IRB Forms

Revised Submission Instructions:

1. Application for New Protocol Review —submit this form for all new protocol submissions. Full board review deadlines are 21 days prior to corresponding meetings.

2. Application for Continuation—submit this form to renew your study each year approximately 90 days before the study expiration date. Please remember that if you are making any changes to your protocol and/or consent document during the continuation process, you will have to submit a request for approval of an amendment specifying all of the modifications to the consent and/or protocol including all of the additional required copies. This also pertains to conforming to the new standard consent/authorization consent template.

3. Application for Approval of Amendment-submit this form if your study requires any modifications or changes to the protocol or consent document.

4. Application for Exemption from Review-Submit this study for all new protocol submissions that meet the exempt category criteria. Click here to view the exempt categories

5. Application for Final Study Closure-submit this form to close your study.

6. Unanticipated Event Report Form-This form must accompany all Serious and Related SAE reports to the IRB.

7. Application for The Emergency Use of Investigational Drug or Device-An emergency is defined as a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain full IRB approval.

• Submit an Application for Approval of Emergency Use to the IRB office.
• Obtain written consent from the parents for use of the investigational drug or biological product in the child. This will require preparation of a consent form. The Emergency Use Consent Form developed by the IRB staff can be adapted, or you may be able to modify a sample consent form provided by the manufacturer of the IND.
• Within five working days, provide a written report to the IRB that includes a description of the emergency situation, a description of the treatment outcome and a copy of the signed consent form. The FDA requires this report, which will be read into the minutes at the next regularly scheduled IRB meeting.

8. You should also download, complete and submit one of the new IRB "Drop-Off receipts" with each of your IRB submissions or responses to IRB findings. The IRB will stamp date these receipts only if hand delivered.

Download load forms using the links on the left of the page.

(In order to view these documents, you MUST have the Adobe Acrobat Reader installed on your system as a helper application to your world wide web browser. Acrobat Reader is available for all popular graphical browsers and computer platforms, and enables you to read a variety of publications available on the world-wide web. Acrobat Reader may be downloaded FREE OF CHARGE from Adobe.

Please go to the Adobe downloads site to obtain the FREE Adobe Acrobat Reader software to suit your needs.)