ࡱ>     { jbjbjBrBr   _  jjJJJtJB:(888 < HBJBJBJBJBJBJB$DGXnBJ!B!!nBjj88 B%%%!j8J8HB%!HB%%9 @t;8ޮi<1"(:4BB0B>:6G$G,;;G <(!!%"! .!W!!!nBnB$!!!B!!!!G!!!!!!!!! 0: Eastern Illinois University Policy on Financial Conflict of Interest For PHS-funded Projects Much of this document was drawn directly from material published by the National Institutes of Health. Some material on Form A was copied or modified from a similar form published by the University of Oregon. Eastern Illinois University thanks the University of Oregon for permission to use this wording. Eastern also thanks Indiana State University for permission to use a sentence from their FCOI policy. TABLE OF CONTENTS I. Introduction.1 II. Relevant Regulations...1 III. Applicability1 IV. Definitions...1 V. Responsibility....3 VI. Public Accessibility.....4 VII. Training Requirement..4 VIII. Subrecipients.4 IX. Institutional Official......5 X. Disclosures Required of Investigators...5 XI. Guidelines for Analyzing Financial Interests..................................................................6 XII. Management of Financial Conflicts of Interest....7 XIII. Handling Noncompliance...8 XIV. Reporting FCOIs to the Public...10 XV. Reporting FCOIs to the PHS...10 XVI. Maintenance of Records.. 12 XVII. Enforcement Mechanisms and Sanctions...12 XVIII. Policy Changes....12 Appendix Form A Form B Form C Form D I. Introduction Eastern Illinois University recognizes the importance of promoting objectivity in research for which Public Health Service funding is sought or accepted. In the design, conduct, and reporting of such research, the university intends to avoid bias caused by financial conflicts of interest on the part of the investigator. This document elaborates Easterns policy on Financial Conflict of Interest. II. Relevant Regulations Easterns policy is designed to comply with all regulations of the National Institutes of Health (NIH) and the Public Health Service (PHS). Specifically, Eastern acknowledges the following portions of the Code of Federal Regulations as the source of such regulations and the guide for setting University policy: 42 CFR Part 50 Subpart F (grants and cooperative agreements) 45 CFR Part 94 (contracts) Initial Regulation effective 10-1-95  HYPERLINK "http://grants.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm" http://grants.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm Revised Final Rule published on 8-25-11  HYPERLINK "http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf" http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf III. Applicability This policy applies to any EIU investigator who participates in the design, conduct or reporting of research supported by NIH or PHS as a result of a proposal submitted on or after July 1, 2012. The policy also applies to subawardees, as described in section VIII. IV. Definitions A. Research Research means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). The term includes any such activity for which research funding is available from NIH or any other PHS component. The funding may be a cooperative agreement, a research grant, a career development award, a center grant, an individual fellowship award, an infrastructure award, an institutional training grant, a program project, or a research resources award. B. Investigator: An investigator is the project director or principal investigator or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by NIH or PHS or proposed for such funding. Collaborators or consultants are investigators. C. Senior/key personnel Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Eastern as part of compliance with FCOI regulations. (This definition differs from the one found in the NIH Grants Policy Statement.) D. PD/PI PD/PI means a project director or principal investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator. E. Institutional Responsibilities Institutional responsibilities are an investigators professional responsibilities on behalf of Eastern Illinois University. Examples of institutional responsibilities includebut are not limited toteaching, research, research consultation, professional practice, and service on university committees. F. Financial Interest A financial interest is anything of monetary value, whether or not the value is readily ascertainable. A financial interest can be created by any of three routes. 1. Equity or remuneration from an entity An investigator has a financial interest in an entity if, within the twelve months preceding the reporting date, the investigator receives remuneration from or owns equity in an entity. (A financial interest by the investigators spouse or dependent child is considered to be a financial interest of the investigator.) 2. Revenue from intellectual property An investigator has a financial interest in intellectual property (e.g., patents and copyrights) if he or she receives revenue from such property within the twelve months preceding the reporting date. 3. Travel An investigator has a financial interest in travel if, within the twelve months preceding the reporting date, the investigator has received reimbursement or sponsorship for travel that is related to institutional responsibilities. If (Sponsorship means that the travel is paid on behalf of the investigator, and the exact monetary value may not be readily available.) G. Significant Financial Interest (SFI) A financial interest rises to the level of a SFI only if three criteria are met: 1. The financial interest reasonably appears to be related to the investigators institutional responsibilities. 