Chapter 10 - Research
Publication Date: August 24, 2012
Responsible Executive: VP for Research
10.04 Conflicts of Interest in Research & Intellectual Property
I. POLICY STATEMENT
The University of Texas at San Antonio (UTSA) promotes objectivity in funded and unfunded Research as well as in Sponsored Activities by establishing standards and procedures (see http://research.utsa.edu/oric/) to reasonably assure that the design, conduct, or reporting of Research and of Sponsored Activities will be unbiased by any conflicting interest of the Researchers.
For purposes of complying with applicable federal and state regulations and maintaining a research environment that promotes faithful attention to high ethical standards, UTSA has promulgated this policy relating to Conflicts of Interest in Research, Sponsored Activities, and Intellectual Property to be administered in conjunction with Public Health Services (PHS) Federal Regulations (CFR Title 42, Part 50 Subpart F), Texas laws setting forth applicable standards of conduct, if any, and The University of Texas System (UT System) Board of Regents' Rules and Regulations (Rules 30103, 30104, Series 90000) and UT System policy (UTS175).
This policy is applicable to all Researchers, engaging in both funded and unfunded Research and Sponsored Activities, regardless of the location where the Research and Sponsored Activities will be conducted.
IV. WEBSITE ADDRESS FOR THIS POLICY
V. RELATED STATUTES, POLICIES, REQUIREMENTS OR STANDARDS
UTSA or UT System Policies or the Board of Regents Rules & Regulations
- UT System Board of Regents' Rules and Regulations (Rules 30103, 30104, Series 90000)
- UT System policy UTS110, Employees of The University of Texas System: Financial Disclosure and Conflict of Interest Statement
- UT System policy UTS175, Disclosure of Significant Financial Interests and Management and Reporting of Financial Conflicts of Interest in Research
- UTSA HOP policy 2.27, Intellectual Property
- UTSA HOP policy 4.05, Outside Employment of UTSA Employees and the Appointment of Employees of Other Texas State Agencies and Public Education Institutions to Positions at UTSA
- UTSA HOP policy 4.31, Conflicts of Interest
- UTSA HOP policy 2.26, Human Subjects
Other Policies & Standards
- 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 Subpart A, 21 CFR Part 50)
If you have any questions about HOP policy 10.04, Conflicts of Interest in Research & Intellectual Property, contact the following office:
Office of Research Integrity (ORI)
Conflict of Interest (COI): situations in which Significant Financial Interests may directly and significantly affect (a) a Researcher’s professional judgment in exercising any UTSA duty or responsibility or (b) the design, conduct or reporting of Research or Sponsored Activities.
Committee on Conflict of Interest (CCOI): a UTSA Research Compliance Committee comprised of: a member of the Office of Research Integrity as an ex-officio non-voting member; and the following voting members: (a) one faculty member from every college at UTSA, (b) a member of the UTSA Institutional Review Board, (c) a representative of the vice president for community services, and a community member not otherwise affiliated with UTSA. Other members of UTSA or university administration may be asked to serve as non-voting members, (e.g., the assistant vice president for technology commercialiation and chief commercialization officer or the associate dean for research).
Disclosure Form: The Disclosure of Financial Interests Form. The electronic form is available online at https://oric.utsa.edu.
Equity Interests: Interests in a business entity, including, but not limited to, any stock, stock options, or other ownership interests or entitlements to such interest, which interests are valued by reference to public prices or other reasonable measures of fair market value.
Intellectual Property: Property that can be protected under federal law, including copyrightable works, ideas, discoveries, and inventions.
Institutional Official (IO): At UTSA, the IO is the provost and vice president for academic affairs.
Institutional Responsibilities: a Researcher’s professional responsibilities on behalf of UTSA. For Researchers who are faculty, this includes the Researcher’s research, teaching, service other professional activities. For Researchers who are staff, this includes the Researcher’s employee responsibilities as they relate to Research and/or Sponsored Activities.
Institutional Review Board (IRB): the UTSA Research Compliance Committee responsible for the oversight of human subjects in Research and for ensuring that human research participants are protected in accordance with federal regulations, UTSA policies and ethical principles.
Manage: taking action to address a financial COI, which can include reducing or eliminating the COI, to ensure, to the extent possible, that the design, conduct, and reporting of Research will be free from bias.
