FINANCIAL CONFLICT OF INTEREST POLICY
The purpose of this policy is to set forth the mechanisms for identifying, disclosing, reviewing, and managing potential Institutional Conflicts of Interest (Institutional COI).
The NOVERATECH seeks excellence in the discovery and dissemination of knowledge regarding the cause, prevention, detection and diagnosis, treatment, survivorship and health policy of cancer. It is the responsibility of all individuals engaged in Research at NOVERATECH to discharge their duties in a manner that promotes and preserves public trust, proper stewardship, and confidence in the integrity of NOVERATECH. The purpose of this Financial Conflict of Interest Policy for Promoting Objectivity in Research (this “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 (https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/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 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.
This Policy is applicable to all Investigators (as defined below) involved in Research for or on behalf of Noveratech, regardless of whether such Research is conducted through the Intramural Research Department or another department of Noveratech, and includes all full and part-time employees of NOVERATECH 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 Noveratech whatever the funding source. Any procedures contained in this Policy that are specific to PHS supported Research shall apply to PHS funded grants or cooperative agreement with an issue date of the Notice of Award to solicitations issued and contracts awarded subsequent to August 24, 2012.
This Policy also extends to any subcontractors, sub-grantees or sub-awardees (collectively “Sub-recipients”) at other institutions conducting Research for or on behalf of NOVERATECH, as further described below. Individuals conducting extramural Research or participating in the Peer Review process under the supervision of NOVERATECH’s Extramural Grants department are governed by NOVERATECH’s Guidelines for Maintaining Research and Peer Review Integrity available at www.noveratech.org and are not subject to this Policy with respect to such Research.
(1). Conflict of Commitment means a situation where an employee engages in external activities, either paid or unpaid, that interfere with his/her obligation and responsibilities to the institution. Employees should evaluate and arrange their external interests in order to avoid conflicts of commitment that would compromise their ability to carry out their obligations to the institution.
(2). Financial Conflict of Interest (FCOI) means a Significant Financial Interest that could directly and significantly affect the design, conduct or reporting of Research.
(3). Financial Conflict of Interest Committee (FCOI Committee) means a committee appointed to review and provide recommendations for the management of Significant Financial Interests in accordance with this Policy. The FCOI Committee will be comprised of one representative from the Office of the Chief Financial Officer, the Office of the Chief Medical Officer and the Office of Corporation Counsel.
(4). 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.
(5). Financial Conflict of Interest Report (FCOI Report) means NOVERATECH’s report of a Financial Conflict of Interest to the awarding agency of PHS.
(6). Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.
(7). Institutional Responsibilities means an Investigator’s professional activities on behalf of NOVERATECH (e.g., teaching, administration, research, clinical care, or service on IRB panels, editorial boards or peer review panels).
(8). 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.
(9). Institutional Official means the individual within NOVERATECH 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 Managing Director, Business Operations in the Office of the Chief Medical Officer has been designated as the Institutional Official for NOVERATECH.
(10). Significant Financial Interest (SFI) means:
(11). Research means a systematic investigation, study, or experiment designed to 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).
All Investigators covered by this Policy are required to disclose Financial Interests that could affect or be affected by Research on which they are working or proposing to work for or on behalf of NOVERATECH. Every Investigator has an obligation to become familiar with, and abide by, the provisions of this Policy and must undergo regular training as described herein. Any Investigator with questions regarding financial conflicts of interest or this Policy should contact the Institutional Official for assistance.
NOVERATECH will review and manage, minimize, or eliminate Significant Financial Interests to ensure that Research will be free from bias resulting from Investigator financial interests. In determining an appropriate FCOI Management Plan, NOVERATECH will work to achieve the following goals:
As required by Federal regulations, NOVERATECH will report to the funding agency Financial Conflicts of Interest for PHS supported projects and provide information to the public when a written request is received. NOVERATECH will also take reasonable steps to ensure that any Investigators for Sub-recipients of Research comply with this Policy and any applicable Federal regulations regarding Financial Conflicts of Interest.
All Investigators must report any Significant Financial Interest that reasonably appears related to the Investigator’s Institutional Responsibilities on an annual basis utilizing a Significant Financial Interest Disclosure Form (the “SFI Disclosure Form”).
In addition to the annual disclosure requirements, certain situations require ad hoc disclosure. Investigators new to NOVERATECH must complete and submit a SFI Disclosure Form to NOVERATECH, within thirty (30) days of their initial employment or appointment.
