Approved: Approved February 16, 2010
Revised: July 27, 2012
Revised: March 14, 2013
Revised: May 25, 2016
Next Scheduled Review: May 25, 2020
TThe Texas A&M Transportation Institute (TTI) is committed to conducting research and educational activities in a manner consistent with the highest standards of integrity and ethics. This rule is adopted to promote objectivity in research and to ensure that the research and educational activities are conducted in a manner free from bias resulting from financial conflict of interest (FCOI).
Reason for Rule
This rule implements the requirements of System Regulation 15.01.03, Financial Conflicts of Interest in Research.
Procedures and Responsibilities
1. APPOINTMENT OF CONFLICT OF INTEREST OFFICIAL
The Agency Director appoints the Assistant Agency Director and Chief Financial Officer (CFO) or his or her designee as the Conflict of Interest Official (COI Official) for TTI. The COI Official shall perform the duties established in System Regulation 15.01.03 relating to the review of financial interest disclosures and the management and reporting of financial conflicts of interest.
2. DISCLOSURE AND REVIEW
Each Investigator shall submit Financial Disclosure Statements to the TTI COI Official as required in System Regulation 15.01.03.
2.1 In accordance with System Regulation 15.01.03 and federal law, 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 and whether a FCOI exists. If an FCOI exists, the COI Official will 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 In accordance with System Regulation 15.01.03, the COI Official may appoint a Conflict of Interest Review Committee (CIRC) to assist in the determination of whether an FCOI exists. If the COI Official appoints a CIRC, the CIRC must be composed of Investigators representing a cross-section of disciplines and at least one research administrator. The COI Official and/or CIRC may involve the Investigator to assist in determining whether an SFI is related to the Investigator’s Research or Research Activities. The System Ethics and Compliance Officer and/or the Office of General Counsel may be consulted as appropriate.
Each Investigator conducting Research under a Management Plan shall comply fully and promptly with the Plan. The COI Official shall be responsible for conducting periodic reviews of Financial Disclosure Statements and Management Plans to determine individual and institutional compliance. The COI Official shall report instances of noncompliance as required in System Regulation 15.01.03 and federal law.
4. TRAINING AND CERTIFICATION
Investigators shall complete training as required in System Regulation 15.01.03. In addition, each Investigator shall annually certify that the Investigator is aware of and has read System Regulation 15.01.03 and this rule and is aware of the Investigator’s responsibilities regarding disclosure of SFIs and applicable federal regulations.
5. PUBLIC ACCESSIBILITY
5.1 The COI Official shall ensure that this rule is available through a publicly accessible website.
5.2 If the COI Official determines that a Financial Conflict of Interest exists that is related to PHS-funded research, the COI Official shall 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:
- The name of the Investigator;
- The title and role of the Investigator in relation to the affected research;
- The name of the entity in which the SFI is held
- A description of the SFI that was determined to be an FCOI; and
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 shall 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 shall coordinate with the public information officer to ensure that responses to requests comply with Texas Government Code, Chapter 552.
6. OTHER CONSIDERATIONS
In addition to the issues addressed in System Regulation 15.01.03 and this rule, there may be other ethical considerations that are separate and distinct from conflict of interest questions, including but not limited to those relating to external employment and conflict of commitment. The primary responsibility of employees of TTI is the accomplishment of the duties and responsibilities assigned to the employee’s position of appointment. External consulting or other outside employment should not interfere with those duties and responsibilities as set forth in system policies and related regulations.
Related Statutes, Policies, or Requirements
- 42 C.F.R. Part 50, Subpart F
- 45 C.F.R. Part 94
- 21 C.F.R. Parts 54, 312, 314, 320, 330, 601, 807, 812 and 860
- National Science Foundation Grant Policy Manual, Chapter V, §510, eff. July 1, 2005
- System Policy 15.01 – Research Agreements
- System Regulation 15.01.03 – Financial Conflicts of Interest in Sponsored Research
- System Policy 07.01 – Ethics
- System Policy 31.05 – External Employment and Expert Witness
- System Regulation 31.05.01 – Faculty Consulting and External Professional Employment
- Texas Government Code, Ch 552
- System Regulation 31.05.02 – External Employment
Definitions of terms used in this rule are found in System Regulation 15.01.03.
TTI Risk and Compliance