Management Plan: A customized set of actions that have been and/or must be taken to eliminate, reduce, or otherwise manage an identified COI. UTSA must begin with a set of standardized actions and terms found in a template approved by the Office of General Counsel (OGC) at The University of Texas System (UT System) and make changes as needed to manage a specific, identified COI. All Management Plans must be reviewed by OGC and approved by the Executive Vice Chancellor for Academic Affairs at UT System.
Payments: Remuneration, that includes, but is not limited to, salary or other payments for services (e.g., consulting fees, honoraria, or paid authorship).
PHS: The U.S. Public Health Service, a Division of the U.S. Department of Health & Human Services, includes federal agencies such as the National Institutes of Health, Food and Drug Administration, Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality.
Related Persons: the Researcher’s spouse/domestic partner, dependent children/step-children and other persons in his or her household with whom the Researcher is financially interdependent as evidenced, for example, by the maintenance of a joint bank account, mortgage, or investments.
Research: a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge. This term encompasses basic and applied research and product development, and includes both funded and unfunded projects. However, this term excludes unfunded projects that are not intended for nor will they be submitted for publication or conference presentation.
Researcher: individuals, regardless of their title, having direct responsibility for the design, conduct or reporting of funded or unfunded Research or of Sponsored Activities (see additional guidance: http://research.utsa.edu/oric/coi/). Examples of individuals who are included in this definition are listed below:
- All Principal Investigators, Project Directors, and all other individuals identified as Senior/Key Personnel;
- Some students, research staff, technicians, and volunteers depending on their level of responsibility in the Research or Sponsored Activity, as determined by the Principal Investigator or Project Director;
- All named inventors, including students, on UTSA inventions; and
- All individuals identified as responsible personnel on a UTSA Application for Use of Human or Animal Subjects.
Senior/Key Personnel: For funded Research and Sponsored Activities, this term encompasses the Project Director/Principal Investigator and any other person identified as senior/key personnel in the grant proposal, progress report, or any other report submitted to the funding agency. For unfunded Research, this term includes the Project Director/Principal Investigator and any other person identified as senior/key personnel in any document related to the Research.
Significant Financial Interest
- A financial interest of a Researcher or Related Person that:
- Is listed in section B.1-B.6 below;
- Is not excluded in section C.1-C.3 below;
- Was received, obtained or held during the 12 months preceding the disclosure; and
- Reasonably appears to be related to the Researcher’s Institutional Responsibilities.
- Information must be provided by the Researcher related to the following:
- Total amount and source of payments received from a publicly traded entity and the value and description of an Equity Interest held in the entity if the total of payments received AND Equity Interests held exceeds $5,000;
- Total amount and source of payments received from a non-publicly traded entity if the total of payments received exceed $5,000 AND the value and description of any Equity Interest held in the entity;
- Fiduciary positions in a for-profit or nonprofit entity, including a position as a member of the board of directors, an officer, or other executive or management position, for which the Researcher received any form of remuneration or reimbursement for expenses, and the name and address of the entity;
- Travel payments (i.e., travel reimbursements or travel paid on the Researcher's behalf):
- For Researchers who request or receive any funding from PHS or other federal agency with similar COI requirements, all travel that is reimbursed or sponsored, including the purpose of the trip(s), the identity of the sponsor/organizer, the destination(s), and the duration(s), and
- For all other Researchers, travel that is reimbursed or sponsored by an entity that, when aggregated, exceeds $5,000, including the purpose of the trip(s), the identity of the sponsor/organizer, the destination(s), and the duration(s);
- Intellectual Property Rights and interests (e.g., patents, copyrights):
- a description of intellectual property rights held and any agreements to share in royalties related to those rights and
- the amount and source of royalty income that the Researcher or Related Persons received or had the right to receive; and
- The value and source of gift(s) from a single source that total more than $250, excluding gift(s) from a family member.
- The following exclusions apply and need not be disclosed on the annual disclosure statement:
- Salary, royalties, or other remuneration paid by UTSA to the Researcher, if the Researcher is currently employed or otherwise appointed by UTSA;
- Income from seminars, lectures, teaching engagements, service on an advisory committee or review panel, and travel reimbursements or sponsored travel from U.S. federal, state, or local governments, a U.S. institution of higher education (e.g., UTSA, UT Health Science Center, and community colleges), academic teaching hospital, medical center, or research institute affiliated with a U.S. institution of higher education (including Southwest Research Institute); and
- Income from certain investment vehicles (e.g., mutual funds, retirement accounts) as long as the Researcher does not directly control the investment decisions made in those vehicles.
Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR): the extramural research program for small business that is established by the funding agencies of the Public Health Service and certain other Federal agencies under Public Law 97-219, the Small Business Innovation Development Act. The term SBIR Program includes the STTR Program, which was established by Public Law 102-564.
Sponsored Activity/Activities: all extramurally funded activities, (including but not limited to, research, training, instruction and/or public service projects) involving funds, materials, or other compensation from Sponsors, under a grant, contract or other agreement between UTSA and the Sponsor that meets any of the following conditions:
- UTSA is bound to a line of scholarly or scientific inquiry specified in a sponsored agreement. Such scholarly or scientific inquiry may be indicated as a deliverable or by the stipulation of requirements for orderly testing or validation of particular approaches, or by the designation of performance targets;
- The Sponsor requires, or the proposal submitted for consideration contains, a line-item budget or an NIH modular budget. A line-item budget details expenses by activity, function, or project period. The designation of overhead (or indirect costs) qualifies a budget as "line item";
- The Sponsor requires financial and/or programmatic reports;
- The Sponsor requires that the services performed, the funds awarded or the materials supplied under the agreement are subject to external audit; OR,
- The agreement provides for the disposition of either tangible (e.g., equipment, records, technical reports, theses, or dissertations) or intangible (e.g., rights in data, copyrights, or inventions) properties that may result from activities covered by the agreement.
Subrecipient: a subcontractor, contractor, or collaborator with whom UTSA has a written agreement regarding Research or a Sponsored Activity.
- Committee on the Conflict of Interest in Research and Intellectual Property (CCOI)
- Reviews COI Disclosures and supplemental information.
- Provides recommendations to the RO regarding: (a) whether a Significant Financial Interest is related to Research or Sponsored Activities or Institutional Responsibilities, and, if so related, (b) whether a Significant Financial Interest is a COI.
- When a COI is identified, helps customize a Management Plan that will be presented to the RO for further action.
- Monitors Researchers’ adherence to Management Plans as specified by conditions described in the Management Plans.
- Reviews and provides recommendations on other types of COI, upon request and direction by the IO.
- Institutional Official (IO)
- In consultation with the RO, approves the overall conflict of interest program.
- Assigns to the CCOI for review at his or her discretion potential conflicts of interest identified for individuals who do not meet the definition of Researcher.
- Reviews terms and conditions contained in Management Plans and makes adjustments as he/she deems necessary.
- In consultation with the RO, makes the final determination (a) that a COI is appropriately Managed through a Management Plan, (b) that an identified COI cannot be Managed and (c) what action(s) will be taken to eliminate an identified, unmanageable COI.
- Files and updates a Disclosure Form in a timely manner as required by this Policy.
- Provides additional information and documentation (i.e., related agreements, contracts, offer letters, or other materials) when requested and as needed to meet the requirements of this Policy.
- Acknowledges, on an annual basis, their understanding of this Policy, the federal regulations (if applicable), and the Researcher’s responsibilities for the disclosure of Significant Financial Interests that reasonably appear to be related to the Researcher’s Institutional Responsibilities.
- Determines whether students, research staff, technicians, and volunteers working on his/her Research or Sponsored Activity constitute a “Researcher” for purposes of this Policy.
- Completes training on the policies, regulations, and responsibilities as required by this Policy.
- Responsible Official (RO)
- Ensures that all COIs are managed, reduced or eliminated before Research, and/or Sponsored Activities are performed or before the expenditure of funds.
- Makes the determination, in consultation with the IO, if needed, that a Significant Financial Interest is a COI. Makes interim decisions regarding the Management of a COI, consulting with the IO as needed.
- Provides guidance and oversight of the development and approval of Management Plans.
- Submits COI reports as required by the UT System Administration and federal Sponsors such as PHS.
- Informs Researchers, on an annual basis, of this policy, the federal regulations, and the Researcher's responsibilities to disclose Significant Financial Interests.
- With the assistance of the Office of Research Integrity and the approval of the IO, oversees the implementation of this policy, adds or updates guidelines, processes and forms as necessary for such implementation, and ensures that UT System always has updated copies of the guidelines, processes and forms used to implement this Policy.
