Researcher Conflicts of Interest in Research UPPS No. 02.02.07
and Sponsored Program Activities Issue No. 2
Effective Date: 09/12/2011
Review: October 1 E3Y
01. POLICY STATEMENTS
01.01 In order to comply with all applicable federal and state regulations and maintain the integrity of its research mission with the highest legal, ethical and moral standards, Texas State University-San Marcos has established this policy relating to conflicts of interest (COI) in all research, funded or unfunded, and in all sponsored programs regardless of the funding source. The university has developed administrative procedures for identification, disclosure, review, and mitigation or management of such COI. As these policies and related procedures support and facilitate research achievements, researchers must become familiar with and abide by them.
01.02 Expansion of the research mission is a critical priority as Texas State moves into the future. Promoting public good by fostering the transfer of knowledge gained through research to the private sector is vital to this mission.
01.03 Texas State is an institution of public trust. Researchers (see Section 03. Definitions) must respect that status and conduct their affairs in ways that will not compromise the integrity of the university or impede its mission of research. It is the policy of Texas State that its researchers conduct the affairs of the university in accordance with the highest legal, ethical and moral standards. Serious challenges arise when actions made during a researcher’s university activities are determined by personal gain. Such behavior calls into question the professional objectivity and ethics of the individual, threatens the objectivity of scientific research, and reflects negatively on the university.
01.04 In addition to traditional externally sponsored programs (see Section 03. Definitions), researchers may be involved in the commercialization of technologies derived from their research, in university-originated startup companies, and other entrepreneurial activities related to research. It is often appropriate to reward faculty for participation in these activities through consulting fees, royalty sharing from the commercialization of their work, or other non-financial rewards or benefits. COI (see Section 03. Definitions) are common and often unavoidable in this modern research environment.
01.05 The federal government has established minimum standards for grantees' COI policies and has required compliance from principal investigators, key personnel, and institutional representatives (see Section 03. Definitions). For example, the National Science Foundation (NSF Award and Administration Guide 08-1 January 2008 Chapter IV – Grantee Standards) and Public Health Service, Department of Health and Human Services (42 C.F.R Part 50, Subpart F and 45 C.F.R. Part 94, Subpart A) have established requirements.
01.06 This policy and resulting administrative procedures are additionally bound to compliance with the Texas Education Code 51.912, The Texas State University System Rules and Regulations, Chapter III sections 12(16)-12(18),Texas State UPPS No. 04.04.06, Additional State Employment and Outside Employment and Activities, UPPS No. 01.04.02, Ethics Policy, UPPS No. 04.04.07, Nepotism and Related Employment, and UPPS No. 02.02.08, Conflicts of Commitment in Research and Sponsored Program Activities.
02. SCOPE OF POLICY
02.01 This policy applies to all research, funded or unfunded, as well as all sponsored programs, regardless of the activity’s funding source or location.
02.02 This policy is applicable to all Texas State researchers or anyone else conducting research for or on behalf of Texas State. The university defines “researcher” broadly to include any other person not listed in the definition but specified by a Texas State department chair or dean.
02.03 Researchers must disclose all significant financial interests (see Section 03. Definitions) via a Financial Interest Disclosure (see Section 03. Definitions) form, available on the Office of Research Compliance Web site.
Filing a Financial Interest Disclosure is mandatory for researchers initiating any sponsored program research activity regardless of the source of funding.
Filing a Financial Interest Disclosure may be required of researchers conducting any other research activity, unfunded or funded, if deemed necessary by the institutional official (see Section 03. Definitions).
02.04 Each person completing a Financial Interest Disclosure must list:
a. all his or her significant financial interests and those of his or her immediate family (see Section 03. Definitions); and
b. all his or her interests in or affiliation with any financially interested company (see Section 03. Definitions), including those of his or her family members as defined in UPPS No. 04.04.07, Nepotism and Related Employment.
02.05 Researchers must update this Financial Interest Disclosure, at a minimum, annually and within 30 days as new reportable significant financial interests are obtained or identified.