2. The value of the financial interest exceeds specific threshold values. a. Interest in a publicly traded entity: The sum of remuneration from and equity in the entity exceeds $5,000. (Remuneration includes salary and any other payment for services, e.g., consulting fees, honoraria, and paid authorship. Equity includes stock, stock options, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value. ) b. Interest in a non-publicly traded entity: Total remuneration from the entity exceeds $5,000 or the investigator (or spouse or dependent child) holds any equity interest. c. Interest in intellectual property rights (e.g., patents and copyrights): Total income related to such rights exceeds $5,000. d. Interest in travel Any reimbursed or sponsored travel is a significant financial interest unless the reimbursement has been made by or routed through Eastern Illinois University. 3. The financial interest does not arise from any of the following sources, all of which are excluded from the PHS definition of a significant financial interest: A. Salary, royalties or other remuneration paid by EIU to the investigator. B. Intellectual property rights that have been assigned to EIU and agreements to share in royalties produced by such rights. C. Income from investment vehicles such as mutual funds and retirement accounts, provided the investigator does not control the investment decisions made in these vehicles. D. Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. E. Income from service on advisory committees or review panels for a federal, state, or local government agency, institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. The foregoing five exclusions are the only ones that EIU recognizes as valid. Eastern Illinois University, rather than the investigator, makes the determination of whether a financial interest should be considered a SFI. H. Financial Conflict of Interest (FCOI) An SFI that could directly and significantly affect the design, conduct, or reporting of research funded by NIH (or PHS) is a Financial Conflict of Interest (FCOI). Eastern Illinois University, rather than the investigator, makes the determination of whether an SFI should be considered an FCOI. I. FCOI Report An FCOI report is Easterns report of a financial conflict of interest which is submitted to NIH or some other component of PHS. V. Responsibilities A. Responsibilities of the Investigator 1. Disclose all Significant Financial Interests. 2. Comply with EIU policies and procedures. B. Responsibilities of Eastern Illinois University 1. Develop and implement policies and procedures that promote compliance with NIH regulations. 2. Provide information to each Investigator. Information will include: a. the existence of the relevant federal regulations mentioned in part II b. Easterns FCOI policy c. the Investigators responsibility to disclose SFIs d. the Investigators responsibility to complete training as described in part VII. The process used to communicate this information will consist of the following action: The director of the Office of Research and Sponsored Programs will send an email message to each new investigator. (A new investigator is an investigator who has not yet completed two steps: (1) submitting a disclosure of financial interests using Form A, and (2) completing FCOI training as described in part VII.) The email will inform the investigator of items 2.a d. 3. Evaluate Significant Financial Interests and identify any that qualify as a Financial Conflict of Interest. 4. Report to the PHS as described in section XIII and XV. 5. Make the FCOI policy publicly available by posting it on the university website. VI. Public Accessibility This FCOI policy will remain accessible on Easterns website. Public disclosure of FCOI information about individual investigators will also be publicly available as described in section XIV. VII. Training Requirement Prior to engaging in PHS-funded research, each investigator must complete the online training program found at  HYPERLINK "https://www.citiprogram.org/Default.asp" https://www.citiprogram.org/Default.asp After initial training, the investigator will complete training at least every four years. In addition to the forgoing two conditions, immediate training is required when any of the following circumstances apply: (1) Eastern revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators; (2) An Investigator is new to Eastern; or (3) Eastern finds that an Investigator is not in compliance with the universitys financial conflict of interest policy or management plan. VIII. Subrecipients If Eastern carries out research through a subrecipient (e.g., a subcontractor or a consortium member), Eastern is responsible for ensuring that each subrecipient Investigator complies with PHS FCOI regulations. In consultation with the subrecipient, Eastern will craft a written agreement that ensures such compliance by either of the following two options: (1) Depend on the Subrecipients FCOI policy If the parties agree that the subrecipients Investigators must comply with the subrecipients FCOI policy, the subrecipient shall certify as part of