- The RO may always serve as the conflict of interest official for UTSA as that term is used in the UT System model policy.
- Office of Sponsored Project Administration (OSPA): Research Service Centers (RSCs)
- Verifies that current Disclosure Forms are on file for all Researchers prior to proposal submission to a potential Sponsor and for maintaining the proposal records until the Sponsor takes action on the request for funds.
- Verifies, upon receipt of funding notification, that Disclosure Forms are on file for all Researchers before the expenditure of funds.
- Communicates disclosure and reporting requirements to all Subrecipients.
- Documents which policy the Subrecipient will follow as defined in UTSA’s agreement or contract with the Subrecipient.
- Serves as the point of contact for Subrecipients who report Significant Financial Interests, either as a result of newly acquired financial interests or from new Researchers who join the ongoing Research or Sponsored Activity.
- Office of Research Integrity (ORI)
- Reviews each Disclosure Form and convenes the CCOI when a full review is necessary.
- Works with the following offices concerning COI:
- OSPA, including its RSCs
- Institutional Animal Care and Use Committee, and
- Other departments or consultants as necessary.
- Notifies the Researcher that work on a funded proposal cannot begin--nor can a sponsored program account be set up--until after an identified COI has been resolved.
- Works with RO and IO as appropriate in the coordination of COI procedures and to promote compliance with this policy.
- Works with the Researcher and the CCOI on Management Plans.
- Works with the UT System on final approval of Management Plans.
- Develops and coordinates the Researchers’ training programs related to this policy.
- Office of Audit, Compliance, and Risk Services
- Performs regular audits of financial interest disclosure statements to determine individual and institutional compliance with this policy.
- Researcher's Disclosure and Training Requirements
- All Researchers must complete a Disclosure Form;
- Each calendar year, no later than March 1;
- Within thirty (30) days of hire for new employees; and
- Within thirty (30) days of joining an ongoing Research project.
- The Disclosure Form must also be updated within thirty (30) days as new, reportable Significant Financial Interests are obtained and/or identified.
- The filing of a Disclosure Form for the current year is a necessary condition for the following activities:
- Submission of a funding proposal for Research or other Sponsored Activities;
- Expenditure of any external funding, such as a grant award or contract (Note: Any identified COIs must be Managed prior to expenditure of external funds); and
- Submission of a UTSA Application for Use of Human or Animal Subjects.
- Content of the Disclosure Form: Each person completing the Disclosure Form must list all requested information that relates to the following interests for the preceding 12 months if they reasonably appear to be related to the Researcher's Institutional Responsibilities:
- All his/her Significant Financial Interests and those of Related Persons; and
- All Significant Financial Interests of any legal entity, including a foundation or a trust that is controlled or directed by the Researcher or by Related Persons because such interests are considered to be the interests of the Researcher as if the separate legal entity did not exist.
- Training: Researchers must complete training relating to this policy, the applicable federal regulations, and their required disclosure of Significant Financial Interests before engaging in Research or Sponsored Activities at UTSA and at least once every four years, and immediately when any of the following circumstances apply:
- Whenever a Researcher starts working at UTSA;
- Whenever the Researcher is found to be out of compliance with this policy or a Management Plan; or
- Whenever this policy is changed in such a way that affects the requirements for Researchers.
- Acknowledgments: Researchers must acknowledge, on an annual basis, their understanding of this policy, the applicable federal regulations, and their responsibilities for the disclosure of Significant Financial Interests.
- Special Provisions for Subrecipient Researchers: If UTSA conducts funded Research or Sponsored Activity through a Subrecipient, UTSA will take the following steps:
- UTSA will enter into a written agreement with the Subrecipient that establishes whether this policy or the Subrecipient's financial COIs policy will apply to the Subrecipient's Researchers while they are working on UTSA Research.
- The Subrecipient is encouraged to follow their own COI policy and, if so, must certify that its policy is consistent with PHS requirements or any applicable federal agency with COI regulations. All financial COIs identified by the Subrecipient must be reported to UTSA within thirty (30) days of their identification.
- If the Subrecipient adopts this policy, the agreement must specify that the Subrecipient's Researchers are subject to the requirements described herein.
