SECTION 1. SCOPE

The purpose of this policy is to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct and reporting of research occurring at ThirdLaw Molecular LLC is free from bias resulting from individual conflicts of interest.

This policy draws upon regulations regarding financial conflicts of interest (“FCOI”) for Public Health Service (“PHS”) funded research, (the “Regulations”). This policy is intended to be in compliance with the Regulations.

This policy applies to each Investigator who is planning to or is participating in research. The defined terms used in this policy are those used in the Regulations, 42 C.F.R. Part 50, Subpart F and 45 C.F.R. Part 94.

SECTION 2. DEFINITIONS

1. “Awarding Sponsor” (sometimes also referred to as “PHS Awarding Component”) means the funding agency that has adopted PHS FCOI Regulation, 42 C.F.R. Part 50, Subpart F.

 

2. “Disclosure of Significant Financial Interest” means an Investigator’s disclosure of significant financial interests to the Company.

3. “Financial Conflict of Interest” (or “FCOI”) means a significant financial interest that could directly and significantly affect the design, conduct or reporting of the research.

4. “FCOI report” means the Company’s report of a Financial Conflict of Interest to an Awarding Sponsor.

5. “Financial Interest” means anything of monetary value, whether or not the value is readily ascertainable.

6. “Immediate Family” means spouse or spousal equivalent and dependent children.

7. “Company” means ThirdLaw Molecular LLC.

8. “Company Official” (sometimes also referred to as “Authorized Official”) for the purpose of this policy means that person designated by the Company, as the person responsible for the administration of financial conflicts of interest pursuant to this policy.

9. “Company Responsibilities” means an Investigator’s professional responsibilities on behalf of the Company and as may be defined by the Company in its policies on conflicts of interest.

10. “Investigator” means 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 or proposed for such funding, which may include, for example, collaborators or consultants. For the purposes of this FCOI Policy, the term “individual” shall be synonymous with “Investigator.”

11. “Manage” or “management” of FCOI means taking action to address the 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.

12. “PD/PI” means a project director or principal investigator of a research project; the PD/PI is included in the definitions of senior/key personnel and Investigator under this FCOI Policy.

13. “PHS-funded research” means a research project funded by the Awarding Sponsor.

14. “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. This 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). For purposes of this policy, research is limited to the above activities when funded by PHS.

15. “Senior/key personnel” means the PD/PI and any other person identified as senior/key personnel by the Company in the grant application, progress report, or any other report under this FCOI Policy.

16. “SFI Disclosure Form” means the disclosure form and accompanying documentation that an Investigator or individual must submit to the Company disclosing any SFI.

17. “Significant Financial Interest” or “SFI” means:

1. A Financial Interest consisting of one or more of the following interests of the Investigator and the Investigator’s Immediate Family that reasonably appears to be related to the Investigator’s Company Responsibilities, including but not limited to:

1. With regard to any publicly traded entity, 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 the disclosure, when aggregated, exceeds $5,000. 

This includes:

1. Remuneration for salary and services not otherwise identified as salary (e.g. consulting fees, honoraria, paid authorship); and
2. Equity interest including any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.

2. With regard to any non-publicly traded entity, if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or if the Investigator or his/her Immediate Family holds any equity interest (e.g. stock, stock option or other ownership interest) in the entity; or
3. Intellectual property rights and interests (e.g. patents and copyrights), upon receipt of income related to such rights and interests.

2. Any reimbursed sponsor travel (i.e. 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 the Investigator’s Company Responsibilities, other than travel that is reimbursed or sponsored by:

1. A federal, state or local government agency (“Public Agency”);
2. An institution of higher education as defined at 20 U.S.C. 1001(a); or
3. An academic teaching hospital, a medical center or a research institute that is affiliated with an institution of higher education.

3. Significant Financial Interest does not include:

1. Salary or other remuneration paid by the Company, if the Investigator is employed by the Company, including intellectual property rights assigned to the Company and agreements to share royalties related to those rights;
2. 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;
3. Income from seminars, lectures or teaching engagements sponsored by a Public Agency, institution of higher education, academic teaching hospital, medical center or research institute that is affiliated with an institution of higher education; or
4. Income from service on advisory committees or review panels for a Public Agency, institution of higher education, academic teaching hospital, medical center or research institute that is affiliated with an institution of higher education.

SECTION 3. PROCEDURES

1. Training Requirements

1. The authorized Official shall inform each Investigator of:

1. This policy;
2. Investigator’s disclosure responsibilities; and
3. Federal regulations.

2. The authorized Official shall require each Investigator to complete FCOI training:

1. Prior to engaging in research;
2. At least every 4 years; and
3. Immediately, if:

1. The Company revises this policy that affects requirements of Investigators;
2. An Investigator is new to the Company; or
3. An Investigator is not in compliance with this policy or Management Plan.

2. Disclosure, Review and Monitoring Requirements

3. An SFI disclosure form is required from all Investigators involved in or proposing to participate in research.

4. The authorized Official shall require each Investigator to disclose SFIs (and those of the Investigator’s Immediate Family) related to the Investigator’s company responsibilities:

1. No later than at the time of application for research;
2. At least annually during the period of the award or research project; and
3. Within 30 days of discovering or acquiring a new SFI.

