FINANCIAL CONFLICT OF INTEREST POLICY
FOR PROMOTING OBJECTIVITY IN RESEARCH
ISCA, Inc. and all its subsidiaries (ISCA) seeks excellence in the discovery and dissemination of knowledge regarding integrated pest management in agriculture in an environmentally sustainable way. It is the responsibility of all individuals engaged in Research at ISCA to discharge their duties in a manner that promotes and preserves public trust, proper stewardship, and confidence in the integrity of ISCA. The purpose of this Financial Conflict of Interest Policy for Promoting Objectivity in Research (Policy) is to assure the objectivity with which Research projects are designed by identifying and managing, through a process of disclosure and review, conflicts of interest between an Investigator’s Research responsibilities and his/her personal financial interests.
This Policy is written to conform to the Public Health Service regulations regarding Financial Conflicts of Interest, 42 Code of Federal Regulations Part 50, Subpart F. These regulations require that all individuals who participate in the design, conduct, or reporting of Research funded by the Public Health Service (PHS) complete training on financial conflicts and disclose personal financial interests that could give rise to an actual conflict of interest or the appearance of a conflict. A copy of the full text of the regulations and the final rule implementing the regulations published in the Federal Register can be accessed at http://www.gpo.gov/fdsys/pkg/FR-2011-08- 25/pdf/2011-21633.pdf
The Signing Official is the person responsible for the procedures under this FCOI Policy but may designate one or more individuals to assist in any or all these responsibilities and/or may delegate any or all these responsibilities to one or more individuals.
This Policy is applicable to all Investigators (as defined below) involved in Research for or on behalf of ISCA regardless of whether such Research is conducted through the Research Department or another department of ISCA and includes all full and part-time employees of ISCA and graduate students, visiting scientists, and researchers. While 42 CFR Part 50 Subpart F applies to all individuals who may be involved with a project supported by or who have submitted a grant application to PHS, this Policy applies to all Investigators engaged in Research at ISCA whatever the funding source.
This Policy also extends to any subcontractors, sub-grantees, or sub-awardees (collectively Subrecipients) at other institutions conducting Research for or on behalf of ISCA as further described below.
This Policy should be read in conjunction with other ISCA’s internal policies about Ethics and Conflict of Interest which provides general instruction on preventing, recognizing, and mitigating conflicts of interest. The requirements of this Policy are intended to supplement, not replace, the disclosure obligations and processes set forth the current internal policies of ISCA.
- Financial Conflict of Interest (FCOI): means a Significant Financial Interest that could directly and significantly affect the design, conduct or reporting of Research.
- Financial Conflict of Interest Management Plan (FCOI Management Plan): means a plan developed in accordance with this Policy for the management, reduction, or elimination of an identified Significant Financial Interest.
- Financial Conflict of Interest Report (FCOI Report): means ISCA’s report of a Financial Conflict of Interest to the awarding agency of PHS.
- Financial Interest: means anything of monetary value, whether the value is readily ascertainable.
- Institutional Responsibilities: means an Investigator’s professional activities on behalf of ISCA (e.g., teaching, administration, research, clinical care, or service on panels, editorial boards, or peer review panels).
- Investigator: means any principal investigator, project manager, research analyst, or member of the research team identified as senior/key personnel on the grant or contract application, progress report, or any other report; and/or other individuals that the principal investigator/project manager identifies as responsible for or having substantial independent decision making with respect to the design, conduct or reporting of Research, including collaborators or consultants.
- Institutional Official: means the individual within ISCA designated as responsible for management of this Policy, including the solicitation and review of disclosures of Significant Financial Interests, training of Investigators, record retention, and reporting to funding agencies, sponsors and the public as detailed herein. The GRANTS ADMINISTRATOR has been designated as the Institutional Official for ISCA.
- Institutional responsibilities: means an investigator’s professional responsibilities on behalf of ISCA including research, research consultation, clinical or other professional practice, participation in scholarly events, institutional committee memberships; and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
- Intellectual Property: Intellectual property rights and interests (e.g., patents, copyrights), must be disclosed upon receipt of income (e.g., royalties) related to such rights and interests. The filing of any patent application also should be disclosed.
- Significant Financial Interest (SFI) means: A financial interest consisting of one or more of the following interests of the Investigator (aggregated together with those of the Investigator’s spouse, same-sex domestic partner and dependent children) that reasonably appear to be related to the Investigator’s Institutional Responsibilities:
- About any 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 and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000.00. 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.
- 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 $5,000.00 or when the Investigator (or the Investigator’s spouse, same-sex domestic partner or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest);
- intellectual property rights and interests (e.g., patents, copyrights), a significant financial interest exists upon receipt of income of related to such rights and interests; or
- 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 institutional responsibilities in the twelve months preceding the disclosure if the value of such travel, when aggregated from all sources, exceeds $5,000; provided. This disclosure requirement excludes travel paid for by ISCA or travel that is reimbursed or sponsored by an U.S. Federal, state, or local government agency. Disclosures relating to travel expenses must specify at a minimum the purpose and duration of the trip, the identity of the sponsor/organizer and the destination, or
- holding any position of influence (e.g., director, officer, trustee, dean, or faculty) in a non-ISCA entity.
