Human Subjects (IRB) Reveiw Process
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Human Subjects (IRB) Review Process

The Committee for the Protection of Human Subjects (CPHS) requires approximately six (6) weeks to review a protocol, then render a vote (decision) on it. Below are the details of this process:

  1. The protocol will be reviewed for completeness and for all pertinent documents that should be attached. If documents should be attached, but are not, the protocol is immediately returned (via TOPAZ) to the principal investigator (PI) without CPHS committee review. For student investigators, the faculty review eSignature is required. The protocol is returned if the faculty eSignature is missing.

  2. If all pertinent documents are attached, the protocol is assigned to the committee for review.

  3. The committee will review the protocol, along with attached documents and instruments, then may provide comments about the protocol. These comments are summarized on the protocol.

  4. If there are modifications that need to be made to the protocol or questions about the protocol, the protocol is returned to the PI for addressing these issues. An e-mail will be sent to the PI and faculty associates listed on the protocol; the investigator has 90 calendar days in which to respond to the committee's comments. The review process of the entire protocol will be re-started for those protocol responses received beyond 90 days.

  5. Once the PI has responded to the committee's findings and re-submitted the protocol, those addressed items will be reviewed by the committee, and if there are no other concerns from the committee, the protocol will be placed on the next meeting agenda for a vote. Protocols that are not exempt from committee review require a vote of the committee quorum.
    • The committee reserves the right to request a meeting with the PI and advisor or committee chair when the protocol has been returned twice, yet questions about the protocol remain.
    • When, upon reviewing a protocol, the committee learns that research has already begun, the protocol is rejected, and the PI will be required to submit another non-related protocol. If this occurs, notification is sent to: the investigator; the PI's committee chair; PI's department chair; the college Dean; the graduate school Dean; and to the Office of the Provost. Included in the correspondence is notice that no part of the unapproved research may be used to satisfy graduation requirements. Working on unapproved research is illegal!

  6. Once the committee has approved the protocol, the protocol's approval status is updated in TOPAZ, and an e-mail is generated to the PI of the approval (research can begin as of this message). The Office of Research also receives notice of the approval, and a hard copy letter is generated for the CPHS chair's signature. When the letter is ready, the PI will be notified via e-mail that the letter is ready for receipt in a manner acceptable to the PI (i.e. mail, pick-up, etc.)

Questions may be addressed by e-mailing the Office of Research at officeofresearch@tsu.edu, or by calling 713-313-4301.