Who is a Covered Individual?

For both funded and unfunded research activities at the University of Texas at Austin, a “Covered Individual” is any person, regardless of title or position, who is responsible for the design, conduct or reporting of research. The Principal Investigator for the research project is responsible for determining who meets the definition of a Covered Individual, based on the person’s responsibilities on the project and their level of independence in carrying out these responsibilities.

In making this determination, PIs should consider whether the researcher is in a position to significantly influence the direction of the research, the acquisition of data, or the method and analysis of the research.

The following is intended to provide guidance to PIs in determining who meets the definition of “Covered Individual.” This does not represent every scenario or description of a Covered Individual:

Researchers who are independently responsible for or who have authority from the PI to significantly influence the way the research is conducted, or the way data is analyzed, evaluated or reported should be considered Covered Individuals. Individuals who make decisions about research protocols, who develop or modify research methods, or who are independently reviewing and analyzing data may be considered Covered Individuals.

Senior/Key Personnel who are identified on a grant application or project report to a funding agency as contributors to the research are considered Covered Individuals, whether or not they receive salary support.

Researchers who are making contributions that would lead to authorship on manuscripts or other presentations of the research may be considered Covered Individuals. This includes students who would meet this definition.

Postdoctoral researchers and clinical fellows may be considered Covered Individuals depending on their ability to independently and significantly influence the research.

Sub-recipients, collaborators and consultants outside of the University of Texas at Austin who are responsible for any portion of the research, data acquisition, or method and analysis of the research are considered Covered Individuals and must meet the requirements of Non-University Covered Individuals.

Who is Not a Covered Individual?

The following are typically not considered Covered Individuals:

  • Administrators or individuals who perform routine or supportive tasks related to the research.
  • Outside consultants who provide a “fee for service” only.
  • Undergraduates (outside of UT-Austin) and high school students who are participating as research volunteers.

The identification of Covered Individuals should be done on a project-by-project basis. For research involving human subjects, the Research Personnel Form for the IRB protocol should accurately identify all Covered Individuals on the research project.

Please note that some research personnel on IRB-approved studies may be required to complete Human Subjects research training, but NOT be considered Covered Individuals on the project. Only Covered Individuals should complete the Financial Interest Disclosure form.

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