- Special Provisions relating to SBIR/STTR: The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs are available for domestic small business concerns to engage in Research/Research Development that has the potential for commercialization. Some of the stipulations in these programs may create actual or perceived COIs for Researchers. UTSA requires that all persons submitting proposals for SBIR/STTR funding disclose their Significant Financial Interests. The processing of these disclosures will follow the same procedures as all other disclosures covered by this policy, including the creation of Management Plans.
- All Researchers must complete a Disclosure Form;
- CCOI Review of Disclosure Forms and Changes during Research or Sponsored Activities Already in Progress
- The CCOI meets regularly to ensure that all disclosures are reviewed in a timely manner and to ensure that Research and Sponsored Activities are not unduly inconvenienced. Understanding that some situations arise quickly and the usual review process might cause problematic delays, the RO may be asked to make an interim decision pending the next meeting of the CCOI for full review of the case.
- The CCOI reviews Disclosure Forms and other documentation in light of the Researcher’s Research or Sponsored Activity and makes recommendations to the RO for dealing with the COI. The President, IO, RO, or the ORI may request and the Researcher will promptly provide further information (i.e., related agreements, contracts, offer letters, or other documentation) from the Researcher as needed for the CCOI review. In addition, the CCOI may, at the IO’s request, review information related to all financial and/or fiduciary arrangements in light of a UTSA employee's administrative position or other UTSA duty or responsibility.
- In its review, the CCOI examines disclosed Significant Financial Interests and considers the magnitude of the risks the proposed activity poses to:
- the integrity of the Research or Sponsored Activity;
- the rights and obligations of collaborators and students participating in the Research or Sponsored Activity;
- the rights and welfare of human and animal subjects; and
- the academic, research, innovation, and community engagement missions of UTSA.
- Special Provisions relating to Sponsored Programs
- The CCOI reivews grants, contracts and other agreements of Senior/Key Personnel who may have a possible or perceived COI. In grants, contracts and other agreements, including faculty consulting agreements and/or contracts, the CCOI examines the terms and conditions to ensure the freedom of timely and unhindered publication of results, to uphold the rights of students and postdoctoral fellows, and to ensure appropriate reporting of inventions and assignment of Intellectual Property rights. In addition, CCOI requires that the Office of Research Integrity (ORI) receive certification of all COI disclosures reviewed by collaborating institutions or corporations for any Subrecipient. OSPA reviews, negotiates and ensures the proper execution of a variety of financial and non-financial agreements associated with Sponsored Programs and Research.
- Neither the Researcher nor UTSA may expend Research or Sponsored Activity funds unless the determination has been made that: (a) no COI exists or (b) any COI is Manageable in accordance with the terms of a Management Plan that has been adopted and implemented in accordance with this policy.
- Following its review, the CCOI submits recommended findings to the RO for a final decision as follows:
- The first finding is either:
- Whether or not a Significant Financial Interest is related to Research or Sponsored Activities in which the Researcher is engaged. The Significant Financial Interest is related if the financial interest could be affected by the Research or Sponsored Activity or is in an entity whose financial interest appears to be affected by the Research or Sponsored Activity; or
- Whether or not a Significant Financial Interest is related to any other UTSA duty or responsibility. The Significant Financial Interest is related if the financial interest could be affected by the UTSA duty or responsibility or is in an entity whose financial interest could be affected by the UTSA duty or responsibility.
- If a Significant Financial Interest is found to be so related, the second finding is whether or not the Significant Financial Interest is a COI. The CCOI may recommend to the RO a finding that a COI exists when a Significant Financial Interest could directly and significantly affect (a) the Researcher’s professional judgment in exercising any UTSA duty or responsibility or (b) the design, conduct, or reporting of the Research or Sponsored Activity.
- The first finding is either:
- Changes during Research or Sponsored Activities Already in Progress
If Research or Sponsored Activities are ongoing and a new Researcher discloses a Significant Financial Interest or any other Researcher discloses a new Significant Financial Interest, UTSA shall, no later than sixty (60) days after the filing of the Disclosure Form:
- Review the Disclosure Form and other documentation to determine if the Significant Financial Interest is related to the Research or Sponsored Activity;
- Determine if a COI exists; and
- If a COI exists, implement an interim Management Plan or implement other interim measures to ensure the objectivity of the Research. Such interim measures must be approved by the RO.
