Policy Number: 94

Research Conflicts of Interest

Subject:

Financial interests of investigators or the university which might affect the design, conduct or reporting of research or compromise the protection of human subjects

Scope:

Members of the university community conducting research using public or private funding from any source.

Date Reviewed: August 2012

Responsible Office: Office of Academic and Research Affairs

Responsible Executive: Executive Vice President for Academic and Research Affairs

I.     POLICY AND GENERAL STATEMENT

The University of Texas Health Science Center at Houston ("university") is committed to ensuring that financial interests of investigators and the institution 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 Executive Vice President for Academic and Research Affairs ("EVPARA") to develop and implement plans to manage, reduce or eliminate conflicts of interest. The approval of The University of Texas ("UT") System Office of General Counsel and Executive Vice Chancellor for Health Affairs is also required for employees who are pursuing sponsored research agreements or licensing agreements for intellectual property with entities where they have equity or serve as a board member, officer or key employee.

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 Conflicts of Interest and Outside Activities.

This policy does not necessarily preclude the conduct of research where a conflict of interest, or potential conflict of interest, is present. Within the process, there may be situations where the research is allowed to proceed if it is of sufficient importance and appropriate safeguards are in place, and in the case of human subjects research there exists compelling circumstances warranting allowing the protocol to proceed.

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

II.     DEFINITIONS

Conflict of Interest Official:  The EVPARA shall perform the duties as the institution’s conflict of interest official required by this policy and other duties as assigned by the President. The EVPARA is responsible for overseeing implementation of this policy and may provide additional procedures and supplementary forms, as appropriate, consistent with this policy and applicable sponsor regulations.

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 fellows) meet the definition of being responsible for the design, conduct, or reporting of the research.

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 definitions 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 or by the individual and 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.

Institutional Officials Covered: 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, EVPARA, executive vice presidents, vice presidents, deans and department chairs.

Significant Financial Interests:

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.

In addition to the exceptions noted above, the term significant financial interests does not include:

The EVPARA 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 Institutional Financial Interests in Research: Include interests held by the institution and/or interests of institutional officials.

a. 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:

b. Institutional Officials: Significant financial interests in research for institutional officials utilize the threshold defined for covered individuals.

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.

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., IRB, AWC, DSMB, RCOI).

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

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.  

III.     PROCEDURE

A. Education

The 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 EVPARA is responsible for ensuring that appropriate faculty, staff, trainees, and other persons participate in training in regard 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. Research Conflicts of Interest Disclosure by Covered Individuals

A covered individual shall submit or update a financial interest disclosure statement that identifies all research projects in which the covered individual is engaged at the time of the disclosure. The disclosure statement will identify each significant financial interest of the individual and covered family member that reasonably appears to be related to the individual’s institutional responsibilities. The financial disclosure should be submitted according to the following schedule:

A covered individual who is planning to participate in a PHS-funded research project shall submit a financial interest disclosure statement not later than the time of application for PHS-funded research, except that an individual who is new to the institution and who is planning to participate in an on-going PHS-funded research project shall submit the statement not later than the 30th day of initial employment.

The President or the EVPARA may require a covered individual to submit additional disclosures.

If a covered individual discloses payments, intellectual property interests, or royalties, the covered individual must provide a copy of any related agreement, contract, offer letter, or other documentation upon request from the President, EVPARA, or any other person or entity with administrative responsibility for reviewing financial interest disclosure statements or approving a related management plan.

In making disclosures under this section, the covered individual shall:

 C. Investigator Research Conflicts of Interest Certification

All grants and research contracts submitted through the Office of Sponsored Projects ("OSP") and research requiring review by research support committees (Committee for the Protection of Human Subjects ("CPHS") and Animal Welfare Committee (“AWC”)) must include a completed Research Conflicts of Interest Certification for all key personnel responsible for the design, conduct or reporting of the proposed research. The principal investigator ("PI"), defined as 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 ensuring completion of the certifications.

Covered Individuals initiating research not reviewed by the CPHS or the AWC, and not requiring the review and approval of OSP, should disclose any potential research conflicts of interest directly to the EVPARA using the Research Conflict of Interest Disclosure form.

Investigators and/or related colleagues or staff who indicate potential conflicts in the Research Conflict of Interest Certification Form must complete a Research Conflict of Interest Disclosure Form. This disclosure must be submitted with the Certification to the OSP and forwarded to the EVPARA for review.

D. Third Party Identification of Potential Research Conflicts of Interest

Investigators 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 Office of the EVPARA (research@uth.tmc.edu) or to the University Compliance Hotline via email (compliance@uth.tmc.edu) or anonymously via phone (1-888-472-9868).

E. Review Process

The Research Conflict of Interest Committee ("RCOIC") will review each financial interest disclosure statement and make a determination of whether any significant financial interest disclosed 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 RCOIC 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.

If the RCOIC determines that the significant financial interest disclosed is related to research in which the covered individual is engaged, the RCOIC will determine whether a financial conflict of interest exists and propose a management plan to manage, reduce or eliminate the financial conflict of interest. A financial conflict of interest exists when the EVPARA agrees with the RCOIC determination that a significant financial interest could directly and significantly affect the design, conduct, or reporting of the research.

