Skip to content. Skip to main navigation.

Operating Procedures

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/research/administration/departments/rs/conflict-of-interest/

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: https://www.uta.edu/ra/real/oric/UTA%20Research%20COI%20Policy%20.docx.

Other funding agencies may elect to adopt the PHS regulations under 42 CFR Part 50 Subpart F, or have alternative conflict of interest policies in place. UT Arlington will comply with the conflict of interest requirements for each individual sponsoring agency.

Scope

 The COI Policy and these Procedures govern the disclosure of individual significant financial interests and the management and reporting of an individual financial conflict of interest in research performed at the University. 

The COI Policy and Procedures apply to Covered Individuals (as defined in Key Terms below).  Covered Individuals must disclose Significant Financial Interests as defined within the Policy and Procedures.  UT Arlington Investigators are expected to make reasonable inquiry as to whether their relationships and activities fall within the provisions of the Policy. 

Program Oversight and the Conflict of Interest Committee (COIC)

 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) is 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.

The conflict of interest program is coordinated and maintained by Research Administration – Office of Regulatory Services:

Ms. Kirstin Morningstar, Director of Regulatory Services
kmorning@uta.edu or regulatoryservices@uta.edu
817-272-1234
Research Administration website: www.uta.edu/research/administration

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 Individual is defined as any Investigator (see definition above) who proposes or conducts:
  1. sponsored research,
  2. non-exempt human subject research, and/or
  3. animal research.
  • Covered Family Member is defined as an Investigator's spouse and dependent children.
  • Sponsored Research is defined as any research for which a proposal is submitted or awarded by a sponsor for extramural funding, or any gift designated for research received by UT Arlington.  Sponsored research (both awards and gifts) can include research, training, and instructional projects involving funds, materials, or other compensation from external sources.
  • Human Subject Research is defined as Research (see Key Term above) that involves obtaining data from a living individual through intervention or interaction with the individual, or obtaining data that is identifiable private information.  This policy does not apply to human subject research that has been determined by the University’s IRB to be exempt. (Note: Both exempt and non-exempt Human Subject Research requires review by the University’s IRB: http://www.uta.edu/ra/oric/human/sops.htm.)    
  • Animal Research is defined as any live, vertebrate animal used or intended for use in research, training, experimentation, teaching, exhibition, biological testing, or for related purposes.  (Note: Animal Research requires review and approval by the University’s IACUC: http://www.uta.edu/ra/oric/animal/.)
  • Investigator’s Institutional Responsibilities are defined as an individual’s professional responsibilities and activities on behalf of the Institution, including but not limited to: research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards.
  • 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 Institutional Responsibilities.
  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 Institutional Responsibilities.
  3. Intellectual Property upon receipt of income related to the IP AND it reasonably appears to be related to the Investigator’s Institutional Responsibilities.
  4. For a Covered Individual that submits to or is awarded funding by the PHS: Reimbursed or Sponsored Travel that is NOT EXCLUDED by any of the SFI EXCLUSIONS described in #5 below AND it reasonably appears to be related to the Investigator’s Institutional Responsibilities.

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.)
  • PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).  Also includes agencies such as DHHS, FDA, CDC, HRSA, etc.
  • Institutional Official (IO) is the individual designated as responsible for ensuring compliance with federal and state regulations pertaining to conflict of interest. The IO is responsible for the delegation of authority for the establishment and enforcement of relevant University policies and procedures including solicitation of disclosures, review and determination of financial conflicts of interest, management of identified financial conflicts of interest, and reporting of financial conflicts of interest as required by federal regulations. The President has designated the Vice President for Research (VPR) as the Institutional Official (IO) for the research conflict of interest program at The University of Texas at Arlington.
  • Conflict of Interest (COI) Disclosure refers to the University’s conflict of interest disclosure form available here:  https://www.uta.edu/mentis/public/#coi/disclosure/my .  Covered Individuals must submit a COI Disclosure annually, or within 30 days of a newly identified or reportable Significant Financial Interest.