a written agreement with Eastern that the subrecipients policy complies with the Code of Federal Regulations sections mentioned in part II of Easterns FCOI policy. Additionally, the written agreementshall specify timeperiod(s) for the subrecipient to reportall identified financial conflicts ofinterest to Eastern Illinois University. Suchtime period(s) shall be sufficient toenable Eastern toprovide the PHS FCOI reports prior to the expenditure of any funds by the subrecipient and within 60 days of any subsequently identified FCOI. By the time of the initial application for funding from the PHS, the potential subawardee shall supply Eastern with a copy of (1) a training certificate and (2) a disclosure of financial interests submitted by each investigator from the subawardee institution. (2) Depend on Easterns FCOI Policy If thesubrecipient is unable or unwilling to certify that its FCOI policy complies with the Code of Federal Regulationsor if Eastern prefers to depend on its own FCOI policy--then the written agreement between the two parties shall state that the subrecipients Investigators must comply with Easterns FCOI policy. The agreementshall also specify timeperiod(s) for the subrecipient to submitall Investigator disclosures of significantfinancial interests to Eastern Illinois University. Such time period(s) shall besufficient to enable Eastern to complete itsreview, management, and reportingobligations prior to the expenditure of any funds by the subrecipient and within 60 days of any subsequently identified FCOI. The procedure for implementing this policy shall consist of adding an attachment to Easterns standard form (based on the Federal Demonstration Project model agreement) for formalizing subawards. IX. Institutional Official Eastern Illinois University designates the Dean of the Graduate School as the Institutional Official responsible for FCOI compliance. The Institutional Official shall solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the PHS-funded research. The Dean of the Graduate School may delegate any or all of these responsibilities by writing a letter that documents the delegation. X. Disclosures Required of Investigators A. Initial Disclosure Each Investigator who is planning to participate in research described in a grant application submitted to the PHS must disclose his or her financial interests (and those of the Investigators spouse and dependent children) no later than the time of application for PHS funded research. Form A shall be used for this disclosure. If, within the 12 months prior to an application for PHS funding, an investigator has already disclosed all financial interests in an Annual Disclosure, a Disclosure of New Financial Interest(s), or a Retrospective Disclosure, then no Initial Disclosure is required at the time of the application. B. Annual Disclosure Each Investigator who is participating in research funded by PHS must submit an updated disclosure of financialinterests to Easterns Institutional Official at least annually during the period ofthe award. Such disclosure shallinclude any information that was notincluded in the Initial Disclosure or in a subsequent disclosure offinancial interests (e.g., anyfinancial conflict of interest identifiedon a PHS-funded project that wastransferred from another Institution),and shall include updated informationregarding any previously disclosedfinancial interest (e.g., theupdated value of a previously disclosedequity interest).Form A shall be used for this disclosure. Annual disclosures are due by June 30 of each year. C. Disclosure of New Financial Interest(s) Each Investigator who isparticipating in research funded by PHS must submit an updateddisclosure of financialinterests to Easterns Institutional Official within thirty days ofdiscovering or acquiring (e.g., throughpurchase, marriage, or inheritance) anew financial interest. Form A shall be used for this disclosure. D. Retrospective Disclosure If Eastern determines that an investigator (who may be a subrecipient) failed to deliver timely disclosure of a financial interest, the investigator shall be required to submit a Retroactive Disclosure. Form A shall be used for this disclosure. XI. Guidelines for Analyzing Financial Interests A. Identifying SFIs Upon receipt of Form A Part 2 (and before Eastern expends any funds on a newly-awarded grant from the PHS) the Institutional Official shall use the following decision rule to identify SFIs: If a disclosed financial interest reasonably appears to be related to the investigators institutional responsibilities, then that financial interest is a SFI. Form B shall be used to document the Institutional Officials analysis and conclusion. A copy of the completed Form B shall be sent to the investigator. B. Identifying FCOIs After determining that a financial interest is a SFI, the Institutional Official shall use the following two criteria to determine whether each SFI is a Financial Conflict of Interest: 1. The SFI is related to PHS-funded research. The SFI is related to PHS-funded research if either of the following two conditions is met: A. The SFI could be affected by the PHS-funded research. B. The SFI is in an entity whose financial interest could be affected by the research. 