Bylaws

Article I - Name

The name of this Committee shall be the “Texas Tech University Health Sciences Center El Paso Conflict of Interest in Research Committee (COIRC)” as stated in Texas Tech University Health Sciences Center El Paso Operating Policy (HSCEP OP) 73.09, Financial Conflicts of Interest in Research.

Article II – Charge

The charge of this Committee shall be to:

  1. Develop institutional policy for the review of Disclosures of Significant Financial Interests

  2. The committee is charged with reviewing Disclosures of Significant Financial Interests to determine the presence of a Financial Conflict of Interest (FCOI) as defined by HCSEP OP 73.09, the nature and magnitude of the conflict, the degree to which the conflict is related to the research, and the extent to which research might be affected by

  3. Advise the Institution/Investigators on regulations and policies involving Disclosures of Significant Financial Interests. If the committee determines that an FCOI exists, the COIRC will determine what, if any, immediate actions must be taken to protect the objectivity and integrity of the research while a final conflict management plan is being

  4. Determine the need to manage, reduce or eliminate the conflict before the expenditure of any funds or the enrollment of any research participants.

  5. Certify to granting agencies, as requested, that procedures, and practices for handling conflicts of interest have been  reviewed  and approved by the Committee, and certify that  the training and expertise of Investigators and Senior/Key Research Personnel is sufficient and appropriate;

  6. Work with Investigators and Senior/Key Research Personnel to develop appropriate Conflict Management Plans (CMP), and obtain and review annual reports regarding ongoing

  7. Periodic review of previously approved CMPs. Review reports from the  Scientific  Advisory Boards associated with active CMPs. Review ongoing CMPs  to  determine  whether they remain adequate to manage the FCOI; and,

  8. Make recommendations to the Vice President for Research (VPR) concerning any perceived or real conflicts of interest.

 

Article III – Members

Section 1.  The membership of this Committee shall consist of at least 5 voting members:

  1. Appointment will attempt to include representation by each School (Medicine, Nursing, and Graduate School of Biomedical Sciences) to serve on the COIRC.
  2. The VPR will appoint at least one additional member of the COIRC whom shall be a community representative with no family or financial ties to TTUHSCEP.
  3. Non-voting Ex-officio members shall include senior research administrators and compliance personnel from various university bodies.
  4. All COIRC members (including Ex-officio) are required to submit annual disclosures of significant financial interest and complete the institutional training as required in TTUHSCEP OP 09.
  5. Committee members should be individuals who have sufficient seniority, research expertise, and independence to evaluate competing interests at stake and make credible and effective All voting members of the COIC shall be independent of the direct line of institutional authority for research.
  6. Members will be appointed to a 2-year term and may be reappointed.

Section 2. The VPR or designee shall appoint the members of the Committee. Confirmation letters will be sent to each member. As deemed necessary throughout the year, the Committee may vote to nominate new members for appointment by the VPR.

Section 3. Each member’s annual term shall coincide with the institution’s fiscal year. If notice of resignation by the member or non-reappointment by the VPR is not given by August 1 of each year, each member’s appointment shall be automatically renewed on a year-to-year basis.

Section 4. Members with more than three (3) unexcused absences per year may be asked to resign from the Committee.

 

Article IV – Officers

Section 1. The officers of the Committee shall be a Chairperson and co-Chairperson. These officers shall perform the duties prescribed by these bylaws and by the parliamentary authority adopted by the Committee. In the event of a conflict of interest between the Chairpersons duties and their own research, the co-Chairperson shall assume the responsibility of review and decision making.

Section 2. The VPR shall appoint the Chairperson and co-Chairperson of the Committee. Unless notice is given to the Officers by the VPR or to the VPR by the Officers, these appointments shall be automatically renewed on a year-to-year basis.

 

Article V – Meetings

Section 1. Meetings will be held as needed, as determined by the COIRC Chairperson or designee.

Section 2. Quorum for this committee to conduct business is defined as fifty percent of members, plus one. A simple majority of voting members must be present for a quorum. This may include members present via teleconference. A quorum is not present when a sitting member who is present is required to recuse him/herself for any reason. If a quorum is lost at any time during the meeting, no further action shall be taken by the COIRC until a quorum is attained.

Section 3. An expedited meeting may be called by the Chairperson to review a new financial disclosure, and approval must be granted prior to the next scheduled COIRC meeting. All members are invited, and a minimum of four members is required to review the financial disclosure. Action is approved by majority vote. Business conducted at an expedited meeting is reported to the full committee at the next scheduled meeting.

Section 4. Special meetings may be called by the Chairperson and may also be requested by any member of the Committee. The purpose of the meeting must be stated in the notice.  Except in cases of emergency, at least three days’ notice shall be given.  For purposes of taking action, a quorum of members is required. Standard meeting minutes will be recorded for business conducted at the special meetings.

Section 5. Written minutes of each convened meetings will be in sufficient detail to demonstrate the following: Attendance at meetings and presence of quorum; actions taken by the COIRC, the vote on these actions including number of members voting for, against, or abstaining; notation of members who were not present during deliberations and voting due to a conflict of interest; major points of discussion of research related issues and their resolution. Meeting minutes and materials shall be maintained for a minimum of 3 years after the meeting date.

 

Article VI - Determination of conflict

Section 1. The initial determination of whether a reported significant financial interest is related to the proposed research project will be made by the Chairperson (or designee) of the COIRC. If the Chairperson (or designee) determines that there is no related financial conflict of interest or there is a related financial conflict of interest that has been sufficiently managed, then no further action is required.  If the Chairperson (or designee) determines that a real or potential financial conflict of interest possibly exists, then the matter will be referred to the full COIRC for further review.

