Financial Procedure Note FPN 13. Financial Conflict of Interest Policy

Transcription

1 Financial Procedure Note FPN 13 Financial Conflict of Interest Policy September 2013 Financial Procedure Notes supplement Financial Regulations, providing detailed guidance on various topics. Failure to comply with these procedures could result in disciplinary action. 1. Purpose This policy applies to all research funded or proposed for funding by the Public Health Service of the U.S. Department of Health and Human Services (PHS), including the National Institutes of Health (NIH) and any components of the PHS to which the authority of the PHS may be delegated. The purpose of this policy is to implement the requirements of the federal regulations set forth in 42 CFR Part 50 and 45 CFR Part 94, and any additional regulations that may be in effect from time to time, governing investigators responsibilities for promoting objectivity in PHSfunded research. 2. Covered Parties This policy applies to all persons responsible for designing, conducting or reporting PHS-funded research under the auspices of the University of Essex. 3. Defined Terms Institution refers to any domestic or foreign, public or private entity or organisation that is the direct recipient of PHS grant funds or that submits an application for a research grant/contract and is accountable for the performance of the research grant/contract. Institutional Official means the Director of Finance or his nominee. The Institutional Official is responsible for ensuring implementation of this policy and for review of disclosures of Significant Financial Interest from investigators. Investigator means any individual who is responsible for the design, conduct, or reporting of PHS funded research, or proposals for such funding. This definition is not limited to those titled or budgeted as principal investigator or co-investigator on a particular proposal, and may include postdoctoral associates, senior scientists, or graduate students. The definition may also include collaborators or consultants as appropriate. Institutional Responsibilities mean an Investigator s professional responsibilities on behalf of the University of Essex including but not limited to research, teaching, and administration such service on committees, boards and panels. Financial Conflict of Interest (FCOI) means a Significant Financial Interest (defined below) that could directly and significantly affect the design, conduct or reporting of PHS-funded research. Significant Financial Interest (SFI) is defined as anything of monetary value that reasonably appears to be related to the Investigator s Institutional Responsibilities, including but not limited to: salary or other payments for services (e.g., consulting fees, honoraria, or paid authorships for other than scholarly works);

2 reimbursed or sponsored travel (sponsored travel being that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to an Investigator s Institutional Responsibilities; equity interests (e.g., stocks, stock options, or other ownership interests); 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 that exceed $5,000. Significant Financial Interest does NOT include: salary, royalties, or other remuneration paid by the University of Essex to the Investigator; intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights income from the authorship of academic or scholarly works; income from seminars, lectures, teaching engagements, service on advisory committees or review panels, or travel expenses that are reimbursed or sponsored by governmental agencies; institutions of higher education; research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centres; 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 also exists if: o with regards to any 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; 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 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. Policy A. Investigator Responsibilities This policy requires Investigators to (i) disclose Significant Financial Interests (including financial interests of the Investigator s spouse and dependent children, (ii) comply with the Review Process, and (iii) complete training with respect to PHS-Funded Research. 1. Disclosure. Each Investigator must disclose all of his/her Significant Financial Interests (SFIs), and those of the Investigator s spouse and dependent children, that reasonably appear to be related to the Investigator s Institutional Responsibilities. i. Upon submitting an application for funding. Each Investigator who is planning to participate in PHS-funded research must complete the SFI disclosure form and submit it to the Director of Finance no later than the time of the application. The Institution will not submit a research proposal unless the Investigator(s) have submitted a disclosure.

3 ii. iii. Annually. Each Investigator who is participating in PHS-funded research must submit an updated disclosure of SFIs at least annually during the period of the award. New SFI. Each Investigator who is participating in PHS-funded research must submit a disclosure within thirty (30) days of discovering or acquiring a new SFI. B. Travel Investigators must also disclose reimbursed or sponsored travel related to their institutional responsibilities, as defined above in the definition of Significant Financial Interest. 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 (e.g., the monetary value if not already disclosed) to determine whether the travel constitutes a Financial Conflict of Interest with the Investigator s research. C. Training Each Investigator must complete training on this Policy prior to engaging in research funded by PHS, and at least every four years thereafter. They must also complete training within a reasonable period of time as determined by the Institutional Official in the event that this Policy is substantively amended in a manner that affects the requirements of Investigators, or if it is determined that the Investigator has not complied with this policy or with a management plan related to their activities. Online training is available via this link: D. Review and Decision of the Institutional Official If the disclosure form reveals a Significant Financial Interest, it will be reviewed promptly by the Institutional Official or nominee for a determination of whether it constitutes a Financial Conflict of Interest. If a Financial Conflict of Interest exists, the Institutional Official will take action to eliminate, reduce, or manage the conflict, as appropriate. A Financial Conflict of Interest will exist when the Institutional Official or nominee determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of PHS-supported research. If the Institutional Official determines that there is a Financial Conflict of Interest that can be managed, he or she must require and approve a written management plan before any related research goes forward. The affected Investigator is responsible for developing and submitting a proposed management plan, in consultation with the Institutional Official. E. Reporting to PHS Prior to the Institution s expenditure of any funds under a PHS-funded research project, the Institution shall provide to the PHS an FCOI report regarding any Investigator s SFI found by the Institution to be conflicting and ensure that the Institution has implemented a management plan in accordance with regulation 42 CFR In the case where there are no FCOI the Institution shall not submit an FCOI report to the PHS. If the funding for the Research is made available from a prime PHS-awardee, such reporting shall be made available to the prime awardee such that they may fulfil their reporting obligations to the PHS F. Investigator Non-Compliance i. Disciplinary Action In the event of an Investigator s failure to comply with this Policy, the Institutional official may suspend all relevant activities or take other disciplinary