2. The SFI could directly and significantly affect the design, conduct, or reporting of PHS-funded research. If both criteria are true of a given SFI, then the Institutional Official shall determine that the SFI is a Financial Conflict of interest. Form B shall be used to document the Institutional Officials analysis and conclusion. A copy of the completed Form B shall be sent to the investigator. A decision by the Institutional Official may be appealed to the Provost within 30 days of the date of notification of the Institutional Officials decision. 3. Timing of Analysis by the Institutional Official Type of DisclosureRequired Completion Date of AnalysisInitialPrior to expenditure of fundsAnnualWithin 60 days of disclosureNew Financial InterestWithin 60 days of disclosureRetrospectiveWithin 60 days of discovery of noncompliance XII. Management of Financial Conflicts of Interest Once a FCOI has been identified and documented, Eastern Illinois University shall be responsible for developing and implementing a management plan that shall specify the actions that have been, and shall be, taken to manage such financial conflict of interest. The Institutional Official shall develop this management plan in consultation with the investigator. Form C shall be used to document the management plan. A management plan shall include the following key elements: (1) Role and principal duties of the conflicted Investigator in the research project; (2) Conditions of the management plan (vida infra); (3) How the management plan is designed to safeguard objectivity in the research project; (4) Confirmation of the Investigators agreement to the management plan; (5) How the management plan will be monitored to ensure Investigator compliance; and (6) Other information as needed. Conditions specified by the plan may include any or all of three options: manage, reduce, or eliminate the FCOI. Examples of each type of action include, but are not limited to the following: Manage Public disclosure of financial conflicts of interest: in publications and/or presentations in which the research results are circulated, to other staff working on the project, to human research subjects participating in the research (this information is usually provided in consent forms), and/or to the grantee institutions Institutional Review Boards (these boards ensure the rights and safety of people participating in clinical trials). Ensure that protections are in place to prevent the exertion of inappropriate pressure on other staff working on the grant-funded project: ensuring that staff who work on the grant knew where to bring any concerns about the impact of the conflict on them or the research, ensuring that 鶹ý and trainees were not involved with the company with which the researcher had a relationship, and/or gaining prior approval before allowing 鶹ý and trainees to conduct research related to the company. Other common methods to manage conflicts include: requiring researchers to notify the grantee institution when and how relationships with the outside companies changed (this included changes in equity amounts, changes in the nature of the researchers relationship with the outside companies, changes in any funding of the research provided by the outside companies, and accrual of royalties), requiring researchers to ensure that an open exchange of research results would take place, monitoring or oversight of the grant research by grantee institution staff not related to the grant research, and limiting or prohibiting researchers from research involving human subjects. Reduce 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 participating in all or a portion of the research. Reduction of the financial interest (e.g., by sale of equity interest) Eliminate Elimination of the entire financial interest (e.g., by sale of equity interest) Severance of relationships that create financial conflicts Eastern shall monitor the Investigators compliance with the management plan on an ongoing basis until the completion of the PHS-funded project. Form D shall be used to document the monitoring of the management plan. Depending on the nature of the significant financial interest, the Institutional Official may determine that additional interim measures are necessary with regard to the Investigators participation in the PHS-funded research project between the date of disclosure and the completion of the Institutions review. A decision by the Institutional Official may be appealed to the Provost within 30 days of the date of notification of the Institutional Officials decision. XIII. Handling Noncompliance Noncompliance with FCOI policy includes (but is not limited to) several possibilities: (1) failure by the Investigator to disclose a significant financial interest that is determined by Eastern to constitute a financial conflict of interest; (2) failure by the Eastern to review or manage such a financial conflict of interest; (3) failure by the Investigator to comply with Easterns FCOI policy or with a FCOI management plan; or (4) bias is found in the design, conduct, or reporting of PHS funded research even if such bias was created with a management plan in place. In the event that Eastern receives evidence of noncompliance with the universitys FCOI policy or with an FCOI management plan, Eastern shall promptly undertake two actions: (1) Within 14 days of receipt of the evidence, the Institutional Official shall review the evidence and