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THE COMMITTEE ON HUMAN RESEARCH

UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES

EXPEDITED REVIEW APPLICATION GENERAL INSTRUCTIONS
(Effective November 2004, Revised April 2006, Revised January 2007)

•  General Instructions
•  Meeting Dates and Deadlines
•  Filling Out the Forms
•  Attachments
•  Expedited Review Categories

General Instructions

The Expedited Review Application is for research which involves no more than minimal risk to the subject and falls under federally defined Expedited Review categories. Please review those categories to make sure the research is eligible for Expedited Review before submitting an application.

The application consists of a set of questions and points which must be addressed for the committee to conduct an adequate review and to comply with federal requirements. For these reasons and to facilitate the review of the thousands of applications submitted to the CHR every year, investigators are asked to prepare their protocols according to a consistent format.

There are hyperlinks throughout the application form to provide quick and easy access to definitions, brief instructions and explanations, other web pages and other forms.

There are two Expedited Review applications. The main Expedited Review Application is for all categories of research that involve no more than minimal risk. The application for Expedited Review Application: No Subject Contact is for research that involves no subject contact.

Use the Expedited Review Checklist or the Expedited Review Application: No Subject Contact Checklist as a guide and final check for preparing and submitting a complete application.

Refer to the CHR web site for detailed Guidance on particular issues, and for information on informed consent.

If also applying to the CTSI, please submit one copy of this application to the CTSI Clinical Research Center where your study will take place. Visit http://ctsi.ucsf.edu/index.html, http://gcrcsfgh.ucsf.edu/, or http://www.gcrc.ucsf.edu/ for additional instructions regarding the CTSI application process.

Meeting Dates and Deadlines

Applications are either circulated to the CHR or are reviewed by a subcommittee in the CHR office. If any of the reviewers believes that the research does not fit into an expedited category, or believes the study should be reviewed by additional members, he/she may refer the application to the Full Committee for further review.

Information about CHR and reviewed at the regular weekly convened meeting dates and deadlines is available on the Applying to the CHR web page under “CHR Review Process.”

A caution about rushing: Please note that applications which are thoughtfully and carefully prepared are invariably approved more quickly than applications which are hastily prepared.

Filling Out the Form

IMPORTANT: SAVE THE FORM IMMEDIATELY - BEFORE FILLING IT OUT. After saving it, start Word (or other word-processing program) and open the form from within that program (i.e., do NOT open it from your desktop).

Please complete all sections of the application. Type your answers in the blank, unshaded areas below questions.

As noted above, many sections include links (blue type) to particular instructions, definitions, or relevant guidelines. Click on the links to activate them.

Do not alter the text and formatting of the form itself.

If you have questions or need assistance, please call 476-1814 or email the CHR.

Attachments

It is almost always necessary to include attachments with the application. The Expedited Review Checklist or the Expedited Review Application: No Subject Contact Checklist lists the possible attachments and explains how many copies are needed.

Expedited Review Categories