Conflict of Interest Process for PHS Subrecipients and Collaborators
The information on this page is intended for
- subrecipients on PHS-funded projects (i.e., NIH, HRSA, FDA, CDC, etc.) that have been identified as “Investigators” and are subject to UT Arlington's Conflict of Interest Policy
- collaborator investigators on greater than minimal risk human subject (IRB) research, or
- collaborator investigators on animal subject (IACUC) research
If you meet the criteria described herein and have been requested by UT Arlington to review this webpage, please send confirmation of your review following the instructions provided at the bottom of this page.
IMPORTANT: The procedures detailed here are required of subrecipients / collaborators as a condition of receiving funding and/or approval to participate on a research protocol. UT Arlington reserves the right to discontinue funding or withhold approval if a subrecipient / collaborator fails to comply.
There are THREE PARTS to this webpage review:
- STEP ONE – review the Training Section and UT Arlington’s COI Policy
- STEP TWO – review the criteria and requirements for Reporting a Significant Financial Interest (SFI)
- STEP THREE – send a Review Confirmation Email to UT Arlington
All questions concerning the COI Policy, Disclosures, management plans, or reports should contact UT Arlington Research Administration – Office of Regulatory Services, Mekka Steinruck: email@example.com, or 817-272-5076. Investigators can also refer to Research Administration’s website: https://www.uta.edu/research/administration
Statement of Principles
It is the policy of The University of Texas at Arlington (UTA) that no proposed, awarded or ongoing Research shall be biased by a COI. The University is committed to moving Research forward and fostering entrepreneurial spirit while maintaining objectivity and integrity.
UT Arlington's position is that with clear guidelines and principles, in conjunction with appropriate supervision and monitoring, it is possible for interaction between industry and the University to take place in a manner that is consistent with the highest traditions of scientific research and in a way that energizes scientific creativity.
Review important points about UTA's COI program: https://resources.uta.edu/research/regulatory-services/conflict-of-interest/coi-operating-procedures.php
Federal Regulations & UT Arlington Policy
UT Arlington complies with the Public Health Service (PHS) 2011 revised Federal regulation on Financial Conflict of Interest (COI) Promoting Objectivity in Research, 42 CFR Part 50 Subpart F.
In response to the revised PHS regulations, UT Arlington updated its policy in August 2012. The University policy prescribes a COI program intended to promote objectivity of research through a process of disclosure, review, mitigation, and monitoring. Review UT Arlington’s COI Policy, here.
- Research is defined as a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied Research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug).
- Investigator is defined as a person having responsibility over: the design of the research (such as developing objectives or procedures), the conduct of research (directing the procedures or progress), or reporting of the research (writing publications, reporting to granting agencies, etc.). This definition could include any person, regardless of title, position, or status (faculty, staff, student) – their role (rather than their title) and the degree of independence with which they work should be considered. Individuals that simply carry out procedures/tasks assigned to them that do not have actual responsibility over the design, conduct, or reporting of the research are not considered Investigators.
- Covered Family Member is defined as an Investigator's spouse, dependent children, or other dependents for purposes of determining federal income tax liability during the period covered by the COI Disclosure..
- Financial Interest is defined as anything of monetary value (existing or potential), whether or not the value is readily ascertainable.
- Conflict of Interest (COI) is defined as a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of Research.
- Remuneration is defined as salary or any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).
- Equity Interest is defined as any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
- Intellectual Property is defined as a work or invention that is the result of creativity, to which one has rights. Includes, but is not limited to, any invention, discovery, creation, know-how, trade secret, technology, scientific or technological development, research data, works of authorship, and computer software, regardless of whether subject to protection under patent, trademark, copyright, or other laws.
- Significant Financial Interest is defined as a financial Interest consisting of one or more of the following interests of the Investigator or the Investigator's Covered Family Members that reasonably appears to be related to the Investigator's Institutional Responsibilities:
- Remuneration or Equity Interest in a Publicly Traded Entity: A Financial Interest in which the value of any Remuneration received from the entity in the twelve months preceding the disclosure and the value of any Equity Interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000;
- Remuneration or Equity Interest in a Non-Publicly Traded Entity: A Financial Interest in which the value of any Remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator holds any Equity Interest;
- Intellectual Property: Any receipt of income for Intellectual property rights and interests (e.g. patents, copyrights);
- Reimbursed or Sponsored Travel: Any reimbursed or sponsored travel in the twelve months preceding the disclosure in which the value (aggregated per entity that reimburses or sponsors the travel) exceeds $5,000. This does not apply to Investigators who do not receive PHS funding; See "SFI Exclusions" below for additional exclusions for travel that is not reportable.
SFI Exclusions: The term Significant Financial Interest (SFI) does not include the following types of financial interests (therefore, is not required to be reported):
- Salary, royalties, or other Remuneration paid by UTA to the Investigator or Covered Family Member if the Investigator or Covered Family Member is currently employed or otherwise appointed by UTA, including Intellectual Property rights assigned to UTA and agreements to share in royalties related to such rights;
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator or Covered Family Member does not directly control the investment decisions made in these vehicles;
- Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a Research institute that is affiliated with an institution of higher education;
- Income from service on advisory committees or review panels for a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a Research institute that is affiliated with an institution of higher education;
- Travel that is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a Research institute that is affiliated with an institution of higher education; and
- Travel not meeting the exceptions in part (5) above, but is valued at less than $5,000 per entity that reimburses or sponsors the travel.