All Investigators also have an ongoing obligation to update disclosures to reflect changes in or additions of Significant Financial Interests. Investigators must disclose within thirty (30) days after a new Significant Financial Interest is acquired or discovered (e.g. through purchase, marriage, or inheritance). These ongoing disclosure obligations apply to any reimbursed or sponsored travel expenses which constitute a Significant Financial Interest under this Policy. Travel expenses paid by a third party through a grant to, or a contract with NOVERATECH do not need to be reported.
In addition, any individual involved with Research at NOVERATECH may report suspected Financial Conflicts of Interest or alleged violations of this Policy through NOVERATECH’s independent and confidential fraud and abuse hotline at 1-812-557-1866.
Prior to entering into or submitting a letter of intent, proposal or application for a sponsored Research project, Investigators or their designees are responsible for accurately completing a Proposal Disclosure Form, which details information about the study and lists NOVERATECH and external Investigators and Sub-recipients on the study. The Investigators will then be prompted to complete an SFI Disclosure Form.
Each year of a sponsored grant or contract, an Investigator must update his/her SFI Disclosure Form. The form must be updated at the time of the annual progress report, twelve (12) months after the notice of award, or the initiation of Research, whichever date is earliest.
The Institutional Official, or his/her designee, will review all SFI Disclosure Forms and will conduct a preliminary inquiry regarding any SFI Disclosure Form that identifies a Significant Financial Interest. Prior to the initiation of any inquiry, the Institutional Official will consult with the Office of Corporation Counsel and follow directions from the Office of Corporation Counsel regarding appropriate procedures to afford the maximum confidentiality and privilege protection for the investigation.
The Institutional Official will forward all SFI Disclosure Forms revealing a Significant Financial Interest to the Financial Conflict of Interest Committee (the “FCOI Committee”) for review, along with the Institutional Official’s recommendations as to which Significant Financial Interests warrant further inquiry to determine whether a Financial Conflict of Interest exists.
It is also the responsibility of the Institutional Official to perform the following tasks, as more fully described in this Policy:
The FCOI Committee is responsible for investigating Significant Financial Interests as necessary and determining whether a Financial Conflict of Interest exists. A Financial Conflict of Interest will exist if the FCOI Committee determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the Research. Per Federal regulations and this Policy, Investigators cannot make the decision about whether a Significant Financial Interest must be managed or whether it is a Financial Conflict of Interest; this determination is made through the review process. The FCOI committee will decide on the appropriate action to manage, reduce or eliminate any Financial Conflict of Interest and, with support from the Institutional Official, will develop a FCOI Management Plan if needed, as more fully described below.
It is also the responsibility of the FCOI Committee to perform the following tasks, as more fully described in this Policy:
As appropriate, the FCOI Committee, with support from the Institutional Official, will develop plans for the management, reduction, or elimination of identified Significant Financial Interests (each a “FCOI Management Plan”). A FCOI Management Plan will focus on the steps by which the objectivity of the Research can be ensured which may include, but not be limited to:
For any FCOI Management Plan, the affected Investigator must agree in writing to the FCOI Management Plan and the proposed management strategies contained therein before the Research goes forward.
Special precautions must be taken to avoid bias with respect to Research involving human subjects involving the evaluation of strategies or products that may affect or be affected by the Financial Interests of NOVERATECH or NOVERATECH Investigators. An NOVERATECH Investigator shall not ordinarily participate in any Research involving human subjects that encompasses evaluation of such a strategy or product if he/she has a Significant Financial Interest that could directly and significantly affect the design, conduct or reporting of the Research unless he/she presents a compelling justification for a waiver of this Policy based on his/her unique qualifications as an Investigator. The compelling justification will be reviewed by the FCOI Committee. If the FCOI Committee determines that compelling circumstances justify a waiver of this Policy, the FCOI Committee Research with support from the Institutional Official will develop a FCOI Management Plan with stringent management measures to ensure the safety of the human participants and the integrity of the Research.
For all Research involving human subjects, the outcome of FCOI Committee reviews and any recommended FCOI Management Plans will be communicated to the appropriate Institutional Review Board (IRB) for review and approval. The IRB may require additional measures to protect the safety and welfare of Research subjects under their purview.
