Financial Conflict of Interest Policy
INTRODUCTION
TSRL, Inc. requires that research and the results of the research conducted are free from bias resulting from Investigator financial conflicts of interest, in compliance with the Public Health Service (PHS) 2011 Revised Conflict of Interest regulation (42 CFR Part 50 Subpart F). This Financial Conflict of Interest Policy (FCO') policy applies to Investigators (defined in PHS regulation* 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, or proposed for such funding, which may include, for example, collaborators or consultants") who propose or conduct PHS-funded research under the auspices of TSRL.
PURPOSE
The purpose of this policy is to ensure that the staff is aware of their responsibilities concerning financial conflicts of interest when performing research at TSRL. TSRL requires that individuals participating in sponsored projects disclose any significant financial interests that may present actual or potential conflicts of interest in regards to externally sponsored projects. This policy has been developed to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research awards will be free from bias resulting from financial conflicts of interest. It also promotes compliance with all applicable Federal and State laws. This policy applies to all funded research and non-research grants, contracts, and cooperative agreements.
DEFINITIONS
A. Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS funded research.
B. Significant Financial Interest (SFI) exists if the value of remuneration received by the employee, employee's spouse or dependent Children that reasonably appear to be related to the employee's TSRL responsibilities exceeds $5000;
1. Including:
o Salary or other payments for services (e.g., consulting fees or honoraria) received in the twelve months preceding disclosure; o Equity interests (e.g., stocks, stock options or other ownership interests) however, equity interest in a non-publicly traded entity, no matter the amount, constitutes an SFI; and, o Income from intellectual property rights owned by the employee. Note: $5,000 threshold is aggregation of foregoing.
2. Excluding o Salary, royalties, stock options or other remuneration from TSRL; o Income from seminars, lectures, teaching engagements, service on advisory committees or review panels, derived from excluded sources (defined below);
Income from investment vehicles, such as mutual funds and retirement accounts, as long as the employee does not directly control the investment decisions; and
Unlicensed intellectual property owned by the employee that does not generate income. Note that Intellectual property owned by TSRL is excluded.
3. SFI disclosure also includes travel. Specifically, externally funded reimbursed or sponsored travel that would appear to be related to employee's TSRL responsibilities, however, that is not funded by TSRL. Such travel must be disclosed, no matter the amount, except when the expenses are covered by excluded sources.
C. Employee's professional responsibilities on behalf of TSRL means conducting research, submitting patent applications, publication, technical committee membership and, teaching as adjunct faculty at an Institute of higher education.
D. An excluded source means a source of remuneration that is excluded from disclosure. With reference to the SFI, excluded sources are — 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.
TRAINING
Investigators will be informed of TSRL's FCOI policy. Investigators will also complete the NIH Web-based Tutorial (http://grants.nih.gov/grants/policy/coi/tutoria12011/fcoi.htm) or other approved training session by maintaining a Certificate of Training in their individual training binder. Investigators are required to complete training (1) when the Investigator is new to TSRL, (2) prior to engaging in any PHS-funded research, and (3) at least every 4 years, or (4) when an investigator is not in compliance with the policy or management plan.
DISCLOSURE, REVIEW, AND MONITORING
To identify any SFls, TSRL Investigators are required to submit a SFI Disclosure Statement annually- A current annual disclosure must be on file prior to submitting an application for PHSfunded research, and at least annually during the period of a PHS award. Each Investigator is required to submit an updated disclosure within 30 days of discovering or acquiring a new SFI.
Prior to TSRL's expenditure of PHS funds, a TSRL official or designee (the "TSRL Official") will (1) review all Investigator SFI disclosures, (2) determine if any SFls relate to PHS-funded research, (3) determine if an FCOI exists, and (4) manage FCOls. A FCOI exists when the TSRL Official reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of PHS-funded research. Conditions or restrictions that might be implemented to manage a FCOI include but are not limited to those suggested by PHS regulation*: (1 ) public disclosure of financial conflicts of interest, (2) for research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants, (3) 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, (4) modification of the research plan, (5) change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research, (6) reduction or elimination of the financial interest, or (7) severance of relationships that create financial conflicts-
When an Investigator is new to participating in a PHS-funded research project, the TSRL Official will (1) review the new Investigator's SFI disclosure(s), (2) determine if any SFl(s) relate to PHSfunded research, (3) determine if a FCOI exists, and (4) manage any FCOls within 60 days.
