity, and minimize reporting and other burdens on investigators.
Prior to proposal submission, each investigator is required to disclose to the Grants and Contracts Office a listing of significant financial interests that would reasonably appear to be affected by the activity proposed for funding. Financial disclosures must be updated during the period of the award, either on an annual basis, or as new reportable significant financial interests are obtained.
"Significant financial interest" means anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights (see 42 CFR 50.603 and 45 CFR 604.3).
A conflict of interest may occur when an investigator's affiliation with an external organization meets any one of the following criteria:
Each investigator must certify on the "conflict of interest disclosure form" that s/he has read and understands the College's conflict of interest policy; that to the best of his/her knowledge, there are no actual or potential conflicts of interest, or if such conflicts exist, they have been or will be managed in a manner satisfactory to the institution or disclosed to the sponsor prior to the award. Investigators also must certify that they will comply with any conditions or restrictions the College imposes to manage actual or potential conflicts of interest.
If the College carries out federally-funded research or educational activities through subgrantees, contractors, or collaborators, the College will take reasonable steps to ensure that investigators working for such entities comply with financial disclosure regulations either by requiring those entities to comply with the College's policy or by requiring the entities to provide written evidence of compliance from their institution.
Disclosure forms will be completed at the time of grant application and turned in to the Grants and Contracts Office.
The Conflict of Interest Committee will review any potential conflicts and determine which disclosed interests could directly and significantly affect the design, conduct or reporting of the research or educational activity. If the Committee determines that a potential conflict exists, it may recommend:
If the Conflict of Interest Committee determines that imposing the above or other conditions or restrictions would be inequitable, or that the potential negative impact that may arise from a significant financial interest is outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the Committee may recommend that, to the extent permitted by federal regulations, the research go forward without imposing such conditions or restrictions.
If the investigator is dissatisfied with the conclusion of the Conflict of Interest Committee, s/he may appeal to the Committee which will consult with the investigator and other appropriate person(s) or entities as the Committee deems necessary and appropriate to the particular circumstances. The decision of the Conflict of Interest Committee shall be final. In the event that the Conflict of Interest Committee working with the investigator, cannot satisfactorily manage, reduce or eliminate the conflict, the College shall inform the federal sponsor of the conflict and provide the disclosure information relevant to the proposal.
The Conflict of Interest Committee will maintain disclosure records in strict confidence. Access to such records will be limited to the federal sponsor, the investigator in question, and the Conflict of Interest Committee, except in the case of an appeal in which case the Conflict of Interest Committee shall disclose to the investigator the other persons or entities with which it intends to consult. The College will maintain records of financial disclosures and records relating to the management of actual and potential conflicts of interest until three years after the termination or completion of the award to which they relate or the resolution of any government action involving the records.
Violations of this policy, such as willful concealment of financial interests, may result in sanctions being imposed upon the violating individual. The Conflict of Interest Committee will review allegations of violations and will make recommendations regarding the imposition of sanctions to the Vice President for Academic Affairs. An investigator may appeal the imposition of sanctions to the President of the College. The decision of the President with regard to sanctions shall be final.
The Conflict of Interest Committee will be composed of: Chair, Human Subjects IRB; Chair, Professional Affairs Committee; Chair, Professional Conduct Committee; General Counsel; Director, Grants and Contracts; Controller.
Approved 12/7/95 (finalized 1-11-96)