Federal regulations require that NOVERATECH report to the funding agency Financial Conflicts of Interest related to PHS-sponsored Research. No expenditure of funding shall occur with respect to any PHS-supported Research project for which the FCOI Committee has determined that a FCOI Management Plan is required unless and until NOVERATECH has provided the funding agency with a FCOI Report containing the following information:
Vii A description of how the Financial Interest relates to the PHS-funded Research and the basis for NOVERATECH’ determination that the Financial Interest conflicts with such Research; and
viii. A description of key elements of the Institution’s FCOI Management Plan including:
For any Significant Financial Interest that is identified after the funding for the Research is awarded, including Significant Financial Interests identified by Investigators new to the project, NOVERATECH will determine whether a Financial Conflict of Interest exists and whether a FCOI Management Plan is required. For PHS-sponsored Research, NOVERATECH shall provide a FCOI Report with the information above to the PHS funding agency within sixty (60) days of identification of the Significant Financial Interest.
Additionally, each award year NOVERATECH must provide the PHS-funding agency an annual FCOI Report that addresses the status of the Financial Conflict of Interest and any changes to the FCOI Management Plan for the duration of the project period (including extensions with or without funding). The annual FCOI Report shall specify whether the Financial Conflict of Interest is still being managed or explain why the Financial Conflict of Interest no longer exists. NOVERATECH must report to the PHS-funding agency the annual FCOI Report at the time of the progress report.
With respect to Research funded by a sponsor other than PHS, the Institutional Official shall review the funding agreement and determine all required reporting to sponsor. The Institutional Official will implement procedures to ensure compliance with all reporting and other Financial Conflict of Interest requirements contained in the funding agreement.
As required by Federal regulations and upon written request, the Institutional Official shall provide to any requestor written information about Financial Conflicts of Interest, which were determined to be a Financial Conflict of Interest after August 24, 2012, of an individual who is listed as a Senior or Key Personnel on a PHS award. Requests must be in writing and received through the US mail. The request must identify the specific PHS project number and the name of Investigator for whom information is being requested. The request must include a named recipient and return address with a physical street address, P.O. Boxes are not acceptable. NOVERATECH will note in its written response that the information is current as of the date of the correspondence, and is subject to updates at least annually and within sixty (60) days of NOVERATECH’ identification of a new Financial Conflict of Interest, which must be requested under separate cover by the requestor.
The following information will be provided to the requestor:
For Research covered by this Policy that involves subcontractors, sub-grantees or sub-awardees at other institutions (collectively “Sub-recipients”), NOVERATECH must take reasonable steps to ensure that any Sub-recipient Investigator complies with Federal regulations by:
For Research funded by a sponsor other than PHS, the Institutional Official shall be responsible for determining and ensuring compliance with any additional Sub-recipient monitoring, disclosure or other requirements contained in the funding agreement.
Each Investigator must complete training prior to engaging in Research, at least every four years, and immediately when:
Each Investigator is ultimately responsible for ensuring that he/she makes any necessary disclosures to NOVERATECH required by this Policy and follows any prescribed plan for the management, reduction, or elimination of an identified Significant Financial Interest. Failure to do so shall be deemed a violation of this Policy and may result in sanctions on the Investigator.
The Institutional Official will maintain an up-to-date version of this Policy on NOVERATECH’s publicly available Web site and is responsible for training on and ensuring compliance with this Policy and the procedures contained herein. In cases where a FCOI Management Plan has been developed, it is the task of the Institutional Official to implement and oversee compliance with such FCOI Management Plan on an ongoing basis.
The FCOI Committee shall be responsible for investigating any alleged violations of this Policy. The FCOI Committee will follow directions from the Office of Corporation Counsel regarding appropriate procedures to afford the maximum confidentiality and privilege protection for all such investigations. In investigating any violation of this Policy, the FCOI Committee shall determine if the violation has biased the design, conduct or reporting of the Research and whether such Research is funded by an outside sponsor such as PHS. The FCOI Committee will promptly report the results of such investigations to the Institutional Official along with any appropriate corrective actions to maintain the objectivity of the Research, sponsor reporting or other recommended notifications. The Institutional Official shall implement such corrective actions, including suspension of the Research project, as the FCOI Committee deems necessary to maintain the objectivity of the Research. The Institutional Official will promptly notify the applicable sponsor for any project in which Research is suspended pending conclusion of the retrospective review process described below.