5. The Company shall designate one or more Company Official(s), to solicit and review disclosures of SFIs of the Investigator (and those of the Investigator’s Immediate Family) related to an Investigator’s company responsibilities.

6. The Company shall provide adequate guidelines for the designated

Company Official(s) to determine whether an Investigator’s SFI is related to the research and, if so related, whether the SFI is an FCOI.

7. The authorized Official shall require its designees, prior to the Company’s expenditure of research funds, to:

1. Review all Investigator SFI disclosures;
2. Determine if any SFIs relate to the research;
3. Determine if an FCOI exists; and
4. Develop and implement Management Plans, as needed to manage FCOIs.

8. The authorized Official shall review disclosures of SFIs, make determination of FCOIs, and implement a Management Plan, when required, within 60 days for an Investigator who is new to participating in the research project or for an existing Investigator who discloses a new SFI.

9. The authorized Official shall review disclosures of SFIs, make determination of FCOIs, and implement a Management Plan, when required, within 60 days whenever the Company identifies an SFI that was not disclosed timely by an Investigator or not previously reviewed by the Company.

10. The authorized Official shall take such actions as necessary to manage FCOIs, including any financial conflicts of a subrecipient Investigator, if applicable, and monitor Investigator compliance with Management Plans until completion of the project.

3. Reporting Requirements for PHS-funded Research

11. The authorized Official shall send initial, annual (i.e., ongoing) and revised FCOI reports, including all reporting elements required by the Regulation, to the Awarding Sponsor for the Company and its subrecipients, if applicable, as required by the Regulation:

1. Prior to the expenditure of funds;
2. Within 60 days of identification for an Investigator who is newly participating in a project;
3. Within 60 days for new, or newly identified, FCOIs for existing Investigators;
4. At least annually (at the same time the Company 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 completion of the project; and
5. Following Retrospective Review to update a previously submitted report, if appropriate.

12. The authorized Official shall notify the Awarding Sponsor promptly if, during a Retrospective Review, bias is found with the design, conduct or reporting of PHS-funded research and to include the requirement to submit a Mitigation Report in accordance with the Regulation.

1. The procedures must include all Mitigation Report reporting elements as required by the Regulation.

13. The authorized Official shall notify the Awarding Sponsor promptly if an Investigator fails to comply with this policy or a FCOI Management Plan that appears to have biased the design, conduct or reporting of the PHS-funded research.

1. The Company shall notify the Awarding Sponsor promptly and take any corrective action for noncompliance with this policy or the Management Plan.

4. Maintenance of Records

1. The authorized Official shall maintain all FCOI-related records for:

1. At least 3 years from the date the final expenditures report is submitted to the Awarding Sponsor, if applicable;
2. At least 3 years from the date the final expenditure is made for research funded from all sources, except the PHS; and
3. From other dates specified in 45 C.F.R. 74.53(b) and 92.42(b).

5. Enforcement Mechanisms, Remedies and Noncompliance

14. The authorized Official shall adequately enforce and provide for employee sanctions or other administrative actions to ensure Investigator compliance.

15. The authorized Official shall complete and document Retrospective Reviews within 120 days of the Official’s determination of noncompliance for SFIs not disclosed timely or previously reviewed, or whenever an FCOI is not identified or managed in a timely manner, and shall document the reviews consistent with the Regulation.

16. The purpose of a PHS-funded clinical research project may be to evaluate the safety or effectiveness of a drug, medical device or treatment. In certain circumstances, the Department of Health and Human Services may determine that such PHS-funded research project was designed, conducted or reported by an Investigator with a FCOI that was not managed or reported by the Company as required by the Regulation. In such instance, the authorized Official shall require the Investigator involved to:

1. Disclose the FCOI in each public presentation of the results of the research; and
2. Request an addendum to previously published presentations.
3. The Company may require similar disclosures for non-PHS-funded research.

6. Subrecipient Requirements for PHS-funded Research

17. Where applicable, the authorized Official shall establish, via a written agreement, whether the subrecipient will follow this policy or the FCOI policy of the subrecipient.

18. If applicable, the authorized Official shall obtain a certification from the subrecipient that its FCOI policy complies with the Regulation.

19. If applicable, the Company shall include in the written subrecipient agreement a requirement for the subrecipient to report identified FCOIs for its Investigators in a time frame that allows the awardee Institution to report identified FCOIs to the Awarding Sponsor as required by the Regulation.
20. Alternatively, if applicable, the Company shall include in the written agreement a requirement to solicit and review subrecipient Investigator disclosures that enable Institution to identify, manage and report identified FCOIs to the Awarding Sponsor

7. Public Accessibility Requirements

21. The Company shall make this policy publicly accessible by posting it on its website.

22. For PHS-funded research only, the authorized Official shall make available information concerning identified FCOIs held by senior/key personnel publicly accessible prior to the expenditure of funds. The information will:

1. Include the minimum elements as provided in the Regulation;
2. Made available within 5 calendar days of written request;
3. Be updated, at least annually;
4. Be updated, within 60 days of a newly identified; and
5. Remain available for 3 years from the date the information was most recently updated.