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The Office of Research Support (ORS) does not administer or oversee HOP policy 5-2011 or training related to the policy. ORS administers HOP policy 7-1210, “Promoting Objectivity in Research by Managing, Reducing or Eliminating Financial Conflicts of Interest” so if you conduct research and have:

  1. Not submitted a Financial Interest Disclosure (FID), you will need to complete mandatory training and file a FID. Instructions for completing these requirements are located at http://www.utexas.edu/research/rsc/coi/training.html.
  2. Previously submitted a FID, you are not required to complete additional training nor re-disclose the same information to comply with the UTS 180/HOP 5-2011 policy requirements.   However, you may have other responsibilities under that policy.

HOP policy 5-2011 QUESTIONS? Contact the Provost’s Office evpp_coi@austin.utexas.edu or call Janet Dukerich, Senior Vice Provost for Faculty Affairs at (512) 232-3310.

Investigators and Collaborators

All Covered Individuals, as defined by The University of Texas at Austin’s (University) policy for Promoting Objectivity in Research by Managing, Reducing, or Eliminating Conflicts of Interest, are required to complete Financial Conflict of Interest (FCOI) training and submit a Financial Interest Disclosure (FID) form if they are involved in University research, regardless of funding or funding source:

Who is a Covered Individual (CI)?

Per University policy, a CI is an individual who is responsible for the design, conduct or reporting of research.  The PI determines who meets the definition of a CI based on the individual’s responsibilities. The following positions and titles often meet the definition of a covered individual.

  • Principal Investigators (PI)
  • Co-Investigator
  • Faculty sponsor
  • Mentor
  • Research assistants

NOTE: If the research involves human subjects, a CI is an individual who is involved in the design, conduct, or reporting of research. Contact the Office of Research Support at orsc@uts.cc.utexas.edu or (512) 471-8871 if you have questions about whether or not your research involves human subjects.

Once the PI identifies who is a CI on a research project, the next step is to determine the appropriate training and disclosure requirements for each CI.


Requirements for University Covered Individual

University CIs must follow the steps below in the order described:

  • FCOI training
  • Submit a FID form. The FID form instructions and web link are provided via e-mail one business day after the FCOI training is complete.

Requirements for Non-University Covered Individuals (Non-University CI)

Requirements are based on the research conducted. Select which of the following applies to you:

Select which of the following describes your involvement in the research.

Conducting research on behalf of your home institution/entity

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. Complete Requirement A as outlined below.

REQUIREMENT A:

The home institution/entity has established an FCOI policy that meets the minimum requirements of the PHS regulations (45 CFR Part 94 and 42 CFR Part 50, Subpart F) AND the non-University CI is compliant with the policy. The following steps must be addressed.

    1. An authorized representative must complete and send the below statement to coi@austin.utexas.edu (copying the IRB Program Coordinator and Office of Sponsored Projects (OSP) staff, as applicable) via e-mail or letterhead.

      [NAME OF INSTITUTION] certifies that we have a compliant financial conflict of interest policy that conforms to the requirements of 45 CFR Part 94 and 42 CFR Part 50, Subpart F. We certify that [NAME OF COOPERATING RESEARCHER (e.g. John Smith, Ph.D)] has complied with our policy. Prior to expenditure of funds and within 45 days of any subsequently identified FCOI, we will report to The University of Texas at Austin any identified financial conflict of interest related to the award, and provide an indication whether the conflict has been eliminated, reduced, or managed.”
    2. Include a copy of or a link to the institution/entity’s FCOI policy for review.

NOTE: If the institution/entity’s FCOI policy is determined to NOT meet the minimum requirements of the PHS regulations or does not have an FCOI policy, the non-University CI must comply with Requirement B.

REQUIREMENT B: Follow the below steps in the order described.

  1. Obtain a guest UT EID. Ensure an active and current e-mail address is listed in your EID profile.
  2. Complete the University FCOI training module. Select to view training slideshow OR download training PDF.
  3. Certify completion of the training as instructed on the last slide of the FCOI training module to receive credit.
  4. Submit a FID form. The FID form instructions and web link are provided via e-mail one business day after The Office of Research Support manually updates your FCOI training record. This is required prior to your submission of the FID form.

The Office of Research Support will manually update your training record after you certify completion of your training. This is required prior to your submission of the FID form. All efforts to send your certification during business hours (Monday-Friday 8 a.m. to 4:30 p.m. CST) are appreciated.