When sponsored program activity, regardless of the source of funding, is initiated, all principal researchers or key personnel (see Section 03. Definitions) on the proposal, contract, or agreement will be required to have an up-to-date Financial Interest Disclosure for the current calendar year on file in the Office of Research Compliance (ORC), before submitting a proposal, signing a contract, or finalizing any agreement. When routing the proposal, contract, or other agreement for approval, the principal researcher must certify that every researcher named on the proposal has filed an up-to-date Financial Interest Disclosure for the current calendar year with the ORC.
02.06 This policy does not apply directly to conflicts of commitment, situations involving researcher participation in activities external to, and in addition to, their commitment to Texas State. UPPS No. 02.02.08, Conflicts of Commitment in Research and Sponsored Program Activities addresses these situations.
03.01 Chief Research Officer: An individual ultimately responsible for the oversight of funded and unfunded research and sponsored programs at Texas State. At Texas State, the chief research officer is the associate vice president for Research (AVPR). The AVPR makes the final decision on resolution, mitigation, or management of all COI.
03.02 Conflict of Interest (COI): A potential or actual COI exists when commitments, professional judgment, obligations to Texas State or to widely recognized professional norms are compromised by a researcher’s other interests or commitments (or those of a member of their immediate family), especially economic, particularly if the researcher does not disclose those interests or commitments. Federal regulations provide that a conflict of interest exists if a significant financial interest could “directly and significantly affect the design, conduct, or reporting” of federally-funded research activities.
03.03 Conflict of Interest Review Committee (CIRC): Committee appointed by the institutional official to review Financial Interest Disclosures and make recommendations regarding management or mitigation of potential or actual COI pertaining to a researcher's engagement in funded or unfunded research or other sponsored program activity.
The CIRC may ask other Texas State faculty, staff, or university administration, as non-voting members, to attend meetings to provide guidance or expertise in a particular subject area. No individual may participate in any review procedures related to a researcher in their own department, college, or administrative unit.
03.04 Financial Interest Disclosure: A document describing:
a. All significant financial interests of the researcher and immediate family that the funded or unfunded research or sponsored program activities affect or reasonably appear to affect; or
b. All significant relationships of the researcher and immediate family to entities whose financial interests are or would reasonably appear as directly and significantly affected by or related to such activities.
03.05 Financially-Interested Company: A commercial or non-profit entity with financial interests that would reasonably appear as affected by the conduct or outcome to Texas State research or sponsored program activities. This includes any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint stock company ownership, receivership, business or real estate trust, or any other legal entity organized for profit or non-profit purposes. This term includes companies that compete with the research sponsor or the manufacturer of the investigational product if the covered individual knows or should know that the financial interests of such a company would reasonably appear affected by the research or business at Texas State. This term also includes any entity acting as the agent of a financially- interested company (e. g., a contract research organization).
03.06 Immediate Family: The researcher, their spouse, and dependent children.
03.07 Intellectual Property: Property, including copyrightable works, ideas, discoveries, and inventions protected under federal law.
03.08 Institutional Official (IO): An individual with the legal authority to act and speak for the institution and who is responsible for ensuring that Texas State will effectively fulfill its oversight function in ensuring objectivity in funded and unfunded research and sponsored programs. At Texas State, the IO is the assistant vice president for Research.
03.09 Management Plan: A plan created on a case-by-case basis with conditions or limitations that will contribute to the elimination, reduction, or management of an actual or potential COI.
03.10 The National Science Foundation (NSF): A federal government funding organization that has established minimum standards for grantees' COI policies and has required compliance from principal investigators, key personnel, and institutional representatives (NSF Award and Administration Guide 08-1 January 2008 Chapter IV – Grantee Standards).
03.11 Public Health Service (PHS): An operating division of the U. S. Department of Health and Human Services, and any components of the PHS to which it may have delegated authority. The PHS has established minimum standards for grantees' COI policies and has required compliance from principal investigators, key personnel, and institutional representatives. (42 C.F.R Part 50, Subpart F and 45 C.F.R. Part 94, Subpart A).
