IRB Decisions

Under the full review process, the IRB may take one of four actions in regard to the protocol and consent forms.

1. Approved: The investigator is sent an approval letter accompanied by an informed consent/assent document with the “IRB Approval” validation stamp.
2. Stipulations and/or Additional Information Required: The principal investigator is sent a letter describing the revisions requested. After revising the protocol and/or consent form, the investigator returns two (2) copies to the IRB Office. The revisions or additions should be “tracked changed” and reference made to the IRB HS number. Also, if revisions to the consent/assent form(s) are necessary, the investigator submits one clean copy of the revised consent/assent forms without tracked changes. If approved, the consent/assent form(s) are returned to the investigator with a valid “IRB Approval” stamp and expiration date. The revisions are forwarded to the IRB Co-Chair or a designated representative for review. If the changes are satisfactory, an approval notice is sent to the Principal Investigator. The clean copy of the revised consent/assent form(s) with the valid “IRB Approval” stamp and expiration date accompanies the approval letter along with any supplemental materials that were reviewed, such as an advertisement, patient materials, or questionnaires. Subjects can only be enrolled using informed consent/assent forms which have a valid “IRB Approval” stamp, unless waiver from this requirement is granted by the IRB.
3. Tabled: The investigator is sent a letter which lists the reasons for tabling and includes a description of the revisions or clarifications requested. After revising the protocol and/or consent form, the investigator submits the response to the IRB Office. The protocol is then scheduled for re-review by the Full Committee.
4. Disapproved: The investigator is sent a letter describing the reasons for disapproving the protocol. Disapproval of a protocol usually occurs when the IRB determine that the risk of the procedures outweighs any benefit to be gained.