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Human Research News v8, n5: New Expedited Review Request Form, Revised Checklist for Amendments

November 12, 2008

As part of ongoing efforts to improve the quality and efficiency of service to the UCLA research community, the Office for Protection of Research Subjects (OPRS) has developed a new form called the HS-2 Expedited Review Request Form and updated the HS-3 Amendment Checklist. These are both now posted on the OPRS Human Research website on the forms page.

HS-2 Expedited Review Request Form
The HS-2 Expedited Review Request Form is intended to allow researchers to specifically request that their applications be assessed for eligibility for expedited review. The inclusion of a completed Expedited Review Request form with submitted HS-1 applications will facilitate the triaging of applications and improve the review and approval turnaround time for expedited studies.

IMPORTANT NOTE: All applications are currently and will continue to be screened to determine whether they meet the federal regulatory requirements for expedited review. Therefore, submission of the Expedited Review Request form is not required in order for an application to be considered for expedited review, though it is hoped that the form will assist in the triage process.

HS-3 Amendment Checklist
The HS-3 Amendment Checklist is an updated checklist to assist researchers in submitting complete amendment applications.

In addition, the revised checklist now includes some examples of "minor" and "major" amendments, in order to provide researchers with guidance as to what type of amendments will require expedited or full committee review. Minor amendments may be reviewed using the expedited approval process, while major amendments to studies previously reviewed by the full board require review and approval by the full board. The list is a brief guide to classifying amendments and as such is neither exhaustive nor a guarantee of the review level. However, the list is intended to assist both investigators and the IRB.

IMPORTANT NOTE: Amendments to studies that were originally approved via expedited review will also be reviewed by the expedited review process unless the amendment changes the study to such an extent that it no longer qualifies for expedited review.

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