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Human Research News v8,n4: Revised HS-4 Continuing Review Application Form and HS-4 Continuing Review Application Checklist

November 7, 2008

As part of its ongoing efforts to improve the quality and efficiency of services to the UCLA research community, the Office for Protection of Research Subjects (OPRS) has revised (or updated) the HS-4 Continuing Review Application Form and the HS-4 Continuing Review Submission Checklist. These forms and checklists are now posted on the OPRS Human Research website on the forms page and are ready for immediate use. Although the revised HS-4 form is longer than the previous version, it is designed to be easier to complete as it makes a liberal use of checkboxes and text boxes with more directive questions.

As of November 10, 2008, the revised HS-4 form replaces both the previous version of the HS-4 and Section IV (1) “Renewal Information” of the HS-1 application.

Investigators will no longer be required to update the HS-1 form every fifth year as has been the practice in the past; therefore, the distinction between a “continuing review” and a “renewal” application will no longer apply. This is because the HS-4 has been updated to request all of the information required by federal regulations for annual IRB review and there is no need to have two processes for conducting annual reviews.

Important Note: All annual continuation or renewal applications must now include the October 2008 version of the HS-4 Continuing Review Application and the November 2008 of the Continuing Review Submission Checklist. Section IV(1) has been removed from the HS-1 application and is no longer considered sufficient information for the UCLA IRB’s annual continuing review of applications.

After February 1, 2009 this is the only version of the HS-4 that will be accepted for review; prior versions will not be accepted.

Feedback or Questions: If you have any suggestions about how to improve these forms, please e-mail Sharon Friend at sfriend@oprs.ucla.edu.