The EVPARA 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.

The approval of the UT System Office of General Counsel and Executive Vice Chancellor for Health Affairs is also required for employees who are pursuing sponsored research agreements or licensing agreements for intellectual property with entities where they have equity or serve as a board member, officer or key employee.

F. Management of Financial Conflicts of Interest

The EVPARA is responsible for overseeing the development and implementation of research conflict of interest management plans. He/she may delegate these oversight responsibilities to the RCOIC, but management plans developed by the RCOIC must be approved by the EVPARA prior to implementation.

While evaluation and management of the potential conflict is the goal, it is recognized that some conflicts may not be manageable. Nonetheless, when the investigator has a unique capability and must be involved with a critical research project to ensure its proper performance, it may be appropriate for the research to go forward with a well-defined and carefully monitored management plan.

Neither the institution nor a covered individual may expend research funds unless the EVPARA 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.

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:

The management plan must be in the form of a written agreement and 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 EVPARA 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.

In cases where sponsored research agreements or licensing agreements for intellectual property are made with an entity where an employee owns an interest or serves as an employee, officer or member of the Board of Directors, the plan must also be approved by the President, the UT System Office of General Counsel and the Executive Vice Chancellor for Health Affairs.  Elements required in the management plans are summarized in UT System's Procedure for Obtaining Approval of Plan to Manage Conflicts of Interest.

The UT System Technology Commercialization Office 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 exploitation 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 applies the rebuttable presumption standard when reviewing financial conflicts of interest in human subjects research, i.e., individuals with significant financial interests may not conduct the research unless there are compelling circumstances. Compelling circumstances include factors such as unique investigator expertise; unique institutional resources; unique access to particular patient populations; nature of the science involved; level of risk for human subjects; and degree to which financial interests and research are linked. 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 in conjunction with each other 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 investigators will comply fully and promptly with this policy. The EVPARA 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, the dean, the RCOIC or other appropriate individuals.

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

If the EVPARA learns of a significant financial interest that was not timely disclosed or was not timely reviewed, the EVPARA 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 EVPARA 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 an investigator 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. An investigator who is the subject of a disciplinary action may appeal such action in accordance with established university faculty 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 EVPARA will take appropriate corrective actions and promptly notify the PHS Awarding Component of corrective actions to be taken.

If the 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 developed when the institution receives equity in entities that license its intellectual property are reported by the Office of Technology Management ("OTM") to the EVPARA. Financial interests of institutional officials must be annually disclosed to the Executive Vice President, Chief Operating and Financial Officer in the Financial Disclosure and Conflict of Interest Report, with the exception of the President who discloses his financial interests through the Texas Ethics Commission. If these individuals have a significant financial interest in a company sponsoring university research, the interests are reported to the EVPARA.

Covered individuals also identify institutional financial interests related to their proposed research, if known, on the applicable Research Conflicts of Interest Disclosure form.

J. Reporting for PHS-Sponsored Projects

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

For PHS-sponsored projects, the EVPARA must notify the 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 EVPARA 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 EVPARA 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 EVPARA 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 EVPARA and who contributes to the scientific development or execution of the research project in a substantive, measureable way, including a covered individual who is the project director or principal investigator, the university will make information publicly available through a posting on the Internet. This posting will include:

The approximate dollar value of the significant financial interest shall be provided within the following ranges if it can be determined by reference to public prices or other reasonable measures of fair market value:

The institution will update the information required by this section annually.  In addition, for any financial conflict of interest of a covered individual whose information must be posted under this section and for which the information was not previously posted, the university will make the information required by this section available not later than the 60th day after the financial conflict of interest is identified.

The website on which the information is posted must note that the information is current as of the date listed and is subject to updates.

The information required by this section will remain available on the Internet for three years after its most recent update.

For project directors, principal investigators, and other senior or key personnel on PHS-funded research, this information must be available on the Internet before PHS funds are expended.

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

L. Appeals Process

An investigator may appeal to the EVPARA 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 days of notice of the proposed management plan or denial and include evidence detailing the investigator's concerns and/or compelling circumstances which support his/her claim that the management plan should be revised and/or the research should go forward. The EVPARA will review the appeal and may request the review/advice of the RCOIC. It is, however, the responsibility of the EVPARA to approve, modify or reject any proposed revisions to the conflict of interest management plan. The EVPARA may also appoint an external ad hoc group to provide an additional level of review in the appeal process and to report its findings and recommendations to the EVPARA. The decision of the EVPARA 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 interest 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 interest 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 interest disclosure statements, management plans, and related records.

The EVPARA, or another person designated by the president, shall provide the chancellor of UT System copies of all guidelines, procedures, and forms used by the university relating to financial conflicts of interest and shall ensure that the chancellor receives copies of any revised guidelines, procedures, and forms simultaneously with the implementation of the revision.

O. Audits

The university, through its Office(s) of Academic and Research Affairs and/or Institutional Compliance, will provide regular audits of financial interest disclosure statements to determine individual and institutional compliance with this policy.

IV.     CONTACTS

ContactTelephoneEmail/Web Address
Office of Academic and Research Affairs 713-500-3082

research@uth.tmc.edu

http://www.uthouston.edu/evpara/