Handbook of Operating Procedures

I. POLICY AND GENERAL STATEMENT

The University of Texas Health Science Center at Houston ("University") is committed to ensuring that financial interests of the institution and individuals involved in research do not affect, or appear to affect, the design, conduct or reporting of research or compromise the protection of human subjects. Therefore, members of the University community conducting research using public or private funding from any source must disclose potential conflicts of interest and, when appropriate, work cooperatively with the Research Conflict of Interest Official (“RCOI Official”) to develop and implement plans to manage, reduce or eliminate conflicts of interest. 

This policy does not necessarily preclude the conduct of research where a conflict of interest, or potential conflict of interest, is present. However, for such research to be initiated, it must be approved in accordance with this policy. 

When a covered individual or the University has a significant financial interest related to the research, neither the institution nor the covered individual may expend research funds unless the RCOI Official has determined that no financial conflict of interest exists or that any financial conflict of interest is manageable in accordance with the terms of a management plan that has been adopted and implemented.

This policy deals exclusively with financial interests related to research. Conflicts of interest related to an employee’s status as an employee of the State of Texas are discussed in HOOP Policy 20, Conflict of Interest, Conflict of Commitment and Outside Activities.  HOOP 221, Institutional Conflicts of Interest, addresses institutional conflicts of interests not related to research.

If a specific federal law or regulation provides different requirements than this policy, the more stringent requirement applies.

II. DEFINITIONS

Research Conflict of Interest Official:  The Executive Vice-President & Chief Academic Officer (“EVP/CAO”) will either serve as the Research Conflict of Interest Official (“RCOI Official”) or designate another individual to serve in the role.  The RCOI Official shall perform the duties required by this policy and other duties as assigned by the President.

Covered Family Member: For purposes of disclosure, a covered family member includes (1) a spouse; (2) a dependent child or stepchild; (3) any other person financially dependent on the covered individual; and (4) any other person with whom the covered individual has joint financial interests such that an objective third party could reasonably conclude that the covered individual’s decisions or other exercise of professional responsibilities at the institution could be influenced by the effect of that action on the person’s financial interest. A person described by Subdivision (3) or (4) is a covered family member without regard to whether a legal or biological family relationship exists with the covered individual.  If the covered individual is in doubt, the covered individual should resolve the doubt in favor of disclosure.

With regard to the definition above, in disclosing financial interests, the interest of any legal entity, including a foundation or a trust, that is controlled or directed by the individual andor covered family members is considered to be the interest of the covered individual or covered family member as if the separate legal entity did not exist.

Covered Individual: An individual who, regardless of title or position, is responsible for the design, conduct, or reporting of research, including a principal investigator, co-investigator, project director, any other person identified as senior/key personnel in a grant application, research protocol, or report, and others who direct or can materially influence the research.  The principal investigator is responsible for determining if other research staff (e.g., research nurses, research coordinators, data managers, graduate students, postdoctoral research fellows) meet the definition of being responsible for the design, conduct, or reporting of the research.

With regard to the definition above, in disclosing financial interests, the interest of any legal entity, including a foundation or a trust, that is controlled or directed by the individual and/or covered family members is considered to be the interest of the covered individual or covered family member as if the separate legal entity did not exist.

Covered Institutional Officials: Individuals whose research related financial interests are considered “institutional” interests include institutional officials who have research oversight authority, act on behalf of the institution, or have immediate oversight of human subjects research. These include, but are not limited to, the President, EVP/CAO, executive vice presidents, vice presidents, deans and department chairs.

Fiduciary Position: a position the covered individual held in a for-profit or non-profit entity in the preceding twelve months, including a position as a member of the board of directors, an officer or other executive or management position, for which the individual received any form of remuneration or reimbursement for expenses.

Financial Conflict of Interest: exists when a significant financial interest could directly and significantly affect the design, conduct, or reporting of the research.

Institutional Responsibilities: any professional responsibility performed by the covered individual on behalf of the University, including conducting research activities, teaching, professional practice, research consultation, institutional committee membership, and service on institutional research committees and panels (e.g., Committee for the Protection of Human Subjects (“CPHS”), Animal Welfare Committee (“AWC”), Data Safety Monitoring Board (“DSMB”), Research Conflict of Interest Committee (“RCOIC”).