- Untimely Disclosure
If the CCOI learns of a Significant Financial Interest that was not timely disclosed or was not timely reviewed, then the following actions shall be taken no later than the 60th day after learning of the interest:
- After reviewing CCOI recommendation and the results of any consultations s/he deems necessary, the RO will (i) determine if the Significant Financial Interest is related to the Research or Sponsored Activity and (ii) if a COI exists; and
- If a COI exists, the CCOI will implement an interim Management Plan or implement other interim measures to ensure the objectivity of the Research going forward. Such interim Management Plans or measures must be approved by the RO.
- CCOI Reports
- Upon completing its review, the CCOI will issue a report that will detail its findings and will recommend to the RO how any identified COI should be Managed.
- The RO will make final decisions on whether a Significant Financial Interest is related to a Researcher’s Research or Sponsored Activity or his/her other Institutional Responsibilities and whether a Significant Financial Interest is a COI (see Section IX. B.3 above) based on a review of:
- the CCOI report, and
- the Researcher's disclosure and other documentation provided to the CCOI.
- The RO will review the report and other information, make any changes he or she deems necessary, and issue an email containing an electronic copy of the report to the Researcher. If the Researcher wishes to respond to the report, he or she will have ten (10) working days following the transmittal of the email containing the report to submit or transmit a written email response to the RO. After the expiration of such ten (10) working days, the RO will submit the report and the Researcher’s response (if any) to the IO for a final determination of what action(s) will be taken to Manage the conflict.
- The CCOI may recommend that Management of the COI be implemented using, for example, one or more of the following:
- Disclosure: Disclosure is typically required in every case including;
- public disclosure of the financial interests of the Researcher and of UTSA, if applicable, in all relevant publications and presentations (whether or not academic presentations), including presentations at the level of the Researcher's primary department or higher;
- disclosure to the appropriate co-investigators, members of the laboratory or research group, and students or trainees; and
- disclosure on human subjects consent forms.
- Restriction on Equity: placement of stock in escrow until a time specified by the CCOI, or requirement that options, warrants and similar instruments not be exercised without the prior approval of the CCOI;
- Limiting the Role of the Researcher with an identified COI: requiring that the role of the Researcher with the identified COI be limited in some way (e.g., the Researcher may not be allowed to serve as principal investigator, analyze data or results, or solicit consent from human research subjects);
- Modification of the research plan;
- Oversight: appointment of a disinterested individual or group to monitor the relevant Research or Sponsored Activity. An oversight committee may be charged with ensuring that the Research is conducted and reported according to scientific and ethical standards and that COI Management measures are observed. In cases concerning a Dean or Associate Dean, the individual or group monitoring the activity shall be appointed by and report to the ORI;
- Divestiture: the sale or disposal of specified Significant Financial Interests to eliminate or reduce the COI by a certain date;
- Severance of Relationships that Heighten or Create Actual or Potential Conflicts: for example, relinquishing a seat on a board of directors or terminating a consulting arrangement with an outside entity in order to reduce the financial or fiduciary COI.
- Disclosure: Disclosure is typically required in every case including;
- The CCOI may recommend other conditions or limitations on the proposed arrangements if, in its view, such conditions or limitations will contribute to the elimination, reduction or management of the COI.
- Special Provisions for Human Subjects Research
For identified COIs involving human subjects Research, the CCOI will prepare a preliminary report containing only a finding of the COI, which finding is the result of applying the standards found in Section IX.B.5 of this Policy. Because such Conflicts may present real or perceived risks to the welfare and rights of human subjects in addition to presenting risks to research integrity, unique coordination with the IRB is required to determine how such COIs will be Managed. The IRB makes recommendations to the CCOI regarding how COIs will be Managed and may also require additional actions/conditions prior to IRB approval or disapproval of the Application for the Use of Human Subjects.
- Management Plans
- If the RO determines that a COI exists and the conflict is Manageable, the CCOI will develop a Management Plan. This Management Plan will be in the form of a written agreement that clearly specifies each person or group responsible for monitoring compliance with the Management Plan. The Management Plan will be written in accordance with federal, state and UT System regulations. All Management Plans are to be created in consultation with the Researcher.
- Understanding that situations may arise quickly, the RO may implement an interim Management Plan for an identified COI, pending the next meeting of the CCOI or until full
- The Researcher will acknowledge that he or she has received, understands, , and agrees with the terms and conditions contained in the Management Plan, including timely performance of required actions.
