Conflict of Interest PolicyPurposeIntroduction Definitions Responsibilities Additional Procedures PurposeThe intent of these Guidelines is to ensure that processes in the Treatment Units on Research on Schizophrenia (TURNS) research contract, including the selection of compounds and the design of TURNS protocols, are not biased by program participants' financial conflicts of interest (as defined in Title 45CFR94,4, "Responsible Prospective Contractors.") These guidelines are intended to supplement, not replace, institutional responsibility for monitoring and management of financial conflict of interest. They provide for an additional level of oversight during the compound selection and study design phases of the TURNS project. The procedures below describe the decision-making process re: compound selection and protocol design, study leadership, and related roles. Management of financial conflicts of interest during the subsequent performance of TURNS protocols at study sites, and the analysis, interpretation, and publication of study findings, will be governed by the financial conflict of interest (COI) policies of the institutions where the studies take place. IntroductionThe success of the TURNS program will depend on its ability to foster collaboration among a diverse group of individuals from academia, industry, and government. The management of TURNS processes requires that promoting and sustaining cooperation among these sectors occur at the same time it assures that decisions are not influenced (or perceived to be influenced) by financial conflicts of interest (COI). This will be accomplished through a process of 1) identification and disclosure of financial interests by all participants in program activities; and 2) development and implementation of specific policies to assure that COIs do not bias the design, conduct or reporting of TURNS research. Participants in TURNS activities were specifically chosen for their expertise in schizophrenia, cognition and drug development. As a result, it is expected that these individuals may have financial relationships with companies or laboratories involved in developing agents that could be considered for inclusion in a TURNS-sponsored clinical trial. It should be noted that TURNS investigators engage in professional activities and relationships outside of their role in the TURNS project and these activities and relationships should not be viewed as inevitably engendering COIs and/or influencing the decisions of TURNS participants as they relate to the TURNS research process. Nonetheless, this document outlines the TURNS approach to dealing with financial disclosure and with any real or perceived conflicts of interest so that they may be managed or removed. The implementation of these Guidelines will be managed by the TURNS Ethics Committee (TEC), which will report to the TURNS Principal Investigator (PI). The TEC and the TURNS PI will rely on the advice of the TURNS Ethics Advisory Board (TEAB). The reporting process for COI and documentation of COI management will be the responsibility of the Financial Disclosure Coordinator, who will report to the TURNS PI. DEFINITIONSRelevant Entities and List of Relevant EntitiesRelevant entities are companies, individuals, academic institutions, and other entities holding intellectual property rights to compounds under consideration for testing in the TURNS clinical trial network. The List of Relevant Entities is a compendium prepared by the PI, based on information provided by the Chair of the TURNS SOU, of companies, individuals, academic institutions, and other entities holding intellectual property rights to compounds under consideration for testing in the TURNS clinical trial network. Financial InterestFor the purpose of these guidelines, financial interest means anything of monetary value received from a relevant entity (such as the manufacturer of a product proposed for study), 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). The term does not include:
All payments made on behalf of a company, including its agent or contractor reimbursements whether made directly or indirectly, should be considered in determining the aggregated total of the monetary interest in an entity. For the purpose of these guidelines, a significant financial interest would include an aggregate total exceeding $10,000 in a calendar year (e.g., 1/1/03 to 12/31/03) with any company. Protocol Development TeamThe group of TURNS Investigators, under the leadership of the Director of the TURNS Trials Management Unit, will be known as the protocol development team. The team will create the research protocols for testing novel compounds targeting cognition in schizophrenia in the TURNS network. Significant Equity InterestSignificant equity interest is an equity interest in a relevant entity (e.g., stocks, stock options, or other ownership interests) for the TURNS participant and immediate family members (spouse and dependent children) that exceeds $10,000 in value determined by fair market value OR is an equity interest (including stock options) that represents more than a 5% ownership interest in any single relevant entity. Stock OptionsAll stock options in a pharmaceutical, diagnostic, or biological company held by a participant or family member.Intellectual Property InterestIntellectual property interest refers to intellectual property rights with a relevant entity (patents, pending patents, copyrights, licensures, royalties, and future stock options) or potential earnings from any patent held by any other party.Potential Conflict of InterestA potential conflict of interest exists when a participant or immediate family member (spouse or dependent children) holds any financial interest including an industry grant or contract, or an equity, stock option, or intellectual property interest in a relevant entity whose product or treatment is involved in a TURNS trial, or being considered for inclusion in a study, or competes with a product or treatment included in a TURNS trial. Compound ReviewerA compound reviewer is a TURNS participant who is designated to collect, summarize, and evaluate all available information on a candidate compound that is nominated for possible testing in the TURNS clinical trial network. RESPONSIBILITIESTURNS ParticipantsTURNS participants include all members of the TURNS Committees