Subrecipients / Collaborators & Responsibilities
As the awardee/funded institution, UT Arlington is responsible for ensuring any subrecipient’s compliance with the PHS Conflict of Interest Regulations and is responsible for reporting identified financial conflicts of interests of Subrecipient Investigators: https://grants.nih.gov/faqs#/financial-conflict-of-interest.htm.
For human subject or animal research, UT Arlington is responsible for ensuring that conflicts of interest do not bias the research, or compromise human subject/animal safety and welfare.
When a subrecipient / collaborator is an entity/organization, it will be determined (and documented through a formal agreement) whether the subrecipient / collaborating organization will apply its own COI policy to its “Investigators” (see definition in Key Terms above), or if it will adopt and adhere to UT Arlington’s COI Policy.
When a subrecipient / collaborator is an individual without an organizational affiliation for the specific work (e.g., consultant), the individual will adhere to UT Arlington’s COI Policy if they meet the federal definition of “Investigator” (see definition in Key Terms above).
When UT Arlington’s COI Policy is applied to a subrecipient/collaborator, the subrecipient/collaborator Investigator(s) must comply with several requirements, including:
- Review and understanding of UT Arlington’s COI Policy,
- Completion of conflict of interest training once every four years or more frequently at the University’s discretion,
- Reporting any existing or new Significant Financial Interests (see procedures in STEP TWO),
- Verifying completion of the above via a Review Confirmation Email (see STEP THREE).
University Oversight of the COI Program
UT Arlington’s President has designated the Institutional Official (IO) for conflict of interest to be the Vice President for Research. In addition, a Research Conflict of Interest Committee (COIC) was established to support the IO, the COI program, and its researchers. The committee is comprised of faculty and staff with expertise and experience in research, commercialization, and conflict of interest standards. The COIC advises the IO and President, reviews subrecipients’ COI Disclosures, and works in coordination with Investigators to develop COI Management Plans when necessary.
COI Management Plans
If the IO or COIC determines that a subrecipient / collaborator Investigator has an actual or potential financial conflict of interest, the official, in cooperation with the Investigator and the COIC, shall develop a Management Plan governing that conflict of interest. The Management Plan shall be implemented before expenditure of funds or prior to initiation of human or animal research. The content of management plans will meet the minimum requirements of federal regulation (e.g., PHS 42 CFR Part 50 Subpart F). Key elements of a COI Management Plan include:
- Role and principal duties of the Investigator;
- Details of the financial interest, its value, and how it is related to the Investigator's responsibilities under the established work agreement/research with UT Arlington;
- Control measures designed to safeguard the objectivity of the research project; and
- How the management plan and/or control measures will be monitored to ensure compliance.
For projects supported by PHS, details of the COI Management Plan must be reported to PHS and are subject to public availability requirements in accordance with 42 CFR Part 50 Subpart F.
- Conflict of Interest Regulations, 42 CFR Part 50,
Subpart F: https://www.ecfr.gov/current/title-42/part-50
- UT Arlington Policy for Disclosure, Management, and Reporting of Financial Conflicts of Interest in Research
- NIH FAQs: http://grants.nih.gov/grants/policy/coi/coi_faqs.htm
- DHHS Office of Research Integrity: https://ori.hhs.gov/
- UTA Handbook of Operating Procedures: https://policy.uta.edu/doctract/documentportal/08D885C804E4E8E612AA2F247DDE620D
- University of Texas Board of Regents Rule 30103, Standards of Conduct: https://www.utsystem.edu/board-of-regents/rules/30103-standards-conduct
- UT Arlington Research Administration: https://www.uta.edu/research/administration
Subrecipient / Collaborator Investigators are responsible for reporting any existing or new Significant Financial Interests (SFI) as described in 1 – 4 of the definition of SFI (see Key Terms above). Investigators must report any existing SFIs to UT Arlington in advance of, or in attachment to, their Review Confirmation Email (see STEP THREE on this webpage). Investigators must report any new SFIs to UT Arlington within 30 days of discovering or acquiring them. Investigators that have a SFI and submit a disclosure will be required to update and/or recertify that disclosure annually.
SFI disclosures must be submitted on the Subrecipient/Collaborator Disclosure Form to Regulatory Services at firstname.lastname@example.org.
Upon receipt of a Subrecipient/Collaborator Disclosure Form, UT Arlington will be in contact if any additional information or action is required (such as development of a management plan).
Subrecipient funding will not be released and/or participation in the research will not be approved until each individual meeting the definition of “Investigator” (see definition in Key Terms above) completes STEP ONE and TWO (if applicable) of this webpage and submits a Review Confirmation Email (STEP THREE).
Send the Review Confirmation Email to Regulatory Services at email@example.com, with the following statement in the body of your email (copy and paste the paragraph below and enter your name, date, and organization):
I have reviewed the training and information found on UT Arlington’s webpage For Subrecipient / Collaborator Investigators: https://resources.uta.edu/research/regulatory-services/conflict-of-interest/conflict-of-interest-process-for-phs-subrecipients-and-collaborators.php. I have reviewed and understand UT Arlington’s Conflict of Interest Policy and the criteria for reporting a Significant Financial Interest (SFI). I will report any existing SFIs to UT Arlington in advance of, or in attachment to, this Review Confirmation Email. I will report any new SFIs within 30 days of discovering or acquiring them. I understand that any disclosures submitted must be updated or recertified annually. I understand that I am subject to UT Arlington’s Conflict of Interest Policy as a condition of receiving funding/participation in research and that UT Arlington reserves the right to discontinue funding/approval if a subrecipient/collaborator fails to comply with these requirements.
NAME OF ORGANIZATION (leave blank if you do not have an organizational affiliation for this work, such as a consultant)