    If you face any issues with submitting the COI Disclosure forms please contact the ERA Helpdesk at 817-272-1060 or email us at erahelpdesk@uta.edu.
  • Conflict of Interest Committee (COIC) is defined as the review body charged with oversight of UTA's conflict of interest program.  The COIC reviews disclosures to determine if an actual or potential conflict of interest exists, advises the IO and President, and works in coordination with Investigators to develop COI Management Plans when necessary.
  • Conflict of Interest Management Plan is defined as a written document describing an actual or potential conflict of interest, control measures designed to safeguard the objectivity of research, and methods of monitoring the potential conflict of interest.

The Conflict of Interest (COI) Disclosure Form

 Purpose

Covered Individuals 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). The tool used to report SFIs is the COI Disclosure Form.  The COI Disclosure form will automatically prompt users to supply appropriate information in regards to SFI.  The COI Disclosure form fulfills federal regulatory requirements, University and UT System Board of Regents policies, and requirements set forth by many funding agencies for reporting and documenting financial conflicts of interest.

Covered Individuals required to submit a COI Disclosure form will be identified at the time of: 1) submission of a Blue Sheet for funding, 2) submission of an IRB (human subject) protocol, or 3) submission of an IACUC (animal subject) protocol.

Access to the Electronic COI Disclosure Form

The COI Disclosure Form has been updated in order to comply with the 2011 COI regulations.  It is fully electronic and accessible here:  https://www.uta.edu/mentis/public/#coi/disclosure/my

If you face any issues with submitting the COI Disclosure forms please contact the ERA Helpdesk at 817-272-1060 or email us at erahelpdesk@uta.edu.

Timing of COI Disclosure Submission

Initial Disclosure:

  1. Covered Individuals conducting PHS-sponsored research, Non-Exempt Human Subject Research, or Animal Research: Covered Individuals must submit or have a current COI Disclosure on file no later than the time of application for sponsorship or at the time of research protocol submission (i.e., submission to the Institutional Review Board or the Institutional Animal Care & Use Committee).
  2. Covered Individuals conducting research not included in part 1 above: Covered Individuals must submit or have a current COI disclosure on file prior to the expenditure of sponsor funds.
  3. New Covered Individuals: When an Investigator becomes a Covered Individual (e.g., is added to an ongoing sponsored research project or a human/animal subject protocol), the Individual must submit or have a current COI Disclosure on file before engaging in the project.

Subsequent Disclosures: 

Following initial disclosure, Covered Individuals must submit an updated Disclosure at least annually, or within 30 days of discovering or acquiring a new reportable Significant Financial Interest (see definition in Key Terms above).

Content of a COI Disclosure

Each Covered Individual must acknowledge at least annually, via the COI Disclosure Form, that the individual is aware of and has read UT Arlington’s COI Policy, and is aware of a Covered Individual’s responsibilities regarding disclosure of Significant Financial Interest and of applicable federal regulations.

Covered Individuals must report each Significant Financial Interest (see definition in Key Terms above) of the individual and Covered Family Members that reasonably appears to be related to the individual’s institutional responsibilities.

Disclosure updates (annual or more frequently) shall include any significant financial interest that was not disclosed initially, and shall include updated information regarding any previously disclosed significant financial interest (e.g., the updated value of a previously disclosed equity interest).

