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 an RCOI program intended to promote objectivity of research through a process of disclosure, review, mitigation, and monitoring.  Review UT Arlington’s RCOI Policy, here.

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.

The RCOI 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 RCOI 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. 

UT Arlington’s President has designated the Institutional Official (IO) for Research Conflict of Interest to be the Vice President for Research. In addition, a Research Conflict of Interest (RCOI) Committee is established to support the IO, the RCOI 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 RCOI Committee advises the IO and President, reviews RCOI Disclosures, and works in coordination with Investigators to develop RCOI Management Plans when necessary. The RCOI Committee meets on a monthly basis or as needed to conduct these activities. 

The Research Conflict of Interest Program is coordinated and maintained by Research Administration – Office of Regulatory Services:

Ms. Mekka Steinruck, RCOI Specialist
mekka.steinruck@uta.edu or regulatoryservices@uta.edu
817-272-3722
Research Administration website: https://www.uta.edu/research/administration

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 who proposes or conducts:

• Sponsored research;
• Greater than Minimal Risk Human Subject Research; and/or
• 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 Investigators obtaining data from a living individual through intervention or interaction with the individual, or obtaining data that is identifiable private information (even if no intervention or interaction with the researcher occurs).  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)

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)

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 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 (SFI) is defined as financial interest consisting of one or more of the following interests of the Investigator and 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 Covered Individual must report a financial interest in which the value of any remuneration received from the entity in the twelve (12) 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 Covered Individual must report a financial interest in which the value of any remuneration received from the entity in the twelve (12) months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator holds any equity interest;
• Intellectual Property (IP): A Covered Individual must report receipt of income related to intellectual property, and any equity or business participation in an entity that sponsors the individual's research or licenses the IP.
• 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 (12) 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 - Significant Financial Interest does not include the following types of financial interests:

• salary paid by UT Arlington to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution;
• 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;
• 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. (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 in Mentis. You can access the COI Disclosure by visiting: https://mentis.uta.edu/public/. 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 Mentis Technical Support Team at mentis@uta.edu or email Regulatory Services at regulatoryservices@uta.edu.

Research Conflict of Interest (RCOI) Committee is defined as the review body charged with oversight of UTA's Conflict of Interest Program. The RCOI Committee 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.

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 RCOI Disclosure Form. The RCOI Disclosure form will automatically prompt users to supply appropriate information in regard to SFI.  The RCOI 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 RCOI 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 RCOI Disclosure Form

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

If you face any issues with submitting the RCOI Disclosure forms please contact the Office of Regulatory Services at 817-272-3723 or email us at regulatoryservices@uta.edu.

Timing of RCOI Disclosure Submission

Initial Disclosure:

1. Covered Individuals Conducting PHS- Sponsored Research, Greater than Minimal Risk Human Subject Research, or Animal Research: Must submit or have a current RCOI Disclosure on file no later than the time of application for sponsorship or at the time of the Research protocol submission [(i.e., submission to the Institutional Review Board (IRB) or the Institutional Animal Care & Use Committee (IACUC)].
2. Covered Individuals conducting research not included in part 1 above: Must submit or have a current RCOI 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 RCOI Disclosure on file before engaging in the Research.

Subsequent Disclosures: 

Following initial disclosure, Covered Individuals must submit an updated RCOI Disclosure at least annually, or within 30 days of discovering or acquiring a new reportable Significant Financial Interest. The President or the RCIO may require additional disclosures for clarity or transparency.

Content of a RCOI Disclosure

Each Covered Individual must acknowledge at least annually, via the RCOI Disclosure, that the individual is aware of and has read this policy, and is aware of a Covered Individual’s responsibilities regarding disclosure of Significant Financial Interests and of applicable federal regulations. If a Covered Individual discloses Remuneration, Intellectual Property interest or royalties, related documents may be requested and reviewed by the President, the RCIO, or any other person with administrative responsibility for reviewing the RCOI Disclosure or management plans. Significant Financial Interests will be disclosed in reportable ranges.

Covered Individuals must report each Significant Financial Interest that reasonably appears to be related to the individual’s UTA institutional responsibilities through disclosure in UTA’s online Research COI Disclosure form: https://mentis.uta.edu/public/#coi/disclosure/my.

Disclosure updates (annual or more frequent) will include any Significant Financial Interest that was not disclosed initially, and will include updated information regarding any previously disclosed Significant Financial Interest (e.g. the updated value of a previously disclosed Equity Interest).

The electronic RCOI 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;

Additionally, the electronic RCOI Disclosure form will prompt users to identify and submit information pertaining to any other relationships, commitments, or activities that are related to their Institutional Responsibilities and might present or appear to present a Conflict of Interest involving research.