draw a conclusion as to whether noncompliance, in fact, occurred. (2) Within 7 days of conclusion of the Institutional Officials review, Eastern shall notify the PHS Awarding Component if noncompliance has occurred. Within 120 days of Easterns determination of noncompliance, the university shall complete a retrospective review. Such a review shall examine all of the Investigators activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research. The Dean of the Graduate School shall be responsible for conducting the retrospective review and may appoint a review panel to participate in the review. Eastern shall document a retrospective review with at least the following key elements: (1) Project number; (2) Project title; (3) PD/PI or contact PD/PI if a multiple PD/PI model is used; (4) Name of the Investigator with the financial interest; (5) Name of the entity with which the Investigator has a (potential) FCOI; (6) Nature of the financial interest (e.g. equity, consulting fee, travel reimbursement, honorarium; (7) Value of the financial interest Value will be reported in dollar ranges: $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; (8) Reason(s) for the retrospective review; (9) Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed); (10) Findings of the review, including a description of how the financial interest relates to the PHS-funded research and, if the financial interest is determined to conflict with the research, the basis for the Institutions determination. (11) Conclusions of the review. (12) If the conclusion is that the investigators financial interest is an FCOI, then The Institutional Official may conclude that the findings and conclusions of the retrospective review warrant further action(s). In such cases, Eastern shall update any relevant FCOI report that was submitted to the PHS. The update shall specify the actions that will be taken to manage the financial conflict of interest going forward. If bias is found, Eastern is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review and a description of the impact of the bias on the research project and Easterns plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, Eastern will annually submit FCOI reports to the PHS. Depending on the nature of an identified financial conflict of interest, Eastern may determine that additional interim measures are necessary with regard to the Investigators participation in the PHS-funded research project between the date that the financial conflict of interest or the Investigators noncompliance is determined and the completion of the Institutions retrospective review. If the failure of an Investigator to comply with an Easterns financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, Eastern shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. In any case in which the HHS determines that a PHS-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 financial conflict of interest that was not managed or reported by the Institution as required by this subpart, Eastern shall require the Investigator 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. XIV. Reporting FCOIs to the Public Prior to expenditure of any funds under a PHS-funded research project, Eastern shall ensure public accessibility of FCOI information to any requestor within five business days of a written request. Information shall be available about any financial interest that meets the following three criteria: (1) The significant financial interest was disclosed and is still held by the senior/key personnel; (2) Eastern determines that the significant financial interest is related to the PHS-funded research; and (3) Eastern determines that the significant financial interest is a financial conflict of interest. The information that the Eastern makes available shall include, at a minimum, the following: (1) the Investigators name; (2) the Investigators title and role with respect to the research project; (3) the name of the entity in which the significant financial interest is held; (4) the nature of the significant financial interest; and (5) the approximate dollar value of the significant financial interest 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. Such information shall remain available to all written requests for three years from the date that the information was most recently updated. XV. Reporting FCOIs to the PHS A. Reporting requirements There are five circumstances that require submission of a report to the PHS component that awarded a grant to Eastern. 1. FCOI identified for investigator(s) on a new award: Prior to expenditure of any funds under a new PHS-funded research project, Eastern shall provide to the PHS Awarding Component an FCOI report regarding any Investigators significant financial interest which Eastern has found to be conflicting. The report shall document that Eastern has implemented a management plan in accordance with section XII. In cases in which Eastern identifies a financial conflict of interest and eliminates it prior to the expenditure of PHS-awarded funds, Eastern shall not submit an FCOI report to the PHS Awarding Component. 