and Subcommittees (including Advisory Committees), consultants, and investigators in TURNS trials. Each TURNS participant should keep in mind the potential for conflicts of interest as he/she pursues TURNS-related activities. If a TURNS participant has questions or concerns about undertaking an activity that could be construed as a conflict of interest, he/she shall bring such concerns to the Chair of the TEC. All TURNS participants are required to complete a TURNS Statement of Financial, Equity, and Intellectual Property Interests (Appendix A) and submit it to the Financial Disclosure Coordinator (FDC) at least annually. Each completed Statement should cover the prior calendar year and any interests that accrue or might accrue in the current calendar year. TURNS participants should update their disclosures annually and whenever there is a change in financial interest that could affect their participation in TURNS activities. This includes the addition of a new financial relationship or the elimination of a prior financial relationship. Should a TURNS participant directly submit a nomination for a compound to be considered for testing in the TURNS clinical trial network, the proposing individual must disclose to the TURNS FDC any financial interest from an industry grant or contract, financial, equity, or intellectual property interest they or their immediate family members may have or anticipate obtaining in an involved company or directly competing company that will be affected by the proposed study. This responsibility can be met by attaching a completed (or updated) TURNS Statement of Financial, Equity, and Intellectual Property Interests form. All members of the TURNS team evaluating compounds or study nominations must submit or have on file a current TURNS Statement of Financial, Equity, and Intellectual Property Interests.The Financial Disclosure Coordinator (FDC)The FDC, appointed by the TURNS PI, will collect the "Statement of Financial, Equity, and Intellectual Property Interests" form from all TURNS participants on an annual basis and as indicated below. The FDC will assist the PI in maintaining a list of "relevant entities" and will maintain a standing list of all significant financial interests disclosed by TURNS scientists. Participants are also responsible for reporting important changes in relationships or new relationships with companies that are involved in TURNS activities that occur after the annual report. The FDC will report TURNS participants delinquent in reporting to the PI. The FDC will maintain a record of actions taken by the TEC to manage potential COIs of TURNS participants and assist the PI in preparing reports to the NIMH Data Safety Monitoring Board (DSMB) and the TEAB of actions taken to manage COI.TURNS PIWith the assistance of the FDC, and based on a comparison of TURNS participants' financial disclosures and the list of relevant entities, the TURNS PI will create a list of all TURNS participants who have disclosed financial interests in companies or other entities holding intellectual property rights to a compound under consideration for testing in the TURNS clinical trial network. This list will be forwarded to the TEC no less than quarterly. In addition, the TURNS PI will be responsible for reporting the identification and management of identified COIs to the NIMH Data Safety and Monitoring Board responsible for overseeing the TURNS clinical trials, and to the TEAB.TURNS Ethics Committee (TEC)The TEC, appointed by the PI, will include TURNS participants from the Trial Management Unit (TMU), the Coordinating Center, the Scientific Operations Unit (SOU), one or more Federal Scientists who do not have significant financial interest or significant equity interest in any pharmaceutical or biotechnology concern, individual(s) with expertise in ethics, patient or family-member representative(s) of the advocacy community, and possibly other experts not affiliated with the participating institutions. The number of TURNS participants voting at each meeting will not exceed the number of voting non-TURNS TEC Committee members. The TEC will report to the TURNS PI, and will be responsible for determining the management plans for all identified conflicts of interest that affect TURNS. The TEC may also propose revisions in the COI policy and guidelines to the TURNS Steering Committee. At least quarterly, the TEC will receive a list from the PI of individual TURNS scientists who have disclosed significant financial interests in relevant entities. For each individual on the list, the TEC will determine how the potential or real COI will affect the individual's participation in program activities. The TEC will utilize the COI Management Guidelines described in the section that follows in making their determinations. In addition, the list of all participating members who disclosed significant financial interest in a relevant entity will be provided by the FDC to the Chair and all members of all TURNS committees including the TURNS Compound Selection Committee, the Publications Committee, the TMU and the SOU. TURNS Ethics Advisory Board (TEAB)The TEAB will advise the TURNS PI and TEC regarding the adequacy of financial COI policies, and other ethical issues including, but not limited to informed consent, decisional capacity and clinical trial design. The TEAB will review and comment on TURNS COI policies and procedures prior to their implementation, and remain available to consult with the TURNS PI on other ethical issues that may emerge in the course of selecting compounds, designing, and conducting clinical studies. It will also receive reports from the FDC of actions taken to manage potential COIs. The TEAB will meet annually in live meetings or by conference call. More frequent meetings may be requested by the TURNS PI.ADDITIONAL PROCEDURESPublic Disclosure of Financial InterestsThe FDC will be responsible for disclosure of potential COIs to the public. This includes listing summarized financial disclosures for each TURNS participant on the TURNS website and responding to inquiries regarding potential COIs.COI Management GuidelinesThe TEC will use the following guidelines for COI management, which will be posted on the TURNS website and distributed to all TURNS participants:
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| Revised: 25-Oct-2004 |