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Approval Designations

The IRB – Human Subjects reviews the research protocol application and evaluates the project as:

APPROVED - the project and its study tools, including the informed consent documents, are approved as submitted.

APPROVED PENDING - The project requires revisions (e.g. the consent documents) or questions that require further attention by the investigator.

DEFERRED - More serious deficiencies in the protocol as submitted with major issues to be worked out with the investigator before the project can be reconsidered.

DISAPPROVED - Serious problems in risk/benefit analysis; protocol inadequate in addressing issues of concern.

CONTINUING REVIEW APPROVAL - Following satisfactory review of information submitted by investigator regarding an ongoing project. Review must occur at least annually but may be more often depending upon the level of risk involved.

Appeal Process: An investigator receiving a letter advising disapproval, may appeal the decision of the IRB - HS at the next meeting by notifying the Chairperson of the reasons for this re-review and supplying additional information for consideration. Should the protocol again be disapproved, the investigator may appeal to the Provost who may request an ad hoc IRB be formed for purposes of review of the protocol. Such review will be made available to the IRB - HS but it may not override the decision of the IRB - HS.

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