Outside (Non-UT) Collaborators

Individuals conducting human subjects research on behalf of their home institution/entity are contributing knowledge and expertise to the research project in association with the institution/entity where they are appointed or employed. This includes academic and research institutions outside of UT-Austin, and for-profit or non-profit entities. These individuals should complete Requirement A as outlined below.

Requirement A for Research Involving Human Subjects

If the home institution/entity can certify that the investigator will comply with their FCOI policy and that the policy is consistent with any applicable federal regulations, the following steps should be taken.

1. If Covered Individuals at the outside institution/entity are engaged in human subjects research using identifiable data as part of the study, the collaborating UT investigators should complete a study site application form: HRP-UT931 – Template Site Specific Request to Rely on UT IRB. This form requires certification by an IRB Contact at the relying institution, allowing the outside entity to certify that the non-UT collaborators are compliant with FCOI policies and to confirm that any financial conflict of interest with the study has been identified and managed.
2. The completed Site Specific Request form must be submitted to the UT IRB in UTRMS as part of the protocol submission.

NOTE: If the non-UT collaborators’ institution/entity does not have an FCOI policy, the non-University Covered Individual must comply with Requirement B.

Requirement B

When a Covered Individual’s home institution/entity does not have a FCOI policy consistent with applicable federal regulations, the investigator is required to complete a University of Texas at Austin Financial Interest form, linked here. The investigator should follow the guidance provided here, to complete and submit this form:

1. Complete the Financial Interest Statement, making sure to provide the requested information about the research project (Project Title, Name of UT Austin Principal Investigator)
2. Investigators who indicate a financial interest related to human subjects research proposed to the UT Austin Institutional Review Board will be contacted by the COI office and asked to provide additional information.

Research collaborators or outside consultants conducting UT-Austin research as independent investigators are those who are providing knowledge and expertise to a research project, but NOT acting on behalf of their home institution/entity. In these cases, the non-University Covered Individual must complete a University of Texas at Austin Financial Interest form, linked here. The investigator should follow the guidance provided here, to complete and submit this form:

1. Complete the Financial Interest form, making sure to provide the requested information about the research project (Project Title, Name of UT Austin Principal Investigator)
2. Investigators who indicate a financial interest related to human subjects research proposed to the UT Austin Institutional Review Board will be contacted by the COI office and asked to provide additional information.

If you are conducting research on behalf of your home institution/entity, you are contributing your knowledge and expertise to the research project in association with the institution/entity where you are appointed or employed. This applies to any non-University institution/entity, even other UT System academic and health institutions.

If the home institution/entity has an established FCOI policy that meets the minimum requirements of the PHS regulations (45 CFR Part 94 and 42 CFR Part 50, Subpart F), as evidenced by registration in the FDP Clearinghouse (include FDP clearinghouse link), no further action is required*.

If the home institution/entity certifies (in the subrecipient agreement form) that the investigator will comply with their FCOI policy and that the policy is consistent with any applicable federal regulations, no further action is required*.

If the research is funded by a non-federal sponsor, no FCOI action is required*.

* For sponsored projects that involve human subjects research, compliance with Requirement A for Human Subjects Research (outlined above) will be necessary prior to IRB approval of the protocol.

For research sponsored by a federal agency, where the subrecipient institution does not have an applicable, compliant FCOI policy:

Requirement B

When a Covered Individual’s home institution/entity does not have an FCOI policy that meets the requirements of the federal funding agency, the investigator is required to complete a University of Texas at Austin Financial Interest form, linked here. The investigator should follow the guidance provided here, to complete and submit this form:

1. Complete the Financial Interest form, making sure to provide all requested information about the research project (Project Title, Name of UT Austin Principal Investigator)
2. Investigators who indicate a financial interest related to the proposed UT Austin research will be contacted by the COI office and asked to provide additional information.

If you are involved in research as an independent researcher (i.e., collaborator or consultant that is paid or unpaid), you are providing your knowledge and expertise to a research project, but NOT acting on behalf of your home institution/entity. Complete Requirement B as outlined below.

Requirement B

An investigator acting as an independent researcher (i.e., outside collaborator or consultant) is required to complete a University of Texas at Austin Financial Interest form, linked here. The investigator should follow the guidance provided here, to complete and submit this form:

1. Complete the Financial Interest form, making sure to provide all requested information about the research project (Project Title, Name of UT Austin Principal Investigator)
2. Investigators who indicate a financial interest related to the proposed UT Austin research will be contacted by the COI office and asked to provide additional information.