Campus Memorandum
Brigham Young University The Institutional Review Board for Human Subjects
Please type information and then print off and sign a paper version to submit. Thank you.
Re: Renewal Application of Approved Research Date:
To: IRB Secretary From: Name:
A-285 ASB Address:
Email: City, State, Zip:
Your renewal application must be approved before your current approval expires. If IRB approval has expired, you cannot enroll new subjects and the research must stop. Studies that have not been re-approved by the expiration date will be closed.
Please send, fax, or email one copy of this completed form to the IRB Secretary, Office of Research and Creative Activities, A-285 ASB, fax (801) 422-0620, by the following date: __/__/__. Please respond even if you are done with your research.
IRB # / (IRB USE - Date Received)Protocol Title:
Principal Investigator:Phone:
/ Email:
Close the protocol. I am no longer actively working with human subjects AND I have completed the data analysis on this study.
*The research is still ongoing. I have attached the following:
A protocol summary (including your hypothesis and methods or procedures, no more than a page long)
and
A status report on the progress of the research, including:
1. any adverse events, unanticipated problems involving risks to subjects or others, any withdrawal of subjects from the research, and any complaints about the research since the last IRB review;
2. a summary of any relevant recent literature, interim findings, and amendments or modifications to the research since the last review;
3. any relevant multi-center trial reports;
4. any other relevant information, especially information about risks associated with the research;
5. a copy of the current date-stamped consent document;
6. a clean copy of the current informed consent document and any newly proposed consent documents;
7. a clean copy of the current recruiting materials.
Any new amendments or proposed changes for the next approval period must be accompanied by the Amendment/Modification of Research Form. (if applicable)
1. / Number of subjects accrued during the course of this study?
2. / How many subjects were enrolled in this study since the last approval date?
*Signature: Date: