This Policy applies to Ting Therapeutics’ Founders/Investigators/Support Personnel who have a Significant Financial Interest that may create a Financial Conflict of Interest. Founders/Investigators/Support Personnel must complete a disclosure form and submit it to Ting Therapeutics annually. This form must also be completed and submitted to Ting Therapeutics within 30 days after a Founder/Investigator/Support Personnel obtains a new or additional Significant Financial Interest during the course of a project that is not included in their annual disclosure.
Failure to comply with this Policy will result in appropriate disciplinary action in accordance with applicable Company policies.
This Policy assures objectivity in research projects funded through Ting Therapeutics by all sources, including grants, contracts, or cooperative agreements. It ensures that the design, conduct, or reporting of research projects will not be biased by any conflicting interest of a Founder/Investigator/Support Personnel or his/her family members. This
Policy also supports Ting Therapeutics’ compliance with the Public Health Service regulations (42 CFR Part 50, Subpart F, and, as applicable, 45 CFR Part 94) and the grant requirements of the National Science Foundation.
All Founder/Investigator/Support shall disclose all known Significant Financial Interests of the Founder/Investigator/Support and his/her family members.
In all cases, Financial Conflicts of Interest will be satisfactorily managed, reduced, or eliminated in accordance with this Policy.
This Policy applies to all Founder/Investigator/Support Personnel.
Disclosure: Founder/Investigator//Support Personnel’s statement to the Company of any Significant Financial Interests. Equity interest: Any stock, stock option, or other ownership interest.
Family member: Founder/Investigator/Support Personnel’s spouse or dependent children.
Financial Conflict of Interest (FCOI): A Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of research.
Company (professional) responsibilities: A Founder/Investigator//Support Personnel’s responsibilities on behalf of the Company, including:
• Research consultation
• Professional practice
• Consulting or other services to third parties related to Founder/Investigator/Support Personnel’s expertise
• Service on panels, such as Institutional Review Boards or Data and Safety
Founder/Investigator/Support Personnel: Ting Therapeutics employees who are involved in the design, conduct, or reporting of a research project. Also includes any Ting Therapeutics’ employees, regardless of title or position, involved in the design, conduct, or reporting of a research project funded in whole or in part by a non-Company source.
Remuneration: Salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).
Research: A systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge, including, but not limited to, that 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, but is not limited to, any such activity for which research funding is available from a PHS awarding component through a contract, whether authorized under the PHS Act or other statutory authority, such as a research grant, infrastructure award, or research resources
Significant Financial Interest: Anything of monetary value (whether or not that value is readily ascertainable) that reasonably appears to be related to the Founder/Investigator/Support Personnel’s company (professional) responsibilities and is received, obtained, or held directly or indirectly by the Founder/Investigator/Support Personnel and/or a family member, including one or more of the following interests:
• With regard to any publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the 12 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, as determined through reference to public prices or other reasonable measures of fair market value. (Note: $5,000 threshold for both remuneration and equity interests.)
• 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 12 months preceding the disclosure, when aggregated, exceeds $5,000, or when the Founder/Investigator/Support Personnel and/or family member holds any equity interest. (Note: Remuneration has a $5,000 threshold, equity interests have a $0 threshold.).
The term Significant Financial Interest does NOT include the following types of financial interests:
• Salary, royalties, or other remuneration paid by the Company to the Founder/Investigator/Support Personnel;
• Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Founder/Investigator/Support Personnel does not directly control the investment decisions made in these vehicles;
• 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; or
• Income from service on advisory committees or review panels for 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.
Subrecipient: Subgrantees, contractors, collaborators, or subcontractors.
