Following each IRB meeting, the investigator will be informed by memo of the protocol status. In this case, the investigator should submit a cover letter along with a modified submission form, protocol, consent form or supplemental information as requested with the changes highlighted. If these conditions have not been met within 30 days, the protocol will be considered terminated unless extensions have been granted as determined by the IRB Office. No research may be started until all conditions have been met and full approval has been obtained. No research may begin until it is given full approval.
Revisions generally entail substantial modifications to the protocol or the consent form.
Generally, most revised deferrals may be reviewed again at the next full board meeting. To respond to IRB concerns, an investigator may submit a letter with the revised submission or may request the opportunity to meet with the IRB to present justification of the deferred protocol and allow further discussion and consideration. If the IRB has not heard from the investigator within six months of notice of deferral, the protocol will be considered terminated. Any future submissions related to the original protocol will then be considered new submissions and given a new protocol number. This may occur if a protocol has been deferred several times and the IRB feels that the proposed research is not justified or poses severe or unnecessary risk to the subjects.