When TSRL identifies any SFls that were not disclosed in a timely manner by an Investigator, or were not previously reviewed by TSRL during an ongoing PHS-funded research project, the TSRL Official will review the SFI disclosures, (1) determine if any SFls relate to PHS-funded research, (2) determine if an FCOI exists, and (3) manage FCOls within 60 days.
The retrospective review will be documented according to PHS regulation*, and include the following: (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 FCOI, (5) Name of the entity with which the Investigator has a financial conflict of interest, (6) Reason(s) for the retrospective review, (7) Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed), (8) Findings of the review, and (9) Conclusions of the review. Retrospective reviews wili be completed and documented within 120 days of TSRL's determination of noncompliance for SFls not disclosed timely or not previously reviewed, or whenever an FCOI is not identified or managed in a timely manner.
SUBRECIPIENT REQUIREMENTS (When Required by Sponsor Agency)
TSRL requires the compliance of all subrecipients either with this policy or with their own policy, which must meet or exceed Federal regulations. In a written agreement, the subrecipient will certify that their FCOI policy complies with PHS regulations. In addition, the subrecipient must report identified FCOls for its investigators within 30 days of identification to allow TSRL enough time to report identified FCOls to the PHS.
TSRL will report to the PHS funding agency any FCOI that are identified by any subrecipient with a FCOI policy that complies with PHS regulations prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.
AWARDING AGENCY REPORTING
When a FCOI is determined, TSRL will notify the awarding agency by submitting a FCOI report through the eRA Commons FCOI Module. The FCOI report will be submitted prior to any expenditure of funds, within 60 days of identification for an Investigator who is new to the project, within 60 days for new or newly identified FCOls for existing investigators, at least annually until completion of the project to provide the status of the FCOI, and following a retrospective review to update a previously submitted report. FCOls that are identified and subsequently eliminated prior to the expenditure of PHS-awarded funds will not be reported to the awarding agency.
For any SFI that TSRL identifies as conflicting subsequent to the Institution's initial FCOI report during an ongoing PHS-funded research project, TSRL will provide to the awarding agency, within 60 days, an FCOI report regarding the financial conflict of interest and ensure that TSRL has implemented a management plan. Where such FCOI reports involve a SFI that was not disclosed timely by an Investigator or was not previously reviewed or managed by TSRL, TSRL will also complete a retrospective review to determine whether any PHS-funded research, or portion thereof, conducted prior to the identification and management of the FCOI was biased in the design, conduct, or reporting of such research. Additionally, if bias is found, TSRL will notify the PHS promptly and submit a mitigation report.
If an Investigator fails to comply with TSRL's FCOI policy or a FCOI management plan appears to have biased the design, conduct, or reporting of -funded research, TSRL will notify the PHS promptly.
MAINTENANCE OF RECORDS
All FCOl-related records will be maintained for at least 3 years from the date the final expenditures report is submitted to the PHS, unless other state or federal law requires a longer retention period.
Any information provided by Investigators to comply with the FCOI Policy is confidential and not accessible to unauthorized personnel. However, if an FCO' exists that relates to PHS-funded research, certain information regarding the FCOI may be required to be publicly disclosed pursuant to the Section :
ENFORCEMENT MECHANISMS AND NONCOMPLIANCE
All Investigators subject to this Policy are expected to comply with it fully and promptly. Whenever an Investigator violates this Policy, the TSRL Official may refer the matter to the TSRL President or Vice President for disciplinary action or other appropriate action to ensure Investigator compliance.
PUBLIC ACCESSIBILITY
TSRL's FCOI policy will be publically accessible on TSRL's website. In addition, prior to TSRL's expenditure of any funds under a PHS-funded research project, TSRL will ensure public accessibility, via written response, to any requestor within five business days of a request, of information concerning any identified FCO's held by senior/key personnel (as defined by PHS regulation). This information will be updated at least annually, be updated within 60 days of a newly identified FCOI, and remain available for three years from the date the information was most recently updated.
