This Financial Conflict of Interest Policy is designed to maintain the trust of the public, research volunteers and the University research community.

Transcription

1 Financial Conflict of Interest Policy for Federal Research Grants Introduction This policy governing financial conflicts of interest (FCOI) applies to all Investigators at Taylor University who apply to or receive external research support from the following federal agencies: the National Science Foundation and Public Health Service (PHS) Agencies, including but not limited to the National Institutes of Health. The Provost, acting as the Institutional Official, is responsible for ensuring implementation of this policy and may suspend all relevant activities until the financial conflict of interest is resolved or other action deemed appropriate by the Institutional Officer is implemented. This Financial Conflict of Interest Policy is designed to maintain the trust of the public, research volunteers and the University research community. Definition of Terms Business Any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, limited liability company, trust, or other commercial entity acting directly, or indirectly, as an agent for, or on behalf, of a commercial entity, or controlled by a commercial entity. CFR Code of Federal Regulations Co-investigators (Co-I) Typically, faculty members who share the responsibility of the primary investigator to put forth the best effort to accomplish the work described in the proposal. The co-investigator(s) may be from the same or other institutions. Family With respect to any Investigator: 1) the spouse or domestic partner of such Investigator or 2) dependent children of such Investigator. Federal Research Grant an award, contract or agreement issued by an agency of the U.S. Federal Government to perform research. Financial Interest Is anything of monetary value, including but not limited to: salary or other compensation of services (i.e. consulting fees or honoraria), stock or other equity interests, intellectual property rights, royalties, license fees, directorships and executive roles, reimbursed or sponsored travel; but excluding salary paid through Taylor University. Interested Business with respect to any federal research grant conduct by an investigator, any business that: o Funds such federal research grant in whole or in part, whether through a research agreement, gift or other arrangement o Supplies drugs, devices or other goods that are subject of such federal research grant or services of such deliverables in connections with the federal research grant pursuant to a material transfer agreement, a research agreement or otherwise o Owns, licenses or has any other contractual interest in the federal research grant; or o Acts for or on behalf of another Interested Business, directly or indirectly. NIH National Institute of Health NSF National Science Foundation PHS - Public Health Service, an operating division of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated. Primary Investigator (PI) A person, typically a faculty member, who takes a lead position in the research, attests that identified space, personnel, services and facilities are available to accomplish the work and agrees to put forth the best effort to accomplish the work described in the proposal.

2 Senior / Key Personnel Faculty or staff members of the institution that the PI has identified in the proposal as having a significant role in the work described in the proposal. Personnel who have specific skills and whose work is necessary to the completion or best effort to accomplish the work described in the proposal. Significant Financial Interest Anything of monetary value, including but not limited to salary or other payments for services, equity interest, and intellectual property. The term DOES NOT include: o salary, royalties, or other remuneration from the applicant institution, o income from seminars, lectures or teaching engagements sponsored by public or nonprofit entities, o income from service on advisory committee or review panels for public or nonprofit entities o an equity interest that, when aggregated for the investigator and the investigator s spouse and dependent children, meets BOTH of the following tests: 1. Does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value; and 2. Does not represent more than a 3% ownership interest in a single entity or o salary, royalties or other payments, that when aggregated for the investigator and the investigator s spouse and dependent children, are not expected to exceed $10,000 during the twelve month period. Policy Federal regulations governing grants from certain federal agencies (i.e. NSF and PHS agencies including NIH) require that the University adopt, monitor, and enforce a Financial Conflict of Interest Policy covering financial conflicts that may arise as a result of research funded by such agencies (see regulations at 42 CFR and following). The University recognizes that these conflicts may arise due to interests and investments that faculty and their families may have. The existence of a significant financial interest and any resulting financial conflict(s) is not prohibited in and of itself, but such conflicts must be disclosed to the University and managed appropriately. For these reasons Taylor University adopts the following Financial Conflict of Interest Policy. Process All investigators who apply for or receive grants from the Federal agencies identified above are required to follow these procedures. 1. Disclosures of Significant Financial Interests Using the University s FCOI disclosure form, each investigator shall disclose to the Institutional Official all Significant Financial Interests (i) that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by the grant source or (ii) in businesses or interested businesses whose financial interests would reasonably appear to be affected by such activities. The disclosure form can be downloaded here (xxxx). Investigators must ensure that required disclosures have been submitted by all other coinvestigators and Senior / Key Personnel on their project. 2. Disclosure of Travel Investigators must also disclose reimbursed or sponsored travel to their institutional responsibilities, as defined below in the definition of Federal interest. Travel reimbursed or sponsored by U.S. Federal, state, or local governmental agencies, U.S. institutions

