Conflicts of Interest Policy

Sunflower is dedicated to maintaining the highest standards of integrity and objectivity in all its activities, especially research. This policy ensures that professional decisions and research outcomes are not compromised by conflicts of interest, encompassing both financial and non-financial considerations. For PHS-funded research, this policy specifically aligns with 42 CFR Part 50, Subpart F (PHS FCOI Regulation).

1. Purpose & Scope

This policy aims to promote objectivity and integrity across all company activities, ensuring the ethical design, conduct, and reporting of research, free from undue influence. It also serves to comply with applicable federal regulations, including 42 CFR Part 50, Subpart F, and to maintain public trust in Sunflower’s endeavors. This policy applies to all personnel at Sunflower with professional responsibilities, including Investigators involved in PHS-funded research and individuals in positions of influence over company decisions. Additionally, it extends to subrecipients and collaborators as appropriate.

2. Conflicts of Interest (COI)

A Conflict of Interest (COI) arises when an individual’s personal interests (financial or non-financial) or relationships could compromise, or appear to compromise, their professional judgment, obligations, or objectivity in their Company Responsibilities at Sunflower. Examples of COIs include, but are not limited to, Financial Conflicts of Interest (FCOI), which are situations where an individual’s Significant Financial Interest (SFI) could directly and significantly affect their company responsibilities, particularly in research. For PHS-funded research, the detailed definition of SFI is consistent with 42 CFR Part 50, Subpart F. Non-financial conflicts of interest also exist, such as those arising from personal relationships where close ties (e.g., family relationships) might influence hiring, supervision, or decision-making. Personal beliefs or advocacy can also present a COI if strong personal views unduly sway professional judgment in research, teaching, or administrative roles. Lastly, conflicts of commitment involve external activities that interfere with an individual’s primary professional obligations to Sunflower. For a detailed list of definitions, including “Investigator,” “Significant Financial Interest (SFI),” and “Institutional (Company) Responsibilities,” please refer to https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50/subpart-F.

3. Individual Responsibilities

All individuals with professional responsibilities at Sunflower must understand and adhere to this policy. They are required to disclose any actual, perceived, or potential conflicts of interest related to their Company Responsibilities. Specifically, for PHS-funded research, Investigators must disclose to Sunflower designated official all SFIs (for themselves, spouse, and dependent children) related to their Company Responsibilities at the time of PHS funding application, annually during the award period, and within 30 days of acquiring a new SFI or relevant reimbursed/sponsored travel. Furthermore, individuals must participate in the management of COIs by cooperating with Sunflower in the review and implementation of any COI management plan, and complete mandatory COI training as required (e.g., initially, every four years for PHS-funded research, and upon policy changes or non-compliance).

4. Sunflower Responsibilities

Sunflower will maintain and enforce this comprehensive COI Policy. Sunflower will appoint designated official(s) responsible for receiving and reviewing COI disclosures, determining if a disclosed interest constitutes a conflict, and developing and implementing management plans to mitigate or eliminate conflicts. When managing COIs, Sunflower will assess the nature and extent of the COI and develop and implement written management plans tailored to the specific COI, which may include public disclosure, independent oversight, modification of roles, recusal from decisions, or divestiture of interests. For PHS-funded research, Sunflower will ensure FCOIs are managed or eliminated before expending funds. Additionally, for FCOI in PHS-funded research, the company is responsible for submitting FCOI Reports to the PHS Awarding Component (initial, annual, and ad-hoc as required by 42 CFR Part 50, Subpart F), and conducting Retrospective Reviews and submitting Mitigation Reports if FCOIs were not timely disclosed or managed, as per PHS FCOI Regulation. Finally, Sunflower will provide necessary COI training to all relevant personnel.

5. Enforcement & Recordkeeping

Failure to comply with this policy, including non-disclosure or non-adherence to a management plan, may result in disciplinary action up to and including termination, consistent with Sunflower’s policies. Records related to COI disclosures and management will be retained for at least three years, or longer as required by specific regulations like 42 CFR Part 50, Subpart F.

6. Point of Contact

For questions or concerns, please contact:

Jodie Crowley
Chief People & Operations Officer
Jodie@sunflowertx.com