Financial Conflict of Interest
On August 25, 2011, The Department of Health and Human Services published its final rule in the Federal Register, entitled “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors.”
The update to the existing rule (promulgated in 1995) and to the university’s policy was necessary to ensure awardee oversight and reporting transparency is in accordance with today’s increasingly complex research environment.
On August 23, 2012, The University of Texas at Austin’s revised Conflict of Interest Policy was put in effect. Investigators must ensure they are in full compliance with the university’s policy. The policy extends to all research conducted at The University of Texas, whether it is funded or unfunded; and if funded, regardless of project’s funding source.
Key Elements of the 2012 Policy
- Key Personnel including PIs, Co-PIs, Co-Is are automatically considered Covered Individuals. It is the responsibility of the Lead PI to make the determination of other Covered Individuals involved in the project. Post docs, graduate students, technical staff and consultants may qualify as Covered Individuals.
- Covered Individuals are required to disclose their own Financial Interests and those of Other Covered Family Members living his/her household including spouse, dependent children, or other dependents as defined in the policy.
- The revised policy defines a financial interest consisting as one or more of the following interests of the Covered Individual and Covered Family Members (CFM) that reasonably appear to be related to the Covered Individual’s institutional responsibilities:
- Travel – any reimbursed or sponsored travel related to institutional responsibilities. (Does not apply to travel reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education in the US as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with a US Institution of higher education.)
- For PHS funded research, all Covered Individuals must disclose Financial Interests to the Institution no later than at the time of application for PHS-funded research.
- Covered Individuals must:
- submit an updated disclosure of SFIs at least annually, in accordance with the specific time period prescribed by the Institution, during the period of award.
- submit an updated disclosure within 30 days of discovering or acquiring a new related Financial Interest or sponsored/reimbursed travel.
- complete training prior to engaging in research and at least every four years. This includes Covered Individuals, including subrecipient Investigator(s).
The following changes will affect OSP and OIE processes for proposals and award actions on or after August 24, 2012:
At the time of proposal for PHS funding (direct or as pass-thru):
- Proposal Specialists at The University of Texas at Austin will verify that all Covered Individuals on a PHS funded project
- Have completed the required COI training;
- Have submitted a current disclosure; and
- If a Significant Conflict of Interest exists, a statement is included in the proposal that discloses those interests
- Per PHS policy, proposals may not be submitted for PHS funded projects if these requirements have not been met.
At the time of any award:
- Grants and Contracts Specialists at The University of Texas at Austin will verify that all Covered Individuals on any funded project
- Have completed the required COI training;
- Have a current disclosure on file; and
- If a conflict of interest exists, that a Management Plan has been approved that includes the project. Access to funds will be withheld until a Management Plan is approved. This includes authorizations for credit.
Compliance throughout the life of the project:
- The lead PI is responsible for informing the appropriate office (OSP or OIE) of any additions to Covered Inviduals.
- Covered Individuals
- must disclose to The University of Texas at Austin any Financial Interests in accordance with the policy during the course of the funded project.
- must certify annually whether there have been any changes to conflict of interest status.
- are required to renew their training every four years.