03.13 Researcher: All individuals who are engaged in research, whether funded or unfunded, or in sponsored program activities. The term researchers includes to the principal (lead) investigators (PI), project directors (PD), co-investigators, key personnel, assistant directors, sub-grantees, contractors, collaborators, post doctoral scholars, graduate assistants, and any other individuals having direct responsibility for the design, conduct or reporting of funded or unfunded research or other sponsored program activities funded or proposed for funding by the federal government or other external funder.
03.14 Significant Financial Interests: Anything of monetary value, salary or other payments for services (e. g., consulting fees or honoraria), equity interests (e. g., stocks, stock options or other ownership interests), gifts, and intellectual property rights (e. g., patents, copyrights and royalties from such rights) if the value of such interests: 1) exceeds $5,000 per annum of salary, fees, and other continuing payments; or 2) represents more than a five percent (5%) ownership interest in any one enterprise or entity when aggregated for the investigator and the investigator's spouse and dependent children.
Significant financial interest does NOT include: income from seminars, lectures, or teaching, and service on advisory committees or review panels for government agencies or institutions of higher education.
After review, the CIRC will determine from this definition, other exclusions on a case-by-case basis.
03.15 Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR): The extramural research program for small business established by the awarding components of the PHS and other federal agencies under the Small Business Innovation Development Act. The term SBIR program includes the STTR program.
03.16 Sponsor: Source outside of Texas State providing funds, materials, or other compensation under a grant, contract or other agreement.
03.17 Sponsored Programs: All extramurally funded activities, including research, training, instruction or public service projects involving funds, materials, or other compensation from sources (sponsors) outside of Texas State, under a grant, contract or other agreement that meets any of the following conditions:
a. Texas State is bound to a line of scholarly or scientific inquiry specified to a substantial level of detail. A plan, the stipulation of requirements for orderly testing or validation of particular approaches, or the designation of performance targets may indicate such specificity;
b. The sponsor requires, or the proposal submitted for consideration, contains a line-item budget or 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 the sponsor requires financial or programmatic reports;
c. The sponsor requires that the services performed, the funds awarded, or the materials supplied under the agreement are subject to internal or external audit; or
d. 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, z, or inventions) properties that may result from activities covered by the agreement separately.
04.01 The assistant vice president of Research, as the IO, is responsible for ensuring that all COI are reduced or eliminated prior to research, whether funded or unfunded, as well as prior to sponsored program activities being performed or prior to the expenditure of funds.
04.02 It is the responsibility of each researcher who is planning to participate in funded or unfunded research or in sponsored program activities to ensure that a current Financial Interest Disclosure is on file when a project proposal is initiated, is being routed for review and approval, and when new researchers join the project.
04.03 When submitting a proposal to a potential sponsor, the Office of Sponsored Programs (OSP) must verify that current Financial Interest Disclosures are on file in the ORC for all researchers, prior to proposal submission and for maintaining the proposal records until the sponsor takes action on the request for funds.
04.04 It is the responsibility of the director of ORC to review each Financial Interest Disclosure and convene the CIRC when a full review is necessary. If a management plan is required, the director of ORC will advise OSP and the researcher. Work on a funded proposal cannot begin nor can a sponsored program account be set up, until the perceived or potential COI has been resolved.
05. CONFLICT OF INTEREST REVIEW COMMITTEE PROCEDURES
05.01 The CIRC reviews information related to all financial and fiduciary arrangements in light of related funded or unfunded research or sponsored program activity and makes recommendations to the IO for dealing with the actual or potential COI.
05.02 In its review, the CIRC examines the financial and other potential COI and considers the risks the proposed activity poses to the integrity of the research or sponsored program activity; to the rights and obligations of collaborators and students participating in the research or sponsored program activity; to the rights and safety of human research subjects; and to the academic, research and educational missions of the university. The CIRC also considers the impact on the availability of research results to the scientific community and on the integrity of research results. The appearance of COI also is an important factor in the review process.
05.03 The CIRC meets as often as necessary to ensure a timely review of the Financial Interest Disclosures and to ensure that funded or unfunded research, as well as sponsored program activities, is not unduly inconvenienced. Understanding that some situations arise quickly and the usual review process might cause problematic delays, the IO may make an interim decision pending CIRC’s full review of it at its next meeting.