The electronic COI Disclosure form will automatically prompt users to identify and submit information pertaining to a Significant Financial Interest as defined in the Key Terms above:

  1. PAYMENTS RECEIVED FROM OR EQUITY INTEREST IN A PUBLICLY TRADED ENTITY:  the total amount and source of payments received in the preceding twelve months from a publicly traded entity and the value of any equity interest held in the entity on the date of disclosure that, when aggregated, exceed $5,000, including:
    (A)  as to payments received:
    (i) salary; and
    (ii) any payment for services other than salary, such as consulting fees, honoraria, or paid authorship; and
    (B)  as to equity interests held, any stock, stock options, or other ownership interest or entitlement to such an interest, valued by reference to public prices or other reasonable measures of fair market value;
  2. PAYMENTS RECEIVED FROM A NON-PUBLICLY TRADED ENTITY OR EQUITY INTEREST IN A NON-PUBLICLY TRADED ENTITY:
    (A)  the total amount and source of payments received in the preceding twelve months from an entity that is not publicly traded that, when aggregated, exceed $5,000, including (i) salary; and (ii) any payment for services other than salary, such as consulting fees, honoraria, or paid authorship; and
    (B)  a description of any equity interest held in an entity that is not publicly traded, including any stock, stock options, or other ownership interests or entitlement to such an interest;
  3. INTELLECTUAL PROPERTY AND ROYALTIES:
    (A)  a description of intellectual property rights held and any agreements to share in royalties related to those rights; and
    (B) the amount and source of royalty income that the covered individual or covered family member received or had the right to receive in the preceding twelve months;
  4. TRAVEL for a Covered Individual that submits to or is awarded funding by the PHS: reimbursed or sponsored travel in the preceding 12 months, including the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration;

Review Procedures and the Conflict of Interest Committee (COIC)

 COI Disclosures with negative responses (no items to disclose) will automatically be marked as “Complete,” however, it is a Covered Individual’s responsibility to update their COI Disclosure in the future when a new SFI is discovered or acquired (within 30 days). 

COI Disclosures with positive responses (items disclosed) will automatically be marked as “Pending” and will forward to the Office of Research Administration for review.  Research Administration staff will review the Pending Disclosure to determine if the information provided on the Disclosure is sufficient.  Investigators may be contacted for additional information, or a Disclosure may be returned to an Investigator (via the electronic system) for addition of information, editing, or clarification.  When an Investigator has a COI Disclosure returned to them, changes or information requested will be noted in the Comments or Notes section of the COI Disclosure.  Investigators should promptly respond to returned COI Disclosures.  A COI Disclosure will not be considered as active/submitted until it contains sufficient information as determined by Research Administration staff.

Following initial review of a Pending COI Disclosure, Research Administration staff shall determine if the Disclosure requires further review by the Conflict of Interest Committee (COIC), or if it can be marked as “Complete” with no further review.  COI Disclosures that require review by the COIC will be marked as such in the electronic system.    

The COIC has been designated by the Institutional Official (Vice President for Research) to review disclosures of Significant Financial Interests, to determine if they constitute an actual or potential Conflict of Interest.  The COIC may review or request (from the Investigator) additional information or documentation in order to make this determination.  The COIC may also request a meeting with an Investigator to discuss and gain a clear understanding of a particular activity. Investigators shall respond and provide any information requested by the COIC in a prompt manner, in order to meet the review deadlines mandated by the federal regulations.

The COIC shall review each financial interest disclosure statement and make two determinations: (1) whether any significant financial interest disclosed is related to research in which the covered individual is engaged; and (2) if so, whether a financial conflict of interest exists.

A financial conflict of interest exists when the significant financial interest could directly and significantly affect the design, conduct, or reporting of research. The COIC will determine whether an Investigator's significant financial interest is related to research when it reasonably determines that the significant financial interest: could be affected by the research; or is in an entity whose financial interest could be affected by the research.

COI Management Plans

 If the IO or COIC determines that an 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 for sponsored research, and before approval of a protocol when research involves human or animal subjects. 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 (NIH, DHHS, FDA, CDC, HRSA, etc.), details of the COI Management Plan will be reported to PHS and are subject to public availability requirements in accordance with 42 CFR Part 50 Subpart F.

