Conflict of Interest
Financial Conflict of Interest (FCOI)
On August 23, 2012, The University of Texas at Austin’s revised Conflict of Interest Policy (http://www.utexas.edu/research/rsc/coi/documents/promoting_objectivity_in_research_coi_policy_v4.pdf) will be 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.
The following changes will affect OIE Processes for proposals and award actions, including IAP or RPA actions, gifts or other types of research projects, on or after August 24, 2012:
At the time of proposal:
- Proposal Specialists at The University of Texas at Austin will verify that all Covered Individuals on a funded project
- Have a current disclosure on file; and
- If a Significant Conflict of Interest exists, a statement is included in the proposal that discloses those interests
- Proposals may not be submitted if these requirements have not been met.
At the time of award:
- Grants and Contracts Specialists at The University of Texas at Austin will verify that all Covered Individuals on any funded project
- 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
The revised Objectivity in Research policy is effective Aug. 23, 2012, and has been added to the UT Handbook of Operating Procedures, Policy No. 5.11:
The revised policy contains significant revisions to the previous policy and incorporates changes that meet updated federal requirements governing disclosure and reporting of financial conflicts of interest. The revised policy affects all individuals who are responsible for the design, conduct or reporting of research.
All federally and privately supported clinical trials listed in the registry of clinical trials at www.ClinicalTrials.gov are eligible for a Clinical Trial F&A rate.
Other clinical trials must meet the following conditions to qualify for the Clinical Trial F&A rate:
- The trial involves:
The testing of investigational new drugs, devices, treatments, interventions or diagnostics, or alternative indications of approved drugs, devices, treatments, interventions or diagnostics, or
The collection or review of data generated or acquired in a clinical setting for the purpose of assessing the safety, efficacy, benefits, costs, adverse reactions or outcomes; and
- Contact with human subjects or the review of patient care clinical data;
- Performed in an off-campus clinical setting or patient care facility; and
- Funded by an industry sponsor.
Preclinical laboratory studies or studies in animals are not included under the term clinical trial.
An advance payment is required on all industrial projects with industry sponsors. This advance payment is required because as an agency of the State of Texas UT Austin is prohibited from extending credit to a private enterprise. Since it may take several months to receive payment for an invoice for materials and salaries necessary to initiate a project, an advance payment for these “start up” or “mobilization” activities is required. The amount of the advance payment is usually 25% of the total project cost. However, the amount of the advance payment may be higher or lower depending on the circumstances, e.g. if the sponsor has a bad credit rating or poor payment history with UT Austin, a higher amount (up to the full project cost) may be required; if the sponsor has a good credit rating and an ongoing history of prompt payment with UT Austin the amount may be lower. The sponsor is notified of this advance payment requirement in the proposal transmittal letter. The amount of the advance payment is cited in the payment clause of the contract. An invoice for the advance payment is transmitted by upon execution of the sponsored research agreement, with payment due within 5 business days of receipt. The advance payment is applied against the final invoice for the project, and any funds remaining are returned to the sponsor.
This policy does not apply when the industrial sponsor has a prime government contract under which UT Austin will be a subcontractor. These subcontracts are administered by UT Austin’s Office of Sponsored Projects.
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