Financial Conflict of Interest (FCOI) Policy for PHS-Funded Research, Study notes of Public Health

Download Financial Conflict of Interest (FCOI) Policy for PHS-Funded Research and more Study notes Public Health in PDF only on Docsity! Page 1 of 9 UNIVERSITY OF CAMBRIDGE CONFLICT OF INTEREST POLICY TO MEET U.S. DEPT OF HEALTH AND HUMAN SERVICES AND PUBLIC HEALTH SERVICES (OF WHICH THE NIH IS PART) The Policy This policy consists of a set of requirements to be followed by senior and key personnel participating in research funded by a Public Health Service (PHS) funder, most notably the National Institutes of Health (NIH). The policy applies to any institution (foreign or U.S. domestic) that is applying for or receives research funding from a PHS funder through a grant or cooperative agreement (either directly or via another institution as a sub-awardee) and, consequently, any investigator planning to or who is already participating in such research. Key requirements  All Investigators must disclose any Significant Financial Interest (SFI) with respect to their Institutional Responsibilities to their Head of Department who will determine whether such interest constitutes Financial Conflict of Interest (FCOI).  Where an SFI is determined to be an FCOI, a management plan will be drawn up to help manage, reduce or eliminate the FCOI.  A disclosure of the FCOI and management plan must be submitted to the PHS-funder.  Adherence to the management plan must be monitored.  All PHS-funded Investigators are required to take training on conflicts of interest.  Annual (and in some circumstances more regular) reporting of FCOIs to the PHS- funder is required.  Before any expenditure of PHS funds, information concerning any disclosed SFI which has been determined to be an FCOI relating to PHS-funded research, must be made publicly accessible by written response within 5 working days of request.  See also Key Definitions This policy is drawn from the original HSS regulations: Title 42 – Public Health, Part 50– Policies of General Applicability, Subpart F – Promoting Objectivity in Research Page 2 of 9 Who administers the policy? Key staff required to administer the policy are:  All Investigators  Each Investigator’s Head of Department (or Head of School if the Head of Department is an Investigator)  Each Investigator’s Departmental Administrator  The Research Operation Office: The Research Support Manager in the relevant ROO School team have authorized access to submit forms through the eRA Commons Financial Conflict of Interest Module and hence will submit the Conflict of Interest disclosure report. Page 5 of 9 constitutes an FCOI. But reports must also be submitted if an Investigator does not disclose an SFI in the timeframe required or the University does not review a disclosure but later determines that an FCOI exists. For new Investigators who join the project, for any SFI disclosed which is judged to be an FCOI, the FCOI report must be submitted within 60 days. For a new SFI that is deemed to be an FCOI, a FCOI report must be submitted within 60 days of disclosure. For any FCOI previously reported, the University must provide an annual FCOI report to address the status of the financial interest and any changes to the management plan. The plan must specify whether the FCOI is still being managed or explain why the FCOI no longer exists. Annual reports must be submitted via eRA Commons for the duration of the project period (including extensions with or without funds) at the same time as submitting the annual progress report. All FCOI reports must include sufficient information to enable the PHS-funder to understand the nature and extent of the FCOI and to assess the appropriateness of the management plan. The regulation provides key elements that must be included in the FCOI report to NIH. These include but are not necessarily limited to the following:  Project number  Programme Director (PD)/PI or Contact PD/PI if a multiple PD/PI model is used  Name of the Investigator with the Financial Conflict of Interest  Name of the entity with which the Investigator has a Financial Conflict of Interest;  Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium)  Value of the financial interest (dollar ranges are permissible: $0-$4,999; $5,000- $9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value  A description of how the financial interest relates to the NIH-funded research and why the Institution determined that the financial interest conflicts with such research NOTE THAT THERE IS NO REQUIREMENT TO SUBMIT A REPORT IF THE UNIVERSITY DETERMINES THAT NO DISCLOSURE OF AN SFI CONSTITUTES AN FCOI. Retention of information All records of all Investigator disclosures of financial interests and the University's review, or response to, such disclosure (whether or not a disclosure resulted in determination of an FCOI), and all actions under our own policies or retrospective review, must be retained for at least 3 years from the date of submission of the final expenditures report (or other dates as specified in the regulations (see NIH Grants and Funding FAQs, Section A, 9). Failure to comply If an Investigator fails to comply with the policy or a management plan subsequently put in place, the University must, within 120 days, undertake a retrospective review of the Page 6 of 9 research project to determine if any bias in the design, conduct or reporting of the research. If a bias is found, the PHS funder must be notified and provided with a mitigation plan and thereafter report annually as normal, unless the University decides further interim measures are necessary. The funder is entitled to suspend or terminate the award. Page 7 of 9 Frequently Asked Questions What about sub-recipients? If the University is passing on some of the funds to a sub-recipient, then as the awardee Institution, the University is responsible for ensuring any sub-recipient's compliance with the regulations and reporting identified financial conflicts of interests for sub-recipient investigators. The ROO will ensure that such requirement is addressed in the contract put in place with the sub-recipient. Sub-recipients are entitled to follow the prime awardee's policy; however, where such party has its own compliant policy (as Cambridge does) they will be expected to follow their own. What will the PHS-funder do with the reports? The funder will evaluate the information received to determine whether the University's actions are sufficient to manage the identified FCOI and will use the information to monitor the University's compliance with the regulation, requesting further information as necessary. What is the special requirement for clinical research? In any case in which the HHS determines that an NIH-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a conflicting interest that was not managed or reported by the Institution as required by the regulation, the Institution must require the Investigator(s) involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations. Where can I find out more information? See the helpful NIH FAQ's