Examples of conditions or restrictions that might be imposed to manage a financial conflict of interest include, but are not limited to:

(i) Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);

(ii) For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;

(iii) Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest;

(iv) Modification of the research plan;

(v) Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;

(vi) Reduction or elimination of the financial interest (e.g., sale of an equity interest); or

(vii) Severance of relationships that create financial conflicts.

COI Training

 A Covered Individual who submits to or is awarded funding by the PHS (NIH, DHHS, FDA, CDC, HRSA, etc.) must complete training in regard to applicable policies, regulations, disclosure of significant financial interests, and investigator responsibilities, before engaging in PHS research at the institution and at least once every four years thereafter. 

A Covered Individual who is new to the institution must complete the training before engaging in PHS research at the institution.

An Investigator with an active management plan (regardless of sponsorship) must complete training at initiation of the plan and at least once every four years thereafter for the duration of the plan’s activity.

A Covered Individual must complete training immediately if the institution finds that the individual is not in compliance with this policy or the individual’s management plan, or if the institution revises this policy in a manner that affects the requirements of Covered Individuals, or as otherwise determined by the Institutional Official.

Other Investigators (non-PHS or non-Covered Individuals) are encouraged to complete this training voluntarily, as it contains some important information and research best practices.

The training is available electronically at the following link: https://www.uta.edu/ra/real/researchspace.php?view=7.

Subrecipients / Collaborators / Contractors

As the awardee institution in a PHS-funded or proposed project, 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).

The policy determination will be made before a subaward agreement is finalized or before funds are approved/expended for a subrecipient.  During the time of agreement negotiation, a subrecipient organization/entity will either certify use of its own PHS-compliant conflict of interest policy, or it will elect to adopt UT Arlington’s COI Policy.  Individual subrecipients will be identified through the APS form process.  Before the Office of Grant & Contract Services approves an APS request, staff will verify 1) if the project is PHS-funded, and 2) if the individual meets the definition of “Investigator” (see definition in Key Terms above).  Individuals meeting the two criteria will be covered by UT Arlington’s COI Policy.

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,
  • verifying completion of the above by sending a Review Confirmation Email to UT Arlington.

When UT Arlington’s COI Policy is applied to a subrecipient, the COI Policy, Training, criteria for reporting a Significant Financial Interest, and instructions for submitting a Review Confirmation Email are communicated to Subrecipient Investigators via special webpage: http://www.uta.edu/research/administration/departments/rs/conflict-of-interest/for-subrecipient-investigators.php.  Subrecipient Investigators must report any existing SFIs to UT Arlington in advance of, or in attachment to, their Review Confirmation Email.  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 UT Arlington, Research Administration.  Review of Subrecipient Disclosures will follow the procedures above for Review of a COI Disclosure.

When a subrecipient organization/entity elects to apply its own PHS-compliant COI Policy to its Investigators, the organization must report any identified financial conflicts of interest of its Investigators to UT Arlington before approval of the sub agreement. In accordance with federal regulation, UT Arlington will provide reports to the PHS awarding component of all financial conflicts of interest prior to the expenditure of funds and within 60 days of any subsequently identified financial conflict of interest.

Public Accessibility

In accordance with PHS Title 42, Part 50, Subpart F, the Institution will maintain this policy as up-to-date, make the policy available on its publicly accessible website (http://www.uta.edu/research/administration/), and make information related to conflicts of interest available upon request.

Requests for public information will be honored when all three of the following criteria are met:

  • The significant financial interest was disclosed and is still held by the senior/key personnel as related to the PHS-funded project,
  • The Institution determines that the Significant Financial Interest is related to the PHS-funded research, and
  • The Institution determines that the Significant Financial Interest is a Financial Conflict of Interest.

Once complete information regarding a request has been received, written disclosure will be sent via U.S. Postal Service to the address provided in the request, and postmarked within five business days.

Public requests must be submitted via email to:

Ms. Kirstin Morningstar
Director of Regulatory Services
The University of Texas at Arlington
regulatoryservices@uta.edu

All other public requests for information (not meeting the criteria described above) must follow the procedures of an Open Records request, described on the following webpage: http://www.uta.edu/business-affairs/open-records.php.

