Approval or Determination Notice
IRB Approval
A research project may not commence without written approval of the IRB. This approval will include specified dates for which the project is approved and dates at which the renewal review must be initiated. Approval dates will span a maximum of one year, at which time application for renewal as set forth below must be submitted. Depending on the content and risks of the research, certain projects may require renewal and IRB approval more frequently than once a year. Such determination for frequency of review can be recommended by the Project Review Panel or initiated by the IRB. The frequency of renewal and review will be outlined in the written approval by the IRB.
In addition, changes in approved research may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subjects. Even then, such changes must be reported immediately to the IRB Chairperson.
Should serious or unexpected adverse events occur during the course of the project, it is the responsibility of the clinical investigator to report such events immediately to the IRB.
In case of modifications made by the IRB in review, final approval is contingent upon written notice from the investigator or documentation of such modifications specifying that the modifications have been made. The research may not commence until such final IRB written approval has been issued.
For further instructions on approval or determination notices, please log in to Cayuse.
Contact Us:
The Office of Clinical Research
2000 Pepperell Parkway
Opelika, AL 36801
P: 334.528.4280
E: IRB@eamc.org