2. FCOI identified for an investigator who is newly participating on an existing project: For any significant financial interest that Eastern identifies as conflicting subsequent to Easterns initial FCOI report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), Eastern shall provide to the PHS Awarding Component, within sixty days, an FCOI report regarding the financial conflict of interest and ensure that Eastern has implemented a management plan. 3. New or newly-identified FCOI for existing investigator(s): This circumstance shall be handled in the same manner specified in section X.A.2. 4. Ongoing awards: For any financial conflict of interest previously reported with regard to an ongoing PHS-funded research project, Eastern shall provide to the PHS-Awarding Component 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. Eastern shall provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component. 5. Noncompliance: Initial reporting of noncompliance is covered in section XIII. Follow-up with a retrospective review can be prompted by any of the circumstances listed in section XIII. Following completion of a retrospective review, Eastern shall submit a report of findings to the PHS Awarding Component if the review identifies an FCOI. The findings shall include a Mitigation Report if this report is required by section XIII. B. Process for reporting The process of reporting to the PHS is implemented by use of Form B. One section of this form is devoted to documenting the need for reporting. Another section includes a signature line in order to verify that reporting to the PHS has been completed. C. Reporting elements Any FCOI report submitted to the PHS shall include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict, and to assess the appropriateness of the Easterns management plan. Elements of the FCOI report shall include at least the following elements: (1) Project number; (2) PD/PI or contact PD/PI if a multiple PD/PI model is used; (3) Name of the Investigator with the FCOI; (4) Name of the entity with which the Investigator has a financial conflict of interest; (5) Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium); (6) Value of the financial interest (dollar ranges are permissible) 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; (7) A description of how the financial interest relates to the PHS-funded research and the basis for the Institutions determination that the financial interest conflicts with such research (8) A description of the key elements of the Institutions management plan, as specified in section XII of Easterns policy. XVI. Maintenance of Records Eastern shall maintain records relating to all Investigator disclosures of financial interests and the Easterns review of, and response to, such disclosures (whether or not a disclosure resulted in the Institutions determination of a financial conflict of interest) and all actions under the Institutions policy or retrospective review, if applicable, for at least three years from the date the final expenditures report is submitted to the PHS or, where applicable, from other dates specified in 45 CFR 74.53(b) and 92.42 (b) for different situations. The procedure to implement this policy shall consist of filing all relevant records in the Office of Research and Sponsored Programs. Files shall not be retained for at least three years from the date on which the final expenditures report is submitted to the PHS. XVII. Enforcement mechanisms and sanctions Easterns FCOI policy is formalized with an internal governing policy. Enforcement mechanisms and sanctions will be determined by the process that is used whenever a violation of an internal governing policy has occurred. XVIII. Policy Changes The institutional official may change this policy document, provided the change is documented with a memo to the Provost and the Director of Research and Sponsored Programs. Form A Part 1 Confidential Eastern Illinois University Financial Conflict of Interest (FCOI) Disclosure Form* 1. Investigator Name: ________________________________________________________________ Status: ( Faculty ( Student ( Staff ( Otherspecify: ________________ Mailing address: ________________________________________________________________ Phone: ________________________ E-mail: ___________________________________ Department or Unit ______________________________________________________________ 2. PHS Project Title: ___________________________________________________________________ 3. Check one box to indicate the type of disclosure you are making: ( Initial ( Annual ( New Financial Interest ( Retrospective 4. Disclosure of Financial Interests A. In making this disclosure, do not include any of the following items: 1. Salary, royalties or other remuneration paid by EIU to the investigator 2. Intellectual property rights that have been assigned to EIU and agreements to share in royalties produced by such rights. 3. Income from investment vehicles such as mutual funds and retirement accounts, provided the investigator does not control the investment decisions made in these vehicles. 4. Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. 