RCOI 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 RCOI Disclosure in the future when a new SFI is discovered or acquired (within 30 days). 

RCOI 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 RCOI Disclosure returned to them, changes or information requested will be noted in the Comments or Notes section of the RCOI Disclosure.  Investigators should promptly respond to returned RCOI Disclosures.  A RCOI 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 RCOI Disclosure, Research Administration staff shall determine if the Disclosure requires further review by the Research Conflict of Interest Committee (RCOIC), or if it can be marked as “Complete” with no further review.  RCOI Disclosures that require review by the RCOIC will be marked as such in the electronic system.    

The RCOIC 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 Research Conflict of Interest.  The RCOIC may review or request (from the Investigator) additional information or documentation in order to make this determination.  The RCOIC 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 RCOIC in a prompt manner, in order to meet the review deadlines mandated by the federal regulations.

The RCOIC 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 RCOIC 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.

If the IO or RCOIC determines that an Investigator has an actual or potential financial conflict of interest, the official, in cooperation with the Investigator and the RCOIC, 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 RCOI Committee will consider when sponsored research or human/animal research is pending resolution of a Management Plan, and will make efforts to complete the process in a timely and efficient manner to avoid unnecessary delays or negative impact on the 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 RCOI 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 RCOI 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.

MONITORING OF RCOI MANAGEMENT PLANS (MP)

The Research COI Committee performs monitoring of approved MPs. The frequency and type of monitoring that occurs is at the discretion of the Committee and/or UTA Research Administration, and may be dependent upon risk factors such as funding status, personnel involved, research subject matter, or other factors. Potential monitoring activities include:

• Monitoring Reports - Investigators with approved MPs are required to submit a Monitoring Report by the anniversary date of their most recently approved MP. There are two versions of Monitoring Reports, a standard version and an abbreviated version. Investigators will be notified in advance by the Office of Regulatory Services which version is required.
  • Abbreviated Monitoring Report - Investigators will be required to provide an update on the status of their outside activities and certify compliance with the requirements of their approved MP over the past year. Abbreviated Monitoring Reports may be reviewed and approved by RCOI Staff unless MP deviations have been reported by the Investigator. In those cases, the Abbreviated Monitoring Report along with supplemental materials from the Investigator describing the deviation will be reviewed at a convened meeting of the RCOI Committee.
  • Standard Monitoring Report - Investigators will be required to provide additional details pertaining to their UTA research and outside activities in the past year, such as presentations, publications, disclosures made, funding, and intellectual property. The Standard Monitoring Report will be reviewed at a convened meeting of the RCOI Committee.
• Periodic Reports - The RCOI Committee may request reports to be submitted more frequently than, or in addition to, the Monitoring Report as described above. Periodic Reports may be reviewed by either RCOI Staff or the RCOI Committee.
• Investigator Meetings - Investigators may be requested to meet with RCOI Staff and/or the RCOI Committee to provide a status update and discuss fulfillment of the terms of the approved MP.
• Oversight Manager - In cases where an oversight and/or academic oversight manager is assigned to an Investigator in an approved MP, the Oversight Manager may be responsible for monitoring fulfillment of the terms of the MP and reporting back to the RCOI Committee.

A Covered Individual who submits to, or is awarded funding by the PHS must complete training in regard to applicable policies, regulations, disclosure of Significant Financial Interests, and Investigator responsibilities, before engaging in PHS Research at UTA and at least once every four years thereafter.

A Covered Individual who is new to UTA must complete the training before engaging in PHS Research at UTA or provide evidence of having completed the training at another institution within the prior four years.

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, but in any event no less than thirty (30) business days, if UTA finds that the individual is not in compliance with this policy or the individual’s management plan, or if UTA revises this policy in a manner that affects the requirements of Covered Individuals, or as otherwise determined by the RCIO.

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 here.

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 RCOI policy to its “Investigators” (see definition in Key Terms above), or if it will adopt and adhere to UT Arlington’s RCOI 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 RCOI 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 RCOI 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 RCOI Policy.

When UT Arlington’s RCOI Policy is applied to a subrecipient, the subrecipient Investigator(s) must comply with several requirements, including:

• review and understanding of UT Arlington’s RCOI 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 RCOI Policy is applied to a subrecipient, the RCOI 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. 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 RCOI Disclosure.

When a subrecipient organization/entity elects to apply its own PHS-compliant RCOI 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.

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 research 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 may 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: https://www.uta.edu/business-affairs/open-records/index.php .

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.