PHS Awarding Component: The organizational unit of the Public Health Service (“PHS”) that funds the research.

Principal Investigator (“PI”): the individual who has primary responsibility for design, management and reporting of applicable research, is responsible for identifying key personnel who must complete the certification and ensures completion of the certifications.

Research: A systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research and product development.

Significant Financial Interests (Related to Research):

The following interests are considered to be significant financial interests.  Unless specifically excluded below, a covered individual’s disclosure statement must include the following information regarding the covered individual and covered family members, but only regarding interests that reasonably appear to be related to the individual’s institutional responsibilities.

• From 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:
  • salary or other payments for services (e.g., consulting fees, honoraria, paid authorship); and
  • equity interests held, including 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.  
• From a non-publicly traded entity:  the total amount and source of payments received in the preceding twelve months from a non-publicly traded entity that, when aggregated, exceed $5,000, or a description  of any equity interest held in the entity on the date of disclosure, including:  
  • salary or other payments for services (e.g., consulting fees, honoraria, paid authorship); or
  • equity interest held in any amount, including stock, stock options or other ownership interest or entitlement to such an interest. 
• 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 covered individual or covered family member received or had the right to receive in the preceding twelve months.
• Service as an officer, director or fiduciary for a for profit or nonprofit entity in the preceding twelve months for which the covered individual  received any sort of remuneration or payment for expenses, and the name and principal address of the entity.
• Gifts received in the preceding twelve months that exceed $250 in value, or multiple gifts from a single entity that in the aggregate exceed $250 in value, other than gifts from a covered family member, and the value and source of the gifts.
• Reimbursed or sponsored travel in the preceding twelve months (see exclusions noted below). The disclosure of this travel must include the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and the value of the travel, if the aggregated value of all payments from the sponsor/organizer (such as salary, consulting fees, honoraria, paid authorship and travel) exceeds $5,000.

The following items do not have to be reported:

• Salary, royalties, or other remuneration paid by the institution to the covered individual, if the covered individual is currently employed or otherwise appointed by the institution.
• Income from seminars, lectures or teaching engagements sponsored by a federal, state, or local government, an institution of higher education as defined by 20 U.S.C. §1001(a), an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.
• Income from service on advisory committees or review panels for a federal, state, or local government, an institution of higher education as defined by 20 U.S.C. §1001(a), an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.
• Income from investment vehicles, such as mutual funds or retirement accounts, as long as the covered individual does not directly control the investment decisions made in those vehicles.
• Travel reimbursed or sponsored by a federal, state, or local government,  an institution of higher education as defined by 20 U.S.C. §1001(a), an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.

The RCOI Official may request further information about a covered individual’s travel, including the monetary value of the travel, in order to determine whether the travel constitutes a financial conflict of interest.

Covered individuals should also disclose other significant financial interests not specifically required by this policy if they have concerns the interests would reasonably appear to be affected by the proposed research (e.g., significant financial interests of family members other than a spouse or dependent children).

Significant Outside Financial Interests of the University (related to research): Include interests held by the institution and/or interests of institutional officials. In these situations, the research will be reviewed to ensure safeguards are in place to protect the integrity of the data.

1. University: Significant financial interest in research refers to anything of monetary value that would reasonably appear to be affected by the outcome of the proposed research. Such interests include, but are not limited to: 
   • Equity interests that exceed $100,000 in value in a publicly traded entity with a financial interest in the proposed research.
   • Any equity interests in a non-publicly traded for-profit entity with a financial interest in the proposed research.
   • Actual or negotiated proceeds from intellectual property rights (e.g., patents, copyrights, and royalties from such rights) associated with such research.
2. Institutional Officials: Significant financial interests in research for institutional officials utilize the threshold defined for covered individuals.

III. PROCEDURE

A. Education

A covered individual must complete training related to this policy and applicable policies, regulations, and laws at least once every two years. A covered individual who is new to the institution must satisfy this training requirement before engaging in research at the University.

A covered individual must complete the training immediately if the institution finds that the individual is not in compliance with this policy or the individual’s management plan, or if the institution revises this policy in a manner that affects the individual’s duties.

The RCOI Official or designee is responsible for ensuring that appropriate faculty, staff, trainees, and other persons participate in training related to this policy and applicable laws.

Each covered individual must acknowledge annually that the individual is aware of and has read this policy and is aware of the covered individual’s responsibilities regarding disclosure of significant financial interests and of applicable federal regulations.

