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Institutional Review Board

Submission Process for IRB Materials

A PDF version of this document is also available.

There are 3 types of review for research protocols which investigators may request from the IRB:

Full Board Review – review by the IRB at a convened meeting
Expedited Review – review by a subcommittee of the IRB
Exempt Review – review by the IRB Chair or a subcommittee of the IRB

The chart below outlines these categories and the general timeline for each.

Type of Review	Brief Description	Estimated Timeline for Response	Application Procedure and Deadlines
EXEMPT Determination	A determination of exemption is made only by the ORC. Research may be exempted if the research is minimal risk, and is considered exempt under 45 CFR 46.101(b) and in compliance with OHRP guidelines.	Approximately 10 business days after receipt by IRB office, *if no revisions are required.*	Submit IRB Request for Study Exemption form, Project Summary and research instruments e.g. surveys.
EXPEDITED REVIEW/ Continuing Review	Research may be reviewed using an expedited procedure if it is minimal risk and is an expedited category, as specified by Categories of Research	Approximately 20 business days after receipt by ORC office, *if no revisions are required.*	Submit Request for IRB Review form. (See Checklist) Continuing Review 60 days prior to expiration date.
FULL BOARD REVIEW	Research is reviewed by a convened IRB if it exceeds minimal risks. Examples include: prisoner research and sensitive research topics.	Approximately 30-45 business days after receipt by IRB office, if no revisions are required.	Submit IRB Request for IRB Review form. (See Checklist) Deadline is 40 days prior to meeting.
PROTOCOL REVISION & AMENDMENT (PRAF)	Changes in exempted and previously reviewed studies.	Varies, depending on type of changes.	Submit Protocol Revision or Amendment form (PRAF).
STUDENT CLASSROOM PROJECTS	For faculty only. Projects conducted during or outside of class with students enrolled in an official course that engage students in interaction with individuals or data about individuals to teach research methods, and not for publication.	10 business days	Submit Student Classroom Projects form and attach syllabus and research assignment.

2009 IRB Meeting Schedule Nov. 17, 2009 10:00 AM to 2:00 PM Ice Arena Alumni Room Gorham Campus Dec. 9, 2009 1:00 PM to 3:00 PM 423/424 Glickman Portland Campus
		Important! Submissions for IRB review must be received 30 days prior to the next Board meeting, be complete, and in no need of major revisions. If it does not meet these requirements, then it will be reviewed at the next available opportunity. Quick Links CITI Training Module CITI FAQ Investigator Guidelines IRB Classroom Presentation General Information Definitions Application Forms Sample Forms USM IRB Application Checklist Submission Types & Timelines Student Handbook on Human Subject Research Student Classroom Policies and Procedures USM Policy & Procedure for Human Subject Research IRB Administration IRB Members Frequently Asked Questions Contact IRB Useful Links Educational Materials IRB Home ORC Home ORC Privacy Statement