5. Income from service on advisory committees or review panels for a federal, state, or local government agency, institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. B. Check all of the following that were true of you, your spouse, and/or any dependent children at any time during the past 12 months or since you last submitted an FCOI disclosure, whichever is shorter. ( Financial Interest in a publicly traded entity: exists if the total of remuneration from and equity in the entity exceeds $5,000. ( Financial Interest in a non-publicly traded entity: exists if there is any equity at all or if total remuneration from the entity exceeds $5,000. ( Financial Interest in intellectual property rights (e.g., patents and copyrights): exists if there is more than $5,000 of income related to such rights that are not assigned to EIU. ( Financial Interest in travel: exists if you travelled and received reimbursement or sponsorship from a source other than EIU. C. ( No Financial Interest Check if none of the types of Financial Interest listed in Part B were true of you, your spouse, and/or any dependent children during the past 12 months or since you last submitted an FCOI disclosure, whichever is shorter. 5. Investigator Assurance I agree to abide by Easterns Financial Conflict of Interest Policy. In submitting this form and any other required documents I certify that the information provided is true to the best of my knowledge. I supply this information for confidential review by Eastern Illinois University and for such other limited purposes as are required by law, regulation, or contract. I do not authorize release of it for any other purpose. I understand and agree that if there is a material change (an acquisition of a significant financial interest) to this information, I must submit a new disclosure and attachment within 30 days of that change. Signature:___________________________________________ Date:_________________________ What should I do next? If you checked only box 4. C., no further disclosure is required. Please mail this form in an envelope marked Confidential to the director of the Office of Research and Sponsored Programs. If you checked any box in 4. B., then complete a separate Form A Part 2 for each financial interest covered by the criteria in 4. B. Please mail both Form A Part 1 and all copies of Form A Part 2 in an envelope marked Confidential to the director of the Office of Research and Sponsored Programs. What response can I expect? If you checked only box 4. C., no response will be sent to you. If you checked any box in 4. B., The director of the Office of Research and Sponsored Programs will review your information. The Dean of the Graduate School will review your information and, if necessary, contact you for discussion. If any of your financial interests meet the criteria for a Financial Conflict of Interest (FCOI), the Dean of the Graduate School will help you develop a management plan. You will receive written communication of all conclusions that result from review of your information. *This form collects information which Eastern Illinois University must collect and analyze in order to qualify for funding from the U.S. Public Health Service (PHS). This form includes some language taken directly from a form created by the University of Oregon. Form A Part 2 Confidential Eastern Illinois University Financial Conflict of Interest (FCOI) Disclosure Form* 1. Investigator Name: ________________________________________________________________________ 2. PHS Project Title: __________________________________________________________________________ 3. Check the type of financial interest that was true of you at any point in the past 12 months. (Check only one.) ( A. Equity worth at least $5,000 in a publicly traded organization. ( B. Remuneration of at least $5,000 from a publicly traded organization. ( C. Any equity in a non-publicly traded organization. ( D. Remuneration of at least $5,000 from a non-publicly traded organization. ( E. Income of at least $5,000 from intellectual property rights assigned to an organization other than EIU. ( F. Travel sponsored or reimbursed by an organization other than EIU. 4. Name of the organization in which the financial interest exists: _________________________________________________________________________________________ 5. Describe the type of business conducted by the organization: _________________________________________________________________________________________ 6. The organization is: ( For profit (publicly-owned) ( For profit (privately-held) ( Non-profit ( Governmental 7. The financial relationship is between the organization and (Check all that apply.) ( Self ( Spouse ( Dependent Child(ren) 8. Estimated value of the financial interest: ( $0 - $4,999 ( $5,000 - $9,999 ( $10,000 - $19,999 ( $20,000 - $100,000 by increments of $20,000: _______________________________________________ ( more than $100,000 by increments of $50,000: _______________________________________________ ( Value cannot be readily determined from public prices or other reasonable measures of fair market value 9. In the box below, answer only one of the following questions: If you checked 3.B. or 3.D., describe the work for which the organization paid you or your family member. If you checked 3.E., describe the intellectual property to which payments are related and how it is or is not related to your work at EIU. If you checked 3.F., describe the purpose of the travel, the destination, and the duration of the travel. 