- All final Management Plans must be approved by the IO in consultation with the RO.
- For Management Plans relating to Research involving human subjects, the IRB must also approve the final Management Plan as it relates to or directly impacts human subjects.
- Once the Management Plan is so approved, the ORI will obtain the signatures of the Researcher, Chair, Dean and other monitoring parties. If approval is not granted by any party, the IO will decide the appropriate course of action to protect research integrity. Once all UTSA signatures are obtained, the Management Plan will be sent to the UT System, Office of General Counsel, for review and approval, and then to the Executive Vice Chancellor for Academic Affairs for final approval.
- Dissemination of Information relating to this policy
- This policy is made available via the UTSA website to all faculty, staff, and students interested in Research and Sponsored Activities and to all entities interested in collaborating on such Research and Sponsored Activities. Periodic notices sent to faculty, staff and students about the university's Sponsored Program administration will include information about the procedures and responsibilities relating to this Policy and will refer individuals to designated offices or officials for additional information.
- ORI, in collaboration with the RSCs is responsible for disseminating information on the duty to submit timely, accurate and complete Disclosure Forms.
- ORI will develop and provide to Researchers education and training regarding this policy and any conduct that could constitute a violation of this policy.
- Public Dissemination of Information relating to Certain Identified COIs
- For each that is found to exist, that relates to Research funded by a PHS agency or other federal agency with similar COI requirements, and that involves the PI, the PD, or any Researcher identified as senior/key personnel (see item A. in the definition of Researcher—Section VII. of this Policy), UTSA will make the information listed in section F.3 below available via a UTSA hosted website.
- For each COI that is found to exist, that relates to Research that is NOT funded by a PHS agency or other federal agency with similar COI requirements, and that involves the PI, the PD, or any Researcher identified as senior/key personnel (see item A. in the definition of Researcher—Section VII. of this Policy), UTSA will make the information listed in section F.3 below available to the public, upon request under the Texas Public Information Act (Chapter 552, Government Code).
- The following information will be made available:
- the Researcher's name;
- the Researcher's title and role with respect to the Research;
- the name of the entity in which the Significant Financial Interest is held;
- the nature of the Significant Financial Interest that constitutes a COI; and
- the approximate value of the Significant Financial Interest by range specified by federal regulation or, if the dollar value cannot be determined by reference to public prices or other reasonable measures of fair market value, a statement to that effect.
- UTSA will update the information annually and within sixty (60) days of identifying a new COI. Information will be available for three years after its most recent update.
- Retention of Records
ORI will maintain in a central repository all records received and created pursuant to this Policy as well as all records of actions taken with respect to each Significant Financial Interest for: (a) at least three (3) years beyond the termination or completion of the Research or Sponsored Activity, (b) for as long as is required under federal or state law or UT System policy, (c) for as long as is required by any agreement covering funded Research or a Sponsored Activity or (d) until resolution of any investigation, audit, or other action by a granting agency or sponsor involving the records, whichever is longer.
- UTSA requires that all Researchers will comply fully, truthfully and in a timely manner with this Policy and are subject to audit as instructed by and under the direction of UTSA’s Executive Director of Audit, Compliance, and Risk Services. Instances of breach, including, but not limited to, failure to submit required Disclosure Forms, statements or updates thereof; failure to provide additional information requested by the RO or his or her designee; knowingly filing an incomplete, erroneous or misleading statement; knowingly violating applicable laws, the Regents' Rules and Regulations, UT System policy, or this Policy; or failure to comply with prescribed conditions or restrictions in Management Plans or that otherwise have been imposed pursuant to this Policy, will subject the Researcher to disciplinary action under policies of UTSA and the Regents' Rules and Regulations, and if applicable, the Federal Government. Such action could result in a formal reprimand, non-renewal of appointment, termination of appointment, or other enforcement action. For Researchers who are not UTSA employees, compliance with this policy is a condition of participating with UTSA in the capacity that qualifies them as a Researcher. UTSA may require the individual to execute a document certifying that they know compliance with this policy is a condition of participation; however, the failure to obtain or to provide such an executed document will not prevent or mitigate any enforcement action taken under this policy.