The Institutional Official, in consultation with the FCOI Committee and the Chief Talent Officer or his/her designee will decide on appropriate sanctions or disciplinary actions to be taken in accordance with NOVERATECH’s Code of Ethics, the Employee Handbook and other established NOVERATECH policies and procedures. Sanctions for non-compliance may include reprimands or other appropriate measures, up to and including termination. The Institutional Official will promptly notify the affected Investigator in writing of the results of the investigation and plans for disciplinary action against the Investigator, if applicable.
In addition, the above review and sanctions, Investigators are subject to the following retrospective review procedures when a Financial Conflict of Interest is not identified or managed in a timely manner. This includes any failure by an Investigator to disclose a Significant Financial Interest that is determined by NOVERATECH to constitute a Financial Conflict of Interest, failure by NOVERATECH to review or manage such a Financial Conflict of Interest, or failure by the Investigator to comply with a FCOI Management Plan. The Institutional Official is responsible for overseeing the procedures outlined below.
the date that the Financial Conflict of Interest or the Investigator’s noncompliance is determined and the completion of NOVERATECH’s retrospective review.
To the extent permitted by law, all SFI Disclosure Forms, FCOI Management Plans, and related information will be treated as privileged and confidential. However, NOVERATECH may be required to make such information available to PHS and/or HHS, to a requestor of information concerning Financial Conflict of Interests related to PHS funding or to the primary entity who made the funding available to NOVERATECH, if requested or required. If NOVERATECH is requested to provide SFI Disclosure Forms, FCOI Management Plans, and related information to an outside entity, the Investigator will be informed of this disclosure.
The Institutional Official, the FCOI Committee and any other parties involved in reviews or investigations under this Policy will follow directions from the Office of Corporation Counsel regarding appropriate procedures to afford the maximum confidentiality and privilege protection for any such reviews or investigations.
The Institutional Official shall be responsible for maintaining records, identifiable to each project, all transactional reports of Significant Financial Interests, and all actions taken by the FCOI Committee or other appropriate departments within NOVERATECH to manage any actual or potential Financial Conflicts of Interest at least three (3) years from: (a) the date of submission of the final expenditures report, for federally funded grants; (b) from the date of termination or completion of the award; or (c) from the date of the resolution of any action by any governmental agency involving the records; or (d) as applicable, from any other date specified in 45 CFR Section 74.53(b) for different situations, as appropriate.
1. Noveratech has hired a reputable financial service company, Associates in Accounting, CPA in Louisville, KY (https://www.bing.com/search?q=associates+in+accounting+cpa+louisville+ky&form=ANNH01&refig=d24e9ccff7c24c509aeff0dff09e3acd&pc=U531&sp=2&qs=UT&pq=associates+in+accounting%2C+cpa&sk=PRES1UT1&sc=529&cvid=d24e9ccff7c24c509aeff0dff09e3acd) to manage and monitor the company’s financial conditions.
2. NOVERATECH has a special financial expert (Cheyrl Busch) to be the accountant for daily financial management.
3. The CEO of NOVERATECH (Sufan Chien) is the only person who can withdraw money from NIH’s PMS system, but the withdrawal and spending are monitored by both the Associates in Accounting, CPA and Cheyrl Busch. If any questionable withdrawal and spending occurs, they will ask the CEO to investigate and report to them.
4. NOVERATECH also has hired a reputable financial company, ADP, Inc. PO Box 842875, Boston MA 02284-2875 (https://www.adp.com/contact-us/company-information.aspx) for payroll management. ADP, Inc. is a comprehensive global provider of cloud-based Human Capital Management solutions and Business Process Outsourcing (BPO) services, analytics and compliance expertise.
5. NOVERATECH also requires a financial report every 3 months to summarize the income and spending. If any problem is found, the company will have to investigate and resolve the problem.
1. NOVERATECH’s FCOI policy is published in the NOVERATECH’s website which allows anyone who is interested in NOVERATECH’s business to review and make complaints and suggestions.
2. The NOVERATECH’s Conflict of Interest Review Board members are updated from time to time to fit company size and the topics the Board will investigate.
3. In special conditions where a meeting of the complete COI board members is impossible (such as in the midnight or in complete quarantine due to severe infectious diseases), the chairperson of the Review Board will gather as many members as possible to discuss and make decision.
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