Section 2. For matters referred to the full COIRC, a determination that a financial conflict of interest exists will be made via a majority (rather than plurality) vote. For a financial conflict of interest to exist the significant financial interest must be both related to the proposed research and could directly and significantly affect the design, conduct, or reporting of the proposed research.

Section 3. The minutes of each COIRC meeting will reflect the vote of each voting member while maintaining the anonymity of the voting member via a numbering system, e.g., Member 1, Member 2, etc. The possible actions that may be taken by the COIRC are:

  1. Determination that a financial conflict of interest exists (see Article VII).
  2. Determination that no financial conflict of interest
  3. Additional information is required, full committee review not required: Upon receipt and review of the additional information, a determination will be made solely by the Chair (or designee).
  4. Additional information is required, full committee review required: Upon receipt of the additional information, the Chairperson (or designee) will share the new information with the COIRC at an expedited meeting or the next scheduled meeting after which a vote will be
  5. Unable to reach a decision due to a lack of a majority. In this situation the Vice President for Research (or designee) will appoint a temporary voting member(s) to the
  6. Action taken by or reply made by the Investigator or Senior/Key Personnel is acknowledged by the COIRC, and no further action is required by the COIRC.

Section 4. The COIRC or designated member may request additional information of a researcher as part of the assessment of a research financial disclosure. The request may refer to clarification of statements made in the disclosure or a request to provide supporting documentation of the claims made therein, these notices are sent electronically with a response deadline. The COIRC may request that the respondent meet with the committee or a subcommittee in person to discuss the requested material in certain cases.

 

Article VII – Financial Conflict of Interest Management Plan/Conflict Management Plan (CMP)

Section 1. If the COIRC finds that an FCOI exists, then the individual in question will be asked to divest of the significant financial interest.  If the individual is unable to or unwilling to divest of the significant financial interest then a CMP will be developed.

Section 2.  The CMP must include:

  1. A description of the compelling circumstances that justify participation of the conflicted investigator in the proposed research project.
  2. A list of actions that will be taken to manage, reduce, or eliminate the

 

Section 3. The CMP must be reviewed and approved by the COIRC (a secure review and vote by e-mail is permissible) prior to the expenditure of any funds.

Section 4. If the proposed research project involves human subjects or animals, then the TTUHSC EP Institutional Review Board for the Protection of Human Subjects or Institutional Animal Care and Use Committee, whichever is applicable, must also approve the CMP prior to the enrollment of human subjects in the project or research involving animals.

Section 5. Examples of conditions that may be imposed to manage an FCOI include, but are not limited to:

  1. Public disclosure of an FCOI when presenting or publishing the results of the
  2. For projects involving human subjects, disclosure of an FCOI to the
  3. Appointment of an independent monitor who is capable of taking measures to protect the design, conduct, and reporting of the research from bias caused by the
  4. Modification of the research protocol/plan.
  5. Change of personnel or the responsibilities of personnel, or disqualifying personnel from participating in all or a portion of the proposed
  6. Reduction or elimination of the significant financial interest, e.g., via the sale of an equity
  7. Severance of relationships that create financial conflicts.

Section 6. CMPs will be monitored by the COIRC. Conflicted investigators or senior/key personnel who have ongoing CMPs will provide a written report regarding action taken under the CMP at intervals indicated by the COIRC. Reports shall be submitted to the COIRC chairperson or designee. 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 written summary to the COIRC at the next convened meeting. The COIRC may choose to review the report in its entirety. Additional information regarding audits and breaches of CMPs can be found in HSCEP OP 73.09.

Section 7. A conflict of interest determination by the COIRC and CMP may be appealed to the Vice President for Research within thirty (30) days of the date the COIRC notifies the faculty, staff, or student of the COIRC’s decision. The decision of the Vice President for Research shall be final.

 

Article VIII - Noncompliance

Section 1: An Investigator or Senior/Key Personnel who fails to provide information that has been requested by the COIRC or VPR regarding a disclosure in a timely manner will be considered to be in breach of HSCEP OP 73.09. The possible consequences of the breach are detailed in section 6 (Noncompliance) of HSCEP OP 73.09.

 

Article IX– Relationship to other TTUHSCEP Compliance Committees

The TTUHSCEP Conflict of Interest in Research Committee functions independently of, but in coordination with other TTUHSCEP Research and Safety compliance Committees, including, but not necessarily limited to the following:

  • Radiation Safety Committee (RSC)
  • Institutional Review Board (IRB)
  • Institutional Biosafety Committee (IBC)
  • Institutional Animal Care and Use Committee (IACUC)
  • Non-Research Conflict of Interest Committee (NRCOIC)
  • Texas Tech University Systems Office of Research Commercialization (TTUSORC)

Subcommittees of the COIRC may be appointed by the COIRC Chairperson as deemed necessary to perform the work of the Committee. The Chairperson shall be an Ex-officio member of any such sub-committees.

 

Article X – Review and Approval of Bylaws

These bylaws shall be reviewed at least annually by the Chairperson of the Committee, the COIRC Lead Analyst, Senior Director and Managing Director of the Office of Research Resources. Proposed amendments to these bylaws will be presented to the full Committee for review and comment. The COIRC Chairperson has authority to provide final approval of the Bylaws.

Article XI – Confidentiality of Records

The TTUHSCEP Conflict of Interest in Research Committee is a “medical committee” as defined under Texas Health & Safety Code chapter 161, and/or other applicable state and federal statutes. All documents generated by, submitted to, or for the purposes of fulfilling COIRC committee duties are considered confidential and privileged as “medical committee documents.”