- Research Sponsored by PHS
The following procedures will be followed if the Research is sponsored by a PHS funding agency. If a COI was not identified or Managed in a timely manner or if a Researcher fails to comply with a Management Plan, the RO, through the CCOI, shall, within one hundred and twenty (120) days after determination of noncompliance, complete and document a retrospective review of the Researcher’s activities and the Research/Sponsored Activity to determine whether the Research conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such Research/Sponsored Activity. If bias is found, the IO, in consultation with the RO will implement any measures necessary with regard to the Researcher’s participation in the Research/Sponsored Activity between the date that the noncompliance is identified and the date the retrospective review is completed. The following are required:
- The retrospective review shall document, at a minimum, the following key elements:
- Project number;
- Project title;
- Name of the Project Director/Principal Investigator or contact Project Director/Prinicipal Investigator if a multiple Project Director/Principal Investigator model is used;
- Name of the Researcher(s) with the financial COI;
- Name of the entity with which the Researcher has a financial COI;
- 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.
- The results of the retrospective review may require an update to the previously submitted Financial COI Report to specify actions that will be taken to Manage the COI; and
- If bias is found, UTSA is required to notify the PHS funding agency promptly and submit to PHS a mitigation report as specified by the federal regulations. The mitigation report will include a description of the impact of the bias on the Research project (e.g., 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) and the plan of action taken to eliminate or mitigate the effect of the bias. Annual Financial COI Reports (as described below) will be submitted, as required by federal regulation.
- The retrospective review shall document, at a minimum, the following key elements:
- Financial COI Report for Certain Federally Funded Research//Sponsored Activities
Before the expenditure of any Research/Sponsored Activity funds supplied by a PHS agency or other federal agency with similar COI requirements, the RO will submit a Financial COI Report to the federal funding agency in compliance with applicable federal regulations. In general, those regulations require a Financial COI Report regarding those interests that were identified as a COI, including any COIs of Subrecipients, and assurance that all such COIs are appropriately Managed. The reporting will include specified information sufficient to enable the federal funding agency to understand the nature and extent of the financial conflict and to assess the appropriateness of the Management Plan related to the COI. The federal regulations require reporting, within a specified period, of COIs identified after an earlier report and require annual updating of reports regarding previously disclosed COIs. A Financial COI Report may not be required if UTSA identifies a financial COI and eliminates it prior to the expenditure of federally-awarded funds.
- Federal Enforcement of Research/Sponsored Activities Funded by PHS
- The PHS federal regulations require UTSA to notify the PHS funding agency of instances in which the failure of a Researcher to comply with this Policy or a Management Plan appears to have biased the design, conduct, or reporting of PHS-funded Research or Sponsored Activity. The RO must also promptly report the corrective action taken or to be taken.
- The PHS funding agency may take enforcement action or require UTSA to take action appropriate to maintaining objectivity in the Research. UTSA must make information available to the U.S. Department of Health and Human Services (DHHS) or the PHS funding agency as required by federal regulation. The PHS funding agency may decide that further corrective action is needed or that UTSA has not appropriately Managed the financial COI and may impose special award conditions, suspend funding, or take other enforcement action until the matter is resolved.
- If DHHS determines clinical Research funded by a PHS funding agency to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by a Researcher with a financial Conflict of Interest that was not managed or reported by UTSA as required by PHS, UTSA will require the Researcher 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.
- Adherence to COI Requirements of Other Federal Agencies
Other federal agencies, such as the National Science Foundation and the Department of Defense, may also have regulations that govern financial COIs associated with Research and Sponsored Activities funded by such agencies. This Policy will apply to such Research and Sponsored Activities only to the extent that this HOP Policy can be read to conform to the financial COI regulations, policies or processes mandated by such agencies. If section(s) in this HOP Policy or its associated procedures conflict with such agency’s mandatory financial COI regulations, policies or procedures, then the agency’s or sponsor’s regulation, policy or procedure will apply.
X. SPECIAL INSTRUCTIONS FOR INITIAL IMPLEMENTATION
XI. FORMS AND TOOLS/ONLINE PROCESSES
Disclosure of Financial Interests: https://oric.utsa.eduRequest for Prior Approval of Outside Employment/Consultation/Appointment/Positions Including Self Employment: http://research.utsa.edu/files/oric/coi/RequestforPriorApprovalofOutsideEmploymentForm.pdf
Editorial Amendment: September 26, 2013