Introduction

Promoting objectivity in Research is defined in 42 CFR 50 Subpart F. The purpose of this policy is to prevent potential bias resulting from any Financial Conflict of Interest (FCOI) by individuals who have direct influence in the allocation and use of public funding in the conduct of research. 

This FCOI policy defines the requirements and processes for investigators or individuals participating in PHS funded research to identify and properly disclose any FCOIs. In addition, it outlines activities related to management, enforcement, and reconciliation for all appropriate studies. 

The following FCOI policy applies to research and initiatives funded by US Public Health Service (PHS) grants to TAXIS Pharmaceuticals Inc. More information can be found at https://grants.nih.gov/grants/policy/coi/index.htm 

What is a Financial Conflict of Interest (FCOI)? 

Conflicts of interest in research are present when Significant Financial Interests directly affect, or could appear to affect, the professional judgment of a researcher when designing, conducting, or reporting research. 

Who needs to disclose? 

• All TAXIS Pharmaceuticals Inc. investigators must disclose at least annually. 

• Non-TAXIS investigators must disclose only those Significant Financial Interests (SFI) related to their research. 

What is considered a Significant Financial Interest (SFI) 

An SFI is present when any of the following are received by an Investigator or their Immediate Family Member: 

• Combined income or equity exceeding $5,000 in a publicly traded company. 

• Income exceeding $5,000 or any equity in a privately held company. 

• Income exceeding $5,000 from Intellectual Property managed by TAXIS as well as IP managed by another institution. 

• Sponsored/reimbursed travel exceeding $50. 

When and how do I disclose? 

Annually all Principal Investigators (PI’s) and key personnel responsible for conducting or designing research should complete the COI disclosure form as it relates to ongoing research. In addition, at the time of proposal submission or when there is significant change, principal investigators and key personnel should submit an FCOI disclosure form. 

Conflicts are reasonably expected to be disclosed when: 

• The conflict has a direct and significant impact on the design, conduct or reporting of the sponsored project. 

• The conflict has the potential to undermine personnel’s obligation to TAXIS or the sponsor. 

FCOI Training for Investigators 

In compliance with federal regulations, all TAXIS Investigators who are planning to participate in or are participating in Public Health Service (PHS) funded research are required to review this TAXIS FCOI policy and complete the NIH’s online FCOI Training module: 

• Prior to engaging in research related to any PHS/NIH-funded grant 

• Every year 

• Immediately, if: 

  • TAXIS revises its FCOI policy that affects requirements of Investigators. 
  • An Investigator is new to the company. 
  • An Investigator is not in compliance with the policy or management plan. 

Upon completion of the training, a certificate of completion must be sent to the Chief Executive Officer (CEO) of TAXIS. Investigators should also retain a copy for their records. 

Process 

Training is provided through a web-based education module. Employees are encouraged to utilize the resources available on NIH’s FCOI Training Webpage at FCOI Training | grants.nih.gov to satisfy the training requirements related to the Federal regulation. 

COI Committee 

The Conflict-of-Interest Committee comprising of TAXIS’s CEO, Chief Scientific officer (CSO) and Chief Finance Officer (CFO) reviews the reporting forms to determine whether a significant financial interest is related to the investigator’s TAXIS research and whether it constitutes an FCOI. Once an FCOI has been identified, the committee recommends a management plan and implementation mechanisms. 

The plan may outline terms, conditions, and restrictions, if any, to ensure compliance with this policy. 

Enforcement Mechanism and Remedies 

Whenever the Company identifies a SFI that was not disclosed timely to the sponsor, 

Company will complete a retrospective review within 120 days of discovery of noncompliance to determine whether any PHS-funded research, or portion thereof, conducted during the period of the noncompliance, was biased in the design, conduct, or reporting of such research. Updated FCOI will be submitted to the sponsor. 

Required retrospective review elements are outlined in 42 CFR 50.605(a)(3)(iii). 

Public Accessibility Requirements 

TAXIS will publish the institution’s policy on its public website. TAXIS will respond to all written requests for information within five (5) calendar days and then release the required information about such SFI containing the minimum elements as provided by regulation. Records of Investigator SFI Disclosure forms will be retained for a minimum of three years from the date the final expenditure report is submitted to the sponsor. 

References 

COI Regulation 42 CFR Part 50 Subpart F 

NIH Guide Notices Related to Financial Conflict of Interest