05.04 The CIRC reviews grants, contracts and other agreements of a researcher who may have possible or perceived COI. In grants, contracts, and other agreements, including faculty consulting agreements or contracts, the CIRC 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, CIRC requires that the ORC receive certification of all Financial Interest Disclosures reviewed by collaborating institutions or corporations for any person considered to be playing a key role on subcontracts or sub-agreements that Texas State may enter into.
05.05 Financial interests involving the use of human subjects in research require additional scrutiny by the CIRC because they may present real or perceived risks to the welfare and rights of human subjects, in addition to presenting risks to research integrity. Texas State researchers are required to report all financial interests related to any human subject research they plan to conduct. Whenever there is more than “minimal risk” to human subjects, it is presumed that individuals (faculty, staff, students, administrators and researchers) may not participate in research projects involving human subjects while they have a significant financial interest in the research project or in a financially interested company. In specific cases, the CIRC may, with the concurrence of the Institutional Review Board (IRB) and IO approval, grant an exception when individuals with a significant financial interest provide a compelling justification for simultaneously holding the financial interest and participating in the human subject research project.
05.06 The IRB is the designated authority for the oversight of human subjects in research at Texas State. The CIRC and IRB will review all management plans that involve research with human subjects. The IRB is the primary authority at Texas State for ensuring that the plans involving research on human subjects comply with federal regulations, university policies and ethical principles. The IRB may require additional provisions which may exceed those recommended by the CIRC to ensure protection of human subjects.
05.07 SBIR and STTR programs are available for domestic small business concerns to engage in research/research development (R/R&D) that has the potential for commercialization. Some of the stipulations in these programs may create actual or potential COI for researchers. Texas State requires that all researchers submitting proposals for SBIR/STTR funding complete a Financial Interest Disclosure regardless of the value of their financial interests. The processing of these SBIR/STTR-related disclosures will follow the same procedures as all other Financial Interest Disclosures, and if deemed necessary by the IO, may include review by the CIRC and creation of a management plan.
05.08 Upon completing its review, the CIRC will issue a report that will detail its findings and will recommend to the IO how the COI should be resolved. The IO will review the report and issue an electronic copy of the report to the researcher. If the researcher wishes to respond to the report, he or she has ten working days following the email’s transmittal to submit a response to the IO, who will submit the report plus the researcher’s response to the AVPR, who will determine what action will resolve the conflict.
05.09 For COI involving human subjects, the CIRC will confer with the IRB prior to issuing its report. The IRB will instruct the CIRC as to what action to include in the report to insure compliance with IRB regulations. The IRB actions shall become a separate section in the CIRC report.
05.10 The CIRC may recommend implementation of COI management using, for example, one or more of the following:
a. Disclosure: Typically required in every case including:
1) public disclosure of the financial interests of the researcher and of Texas State, 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,
2) disclosure to the appropriate co-investigators, members of the laboratory or research group, and students or trainees, and
3) disclosure on human subject consent forms;
b. Restriction on Equity: The CIRC may restrict the placement of stock in escrow until a CIRC-specified time or forbid exercise of options, warrants and similar instruments without prior approval;
c. Limiting the Role of the Researcher with a Financial Interest: Examples of such limits include that the researcher may not serve as principal investigator, analyze data or results, or solicit consent from human research subjects;
d. Oversight: Appointment of a disinterested individual or group to monitor the relevant research or sponsored activity. An oversight committee may insure 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 AVPR will appoint the individual or group monitoring the activity, with the report going to the AVPR.
e. Divestiture: The sale or disposal of specified financial interests to eliminate or reduce the financial COI by a certain date;
f. 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.
05.11 The CIRC 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 conflict.
06. MANAGEMENT PLANS
06.01 The AVPR, after reviewing the CIRC’s recommendations, will decide what actions will resolve the COI. The AVPR, through the IO, can request that the CIRC outline a management plan in accordance with federal, state and Texas State regulations. When creating any management plans, the CIRC will consult with the researcher.