3 of higher education, research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers need not be disclosed. Such disclosures must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and, if known, the monetary value. The Institutional Official will determine if additional information is needed (i.e. the monetary value if not already disclosed) to determine whether the travel constitutes a Financial Conflict of Interest with the investigator s research. 3. Timing of Disclosures - Investigators and designated personnel are required to submit FCOI disclosures as follows: a. Prior to submission of a proposal to the designated external funding agency. b. Annual updates In August of each year, Investigators and Senior/Key Personnel shall complete a FCOI Annual Disclosure Form and submit it to the Institutional Official. c. Within 30 days of acquiring or discovering any new reportable significant financial interests. d. Investigators joining the University who are conducting research sponsored by the agencies to which this policy applies will provide all necessary disclosures within 30 days. e. All Investigators with active external funding from the federal agencies referenced in the above Policy Statement at the time of this Policy s adoption will complete the required disclosure form before xx/xx/xxxx. 4. Review of Disclosures The Institutional Official shall review financial disclosures prior to the expenditure of any funds and determine whether a Financial Conflict of Interest exists. A Financial Conflict of Interest will exist if the Institutional Official or designee determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of federally-supported research. 5. Management Plans Written plans will manage, reduce, or eliminate any Financial Conflict(s) of Interest. Such plans will be designed to meet applicable legal requirements, facilitate the local resolution or management of any conflict, and protect the sensitivity of disclosed information. If the Institutional Official determines that there is a Financial Conflict of Interest, he or she must approve a written management plan before any related research goes forward. The affected investigator is responsible for developing and submitting a proposed management plan to, and in consultation with, the Institutional Official. Management Plans may include one or more elements, such as the following: a. Monitoring of the sponsored program by independent researchers or reviewers, the Institutional Official, an FCOI committee, or a designee. b. Modifications to the research or program plan. c. Appointment of an oversight panel or person to review research / scholarship d. Limitations on the employee s involvement in personnel or other decisions on behalf of the University e. Divestiture of Significant Financial Interests and/or f. Other arrangements that manage, reduce or eliminate a potential Financial Conflict of Interest 6. Reporting to a Federal Agency If any identified conflict or non-compliance requires reporting to the sponsoring federal agency, the Institutional Official will produce such a report in accordance with applicable regulations.

4 Investigator Non-Compliance 1. Disciplinary Action - If an investigator fails to comply with this policy, the Institutional Official may suspend all relevant activities or take other disciplinary action until the matter is resolved or other action deemed appropriate by the Institutional Official is implemented. The decision to impose sanctions on an Investigator because of failure to comply with this policy or with the decision of the Institutional Official will 1) be described in writing to the Investigator and 2) notify the individual with his/her right to appeal the decision. 2. Retrospective Review In some cases the Institutional Official may determine that a FCOI was not identified or managed in a timely manner, including but not limited to an Investigator s failure to disclose a Significant Financial Interest that is determined to be a Financial Conflict of Interest, or an Investigator s failure to materially comply with a management plan for a Financial Conflict of Interest. In such cases a committee appointed by the Institutional Official will complete a retrospective review of the Investigator s activities and the research project to determine whether the research conducted during the period of non-compliance was biased in the design, conduct or reporting of the research. Training Documentation of the retrospective review shall include the project number, project title, PI, name of investigator with the Financial Conflict of Interest, name of the business or interested businesses with which the Investigator has the FCOI, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review. The Institutional Official will update any previously submitted report to the funding agency, specifying the actions that will be taken to manage the FCOI going forward. If bias by the investigator is found, the report will include a mitigation report in accordance with the applicable regulations, including a description of the impact of the bias on the research project and the plan of action to eliminate or mitigate the effect of the bias. Each investigator must complete training on this policy: 1. Prior to engaging in research funded by the above-referenced agencies and at least every four years thereafter 2. When the University revises its policy 3. When an Investigator is new to the University 4. When the University determines that an investigator is not in compliance with the University s policy or the management plan related to their activities. All investigators with active external funding from the federal agencies referenced in the above Policy Statement at the time of this policy s adoption will complete training before 06/01/2013. Record Retention The Institutional Official will retain all disclosure forms, conflict management plans, and related documents for a period of three (3) years from the date the final expenditure report is submitted to the funding agency. Confidentiality

5 To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be kept confidential. However, the University may make such information available to the agency funding the research or to a requestor of information concerning FCOI related to relevant federal funding if requested or required. If the University is requested to provide disclosure forms, conflict management plans, and relate information to an outside entity, the Investigator will be informed of this disclosure.