Conflict of Interest in Research Committee (COIRC)
The TTUHSC Conflict of Interest in Research Committee (COIRC) has been established by the SVPRI to review Disclosures of Significant Financial Interests to determine whether a conflict of interest exists, and if so, the nature and magnitude of the conflict, the degree to which the conflict is related to the research, and the extent to which the interest could be directly and substantially affected by the research.
The COIRC is also charged with periodic review of previously approved Conflict Management Plans (CMPs). The committee will work with Investigators and Key Study Personnel to develop appropriate CMPs, provide copies of the CMPs to appropriate review committees and administrators, and will obtain and review annual reports regarding ongoing CMPs.
COIRC Overview
- Disclosure Submission: All Principle Investigators (PI) and Key Study Personnel (KSP) who are involved in
the design, conduct, and/or reporting of Human Subject Research are required to submit
a disclosure in TTUHSC's electronic platform BEFORE any research can be initiated.
Disclosures are required to be submitted at least annually, AND updated within thirty (30) days of a change in significant financial interests. - Disclosure Review: Once a disclosure is received, the COIRC Administrator conducts a preliminary review to verify if there are any probable conflicts disclosed. If an actual, potential, or perceived financial conflict of interest (FCOI) is identified that has not been previously managed, the COIRC Administrator (along with the COIRC Chair) will determine the need to manage, reduce, or eliminate the conflict before the expenditure of any funds or the enrollment of any research participants.
- Committee Review: If Committee Review is deemed necessary, the convened COIRC shall review and (where necessary) investigate the information in the completed disclosure form, as well as a summary of the proposed project(s) to make a determination as to whether any significant financial interest is related to any ongoing project. Relatedness involves a determination that the significant financial interest could be affected by the research or is in an entity whose financial interest could be affected by the research. A determination that a financial conflict of interest exists will be made when the COIRC reasonably determines that the significant financial interest is both related and could directly and significantly affect the design, conduct, or reporting of the proposed research.
- Determination of Conflict: If the COIRC makes a determination that an actual FCOI does exist, the COIRC shall
work with the PI/KSP to determine a method for managing the conflict. If the PI/KSP
is unwilling or unable to divest of the significant financial interest creating the
conflict, a written Conflict of Interest Management Plan (CMP) must be developed.
The plan will include a description of the compelling circumstances that justify the
participation of the conflicted investigator(s) in the project, as well as appropriate
restriction(s) that will be taken to mitigate potential effects of the conflict on
the research. The CMP must be reviewed and approved by the COIRC prior to the expenditure
of any funds for sponsored projects.
If the proposed research involves human subjects, the TTUHSC IRB reviewing the project must also approve the Conflict Management Plan prior to enrollment of any human subjects in the research. - Monitoring of CMPs: Investigators or Senior/Key Personnel who have ongoing CMPs shall provide annual (or at any time upon request from the COIRC) written reports regarding action taken under the CMP. Reports shall be submitted to the COIRC Chairperson or designee. Annual reports shall be submitted on or before the anniversary date that the CMP was approved by the COIRC. The Chairperson will review the reports and provide a summary to the COIRC at the next convened meeting. The COIRC may choose to review the report in its entirety. These written reports will be required until the completion of the project for which the conflict was identified.
- Audits of CMPs: The SVPRI or COIRC may also request interim compliance audits of the monitoring plans be conducted by the Research Integrity Office or the TTU System Office of Audit Services. These audits may be requested either for cause or on a routine basis.
The existence of an actual or potential conflict of interest does not imply wrongdoing. Activities can often continue when conflicts are managed. If the COIRC determines that the conflict is capable of management, a written plan is implemented (CMP). The purpose of the plan is to:
- Accurately describe the potential conflicts in writing
- Create explicit agreements to protect against actual conflicts
- Facilitate oversight
A plan manager is assigned to monitor the plan and ensure that safeguards are followed.
Managers review plans with employees annually to cover the upcoming fiscal year.
Plans are updated as circumstances change, and the annual reviews continue until the
conflict no longer exists.
Management plans offer protection to both employees and the institution because they demonstrate a commitment to TTUHSC, integrity, transparency, and a mechanism for monitoring.
Click HERE to see a sample Conflict Management Plan (CMP).
Conflict of Interest in Research Committee
- Frequency: The committee will meet as needed when there is business to conduct.
- Quorum: A quorum of at least half of the voting members will be required to conduct official business. While every effort will be made to reach consensus, decisions will be by majority vote. A quorum may include members present via teleconference.
- The COIRC shall consist of at least seven voting members.
- The Dean of each School (Medicine, Nursing, Health Professions, Pharmacy, DPH, and Graduate School of Biomedical Sciences) shall appoint at least one faculty member from that School to serve on the COIRC.
- The SVPRI will appoint two additional members of the COIRC. At least one member shall be a community representative with no family or direct financial ties to TTUHSC.
- Non-voting Ex-officio members shall include the Assistant Vice President for Research integrity, the Director of the Office of Sponsored Programs, and a representative of the TTU System Office of General Counsel.
- All voting members of the COIRC shall be independent of the direct line of institutional authority for research.
Members with a Conflict: COIRC members shall not participate in reviews, deliberations or decisions in which the member has an actual or perceived conflict of interest as determined by the COIRC or the member him/herself.
VOTING MEMBERS:
- Phil Sizer, PhD (Chair)
TTUHSC Research Integrity Office, Lubbock - VACANT - TBD (Co-Chair)
- Ulrich Bickel, MD
TTUHSC School of Pharmacy, Amarillo - Sonya Castro, MBA
TTUHSC Office of Institutional Compliance, Lubbock - VACANT - TBD
TTUHSC School of Nursing, Lubbock - Marianne Evola, PhD
TTU Office of Research and Innovation, Lubbock - Lan Guan, MD, PhD
TTUHSC Cell Physiology Molecular Biophysics, Lubbock - Courtney Queen, PhD
TTUHSC Department of Public Health, Abilene - Surendra Varma, MD
TTUHSC SOM Pediatrics, Lubbock - Steven Zupancic, PhD
TTUHSC School of Health Professions-SLHS, Lubbock
EX-OFFICIO MEMBERS:
- Kristyn Sorensen, JD, PhD
TTUHSC Research Integrity Office, Lubbock - Erin Woods, MRA, CRA
TTUHSC Office of Sponsored Programs, Lubbock - Sara Gray, BBA, JD
TTU General Counsel, Lubbock