Article I - Name
The name of this Committee shall be the “Texas Tech University Health Sciences Center El Paso Institutional Review Board (TTUHSC El Paso IRB)”.
Article II – Charge
The charge of this Committee shall be to:
- Develop institutional policy to protect and promote the rights and welfare of those who serve as participants in biomedical or behavioral research projects ;
- Advise the Institution/Investigators on regulations and policies involving human subjects in research;
- Develop recognized standard and ethical procedures for research with human subjects;
- Review any protocols submitted to the IRB;
- Approve, require modifications to secure approval, or disapprove all human research overseen and conducted by TTUHSC El Paso faculty and staff.
- Certify that applicable regulations governing research involving human subjects, such as the Common Rule, Food and Drug Administration related to human subjects, and ethical standard founds in the Belmont Report, are being adhered to;
- Supervise the institutional educational programs related to the human research protection program;
- Monitor research involving human subjects and enforce compliance with applicable federal and state law, regulations, or guidelines;
- Suspend or terminate approval of research not being conducted in accordance with the IRB’s requirements, or that has been associated with unexpected serious harm to subjects. Make recommendations to the Vice President for Research (VPR) concerning the human research protection program.
Article III – Members
Section 1. The membership of this Committee shall consist of:
A least five voting members. Each IRB must include at least one member whose primary interests are in a scientific area, one member whose primary interests are in a non-scientific area, and at least one member who is unaffiliated with TTUHSC El Paso (i.e. not a family member or spouse of an employee). A single member may fulfill more than one of these characteristics.
Section 2. The VPR or designee shall appoint the members of the Committee. Any interested party may recommend new members, including self-referrals.
Section 3. Members are appointed to a two year term. Generally, terms will begin on September 1 of each even-numbered year. If notice of resignation by the member or non-reappointment by the VPR is not given byAugust 1 of each year, each member’s appointment shall be automatically renewed on a bi-annual basis.
Section 4. Members will sign an agreement to serve and a confidentiality agreement, and shall
disclose any known or potential conflicts of interest.
Section 5. All new members are required to successfully complete two online courses offered through the University of Miami’s Collaborative Institutional Training Initiative (CITI) Program. These include a) Protection of Human Research Subjects, Biomedical Investigator Course and b) Conflicts of Interest Course. Members are encouraged to participate in at least six hours of continuing education annually on the protection of human research subjects.
Section 6. No member may participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, either financial or non-financial, except to provide information requested by the Board.
Section 7. Members with more than three (3) absences per fiscal year may be contacted to confirm their commitment/ability to continue as an IRB member.
Article IV – Officers
Section 1. The officers of the Committee shall be a Chairperson and Vice-Chairperson. These officers shall perform the duties prescribed by these bylaws and by the parliamentary authority adopted by theCommittee.
Section 2. The VPR shall appoint the Chairperson and Vice-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. Each board will meet monthly.
Section 2. The regular meetings of IRB #1 will be held on the first Tuesday of each month; IRB #2 on the second Tuesday of each month, unless another arrangement is made by the Chairperson.
Section 3. A quorum is present when a simple majority of the appointed voting members (or their alternates) are present, including at least one member whose primary concerns are in non-scientific areas.
Section 4. Federal regulations limit the use of expedited review procedures to specific research categories published in the Federal Register and that present no more than minimal risk to human subjects. The acceptable categories of research that may receive expedited review may be found on the HHS.gov website.
Section 6. The IRB shall retain IRB paper files for three (3) years after the final closure date of the research study. Electronic files are maintained in iRIS for a minimum of three (3) years after final closure date of the research study. Both paper and electronic records will be maintained for three (3) years after the final closure date of the research study, even if the project is cancelled without participant enrollment.
Article VI–Relation to other TTUHSC El Paso Compliance Committees
The TTUHSC El Paso IRBs function independently of, but in coordination with other TTUHSC EP research committees, including but not limited to:
- Conflict of Interest Research Committee (COIRC)
- Institutional Biosafety Committee (IBC)
- Radiation Safety Committee (RSC)
The IRB may request that approval from any of these, or additional, committees be obtained prior to TTUHSC El Paso IRB approval. For detailed information refer to TTUHSC EP OP 73.14 Research Compliance.
Article VII – Review and Approval of Bylaws
These bylaws shall be reviewed at least bi-annually by the Chairperson of the Committee, the Director, and the Managing Director of the Office of Research Resources. Proposed changes to the bylaws will be presented to the full Committee for review and comment. The IRB Chairperson has authority to provide final approval of the Bylaws.
Article VIII – Amendment of Bylaws
These bylaws may be modified or amended as needed at the request of the VPR or designee, in consultation with the IRB Chairperson.
Article IX – Confidentiality of Records
The IRB is a committee of TTUHSC El Paso established for the purpose of carrying out requirements governing research involving human subjects under federal law and TTUHSC El Paso policies and procedures. The IRB is a “medical committee” as defined under Texas Health & Safety Code Chapter Section 161, and/or other applicable state and federal statutes. All documents generated by, submitted to, or for the purposes of fulfilling IRB committee duties are confidential and privileged as “medical committee documents.”