The IRB shall review and have the authority to approve, tentatively approve pending receipt of additional information, or disapprove the subject research according to the following.
The protocol is approved as submitted.
A protocol is considered pending when the problems identified in the protocol are not serious and generally fall into two categories: 1) the investigator needs to clarify an aspect of the study or provide additional information, or 2) minor changes need to be made in the informed consent document. In these cases, approval can be given after the investigator rewrites the informed consent and/or submits to the Chair a written response to the IRB's questions and concerns. The Chair will then poll IRB members to receive final approval.
The IRB will disapprove the proposed research if it places the subjects at risks which far outweigh the benefit or value of the knowledge to be gained, or it raises such serious ethical questions as to be unacceptable. In the event a disapproval is foreseen, the investigator will be invited to attend the meeting of the IRB to discuss the protocol. A research activity may be disapproved only after a full IRB review has been conducted.
In each of the above cases, the IRB shall notify the principal investigator of the results of its action in writing. The continuing review of research shall be conducted according to the procedures outlined in Continuation/Renewal.
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