The term significant financial interest does not include the following:
- Salary, royalties, or other remuneration paid by ISCA to the Investigator if the Investigator is currently employed or otherwise appointed by ISCA, including intellectual property rights assigned to the ISCA and agreements to share in royalties related to such rights.
- 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.
- Income from seminars, lectures, or teaching engagements sponsored by an U.S. Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), or a research institute that is affiliated with an Institution of higher education; or
- Income from service on advisory committees or review panels for an U.S. federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), a research institute that is affiliated with an Institution of higher education.
- Research: The term “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 a PHS Awarding Component through a grant or cooperative agreement.
- Senior/key personnel: means the project director or principal investigator and any other person identified as senior/key personnel in the grant application, progress report or any other report submitted to the PHS.
- Immediately: shall mean the training is provided or made accessible and the investigators participate in the training expeditiously following the event that triggers the training requirement.
- Manage: means taking action to address an FCOI, which can include reducing or eliminating the financial conflict of interest to ensure, to the extent possible, that the design, conduct and reporting of research will be free from bias.
- RESEARCHERS COVERED AND FINANCIAL INTERESTS THAT MUST BE DISCLOSED
All “investigators” planning to or participating in PHS-funded “research” are required to disclose to ISCA his/her known “significant financial interests” (and those of his/her spouse and dependent children) that reasonably appear to be related to the investigator’s “institutional responsibilities”.
- MANDATORY INVESTIGATOR TRAINING REQUIREMENTS
The Signing Official is responsible for ensuring that each investigator is informed about
- this FCOI Policy,
- the investigator’s responsibilities regarding disclosure of significant financial interests relating to the investigator’s institutional responsibilities and
- the FCOI Regulations.
The Signing Official shall ensure that each investigator completes training regarding items (i)–(iii) prior to engaging in research related to any PHS-funded grant or cooperative agreement, immediately upon being hired and at least every four (4) years. Investigators are required to complete the FCOI training module prior to engaged in PHS-supported research at least every four years, and immediately under the designated circumstances: (1) ISCA FCOI policies change in a manner that affects investigator requirements, (2) an investigator is new to ISCA, or (3) ISCA finds an investigator noncompliant with ISCA’s FCOI policy.
The Signing Official also shall ensure that each investigator completes training immediately when any of the following applies: (1) this FCOI Policy or procedures are revised in any manner that affects the requirements of the investigators or (2) ISCA finds that an investigator is not in compliance with this FCOI Policy or a management plan.
- DISCLOSURE REQUIREMENTS
Prior to submission to PHS of an application for a research grant, the principal investigator shall identify to the Signing Official (1) all investigators (as defined above) anticipated to be participating in the research, (2) those who are senior/key personnel (as defined above) and (3) those who are subrecipients and the institution(s) employing them.
Also prior to submission of the application, the Signing Official shall ensure that each investigator submits a listing of his/her known significant financial interests (as described above) and those of his/her spouse and dependent children that reasonably appear to be related to the investigator’s institutional responsibilities, if any. In accordance with Section H, the Signing Official shall ensure that subrecipient investigators either comply with this FCOI Policy or that their institution(s) provides assurances to enable ISCA to fulfill the requirements of this FCOI Policy. In either case, the Signing Official shall ensure that the proper documentation as required under the FCOI Regulations is executed, also in accordance with Section H. Disclosure forms will be made available by ISCA General Counsel.
All disclosures must be updated annually during the period of the award or within 30 days of discovering or acquiring (e.g., through purchase, marriage, inheritance, or expansion of responsibilities) a new significant financial interest. The Signing Official shall ensure that annual update forms are sent to and promptly returned by each investigator. (One annual disclosure is sufficient to cover all ongoing PHS awards) Each investigator is responsible for submitting disclosure forms within 30 days of discovering or acquiring a new significant financial interest. Disclosures shall be provided by an investigator at any other time upon request.
- REVIEW OF DISCLOSURES AND MONITORING AND REPORTING FCOI
The Signing Official shall be responsible for reviewing all forms disclosing a significant financial interest, making the requisite determinations, and taking any subsequent action.
Prior to the expenditure of funds or, with respect to an ongoing PHS-funded project, within 60 days of the disclosure or discovery of a significant financial interest, the Signing Official shall:
- review all disclosure forms and determine whether
- an investigator’s significant financial interest is related to PHS-funded research and
- if so related, whether the significant financial interest is a financial conflict of interest (FCOI); and
- in the case of a FCOI, develop and implement a management plan specifying actions that have been and shall be taken to manage the FCOI; and
- submit initial and ongoing FCOI reports to the PHS Awarding Component as required under the FCOI Regulations.