1. Disclosure of Significant Financial Interests
a. Initial Disclosure of Significant Financial Interests
i. Annual Disclosure: Founder/Investigator/Support Personnel shall submit an
updated disclosure form annually.
ii. New Research Projects. If an annual disclosure form has not been submitted, all Founder/Investigator/Support Personnel shall complete and submit a disclosure form before any research project may be submitted to an external sponsor, as well as before all Institutional Review Board/Institutional Animal Care and Use Committee/Institutional Biosafety Committee applications are submitted.
iii. Founder/Investigator/Support Personnel Added to an Existing Project. If an annual disclosure form has not been submitted, all Founders/Investigators/Support Personnel added to an existing research project shall complete and submit a disclosure form. No one shall be added to the project until the disclosure form has been reviewed pursuant to
b. New or Additional Financial Interests. Any Founder/Investigator/Support
Personnel or his/her family member who discovers or acquires (e.g., through purchase, marriage, or inheritance) a new or additional Significant Financial Interest during the period of a research project must submit an updated disclosure form to the Company within 30 days of discovering or acquiring the new or additional Significant Financial Interest.
2. Review Process
a. Initial Review: Ting Therapeutics, will review each disclosure form to ensure that it has been properly filled out and signed by the Founder/Investigator/Support Personnel to determine the existence of any Significant Financial Interest.
i. If NO Significant Financial Interest is disclosed, the disclosure form is filed and no further action is required.
ii. If a Significant Financial Interest is disclosed, Ting Therapeutics shall determine whether it is related to any grants or contracts, or to any open human, animal, or laboratory research.
b. Intellectual Property Rights. A Founder/Investigator/Support Personnel is NOT required to disclose as a Significant Financial Interest income (including royalties, license fees, or other forms of revenue) paid by the Company to the Founder/Investigator/Support Personnel due to intellectual property rights assigned to the Company by the Founder/Investigator/Support Personnel and agreements to share in revenue related to such rights.
c. New or Undisclosed Significant Financial Interests. Whenever:
i. a Founder/Investigator/Support Personnel new to a research project discloses a Significant Financial Interest,
ii. an existing Founder/Investigator/Support Personnel discloses a new Significant Financial Interest, or
ii. the Company identifies a Significant Financial Interest that was not previously disclosed by a Founder/Investigator/Support Personnel or, for whatever reason, was not previously reviewed by the Company during an ongoing research project (e.g., was not reviewed or reported by a subrecipient).
Depending on the nature of the Financial Conflict of Interest, the Company may determine that additional interim measures are necessary regarding the
Founder/Investigator/Support Personnel’s participation in the research project between the date that the Financial Conflict of Interest or the Founder/Investigator/Support Personnel’s noncompliance is determined and the completion of the Company’ retrospective review.
5. Records Retention:
The Company shall retain records of all disclosures and the Company’s review of and response to each disclosure.
6. Enforcement, Sanctions, and Noncompliance
a. General. Founder/Investigator/Support Personnel shall fully comply with this Policy. Failure to comply with this Policy may result in disciplinary action.
b. PHS-Funded Projects
i. Retrospective Review: When a Financial Conflict of Interest is not identified or managed in a timely manner, the Company shall, within 120 days of the Company’s determination of noncompliance, complete a retrospective review of the Founder/Investigator/Support Personnel’s activities and the PHS-funded research project. This review shall determine whether there was any bias in the design, conduct, or reporting of the PHS-funded research, or any portion thereof, conducted during the time period of the noncompliance.
The Company shall document the retrospective review, including, but not limited to, all of the following key elements:
1. Project number
2. Project title
3. Project Director/Principal Investigator (or contact Project Director/Principal Investigator, if a multiple Project Director/Principal Investigator model is used)
4. Name of the Founder/Investigator/Support Personnel who has the Financial
Conflict of Interest
5. Name of the entity with which the Founder/Investigator/Support Personnel 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
9. Conclusions of the review
If a Founder/Investigator/Support Personnel’s failure to comply with this Policy or a management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, the Company shall promptly notify the PHS awarding component of the corrective action taken or to be taken.
ii. PHS Notification
1. Prior to the Company’s expenditure of any funds under a PHS-funded research project, the Company shall provide to the PHS awarding component a Financial Conflict of Interest report regarding any Founder/Investigator/Support Personnel’s Financial Conflict of Interest, and ensure that the Company has implemented a management plan.
