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.
Renewal Instructions
For projects spanning more than one year, renewal IRB approval is required. The investigator will receive from the IRB office a renewal notice in advance of the expiration date. The principle investigator must submit to the IRB an IRB Application along with the following material:
- A written progress report/brief project summary that includes the following or references other documents made available to the IRB (see Appendix F):
- The number of subjects accrued; (For multi-site studies, the number of subjects accrued at the local site and the number accrued study-wide, if available, should be provided.)
- A brief summary of any amendments to the research approved by the IRB since the IRB’s initial review or the last continuing review;
- Any new and relevant information, published or unpublished, since the last IRB review, especially information about risks associated with the research;
- A summary of any unanticipated problem. In many cases, such summary could be a brief statement that there have been no unanticipated problems;
- A summary of any subject withdrawals from the research since the last IRB review, and the reason for withdrawal, if known; and
- A summary of any complaints about the research from subjects enrolled at the local site since the last IRB Review;
- The last version (documenting version number and/or date) of the protocol and sample informed consent document(s) in use:
- Any proposed modifications to the informed consent document or protocol;
- The current Investigator’s Brochure, if modified since initial review;
- Any other significant information related to subject risks, such as the most recent report, if any, from data monitoring committees (DMCs); and
- Aggregate information about relevant regulatory actions occurring since the last review that could affect safety and risk assessments.
Final Report Instructions
If your project is completed, you should submit one copy of a final progress report. The progress report should state that the study has been completed and research protocol terminated. A Final Study Report form is included in Appendix F.
Contact Us:
The Office of Clinical Research
2000 Pepperell Parkway
Opelika, AL 36801
P: 334.528.4280
E: IRB@eamc.org