An investigator’s significant financial interest is related to PHS-funded research when the Signing Official reasonably determines that the significant financial interest could be affected by the PHS-funded research or is in an entity whose financial interest could be affected by the research. In determining whether an investigator’s significant financial interest is related to PHS-funded research the Signing Official will consider all relevant factors and information, including but not limited to whether there is an ongoing relationship between the investigator and the payer.
A financial conflict of interest (FCOI) exists when the Signing Official reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research. In determining whether there is an FCOI, the Signing Official will consider all relevant factors and information, including but not limited to the nature of the research, the magnitude of the financial interest and degree to which it is related to the research, the extent to which the interest could be directly and substantially impacted by the research, and the degree of risk to the human subjects, if any, that is inherent in the research protocol.
Prior to making the decision whether an FCOI exists, the Signing Official may impose interim measures, may ask the investigator to submit additional information and may meet or communicate with the investigator. The investigator may be encouraged to suggest procedures, protocols, or other measures designed to manage the FCOI.
Examples of conditions or restrictions that might be imposed to manage an FCOI include, but are not limited to:
- Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research).
- For research involving human subjects, disclosure of financial conflicts to research participants.
- Monitoring of the research by independent reviewers.
- Modification of the research plan.
- Change of personnel or personnel responsibilities or disqualification from participation in all or a portion of the research.
- Reduction or elimination of the financial interest; and/or
- Severance of relationships that create such conflicts.
For all management plans, the Signing Official shall (1) monitor ongoing investigator compliance and (2) submit annual updates to the PHS Awarding Component at the time and in the manner specified by the PHS Awarding Component, both until the completion of the PHS-funded research project to which the FCOI relates.
With respect to FCOI related to research sponsored by NIH, annual FCOI reports will be submitted through the eRA Commons FCOI Module for the duration of the project period (including extensions with or without funds) at the same time annual progress reports are required to be submitted and at the time of extension (if any).
If the FCOI is identified and eliminated prior to the expenditure of any PHS-awarded funds, no FCOI report need be submitted.
- NONCOMPLIANCE AND REMEDIES
If an investigator has failed to comply with a management plan or, for whatever reason, an FCOI is one that was not identified, reviewed or managed in a timely manner, the Signing Official shall (in addition to the steps required in Section D above), within 120 days of the determination of noncompliance, conduct a retrospective review of the investigator’s activities and the research project to determine whether any PHS-funded research or portion thereof conducted during the period of noncompliance was biased in design, conduct or reporting. The review shall be documented consistent with the FCOI Regulations. If bias is found during the review, the Signing Official will promptly notify the PHS Awarding Component (which may take its own action and/or require further action by ISCA and/or the investigator, as it deems appropriate) and submit a mitigation report consistent with the FCOI Regulations. If appropriate, the Signing Official will update the previously submitted FCOI report. In any event, the Signing Official shall submit FCOI reports annually thereafter.
For clinical research projects supported by the PHS, if the Department of Health and Human Services 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 was designed, conducted, or reported by an investigator with an FCOI that was not properly disclosed or managed as required under the FCOI Regulations, the investigator shall disclose the FCOI in each public presentation of the results of the research (such as articles, manuscripts and oral presentations) and ISCA shall request an addendum to previously published presentations.
- MAINTENANCE OF RECORDS
The Signing Official shall maintain all disclosure forms and related records of determinations made and actions taken for a period of three years from the date of submission of the final expenditures report to the PHS (or, where applicable, from other dates specified in 45 CFR 74.53(b)).
- ENFORCEMENT MECHANISM AND SANCTIONS
All researchers to whom this FCOI Policy applies are expected to comply with it fully and promptly. The Signing Official may impose sanctions for noncompliance which may include, but is not limited to, the following:
- Failure to make timely, full, or accurate disclosures.
- Failure to provide information requested.
- Failure to update a disclosure form as necessary; or
- Failure to comply with a management plan.
For ISCA employees, sanctions may include suspension or dismissal, denial of eligibility to engage in the research at issue or other appropriate penalties. Such sanctions may require giving notice of relevant information to funding agencies, professional bodies or journals, or the public. The Signing Official will determine what sanctions, if any, are to be applied.
- PUBLIC ACCESSIBILITY REQUIREMENTS
This FCOI Policy will be posted on ISCA’s publicly accessible website, as required by the FCOI Regulations.
Prior to expending any funds under a PHS-funded grant or cooperative agreement, ISCA shall ensure public accessibility to information concerning an FCOI held by a senior/key personnel member by providing a written response to any written request, such response to be postmarked or dated (if replying by electronic means) within five (5) business days of the receipt of the written request. Such information shall consist of that required to be provided under the FCOI Regulations, shall be updated at least annually and within 60 days of the receipt or identification of information concerning an additional significant financial interest, and shall remain available for three years from the date the information was most recently updated.
- ADDITIONAL INFORMATION
ISCA may be asked to provide records related to this FCOI Policy, including disclosure forms, to the Department of Health and Human Services or other federal agencies or entities. ISCA will provide the requested information and make any other disclosures necessary to comply with this FCOI Policy or as required by law. Such records may be requested and provided whether the disclosure resulted in a determination that an FCOI existed.