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Human Subjects Research

TCU encourages students to conduct research, under the supervision of a faculty sponsor.  This page helps to guide a student, who wishes to conduct human subjects research, which is no more than minimal risk, through the TCU IRB review process.

Preliminary requirements

1. The student must be sponsored by a TCU faculty member, who is knowledgeable in the area in which the student wishes to research.

2. The student and faculty sponsor should submit a proposed protocol to the appropriate Departmental Review Board (“DRB”).  Below is a chart that illustrates the review process.

chart-proposal-review-(1)

3.  Protocols must be approved prior to the project initiation. No research activities may take place before IRB approval.

4. All investigators, both students and faculty investigators, must show evidence that they have had human subjects research training. On-line training is available through CITI.

5. Ensure compliance with applicable law, and TCU policies and procedures, including those specific to human subjects research:    IRB Forms, policies and guidelines.

 

Questions should be directed to Dr. Sally Fortenberry  or Dr. Morrison Wong, each a co-chairperson of the IRB and lead reviewer of DRB referrals and recommendations.

 

Requirements for appointment of Departmental/College Review Board (DRB)

The DRB shall be composed of not less than five members with at least one member for each of these categories:

  • Chair of the board and a faculty member of the department or college,
  • A member from the community and not affiliated with TCU, and
  • A member whose primary concerns are in nonscientific areas (a nonscientist).

Appointments to the DRB are made by the department chair or the college dean. The Chair of the TCU IRB should be informed of the DRB membership.

Responsibilities of the DRB

The DRB does not approve or reject protocols, but rather reviews and recommends. The DRB will review proposals, keep minutes and files of each review and forward protocols with their recommendations to IRB.StudentSubmit@tcu.edu in a timely manner. The DRB will follow the procedures and criteria for review by the IRB as presented in this document.  If the DRB finds that the research involves invasive measurements that contain more than a minimal degree of risk or that the research includes special populations such as children or prisoners, the DRB shall refer the student protocol to the IRB for further review with an explanation of that determination from the DR Board chair.

In any event, the DRB shall report all recommendations and forward all protocols to IRB as soon after their review as possible.