 B. Financial Disclosure by Covered Individuals

A covered individual shall submit or update a financial disclosure statement in accordance with HOOP 20, Conflict of Interest, Conflict of Commitment and Outside Activities and/or at the time of application for PHS-funded research if a current financial disclosure statement is not on file.

The RCOI Official or designee may require a covered individual to submit additional disclosures, including a copy of any related agreement, contract, offer letter or other documentation.

 C. Research Conflicts of Interest Certification

Covered individuals must submit a completed Research Conflicts of Interest Certification Form (1) upon funding through Sponsored Projects Administration (“SPA”) and (2) for human subjects and animal research, as part of the submission to the CPHS and/or AWC. 

Covered individuals initiating research not reviewed by the CPHS or the AWC, and not requiring the review and approval of SPA, should disclose any potential research conflicts of interest directly to the RCOI Official using the Research Conflict of Interest Certification Form. 

Covered individuals who indicate potential conflicts in the Research Conflict of Interest Certification Form may be required to complete a Research Conflict of Interest Disclosure Form. This disclosure must be submitted to the RCOI Official for review.

D. Third Party Identification of Potential Research Conflicts of Interest

Covered individuals are responsible for certifying whether significant financial interests exist and, as applicable, disclosing such potential conflicts of interest with their research. Third parties (e.g., faculty, department chairs and other administrative persons, representatives of pharmaceutical companies) may also report potential conflicts of interest. Such identifications may be made directly to the Conflicts of Interest Office (research_coi@uth.tmc.edu) or to the University Compliance Hotline.

E. Review Process

The RCOI Official or designee will review Research Conflict of Interest Certification Forms and Research Conflict of Interest Disclosure Forms to determine whether any disclosed significant financial interest is related to research in which the covered individual is engaged. A significant financial interest is related to research in which the covered individual is engaged if the RCOI Official or designee reasonably determines that the financial interest appears to be affected by the research or is in an entity whose financial interest appears to be affected by the research.

All significant financial interests related to research are referred to the RCOIC for review.  The RCOIC will determine whether a financial conflict of interest exists and, if so, will propose a management plan to manage, reduce or eliminate the financial conflict of interest, as described in (F) below. When there is a significant outside financial interest of the University related to research, the RCOIC will work with the Institutional Conflict of Interest Committee to manage the conflict (HOOP 221, Institutional Conflicts of Interest).

The RCOI Official makes the final determination regarding what actions are required to manage, reduce or eliminate conflicts of interest.  If the research involves human research subjects, appropriate information will also be made available to CPHS to consider in its review of the CPHS application as provided in (G) below.

F. Management Plans

A management plan may impose any condition and prescribe any action necessary to manage a financial conflict of interest, including an action reducing or eliminating the financial conflict of interest, to ensure to the extent possible that the design, conduct, or reporting of the research is free from bias or the appearance of bias. Examples of conditions or actions that may be prescribed include, but are not limited to:

• public disclosure of the conflict of interest in presentations and publications;
• for human subjects research, direct disclosure of the conflict of interest to research participants;
• appointment of an independent monitor with authority to take measures to protect the design, conduct, and reporting of research against bias, or the appearance of bias, resulting from the conflict of interest;
• modification of the research plan;
• change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
• divestiture or reduction of the financial interest; or
• severance of relationships that create an actual or potential financial conflict of interest.

The management plan must be in the form of a written agreement; must provide that the covered individual acknowledges receipt of the plan and understands the requirements of this policy and the required actions and other terms of the plan, including the time frames for required actions; and must clearly identify each specific person responsible for monitoring compliance with the management plan. Each person conducting research under a management plan shall comply fully and promptly with the plan, and each person identified in the management plan as having responsibility for monitoring compliance with the plan shall carefully and fully monitor that compliance.

If research is ongoing and a new covered individual discloses a significant financial interest related to that research or any other covered individual discloses a new significant financial interest related to that research, the RCOI Official shall, not later than the 60th day after the filing of the disclosure statement: (1) review the disclosure statement to determine if a financial conflict of interest exists; and (2) if a financial conflict of interest exists, implement an interim management plan or implement other interim measures to ensure the objectivity of the research.

