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IRB Protocols

Submitting an Addendum (Protocol Modification) Request

Requests to modify an active protocol (also called “addenda” or “amendments”) may be submitted at any time by sending a signed letter from the principal investigator to the IRB or an email from the principal investigator to Tykisha Bell, IRB Assistant Manger, at tbell@umresearch.umd.edu.  The letter should state the specifics of the changes being sought and should include: the rationale for the changes, a detailed description of the procedures, an explanation for how the changes will affect the risk to the subjects, and any appropriate supporting documents -- such as new versions of consent forms, data collection instruments, and recruitment materials. Also include the project title and the IRB application number in the letter.

If revised versions of documents previously approved by the IRB are being submitted, they should be labeled as such (for example revised on March 20, 2008).  If the original application was reviewed by an IRB Liaison, please send a copy of the addendum request to the IRB Liaison.

Please do not submit modification requests on IRB application forms. Also please note that addenda do not change the duration of IRB approval. The expiration of IRB approval is based on the date when the most recently submitted application was approved, not when the addendum was approved.

Adding Investigators to a Research Project

Prior IRB approval is also required to add investigators to a research project. The Principal Investigator should submit an addendum request to the IRB as described above.

IRB Staff Contact Information

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IRB Applications, Consent Forms and Addendum Requests

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This page is maintained by the UM Division of Research and Graduate Studies. 

Questions, comments, and/or suggestions should be directed to IRB@deans.umd.edu

Institutional Review Board, 2100 Lee Building, University of Maryland, College Park, MD 20742 USA

This page last modified 01 March 2006
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