From NIH Conflict of Interest Policy Text December D. Public Health Service (PHS) Agency-Supported Rules

Transcription

1 D. Public Health Service (PHS) Agency-Supported Rules Idaho State University has developed a conflict of interest (CoI) policy that applies to all ISU employees. Additionally, the following policies and procedures apply to faculty who apply for and for those who receive funding from the Public Health Service (PHS), such as NIH funding. When there is a difference between policies and PHS funding is involved, these policies take precedence over the general ISU CoI policy. 1. PHS agencies include the National Institutes of Health (NIH), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), Indian Health Service (IHS), Health Resources and Services Administration (HRSA), Substance Abuse and Mental Health Services Administration (SAMHSA), Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare & Medicaid Services (CMS), Administration for Children and Families (ACF), and Administration on Aging (AOA). 2. Investigator Requirements This section of the policy applies to all Investigators on an NIH grant. An Investigator is defined as the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research funded by the PHS (e.g., NIH). Investigators (as defined by the regulation) who are planning to participate in, or are participating in, NIH-funded research, with the exception of Phase I SBIR/STTR applications, are required to disclose to the designated official(s) of the Institution a listing of Significant Financial Interests (SFI) and those of her/his spouse and dependent children that reasonably appear to be related to the Investigator s institutional responsibilities. See below for a description of SFI. Investigator s Institutional Responsibilities means an Investigator's professional responsibilities on behalf of the Institution, and as defined by the University in its policy on financial conflicts of interest, which may include for example: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards. Investigators are required to disclose their Significant Financial Interests and those of the Investigator s spouse and dependent children that reasonably appear to be related to the Investigator s institutional responsibilities: (a) no later than at the time of application for NIH-funded research; (b) within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest; and (c) at least annually, in accordance with the specific time period prescribed by the Institution, during the period of award (this is annually, at the time of the annual performance evaluation as required by University policy). At the proposal application stage, all Investigators applying to NIH (and other PHS agencies) will be provided a copy of the ISU CoI policy and the additional procedures laid out in this policy. They will be asked to verify whether or not they or the Investigator s spouse and dependent children have a Significant Financial Interest that reasonably appears to be related to the Investigator s institutional responsibilities. Note that this is any SFI that appears to be related to the Investigator s institutional responsibilities, not

2 merely related to the research project for which funds are requested. When the Sponsored Programs Office receives a proposal to the NIH a SFI questionnaire will be ed to all Investigators, requesting information concerning SFI. If an Investigator reports a SFI, the Sponsored Programs staff will report this to the Executive Director of Sponsored Programs and additional information may be requested. This information will be given to the Institutional Official who will make the determination if the SFI constitutes a Financial Conflict of Interest (FCOI) in relation to the NIH proposal/funded project. If an FCOI is determined to exist, if feasible, a plan will be developed, according to ISU procedures, to manage the FCOI while the project is being conducted. If it is not possible to manage the SFI the proposal may not be submitted. The SFI for all NIH Investigators will be completed again at least annually during the period of the award and within 30 days of discovering or acquiring a new SFI. In addition to completing the SFI questionnaire Investigators will be required to complete the CITI training in Conflict of Interest as well as verifying that they have read the ISU CoI policy before spending can begin. When Just in Time documents are requested the Investigators will be provided with the CITI information and the ISU CoI Policy. The Technical Records Specialist in the Sponsored Programs Office will monitor all requirements associated with the new PHS CoI policy. Training will be repeated once every four years or sooner, when the University revises its FCOI policy that affects requirements of Investigators, when an Investigator is new to an Institution, or when an Investigator is determined not in compliance with the policy or management plan. 3. Significant Financial Interest Federal regulations establish a certain financial threshold for examining financial interests of Investigators who work on research funded by Public Health Service Agencies. Significant financial interests involving PHS-funded research consist of one or more of the following interests of the Investigator and those of the Investigator s family members that reasonably appear to be related to the Investigator s institutional responsibilities: (a) With regard to any publicly traded entity, remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. [For purposes of the definition of SIGNIFICANT FINANCIAL INTEREST, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship), equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.] (b) With regard to any non publicly traded entity, the value of any remuneration received from the entity in the calendar year preceding the disclosure, when aggregated, exceeds $5,000, or any equity interest (e.g., stock, stock option, or other ownership interest); (c) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests; or (d) A position giving rise to a fiduciary duty, such as director, officer, partner, trustee, employee, or any position of management.

