Financial Conflict of Interest, Slides of History

Download Financial Conflict of Interest and more Slides History in PDF only on Docsity! "" Canadian Cancer Trials Group Financial Conflict of Interest 003 March 16, 2022 Financial Conflict of Interest Policy Doc. No: Version: Date: GAO-POL-0005 V003 2022-Mar-16 Page 2 of 9 Table of Contents 1 Policy Description ..................................................................................................................... 3 2 Introduction and Scope ............................................................................................................ 3 3 Definitions ................................................................................................................................. 3 3.1 Terms............................................................................................................................... 3 3.2 Acronyms ......................................................................................................................... 4 4 Procedure ................................................................................................................................. 5 4.1 Part 1 – The Policy .......................................................................................................... 5 4.1.1 Required Disclosure .................................................................................................... 5 4.1.2 Ceiling Affecting Participation ...................................................................................... 6 4.1.3 Timing .......................................................................................................................... 6 4.1.4 Managing and Reporting Declared Conflicts of Interest .............................................. 7 4.1.5 Investigator Training .................................................................................................... 8 4.2 Non-Compliance and Sanctions ...................................................................................... 8 5 Appendix................................................................................................................................... 9 6 References ............................................................................................................................... 9 7 Revision History ....................................................................................................................... 9 8 Signature .................................................................................................................................. 9 Financial Conflict of Interest Policy Doc. No: Version: Date: GAO-POL-0005 V003 2022-Mar-16 Page 5 of 9 COIC Conflict of Interest Committee FCOI Financial Conflict of Interest CIRB Central Institutional Review Board (US) 4 Procedure 4.1 The Policy 4.1.1 Required Disclosure In accordance with the “Conflict of Interest Policy for Cooperative Group Phase 3 Clinical Trials” (August 2012) and the “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought” (42 CFR Part 50, Subpart F) revised 2011, the CCTG requires the disclosure of significant financial interests related to the Investigator, his/her spouse and dependent child(ren) as follows: • A financial interest consisting of one or more of the following interests (i.e. de minimus threshold) of the Investigator (and those of the Investigator’s spouse and dependent child(ren)) that reasonably appears to be related to the Investigator’s institutional responsibilities: o With regard to any publicly-traded entity, a significant financial interest exists if the value of any remuneration (i.e. salary and any payment for services not otherwise identified as salary [e.g. consulting fees, honoraria, paid authorship] received from the entity in the twelve months preceding the disclosure and the value of any equity interest (i.e. stock, stock option, or other ownership interest in the entity) as of the date of disclosure, when aggregated, exceeds $5,000. o 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 when the Investigator (or the Investigator’s spouse or dependent child(ren)) holds any equity interest (e.g. stock, stock option, or other ownership interest); or o Intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income related to such rights and interests. • Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e. 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 their Group responsibilities; provided, however, that this disclosure requirement 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. The details of this disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration, and may include a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research. • The term significant financial interest does not include the following types of financial interests: Financial Conflict of Interest Policy Doc. No: Version: Date: GAO-POL-0005 V003 2022-Mar-16 Page 6 of 9 o salary, royalties, or other remuneration paid by the Group to the Investigator if the Investigator is currently employed or otherwise appointed by the Group, including intellectual property rights assigned to the Group and agreements to share in royalties related to such rights; o income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; o income from seminars, lectures, or teaching engagements 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; or, o income from service on advisory committees or review panels for 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. 4.1.2 Ceiling Affecting Participation The “Conflict of Interest Policy for Cooperative Group Phase 3 Clinical Trials” (August 2012 defines a maximum threshold above which an Investigator cannot be involved in the development and management of a clinical trial. The following are the criteria for this threshold and CCTG will ensure that the information necessary to determine whether this threshold has been exceeded will be collected. • Payments from sponsor in excess of $25,000 per year during the research and for one year after, not including research compensation; • Any financial arrangement in which value of compensation could be influenced by outcome of the study; • Equity interest in a publicly-traded company sponsor exceeding $50,000 per year during the time of the research and one year after; and/or, • Any interest in a non-publicly traded company whose value cannot be readily determined referencing public prices considered by the Financial Conflict of Interest Committee to be substantial enough to meet the de maximus threshold. 4.1.3 Timing Disclosure of an Investigator’s potential financial conflict of interest (and those of the Investigator’s spouse and dependent children) that reasonably appear to be related to the Investigator’s Group responsibilities by completion of the CCTG Financial Conflict of Interest Form is required as follows: • No later than at the time of application for NIH-funded research; • Within thirty days of discovering or acquiring (e.g. through purchase, marriage, or inheritance) a new Significant Financial Interest; Financial Conflict of Interest Policy Doc. No: Version: Date: GAO-POL-0005 V003 2022-Mar-16 Page 7 of 9 • Prior to/upon assuming a role as outlined in Section 2; and, • At least annually while in a relevant role as outlined in Section 2 to ensure that potential conflicts which develop during the conduct and/or analysis of the trial or the research product or during the dissemination of results, are also disclosed. 4.1.4 Managing and Reporting Declared Conflicts of Interest D isclosures whose value falls between the de minimus and de maximus thresholds will be reviewed by COIC Administrators. Disclosures that relate to PHS-funded research or have a financial conflict of interest will be brought to the COIC meeting for formal review and development of a management plan as applicable. If the COIC believes that the individual’s financial conflict of interest should not disqualify her/him from a leadership position in the study, the Group must submit the financial conflict of interest and a management plan to the NIH through the eRA Commons website via Queen’s as required and to the CIRB at the time of the application, as applicable. For any financial conflict of interest previously reported by CCTG, the CCTG shall provide, through eRA Commons, an annual FCOI report that addresses the status of the financial conflict of interest and any changes to the management plan for the duration of the PHS- funded research project. The annual FCOI report shall specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists. Examples of conditions or restrictions that might be imposed to manage a financial conflict of interest include, but are not limited to: • Public disclosure of financial conflicts of interest (e.g. when presenting or publishing the research); • Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest; • Modification of the research plan; • Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research; • Reduction or elimination of the financial interest (e.g. sale of an equity interest); • Severance of relationships that create financial conflicts; or, • Others at the discretion of the Group. Additionally, specifically for Phase III trials, financial conflicts of interest whose value falls between the de minimis and de maximus thresholds will require that the Management Plan be submitted with any Central Institutional Review Board (CIRB) applications which will require answers to the following two questions be provided (along with the Management Plan): 1. Does the study chair or any principal involved in the development or coordination of this study have any significant financial conflicts of interest as defined in the “Conflict of Interest Policy for NCI/DCTD-supported Cooperative Group or Network Group Randomized Phase 2 and 3 Clinical Trials?” 2. If so, does the Cooperative Group or Network Group have a management plan in place to address the conflicts disclosed in question #1?