Home Page	IRB Application Process IRB Application Form The initial IRB application form (Word doc) requires the signature of the Principal Investigator, Co-Principal Investigator (if applicable), Student Investigator (if applicable) and the Departmental Human Subjects Review Committee Chairperson or Designee or Department Head (Chairperson) or Designee or Unit Head (Director) or Designee for departments or units without an HSRC.  Refer to the instructions on the IRB application and provide all of the information required in the 10 items in the instructions.  Include all relevant supporting documents including consent forms, letters to recruit participants, questionnaires, the ORAA Internal Routing Form for Proposals (if any), and any other material germane to human subjects review.  If you submit an incomplete application, you will receive a notice from the IRB Office and the review of your research will be delayed until all required information is received. Refer to the Instructions on the IRB Application for information on the number of copies to send and the mailing address. Exempt Research The IRB Manager or an IRB Co-Chair may use exempt review procedures to review and approve an IRB application when the research involves no more than minimal risk to the subjects and the only involvement of human subjects will be in one or more of the exemption categories.  The application requires no further review until the 3 year approval period expires or the investigator would like to modify the research.  You may review the Exemption Categories to determine if you find the research to be exempt.  If you determine that your application meets one of the exempt categories, you should write the category number(s) on your IRB Initial Application cover sheet and explain why your proposal is exempt.  Your notation for exemption is a recommendation to the IRB.  The IRB Manager or an IRB Co-Chair must decide whether the research is exempt and by which category(s). Turnaround Time for the Review of IRB Applications The turnaround time for exempt reviews is approximately three weeks upon receipt of the application at the IRB office. The turnaround time for expedited reviews is approximately four weeks upon receipt of the application at the IRB office. Please note that the amount of time for an exempt review or an expedited review may be longer if the reviewers request changes or clarification. The turnaround time for Full Board reviews is at least one month since Full Board review meetings are held once a month. However, the turnaround time for applications reviewed by the Full Board may be longer than one month if the application is not submitted by the application deadline, the meeting agenda is full when the application is submitted, or the application is not approved as submitted when first reviewed by the Full Board. Notification of IRB approval Approval letters are mailed to the Principal Investigator at the location cited on the IRB application cover page. For applications reviewed by the full board, Principal Investigators are notified of the IRB's decision within approximately one week of the meeting. If you would like to know the status of an application, you should send an e-mail to Rennica Wickham at rwickham@umresearch.umd.edu or irb@deans.umd.edu
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This page is maintained by the UM Division of Research. 

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 06 June 2006
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