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

Under institutional authority and, in some cases, pursuant to Federal regulations (42 CFR Part 50 Subpart F), the University of Texas at Arlington is responsible to maintain and enforce a policy on financial conflicts of interest in research. Under these policies, the University is required to obtain information from investigators on outside financial or business interests, review the information for potential conflicts of interest, manage identified conflicts where possible, eliminate conflicts where management is not possible, and report existing conflicts to research sponsoring agencies as required by sponsoring agency rules and regulations. The University may suspend research and/or impose remedial measures on investigators who fail to disclose interests where required, or who fail to comply with their approved management plan. The Research Conflict of Interest (RCOI) Committee is responsible for investigations into alleged noncompliance, and for findings of noncompliance, and is supported by the Office of Regulatory Services in this process.

Applicability

The following procedures apply to all research activities of faculty, staff, students and others who are subject to the disclosure requirements of UTA RA-PO2, “Policy for Disclosure, Management, and Reporting of Conflicts of Interest in Research”.

Definitions

Allegation of Noncompliance is an unproven assertion of noncompliance.

Noncompliance is defined as failure to comply with Federal regulations, Research Conflict of Interest (RCOI) policy, an approved RCOI management plan or the determinations or requirements of the RCOI Committee.

1. Non‐serious and non‐continuing noncompliance involves isolated incidents, e.g., an unintentional mistake, an oversight or a misunderstanding. The issue is not serious or continuing in nature.
2. Serious noncompliance is an action or omission taken by an investigator, that is noncompliant with Federal regulations, RCOI policy, a RCOI management plan or the determinations or requirements of the RCOI Committee, and that any other reasonable investigator would have foreseen as increasing the potential for bias or perceived bias in research, or otherwise compromising the integrity of research at UTA. Information which can be used to evaluate the seriousness of noncompliance includes, but is not limited to:
   1. An established record of noncompliance by the same researcher(s);
   2. An existing knowledge of RCOI policies on the part of the same researcher(s) as evidenced by and documented in
      • past compliance, or
      • efforts to mitigate the present alleged noncompliance
   3. A failure to timely disclose information relating to financial or business interests which was clearly requested in a grant/contract application or award or in UTA’s RCOI Disclosure Form;
   4. Internal forms and documents relating to disclosure of significant financial or business interests;
   5. Changes in relationships with companies or research personnel that are inconsistent with the original research plan without notification to and approval from the RCOI Committee;
   6. Communications with the researcher(s) during the course of investigating the noncompliance.
3. Continuing noncompliance is a pattern of repeated actions or omissions taken by an investigator that indicates a deficiency in the ability or willingness to comply with Federal regulations, RCOI policy, a RCOI management plan or determinations or requirements of the RCOI Committee.