3 (e) For Investigators applying for or conducting research funded by the PHS, any reimbursed or sponsored travel related to the Investigator s institutional responsibilities (i.e., travel is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available). See below for additional information. The above terms do not include the following types of financial interests: Salary, royalties, or other remuneration paid by the institution to the Investigator, if the Investigator is currently employed or otherwise appointed by the institution. The term also does not apply to diversified mutual funds in which the shareholder has no control over the equities held by the fund. The terms also do not include income from seminars, lectures or teaching engagements sponsored by a federal, state or local government agency, an accredited U.S. college or university, a U.S. academic health center, or a U.S. research institution that is formally affiliated with a U.S. college or university. The terms do not include income from serving on advisory committees or review panels for a federal, state or local government agency, an accredited U.S. college or university, a U.S. academic health center, or a U.S. research institution that is formally affiliated with a U.S. college or university. 4. Travel disclosure In addition to financial disclosures, faculty, staff and students who have participated as project directors, principal Investigators or senior/key personnel on PHS-funded research projects in the past twelve (12) months or who reasonably expect to receive new PHS funding during the current calendar year must disclose the occurrence of any reimbursed or sponsored travel related to their institutional responsibilities. Public Health Service agencies include the National Institutes of Health (NIH), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), Indian Health Service (IHS), Health Resources and Services Administration (HRSA), Substance Abuse and Mental Health Services Administration (SAMHSA), Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare & Medicaid Services (CMS), Administration for Children and Families (ACF), or Administration on Aging (AOA). This travel disclosure requirement does not apply to the following types of travel: or Travel that is reimbursed or sponsored by a federal, state or local government agency (e.g., travel associated with service on an NIH or NSF or other federal agency study section, site visits, and/or grant peer review panel); Travel that is sponsored by an accredited U.S. college or university (e.g., travel for providing peer review consultation or speaking engagements); Travel sponsored by a U.S. academic health center (e.g., speaking engagements); Travel sponsored by a U.S. research institution that is formally affiliated with a U.S. college or university; Travel that is paid for as part of an Office of Sponsored Program sponsored research study/program (e.g., Investigator meetings).

4 At a minimum, faculty, research staff and students who are required to report reimbursed and sponsored travel must indicate the purpose of the trip, the identity of the sponsoring organization/business, the destination of the travel and the duration of the trip. (See USUPP Travel Policy). 5. Institutional Requirements Related to PHS applications and/or awards, the VPR or his/her designee will determine, in consultation with the department chair (see ISU CoI) whether a significant financial interest may be related to a faculty, student or staff member s institutional responsibilities on a case-by-case basis using the following general considerations: Is the financial interest with a company, foundation or other organization that provides products or services in the faculty, staff member or student s academic discipline - or area of study? Will the entity likely make use of the scholarly work or research - either directly or indirectly? Is the financial interest with a member of an industry, trade, or advocacy group that funds scholarly work or research in the faculty, staff member or student s discipline or area of study? Does the entity have some other relationship not described above that could be related to or could be affected by the faculty, staff member or student s university responsibilities? Any employee who has an actual or apparent conflict of interest or commitment to disclose must complete Disclosure of Conflicts Form and include a proposed management plan with the submission of their completed disclosure form to their supervisor or department head/chair. The proposed management plan must be reviewed and signed by the supervisor and the dean or unit head, and submitted to the Committee on Ethical Guidance and Oversight (CEGO). The CEGO shall review the proposed plan and make a recommendation to the President or the President s designee as to whether to approve the proposed plan and allow the situation to proceed under the management plan. The President or President s designee shall make the final decision of whether to approve a proposed plan. The CEGO during its review shall work with the employee and the employee s supervisor and/or unit head or dean to amend, if feasible, the proposed plan as needed. The management plan must be approved by the president or president s designee prior to any party thereto implementing any part of a proposed plan. 6. Reporting The Vice President for Research designated the Sponsored Programs Office (SPO) as the entity responsible for submitting required reports to the NIH. This includes initial, annual and revised FCOI reports. These reports will be submitted: Prior to the expenditure of funds; within 60 days of identification for an Investigator who is newly participating in the project; within 60 days for new, or newly identified, FCOIs for existing Investigators; at least annually (at the same time as when the Institution is required to submit the annual progress report, multi-year progress report, if applicable, or at time of extension) to provide the status of the FCOI and any changes to the management plan, if applicable, until the completion of the project; following a retrospective review to update a previously submitted report, if appropriate. If bias is found with the design, conduct or reporting of NIH-funded research a report will be sent to NIH, including the Mitigation Report, submitted in accordance with the regulation 42 CFR (a)(3)(iii). If an Investigator fails to comply with the Institution s FCOI policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the NIH-funded research the SPO will notify NIH