In cases in which the Company identifies a Financial Conflict of Interest and eliminates it prior to the expenditure of PHS-awarded funds, the Company shall not submit a Financial Conflict of Interest report to the PHS awarding component.
2. For any Financial Conflict of Interest that the Company identifies after its initial report during an ongoing PHS-funded research project (e.g., upon the participation of a Founder/Investigator/Support Personnel who is new to the research project), the Company shall provide to the PHS awarding component, within 60 days, an updated Financial Conflict of Interest report regarding the conflict and ensure that the Company has implemented a management plan.
3. Mitigation Report: If, after conducting a retrospective review, the Company finds that it is warranted, it shall update the previously submitted Financial Conflict of Interest report, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward. If bias is found, the Company shall 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, as well as a description of the impact of the bias on the research project (e.g.,
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) and the Company’s plan of action or actions taken to eliminate or mitigate the effect of the bias.
4. For any Financial Conflict of Interest associated with an ongoing PHS-funded research project that was previously reported by the Company, the Company shall provide to the PHS awarding component an annual Financial Conflict of Interest report that addresses the status of the conflict and any changes to the management plan. These annual reports will be required for the duration of the PHS-funded research project, including extensions with or without funds.
The annual Financial Conflict of Interest report shall specify whether the Financial Conflict of Interest is still being managed, or explain why the Financial Conflict of Interest no longer exists.
5. In some cases, the Federal Department of Health and Human Services (HHS) may determine that a PHS-funded clinical research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by a Founder/Investigator/Support Personnel with a Financial Conflict of Interest that was not managed or reported by the Company as required. In
these cases, the Company shall require the Founder/Investigator/Support Personnel 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.
c. NSF Notification: The Company shall keep the NSF Office of the General Counsel appropriately informed if Ting Therapeutics finds that it is unable to satisfactorily manage a Financial Conflict of Interest under an NSF-funded project.
d. Other Sponsors: The Company shall notify any other sponsor of Financial
Conflicts of Interest and management plans imposed, as required by sponsor policy or contractual obligation.
8. Public Accessibility
a. Policy Availability. The Company shall post and maintain this Policy on a publicly accessible Ting Therapeutics web site.
a. Initial Training: All current Founder/Investigator/Support Personnel shall be informed of and trained on this Policy, including the Founder/Investigator/Support Personnel’s responsibilities regarding disclosure of Significant Financial Interests, and the PHS Federal regulations on Financial Conflict of Interest. All Founder/Investigator/Support Personnel must complete initial Financial Conflict of Interest training before beginning work on any research project.
b. Training Updates: Founder/Investigator/Support Personnel shall complete retraining on Financial Conflict of Interest every four years after initial training.
10. Federally Funded Subcontracts
If the Company carries out Federally funded research through a subrecipient, the Company shall take reasonable steps to ensure that any subrecipient
Founder/Investigator/Support Personnel complies with Federal requirements for Financial Conflicts of Interest by:
a. Providing Financial Conflict of Interest reports to the Federal agency regarding all Financial Conflicts of Interest of all subrecipient Founder/Investigator/Support Personnel (i.e., prior to the expenditure of any funds and within 60 days of any subsequently identified Financial Conflict of Interest.
If the subrecipient does not have a Financial Conflict of Interest policy or refuses to apply the policy or certify compliance of the policy with Federal regulations, the agreement with the subrecipient shall:
a. require the subrecipient’s Founder/Investigator/Support Personnel to comply with this Policy, and
b. specify time period(s) for the subrecipient to submit all Founder/Investigator/Support Personnel disclosures of Significant Financial Interests to the Company. Such time period(s) shall be sufficient to enable the Company to comply with its review, management, and reporting obligations.
AMENDMENTS OR TERMINATION OF THIS POLICY
Ting Therapeutics reserves the right to modify, amend, or terminate this Policy at any time. Nothing in this Policy should be construed as a contract between the Company and its employees