06.02 The IO must approve the final management plan, after which the CIRC will obtain the researchers’ signatures and forward the management plan to The Texas State University System (TSUS) Office for review. A compliance assessment may require internal audit or further review during the covered project period.
07. PROCEDURES FOR GRADUATE STUDENTS AND POSTDOCTORAL SCHOLARS
07.01 Graduate students and postdoctoral scholars may not associate with companies in which their advisor or faculty mentor has a significant financial interest. Involvement means they may not work for the company, undertake training in the company, or do their dissertation research in the company.
07.02 Graduate students and postdoctoral scholars may undertake educationally-related research activities at companies as long as:
a. their faculty advisor does not have a significant financial interest in the company;
b. the company places no confidentiality or non-disclosure restrictions on the student and permits the student to freely discuss and publish the results of work without delays; and
c. any company patent agreement the student is required to sign is reviewed and approved by the university.
*07.03 Graduate student participation in on-campus industry-sponsored research is encouraged as long as:
a. the participation furthers the student's educational program; and
b. the student's faculty advisor and the researcher directing the project do not have a significant financial interest in the company sponsoring the campus research project.
*07.04 Postdoctoral scholars may participate in on-campus industry-sponsored research provided that:
a. the participation furthers their professional and academic program; and
b. if the faculty member or researcher directing the project has significant financial interest in the company, there is a monitoring plan in place which has been approved by the AVPR and chief research officer.
07.05 Researchers must not allow outside activities or interests to prevent them from meeting their responsibilities to students as teachers, mentors, or supervisors of research.
08. DISSEMINATION PROCEDURES
08.01 This policy is made available to all faculty, staff, students, and all entities interested in collaborating with such, in funded or unfunded research as well as sponsored program activities. Periodic notices sent to faculty, staff and students about the university's sponsored program administration will include information about the procedures and responsibilities and will refer individuals to designated offices or officials for additional information.
08.02 ORC, in collaboration with the OSP, is responsible for disseminating information on the duty to submit timely, accurate and complete Financial Interest Disclosures.
08.03 Education and training will be provided as necessary to researchers regarding this policy and any conduct that could constitute a violation of this policy. Information, updates, and tutorials will be available on the ORC website.
08.04 ORC, in collaboration with the OSP, will maintain 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 years beyond the termination or completion of the research or award;
b. for as long as is required under federal or state law;
c. for as long as is required by any agreement covering unfunded or funded research or a sponsored program activity; or
d. until resolution of any action by a granting agency or sponsor involving the records, whichever is longer.
09.01 Texas State requires that all researchers will comply fully, truthfully and in a timely manner with this policy. Instances of deliberate breach, including failure to submit required Financial Interest Disclosures, statements or updates thereof; failure to provide additional information requested by the CIRC or the IO; knowingly filing an incomplete, erroneous or misleading disclosure; knowingly violating applicable laws, TSUS regulations or this policy; or failure to comply with prescribed conditions or restrictions that have been imposed pursuant to this policy, will subject the researcher to disciplinary action under policies of Texas State and TSUS, 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.
09.02 If the failure of a researcher to comply with this policy has biased the design, conduct or reporting of funded or unfunded research or sponsored programs activities, Texas State will promptly notify the appropriate granting agency, sponsor, or other appropriate agency of the incident and corrective action will be taken.
10. REQUIRED CHANGES
10.01 The policy and procedures set forth in this document will change as required by future changes in federal, state, TSUS, or university regulations.
11. REVIEWERS OF THIS UPPS
11.01 Reviewers of this UPPS include the following:
Assistant Vice President for Research Oct 1 E3Y
and Federal Relations
Director, Office of Research Oct 1 E3Y
Contract and IP Specialist, Office of Oct 1 E3Y
12. CERTIFICATION STATEMENT
This UPPS has been approved by the following individuals in their official capacities and represents Texas State policy and procedure from the date of this document until superseded.
Assistant Vice President for Research and Federal Relations; senior reviewer of this UPPS
Associate Vice President for Research and Director of Federal Relations
Provost and Vice President for Academic Affairs