5 within 10 working days of becoming aware of the situation. The Investigator will be contacted to determine why the noncompliance occurred. 7. Maintenance of Records Records will be maintained by the Technical Records Specialist in the Sponsored Programs Office for at least three years from the date the final expenditures report is submitted to PHS (NIH) and from other dates specified in 45 CFR 74.53(b) and 92.42(b), where applicable. 8. Enforcement Mechanisms and Remedies and Noncompliance If an Investigator does not provide the required SFI information at the time of the submission of an NIH proposal, the proposal will not be submitted. 9. Corrective action for noncompliance with the Institution s policy or the management plan. Written Reprimand Suspension of project funding Potential notification of non-compliance to the research sponsor Other appropriate sanctions or discipline, depending on the severity and nature of the noncompliance. All Idaho State Board of Education and University policies and procedures, and applicable state and federal laws shall govern the procedures for imposing sanctions or discipline, and the nature of the sanctions. 10. Subrecipients If the University carries out the PHS funded research through a subrecipient, the University will incorporate as part of a written agreement with the subrecipient terms that establish whether the University s or the subrecipient s policy on conflict of interest in research will apply to the subrecipient Investigators. If the subrecipient s policy will apply, the subrecipient will certify as part of the agreement that its policy complies with the PHS regulations on Objectivity in Research. Additionally, the agreement shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to the University to enable the University to provide timely reports to PHS. Alternatively, if the University s policy on conflict of interest will apply, the agreement shall specify time period(s) for the subrecipient to submit all subrecipient Investigator disclosures of significant financial interests to the University. Such time periods shall be sufficient to enable the University to comply with timely review, management, and reporting obligations under the PHS regulations. 11. Retrospective Review In the event the University identifies a significant financial interest that was not disclosed in a timely manner by an Investigator or, for whatever reason, was not previously reviewed by the University during an ongoing research project, and where the CEGO has determined that the undisclosed significant

6 financial interest constitutes a financial conflict of interest related to a PHS funded research project, the CEGO will review the financial conflict of interest and the University will implement a management plan for the project within 60 days of identification of that interest. In addition, the CEGO will, within 120 days of its determination of noncompliance, complete a retrospective review of the Investigator's research activities associated with the project to determine whether the research conducted during the period of the noncompliance was biased in the design, conduct, or reporting of such research. 12. Public Access of Disclosed Significant Financial Interest The University will make available to the public upon request information concerning any significant financial interest disclosed to the University that meets the following three criteria: (a) The disclosed significant financial interest is still held by the senior/key personnel of the active PHS project; (b)the University determines that the significant financial interest is related to the PHS funded research; and (c)the University determines that the significant financial interest is a financial Conflict of Interest. The information request must be made to the VPR who will respond within five (5) business days of receipt of the request. Disclosed information will be provided to the extent required by applicable PHS regulations and state law. 13. Significant Financial Interests Held by Institutional Officials University officials who have a significant financial interest in an externally sponsored research project may not participate in the solicitation, negotiation of contract terms and conditions, oversight of the research (unless named as a member of the research team), or management of any financial conflict of interest held by members of the research team. As a general policy, the University will not allow an Investigator with a financial conflict of interest to conduct a clinical research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment. In such cases, disclosure or standard conflict management strategies may be inadequate and adequate monitoring plans may be difficult or impossible to implement. This prohibition applies not only to the principal Investigator of a clinical research project, but also to any Investigator involved in the design, conduct, or reporting of the research. A principal Investigator would thus be prohibited not only from serving in that role, but in any Investigator role on the study. The University may waive this prohibition only where the Investigator provides a compelling justification for its waiver. In considering an Investigator s request for waiver, the CEGO at a minimum will require the Investigator to address the following points: (a) The nature of the research project (including whether it is early stage or closer to commercial application); (b) The size and nature of the Investigator s financial interest; (c) The degree to which the financial interest is related to the research; (d) The extent to which the interest is or may be affected by the research; (e) The degree of risk to participants in the research;

7 (f) The Investigator s proposed role in the research, including protocol design, selection of participants, administration of informed consent, performance of protocol mandated clinical procedures, evaluation of the effectiveness of the drug, device, or treatment, and evaluation of adverse effects; and (g) The existence of unique circumstances that would require the research to be performed at this institution as opposed to another (such as the unique qualifications of the Investigator and/or unique resources/capabilities of the University). If the Committee finds a compelling justification for waiver of the prohibition in a particular case, a stringent management plan, including a plan for rigorous oversight of the study, will be implemented to ensure the safety of study participants and the integrity of the research.