Research continuation may be allowed in the face of a conflict depending upon (1) the nature of the science, (2) the specific financial interest, (3) the magnitude of the interest and the degree to which it is related to the research, and (4) the extent to which the interest is amenable to effective oversight and management.

The UT System Office of Innovation and Strategic Investment must be informed by September 30 of each year of University employees who own an interest or are employees, officers or members of the boards of directors in business entities with UT System agreements involving the research, development, licensing or commercialization of the employees' intellectual property.

The RCOIC will review existing management plans on an annual basis to ensure that conflicts continue to be managed appropriately.

G. Research Involving Human Participants

While the thresholds for disclosure are the same for all types of research, additional diligence in evaluation and management is required for research with potential risks to human subjects or with potential implications for medical care and the practice of medicine.  The RCOIC will carefully consider various factors, such as the degree to which the financial interest could affect the research, the degree to which the research could affect the financial interest, level of risk for human subjects, nature of the science involved, investigator expertise, institutional resources and access to particular patient populations, in deciding whether to allow an individual with financial conflict of interest to participate in the research (RCOIC Review Process Guidelines). While this policy is consistent with simultaneous review of a given research proposal by both RCOIC and CPHS, the RCOIC review process will be completed and the report forwarded to the CPHS before the protocol receives final review and approval. CPHS may request revision of the recommended management plan if it feels the conflict cannot be managed or the proposed plan is insufficient. These two committees will work together, and the RCOIC process should provide sufficient information to ensure that, as applicable, conflicts are managed and research participants are informed.

H. Noncompliance with Research Conflicts of Interest Policies

The University anticipates that covered individuals will comply fully and promptly with this policy. The RCOI Official is responsible for investigating instances of non-compliance and determining whether to impose sanctions and what sanctions will be applied. In making these determinations, he/she may consult with the applicable department chair, dean, RCOIC or other appropriate individuals.

Examples of non-compliance include, but are not limited to:

• failure to submit required statements or updates;
• failure to provide additional information requested by the RCOI Official or RCOIC;
• knowingly filing an incomplete, erroneous or misleading statement;
• failing to comply with conflict of interest management plans; or
• knowingly violating applicable laws or regulations.

If the RCOI Official learns of a significant financial interest that was not timely disclosed or reviewed, the RCOI Official shall, not later than the 60th day after learning of the interest: (1) determine whether the significant financial interest is a financial conflict of interest; and (2) if a financial conflict of interest exists, implement an interim management plan or implement other interim measures to ensure the objectivity of the research going forward.

In addition, if a financial conflict of interest was not timely identified or managed, or if a covered individual fails to comply with a management plan, the RCOI Official shall, not later than the 120th day after determining noncompliance:  1) complete and document a retrospective review and determination as to whether research conducted during the period of noncompliance was biased in the design, conduct or reporting of the research; and 2) implement any measures necessary regarding the covered individual’s participation in the research between the date that the noncompliance is identified and the date the retrospective review is completed. 

Failure on the part of a covered individual to comply with this policy may result in disciplinary action and/or sanctions. Examples of possible sanctions include formal reprimand; non-renewal of appointment; termination of appointment for good cause; and/or any other enforcement action mandated by the applicable government granting agency. A covered individual who is the subject of a disciplinary action may appeal such action in accordance with established University grievance and/or disciplinary procedures.

For a covered individual who is not an employee of the institution, compliance with this policy is a condition of participating with the institution in the capacity that qualifies the person as a covered individual.  The institution may require the individual to execute a document certifying that the individual knows that compliance with this policy is a condition of participation.

For PHS-covered research projects, the retrospective review shall cover key elements as specified by federal regulations and may result in updating the financial conflict of interest report, notifying the PHS, and submitting a mitigation report as required by federal regulations.

If the failure to comply has resulted in a bias of the design, conduct or reporting of research, the RCOI Official will take appropriate corrective actions and promptly notify the PHS Awarding Component of corrective actions to be taken.

If the U.S. Department of Health and Human Services (“HHS”) determines that clinical research funded by PHS to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by a covered individual with a financial conflict of interest that was not managed or reported by the institution as required by federal regulations, the institution will require the covered individual 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.

