15.01.03.I1 Financial Conflicts of Interest in Research

2.1 In accordance with System Regulation 15.01.03 and federal regulations, the COI Official will review all financial disclosure statements by investigators and determine whether any disclosed significant financial interest (SFI) is related to the investigator’s research or research activities and whether an FCOI exists. If an FCOI exists, the COI Official will notify the investigator in writing and work with the investigator to develop a management plan specifying the actions that will be taken to manage, reduce or eliminate the FCOI. All FCOIs identified by the COI Official will be satisfactorily managed, reduced or eliminated prior to the expenditure of any sponsored research funds or prior to the start of an unfunded research activity.

2.2 If an investigator disagrees with the COI Official’s determination on whether an FCOI exists, the investigator may challenge the COI Official’s determination to the Chief Executive Officer (CEO) or designee in writing within ten business days after receiving the COI Official’s determination. The challenge must state:

1. Why the investigator disagrees with the determination;
2. How the SFI could not reasonably result in the influence or bias of the planning, conduct, or reporting of research, and
3. Any other additional facts the investigator wishes to have considered.

The CEO or designee must provide the investigator with a written decision on their challenge within 30 business days. The decision of the CEO or designee is final.

5.1 The COI Official must ensure that this rule is available through a publicly accessible website.

5.2 If the COI Official determines that a FCOI exists that is related to Public Health Service (PHS)-funded research, the COI Official must coordinate with the public information officer to make the following information available in writing to any requestor within five business days after receipt of a request, so long as the investigator still holds the SFI:

1. The name of the investigator;
2. The title and role of the investigator in relation to the affected research;
3. The name of the entity in which the SFI is held;
4. A description of the SFI that was determined to be an FCOI; and
5. The approximate dollar value of the SFI. If the dollar value cannot be determined by reference to publicly available prices or another reasonable method, the system member must include a statement to that effect. Dollar values may be provided within ranges, e.g., $0-$4,999; $5,000-$10,000; $10,000-$20,000; $20,000-$50,000; $50,000-$100,000. Amounts over $100,000 may be stated in increments of $50,000.

5.3 For all public information requests related to non-PHS funded research, the COI Official must coordinate with the public information officer to ensure that responses to requests comply with Texas Government Code, Chapter 552, and state and federal law.

5.4 Information required under this section must remain available to any requestor for the longer of three years after the date of the last expenditure on the research project or as required by applicable federal law.

6.1 Research conducted in cooperation with or through a subrecipient (e.g., a subcontractor, contractor, or collaborator) who performs part of the statement of work described in the prime contract, the member must enter into a written agreement with the subrecipient to ensure compliance with this regulation, federal regulations and funding agency requirements, as applicable, in accordance with System Regulation 15.01.03.