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For Subrecipient Investigators

Instructions

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.  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 as a condition of receiving funding.  UT Arlington reserves the right to discontinue funding if a subrecipient 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

Contact Information

All questions concerning the COI Policy, Disclosures, management plans, or reports should contact UT Arlington Research Administration – Office of Regulatory Services, Ms. Kirstin Morningstar:  kmorning@uta.edu, or regulatoryservices@uta.edu, or 817-272-1234.  Investigators can also refer to Research Administration’s website: www.uta.edu/research/administration

STEP ONE: Training Section and UT Arlington’s Conflict of Interest Policy

Statement of Principles

It is the policy of UT Arlington that no proposed, awarded or ongoing research shall be biased by Conflicts of Interest. 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 here: http://www.uta.edu/ra/oric/coi/index.htm.

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.

Key Terms

  • 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 and dependent children.
  • 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 (and the Investigator's Covered Family Members):
  1. Remuneration or Equity Interest in a Publicly Traded Entity in which the value of Remuneration received from the entity in the preceding 12 months and the value of any Equity Interest in the entity as of the current date exceeds $5,000 when aggregated, AND it reasonably appears to be related to the Investigator’s responsibilities under the established work agreement with UT Arlington;
  2. Remuneration or Equity Interest in a Non-Publicly Traded Entity in which the value of Remuneration received from the entity in the preceding 12 months exceeds $5,000, or when the Investigator holds any Equity Interest, AND it reasonably appears to be related to the Investigator’s responsibilities under the established work agreement with UT Arlington;
  3. Intellectual Property upon receipt of income related to the IP AND it reasonably appears to be related to the Investigator’s responsibilities under the established work agreement with UT Arlington;
  4. Reimbursed or Sponsored Travel A Covered Individual that submits to or is awarded funding by the PHS must report the occurrence of any reimbursed or sponsored travel which occurred in the twelve months preceding the disclosure and with a value (aggregated per entity that reimburses or sponsors the travel) that 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:
  1. salary paid by UT Arlington to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution;
  2. income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
  3. 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;
  4. 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;
  5. 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.  (Travel for a subrecipient that is reimbursed/sponsored by UT Arlington is not required to be reported.)

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: http://grants.nih.gov/grants/policy/coi/coi_faqs.htm#3222.

When a subrecipient is an entity/organization, it will be determined (and documented through a formal agreement) whether the subrecipient 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 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, the subrecipient 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 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 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. 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 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.

Resources

STEP TWO: Reporting a Significant Financial Interest (SFI)

Subrecipient 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 Disclosure Form to Ms. Kirstin Morningstar, Director of Regulatory Services, at kmorning@uta.edu or regulatoryservices@uta.edu.

Upon receipt of a Subrecipient Disclosure Form, UT Arlington will be in contact if any additional information or action is required (such as development of a management plan).

Subrecipient Disclosure Form

STEP THREE: Review Confirmation Email
 

Subrecipient funding will not be released and/or the agreement will not be finalized 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 Ms. Kirstin Morningstar at regulatoryservices@uta.edu or kmorning@uta.edu, 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 Investigators: http://www.uta.edu/research/administration/departments/rs/conflict-of-interest/for-subrecipient-investigators.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 and that UT Arlington reserves the right to discontinue funding if a subrecipient fails to comply with these requirements.

YOUR NAME
DATE
NAME OF ORGANIZATION (leave blank if you do not have an organizational affiliation for this work, such as a consultant)