10. Investigator Assurance I agree to abide by Easterns Financial Conflict of Interest Policy. In submitting this form and any other required documents I certify that the information provided is true to the best of my knowledge. I supply this information for confidential review by Eastern Illinois University and for such other limited purposes as are required by law, regulation, or contract. I do not authorize release of it for any other purpose. I understand and agree that if there is a material change (an acquisition of a significant financial interest) to this information, I must submit a new disclosure and attachment within 30 days of that change. Signature:___________________________________________ Date:_________________________ What response can I expect? The Dean of the Graduate School will review your information and may contact you for discussion. If any of your financial interests meet the criteria for a Financial Conflict of Interest (FCOI), the Dean of the Graduate School will help you develop a management plan. You will receive written communication of all conclusions that result from review of your information. *This form collects information which Eastern Illinois University must collect and analyze in order to qualify for funding from the U.S. Public Health Service (PHS). This form includes some language taken directly from a form created by the University of Oregon. Form B Eastern Illinois University Financial Interest Review Form 1. Investigator Name: ________________________________________________________________________ 2. PHS Project Title: __________________________________________________________________________ 3. Disclosed Financial Interest: _________________________________________________________________ Part 1: Identifying a Significant Financial Interest 4. Does the disclosed financial interest appear to be reasonably related to the investigators institutional responsibilities? ( Yes ( No Briefly explain the reasoning behind the conclusion: If the answer is yes, then the financial interest is a Significant Financial Interest (SFI). Proceed to 5. If the answer is no, then the financial interest is not a Significant Financial Interest. Skip all remaining parts of this form except the signature. Part 2: Identifying a Financial Conflict of Interest (FCOI) 5. Determine relatedness by answering both questions A. and B. A. Could the SFI be affected by the PHS-funded research? ( Yes ( No B. Is the SFI in an entity whose financial interest could be affected by the research? ( Yes ( No 6. Could the SFI directly and significantly affect the design, conduct, or reporting of PHS-funded research? ( Yes ( No If the answer to either question 5. A. or 5. B. is yes AND if the answer to question 6 is yes, then the SFI is a FCOI. 7. Conclusion (check one): ( The SFI is an FCOI ( The SFI is not an FCOI. Part 3: Reporting to the PHS 8. A report to the PHS ( is required. ( is not required. ___________________________________________________________________________________________ Part 4: Verification of Analysis (Parts 1 3) by Institutional Official Signature:___________________________________________ Date:_________________________ Institutional Official ___________________________________________________________________________________________ Part 5: Verification of Reporting to the PHS 9. A report to the PHS was submitted on __________________. Date Signature:___________________________________________ Date:_________________________ Institutional Official Form C Eastern Illinois University Financial Conflict of Interest Management Plan 1. Investigator Name: ________________________________________________________________________ 2. PHS Project Title: __________________________________________________________________________ 3. Disclosed Financial Conflict of Interest: ________________________________________________________ 4. Role and principal duties of the Investigator in the research project: 5. Conditions of the management plan include (check all that apply) ( Reduce ( Manage ( Eliminate 6. List and describe all detailed actions that will be taken in order to accomplish the conditions of the management plan. Describe how each action will contribute to the objectivity of the research. 7. List and describe all detailed actions that will be taken in order to accomplish the conditions of the management plan. Describe how each action will contribute to the objectivity of the research. 8. List and describe all actions that will be taken in order to monitor this management plan. Include dates by which actions are to be accomplished. 9. Assurances: We agree to the management plan as it is described on this form. Signature:___________________________________________ Date:_________________________ Investigator Signature:___________________________________________ Date:_________________________ Institutional Official Form D Eastern Illinois University Monitoring Report on Financial Conflict of Interest Management Plan 1. Investigator Name: ________________________________________________________________________ 2. PHS Project Title: __________________________________________________________________________ 3. Disclosed Financial Conflict of Interest: ________________________________________________________ 4. List and describe all actions that were required by the financial management plan. Indicate whether the actions have been completed. Add explanations as necessary. 5. Conclusion: The management plan ( has ( has not been followed to date. 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