4 action until the matter is resolved or other action deemed appropriate by the Institutional official is implemented. ii. Retrospective Review G. Record Retention In addition, if the Institutional Official determines that a Financial Conflict of Interest 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 failure by an Investigator to materially comply with a management plan for a Financial Conflict of Interest, 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. The Institutional Official will retain all disclosure forms, conflict management plans, and related documents for a period of three years from the date the final expenditure report is submitted to the PHS or to the prime PHS awardee. H. Confidentiality To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential. However, the Institution may make such information available to an agency funding research of the faculty member, to a requestor of information concerning financial conflict of interest related to PHS funding or to the primary entity who made the funding available to the Institution, if requested or required. If the Institution is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the Investigator will be informed of this disclosure. I. Public Accessibility Prior to the expenditure of funds, the Institution will publish on a publicly-accessible website or respond to any requestor within five business days of the request, information concerning any Significant Financial Interest that meets the following criteria: a) The Significant Financial Interest was disclosed and is still held by the Investigator; b) A determination has been made that the Significant Financial Interest is related to the PHS-funded research; and c) A determination has been made that the Significant Financial Interest is a Financial Conflict of Interest. According to the U.S. DHHS Organizational Chart and the Catalog of Federal Domestic Assistance, the following organizations require compliance with PHS regulations. U.S. Public Health Services Agencies include: Administration for Children and Families Administration on Aging Administration for Community Living Agency for Healthcare Research and Quality (AHRQ) Agency for Toxic Substances and Disease Registry (ATSDR) Biomedical Advanced Research and Development Authority (BARDA) Centers for Disease Control (CDC)

5 Centers for Medicare and Medicaid Services (CMS) [formerly HCFA] Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Indian Health Services (IHS) National Cancer Institute (NCI) National Institutes of Health (NIH) Office of Consumer Information and Insurance Oversight Office of Disease Prevention and Health Promotion Office of Global Affairs Office of the Assistant Secretary for Health, including Office of Minority Health Resources Center (OMH) Office of Population Affairs (OPA) Office of Research Integrity (ORI) Office of Research on Women s Health (OWH) Office of the Assistant Secretary for Preparedness and Response, including President s Council on Physical Fitness and Sports Program Support Center Substance Abuse and Mental Health Services Administration (SAMHSA) Non PHS organizations which have adopted the PHS regulations: Alliance for Lupus Research American Cancer Society American Heart Association Arthritis Foundation California Institute for Regenerative Medicine (CIRM) Susan G. Komen for the Cure

6 University of Essex Significant Financial Conflict of Interest Disclosure Form For the period 1st September 20[ ] 30 August 20[ ] To be completed by all investigators involved in Research Projects funded by PHS Public Health Service of the U.S. See page two of this form for the definition of investigator and other terms according to U.S. regulations. Section A Name School Telephone Address 1. Do you, your spouse, or any dependent children, in aggregate have Significant Financial Interests (a) that would reasonably appear to be affected by activities funded or proposed for funding by NIH; or (b) in Entities not controlled by the University whose financial interests would reasonably appear to be affected by such activities? 2. YES NO 3. Please sign below to certify (a) that you have fully and to the best of your ability completed this disclosure form (including, if you answered YES to question 1, separate entries for each relevant entity on photocopied duplicates of Section B below), and (2) that you will update your disclosure form promptly if relevant circumstances change. Signature Date Section B (To be completed only if answer is yes to Question 1, Section A) Name of Entity: Activity or product of entity related to current or prospective university-based research or educational activities: Annual income from entity, including fair value of nonmonetary payments: $5,000 or less More than $5,000 Basis for payments or gratuities to you or your family: Participation as employee Consulting or occasional lecturing Service on Advisory or Directors Boards Writing commissioned papers or reports Payments of royalties on patents and copyrights, etc. Other ( ) Nature of ownership interest in entity: Stocks or Stock options Partnership Other ( ) Value of ownership interest: $5,000 or less More than $5,000 Percentage of ownership,

7 5% or less 5%-15% 15%-50% More than 50% Travel - Investigators must also disclose details of sponsored travel related to their institutional responsibilities. Purpose of Trip Sponsor Destination Dates and Duration Continue on separate sheet if necessary CONFLICT OF INTEREST DISCLOSURE FORM DEFINITIONS The term significant financial interest signifies 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). Significant Financial Interest does NOT include: salary, royalties, or other remuneration paid by the University of Essex to the Investigator; intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights income from the authorship of academic or scholarly works; income from seminars, lectures, teaching engagements, service on advisory committees or review panels, or travel expenses that are reimbursed or sponsored by governmental agencies; institutions of higher education; research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centres; An equity interest that when aggregated for the investigator and the 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 The term investigator signifies any individual who is responsible for the design, conduct, or reporting of PHS funded research, or proposals for such funding. This definition is not limited to those titled or budgeted as principal investigator or co-investigator on a particular proposal, and may include postdoctoral associates, senior scientists, or graduate students. The definition may also include collaborators or consultants as appropriate.