Involved as an independent researcher

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: The non-University CI must follow the below steps in the order described.

  1. Obtain a guest UT EID. Ensure an active and current e-mail address is listed in your EID profile.
  2. Complete the University FCOI training module. Select to view training slideshow OR download training PDF.
  3. Certify completion of the training as instructed on the last slide of the FCOI training module to receive credit.
  4. Submit a FID form. The FID form instructions and web link are provided via e-mail one business day after The Office of Research Support manually updates your FCOI training record. This is required prior to your submission of the FID form.

The Office of Research Support will manually update your training record after you certify completion of your training. This is required prior to your submission of the FID form. All efforts to send your certification during business hours (Monday-Friday 8 a.m. to 4:30 p.m. CST) are appreciated.

All non-University CIs who are responsible for sponsored research must comply with The University’s FCOI requirements. To ensure timely processing of proposals and awards, the below requirements should be addressed well in advance of any submissions to The Office of Sponsored Projects (OSP) or The Office of Industry Engagement (OIE).

Select which of the following describes your involvement in the research.

Conducting research on behalf of your home institution/entity.

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.

Registration in the FDP Clearinghouse may apply to you or complete Requirement A as outlined below.

REGISTRATION IN THE FDP CLEARINGHOUSE:

The University will accept the institution/entity’s certification with The Federal Demonstration Partnership (FDP) Clearinghouse in lieu of compliance with Requirement A or B.*

*For projects that involve human subjects research, compliance with Requirement A will be necessary prior to IRB approval of the protocol.

REQUIREMENT A:

The home institution/entity has established an FCOI policy that meets the minimum requirements of the PHS regulations (45 CFR Part 94 and 42 CFR Part 50, Subpart F) AND the non-University CI is compliant with the policy. The following steps must be addressed.

  1. An authorized representative must complete and send the below statement to coi@austin.utexas.edu (copying the IRB Program Coordinator and Office of Sponsored Projects (OSP) staff, as applicable) via e-mail or letterhead.

    [NAME OF INSTITUTION] certifies that we have a compliant financial conflict of interest policy that conforms to the requirements of 45 CFR Part 94 and 42 CFR Part 50, Subpart F. We certify that [NAME OF COOPERATING RESEARCHER (e.g. John Smith, Ph.D)] has complied with our policy. Prior to expenditure of funds and within 45 days of any subsequently identified FCOI, we will report to The University of Texas at Austin any identified financial conflict of interest related to the award, and provide an indication whether the conflict has been eliminated, reduced, or managed.”
  2. Include a copy of or a link to the institution/entity’s FCOI policy for review.

NOTE: If the institution/entity’s FCOI policy is determined to NOT meet the minimum requirements of the PHS regulations or does not have an FCOI policy, the non-University CI must comply with Requirement B.

REQUIREMENT B: Follow the below steps in the order described.

  1. Obtain a guest UT EID. Ensure an active and current e-mail address is listed in your EID profile.
  2. Complete the University FCOI training module. Select to view training slideshow OR download training PDF.
  3. Certify completion of the training as instructed on the last slide of the FCOI training module to receive credit.
  4. Submit a FID form. The FID form instructions and web link are provided via e-mail one business day after The Office of Research Support manually updates your FCOI training record. This is required prior to your submission of the FID form.

The Office of Research Support will manually update your training record after you certify completion of your training. This is required prior to your submission of the FID form. All efforts to send your certification during business hours (Monday-Friday 8 a.m. to 4:30 p.m. CST) are appreciated.

Involved as an independent researcher

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: The non-University CI must follow the below steps in the order described.

  1. Obtain a guest UT EID. Ensure an active and current e-mail address is listed in your EID profile.
  2. Complete the University FCOI training module. Select to view training slideshow OR download training PDF.
  3. Certify completion of the training as instructed on the last slide of the FCOI training module to receive credit.
  4. Submit a FID form. The FID form instructions and web link are provided via e-mail one business day after The Office of Research Support manually updates your FCOI training record. This is required prior to your submission of the FID form.

The Office of Research Support will manually update your training record after you certify completion of your training. This is required prior to your submission of the FID form. All efforts to send your certification during business hours (Monday-Friday 8 a.m. to 4:30 p.m. CST) are appreciated.


Contact The Office of Research Support with questions or concerns regarding financial conflicts of interest in research at coi@austin.utexas.edu or (512) 232-2044