I. Reporting of Research Related Institutional Financial Interests

Significant University financial interests that result when the institution receives/will receive equity in or proceeds from entities that license its intellectual property are reported by the Office of Technology Management ("OTM") to the RCOI Official. Financial interests of institutional officials will be reported in accordance with HOOP 221, Institutional Conflicts of Interest. If these individuals have a significant financial interest in a company sponsoring University research, the interests are reported to the RCOI Official.

J. Reporting for PHS-Sponsored Projects

Federal regulations require that each application for funding to the PHS include specific certifications and agreements related to this policy and financial conflicts of interest.  Federal regulations also require that the institution file the reports required by this policy for PHS-funded research.

For PHS-sponsored projects, the RCOI Official must notify the PHS Awarding Component prior to expending any funds that a conflict of interest exists by submitting a financial conflict of interest report in compliance with 42 CFR Part 50, Subpart F, and 45 CFR Part 94, and must provide assurance the conflict is being managed, reduced or eliminated. The financial conflict of interest report will include information sufficient to enable the awarding component to understand the nature and extent of the financial conflict and to assess the appropriateness of the management plan related to the conflict of interest. The RCOI Official must file financial conflict of interest reports annually for the duration of the project period as required by federal regulation.

The institution must make information available to HHS or the PHS Awarding Component as required by federal regulation.  Reporting is not required for applications for Phase I support under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.

If conflicts are identified after the initial award is made, the RCOI Official must notify the PHS within 60 days of identifying the conflict by filing a financial conflict of interest report as required by federal regulation.

The RCOI Official must also promptly notify the PHS Awarding Component of corrective actions taken if an investigator has biased the PHS funded research.

K. Web Posting of Financial Conflict of Interest Information and Policy

For each covered individual for whom a financial conflict of interest is found to exist by the RCOI Official and who contributes to the scientific development or execution of the research project in a substantive, measurable way, the University will make information publicly available through a disclosure upon request within 5 business days. The information will include items specified on the following NIH Financial Conflict of Interest link. 

This policy and each update of this policy must be publicly accessible on the Internet.

L. Appeals Process

A covered individual may appeal to the EVP/CAO if he/she does not concur with the proposed plan for managing/eliminating research conflicts of interest, or if the research is not permitted to be conducted. A written appeal should be submitted within 30 calendar days of notice of the proposed management plan or denial and include evidence detailing the investigator's concerns which support his/her claim that the management plan should be revised and/or the research should go forward. The EVP/CAO or his or her designee will review the appeal and may request the review/advice of the RCOIC. In cases involving human subjects research, the EVP/CAO will also consult the CPHS.  It is, however, the responsibility of the EVP/CAO to approve, modify or reject any proposed revisions to the conflict of interest management plan. The decision of the EVP/CAO is final.

M. Contractors and Collaborators

If research is carried out in cooperation with or through a subcontractor, contractor, or collaborator, including a person identified under federal regulations as a “sub-recipient,” the University must enter into a written agreement with the contracting party that provides legally enforceable terms that establish whether this policy or the financial conflicts of interest policy of the contracting party applies to the researchers of the contracting party.

If the policy of the contracting party applies to its researchers, the contracting party must certify that its policy is consistent with the requirements of any applicable federal regulations.  If the contracting party cannot so certify, the agreement must state that the researchers are subject to this policy as covered individuals for disclosing significant financial interests that are directly related to the researcher’s work at the University.

If the policy of the contracting party applies to its researchers, the agreement must specify the time periods for the contracting party to report identified financial conflicts of interest to the University.  The time periods must be sufficient for the University to make any reports required by federal regulations.

If the policy of the University applies to the researchers of the contracting party, the agreement must specify the time periods for the researchers to submit a financial disclosure statement to the University.  The time periods must be sufficient for the University to comply with its review, management, and reporting obligations under federal regulations.

N. Records 

Records regarding the disclosure of financial interests and the management of a conflict of interest, including financial disclosure statements, a reviewing official's determinations, and other records of institutional actions, shall be retained in accordance with the University’s records retention schedule. 

The University will provide a centralized repository for financial disclosure statements, management plans, and related records.

O. Reviews

The University, through its Conflict of Interest Office will provide regular reviews, at least annually, of financial disclosure statements to determine individual and institutional compliance with this policy.

IV. CONTACTS

• • Office of the Executive Vice President & Chief Academic Officer - Conflicts of Interest Office
  • research_coi@uth.tmc.edu
  • https://inside.uth.edu/evpara/coi/index.htm

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