Procedures for Handling Alleged Noncompliance

1. RCOI staff, as designees of the RCOI committee, may become aware of alleged noncompliance during review of disclosures or other information submitted by researchers or other administrative offices, or as a result of an allegation made by a third party.
2. When alleged noncompliance comes to the attention of RCOI staff, the staff will review the information to determine whether it is valid. If it is valid, then RCOI staff will undertake an inquiry and determine if the alleged noncompliance appears to be serious or non-serious
3. During the inquiry, RCOI staff will evaluate and compile information related to the researcher’s RCOI and management plan (if available), previous disclosures on file, and funding sources. RCOI staff may request additional information from the researcher for clarification.
4. After conducting an inquiry, if RCOI staff are able to determine that the alleged non‐compliance is non‐serious and non‐continuing:
   1. The issue will be resolved by RCOI staff in coordination with the RCOI Committee Chair.
   2. RCOI staff and the RCOI Chair will document the outcome in writing, including any remedial measures required. This documentation may be in the form of email communications with the researcher(s), a letter or memo, or notes to the file. Remedial measures for non‐serious or non‐continuing noncompliance can include:
      1. Required correction of omissions and/or errors in the RCOI disclosure;
      2. A request to the researcher(s) to fulfill obligations under the management plan and/or RCOI policies;
      3. A reminder to the researcher(s) to adhere to management plan requirements and RCOI policies in the future;
      4. A meeting between RCOI staff and the researcher(s) to explain RCOI requirements and policies;
      5. Issuance of a letter to the researcher(s) signed by the Research Conflict of Interest Official outlining the findings and any remedial measure(s), sent to the researcher(s), and others as deemed appropriate.
   3. The researcher must reply to RCOI program notifications of noncompliance within the timeframe established by the committee, to acknowledge the noncompliance and agree to any remedial measures, if
   4. The inquiry findings and remedial measures will be reported to the RCOI Committee at the next scheduled meeting.
5. If, after conducting an inquiry, RCOI staff determines that the alleged non‐compliance may be serious or continuing, RCOI staff will present the information to the RCOI Committee Chair.
6. If the RCOI Committee Chair determines that the alleged noncompliance may be serious and/or continuing:
   1. RCOI staff or a subcommittee of RCOI Committee members may undertake a further inquiry. Other staff may be requested by the RCOI Committee to assist and/or provide information for the inquiry.
   2. If the related research involves human participants, RCOI staff will notify the IRB that the RCOI Program has received an allegation of noncompliance, and that it will keep the IRB informed of developments in the inquiry and determination as appropriate. The RCOI Staff will notify the IRB if, after the inquiry and determination of noncompliance, any part of the noncompliance or remedial measures is/are related to the protection of human subjects.
   3. RCOI staff will document and compile the information and present the findings to the RCOI Committee. The Committee will receive copies of any existing management plan(s), disclosures, and any communications and discussions concerning the alleged noncompliance from the inquiry
   4. The Committee will review the findings at a scheduled meeting. The researcher(s) alleged of noncompliance will be invited to attend the Committee meeting to discuss the alleged noncompliance with the Committee.
   5. The Committee may ask for further investigation if necessary.
   6. The Committee will make a determination regarding whether there was serious and/or continuing noncompliance.
   7. If serious or continuing noncompliance is found to exist, the Committee will determine if remedial measures are necessary to encourage future compliance with RCOI policies and/or management plans. Examples of remedial measures include, but are not limited to:
      1. Required training on research ethics, the content and number of hours of which to be determined by the Committee based on the severity of the noncompliance;
      2. A requirement that the researcher(s) work with RCOI Staff to organize a RCOI information session for their lab, department or college;
      3. Required disclosure to a broader audience than previously required under the existing management plan, if any;
      4. Increased monitoring, (e.g., quarterly instead of annually);
      5. Referral to the IRB if, as a result of the finding of noncompliance, any part of the noncompliance or remedial measures is/are related to the protection of human subjects;
      6. Suspension of funds on sponsored research projects pending resolution of the noncompliance matter;
      7. Reporting of the noncompliance to UTA Administration where appropriate, such as department Chairs, college deans, Human Resources, Office of Legal Affairs, Office of the Vice President for Research, and/or Office of the President;
      8. Reporting of the noncompliance to external agencies where required, such as research sponsoring agencies
   8. The researcher will be issued a letter signed by the RCOI Committee Chair outlining the findings and any remedial measure(s). The letter will be sent to the researcher(s), the researcher’s department chair, the Vice President for Research, and others as deemed appropriate. The researcher must reply to RCOI program notifications of noncompliance to acknowledge the noncompliance and agree to any remedial measures, if applicable, within the timeframe established by the RCOI committee.
   9. If, in the course of investigating or evaluating alleged noncompliance with RCOI policies, RCOI staff or the RCOI Committee receive or discover other information which may form the basis of a potential research misconduct matter, the staff or Committee will follow steps for reporting such possible misconduct according to the requirements of policy RA-PO1 or any other pertinent policies.

Appeal

1. Researchers may appeal a determination of non-compliance once. The appeal request consists of sending the RCOI staff a letter outlining the basis for the appeal and the document(s) that support the appeal. 
2. The appeal is heard at a convened meeting of the RCOI Committee. At the discretion of the RCOI Committee Chair, the researcher may also present the appeal in person to the Committee.
3. Following discussion, the RCOI Committee votes whether to take one of the following actions:
   1. Approve the appeal and modify the original determination;
   2. Disapprove the appeal and uphold the original determination; or
   3. Defer the appeal to obtain additional information or consultation in order to make a final decision.
4. The RCOI Committee’s appeal determination, and any other considerations or requirements associated with it, are communicated to the researcher in writing within 10 business days.
5. The concluding RCOI Committee decision of an appeal is final and cannot be appealed again.

Records will be maintained in accordance with federal and state regulations and the institution’s policies and procedures for records management and retention.

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.

• PHS Federal Regulations (42 CFR Part 50 Subpart F, 45 CFR Part 94)
• Texas Government Code (Chapter 572 Section 572.051)
• Protection of Human Subjects (45 CFR Part 46, 21 CFR Part 50)
• Humane Care and Use of Laboratory Animals (PHS Policy on Humane Care and Use of Laboratory Animals, Animal Welfare Act)

• UT System Board of Regents' Rules and Regulations: 30103 (Standards of Conduct), 30104 (Conflict of Interest), Series 90000 (Rules for Intellectual Property)
• UTS 180 Conflicts of Interest, Conflicts of Commitment, and Outside Activities
• UT Arlington Intellectual Property Policy
• UT System Policy UTS 175: Disclosure of Significant Financial Interests and Management and Reporting of Financial Conflicts of Interest in Research
• UT Arlington Conflicts of Interest, Conflicts of Commitment, and Outside Activities Policy
• UT Arlington Policy on Records Management and Retention
• UT Arlington Statement of Principles and Policies Regarding Human Subjects in Research: http://www.uta.edu/policy/hop/adm/5/705