Certification and Reports to PHS

Federal regulations require that each application for funding to the PHS include specific certifications, agreements, and reports in regard to this policy and financial conflicts of interest.  Before the expenditure of any funds under a PHS-funded research project, the appropriate institutional officials will make the Financial Conflict of Interest Report to the PHS awarding component in compliance with 42 CFR Part 50 Subpart F, and 45 CFR Part 94.  The institution will comply with PHS requirements for conducting, documenting, and reporting retrospective reviews where applicable.

Noncompliance and Retrospective Reviews

Whenever a financial conflict of interest related to PHS-funded research is not identified or managed in a timely manner including failure by the Investigator to disclose a significant financial interest that is determined by the Institution to constitute a financial conflict of interest; failure by the Institution to review or manage such a financial conflict of interest; or failure by the Investigator to comply with a financial conflict of interest management plan, the Institution shall, within 120 days of the Institution's determination of noncompliance, complete a retrospective review of the Investigator's activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.  The Institution will document the retrospective review with all of the following key elements: Project number; project title; PD/PI or contact PD/PI if a multiple PD/PI model is used; name of the Investigator with the FCOI; name of the entity with which the Investigator has a financial conflict of interest; reason(s) for the retrospective review; detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed); findings of the review; and conclusions of the review.

Based on the results of the retrospective review, if appropriate, the Institution shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward. If bias is found, the Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the Institution's plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the Institution will submit FCOI reports annually, as specified elsewhere in this subpart. Depending on the nature of the financial conflict of interest, an Institution may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded research project between the date that the financial conflict of interest or the Investigator's noncompliance is determined and the completion of the Institution's retrospective review.

If the failure of an Investigator to comply with an Institution's financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, the Institution shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the PHS-funded research project. PHS may, for example, require Institutions employing such an Investigator to enforce any applicable corrective actions prior to a PHS award or when the transfer of a PHS grant(s) involves such an Investigator.

In any case in which the HHS determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was not managed or reported by the Institution as required by this subpart, the Institution shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

Enforcement

Compliance with the terms of this policy is required as a condition of conducting research as an employee, representative, collaborator, or student of this institution.  Consequences for violation of this policy are described and enforced by the University of Texas Board of Regents Rule 30103, Standards of Conduct: http://www.utsystem.edu/bor/rules/30000Series/30103.pdf

Cooperation with Institutional Committees

The conflict of interest official and the appropriate IRB, IACUC, IBC, and other relevant committees shall cooperate in the consideration of whether a covered individual has a financial conflict of interest in regard to research and in the development and implementation of a management plan for that conflict of interest.

Records

Records will be maintained in accordance with federal and state regulations and the institution’s policies and procedures for records and information management and retention: http://www.uta.edu/policy/rim/.

For PHS-funded research, the institution will maintain records relating to all Investigator disclosures of financial interests and the Institution's review of, and response to, such disclosures (whether or not a disclosure resulted in the Institution's determination of a financial conflict of interest) and all actions under the Institution's policy or retrospective review, if applicable, for at least three years from the date the final expenditures report is submitted to the PHS or, where applicable, from other dates specified in 45 CFR 74.53(b) and 92.42 (b) for different situations.

Relevant Federal and State Statutes

RELEVANT UT SYSTEM POLICIES, PROCEDURS AND FORMS

DATES APPROVED OR AMENDED

September 2012

CONTACT INFORMATION

All questions concerning this policy, COI Disclosures, management plans, or reports should be directed to Research Administration – Office of Regulatory Services: regulatoryservices@uta.edu or 817-272-3723; www.uta.edu/research/administration

For Technical Questions regarding the COI Disclosure forms, contact ERA Helpdesk at 817-272-1060 or email us at erahelpdesk@uta.edu.