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Human Subjects Division (HSD)

Announcements

eNews re: IRB Review, August 6, 2013

Aug 8, 2013 at 9:19am

WIRB Changes

Western IRB (WIRB) reviews all industry-sponsored-and-initiated clinical trials for the UW. In the past year or so, WIRB was purchased by a new group and merged with another large, reputable, commercial IRB (Copernicus). The combined group is developing new systems, tools, and processes to provide better service to researchers and sponsors. UW researchers whose studies are reviewed by WIRB will receive email announcements about these changes, but we would like to draw your attention to one particular change: a new web portal. ConnexusTM is a secure web portal that is now an integrated part of the existing WIRBNet and can be used by both researchers and sponsors to:
  • Submit IRB applications, using web-based "smart" forms
  • Track the status of IRB applications, modifications, and renewals
  • Manage the study and the site participants
  • Organize documents
  • Access IRB application and approval documents
This new ability to track the status details of an IRB application is especially important for researchers. It will improve your ability to plan and coordinate the many start-up components of a clinical trial. For more information, contact WIRB Client Services at clientservices@wirb.com or call 800-562-4789.

Use of Central IRBs for Multi-Site Clinical Trials

The default IRB review model for each site in a multi-site clinical trial is for each site to obtain IRB review from its own IRB. These multiple reviews by multiple IRBs can result in duplication of effort, delays, and increased expenses in the conduct of multi-site clinical research. There is growing national acceptance of the use of a central IRB for multi-site studies. Central IRB review involves an agreement under which the sites rely in whole or in part on the review of a single "central" IRB instead of the IRBs affiliated with the research sites. The goal is to increase efficiency and decrease duplicate efforts and workload by both researchers and IRBs that do not contribute to meaningful human subject protection. Recent National Institutes of Health (NIH) announcements soliciting grant applications for clinical trial networks or cooperative groups have made the use of a central IRB mandatory for any site that wishes to participate in those networks or cooperative groups. The UW and reliance on central IRBs. HSD agrees that the use of central IRBs is a sensible approach for many multi-site studies. We have recently signed agreements with some central IRBs.
  • WIRB (Western IRB) WIRB acts as the central IRB for industry-sponsored-and-initiated trials. Available since 2005. Contact HSD's Brecken Cardinal at hsdinfo@uw.edu
  • National Cancer Institute (NCI) Central IRB Almost all UW cancer-related studies have been reviewed for the UW by the IRB at Seattle Children's or the Fred Hutchinson Cancer Research Center. In July, the UW signed agreements with these two institutions and the NCI Central IRB. These agreements allow certain multi-site and cooperative group UW cancer studies to be reviewed by the NCI Central IRB instead of the local IRBs. Available now. Contact the IRB at Seattle Children's or the Hutch. https://www.ncicirb.org
  • IRBShare In this variation of the central IRB model, institutions share review documents and a review process. It is supported by a centralized, secure web portal and an IRBShare Master Agreement. HSD recently signed the Master Agreement. At the UW, IRBShare will be jointly administered by HSD and by the Institute for Translational Health Sciences (ITHS). See the HSD eNews in the next 2-3 months for more information. Available approximately November 1. Contact Shannon Sewards at HSD or Jason Malone at ITHS. https://www.irbshare.org/#what
Limitations. These process are available only for new studies. Use of a central IRB does not necessarily reduce the amount of work required for initial review but it almost always is a faster process from submission to IRB approval. HSD is usually still involved in the process to manage and oversee local issues such as: requirements imposed by Washington State laws; and compensation for research-related injury. Applying for a grant that requires the use of a central IRB? We are happy to provide you with the requisite Letter of Support from the UW IRB. Contact Karen Moe (HSD Director) or Shannon Sewards (Assistant Director of Biomedical Operations).

PAVE post approval monitoring program

HSD is pleased to announce the formal launch of a new program called Post Approval Verification and Education (PAVE). The purpose of the program is to use a collegial approach to:
  • Confirm by observation that UW human subjects research is conducted in compliance with relevant regulations, policies, and IRB-approved procedures;
  • Provide specific education and tools to researchers, to address potential or actual research problems;
  • Identify and highlight best practices of UW researchers.
Federal regulations provide Institutional Review Boards (IRBs) with the authority to conduct post approval monitoring of research studies. The UW program was developed and tested during the past year, based on similar programs already established at most of the UW's peer institutions. Participation in the program is mandatory, if your study is selected for a PAVE visit. However, note that the program's approach is educational, not punitive. Studies will be selected for a PAVE visit based on:
  • Random selection from among studies sharing specific characteristics. The characteristics used to identify these "not-for-cause" visits will be identified and publicized at the beginning of each academic year.
  • Requests from the UW IRBs and other sources.
Not-for-cause visits will begin in August 2013. These studies will be selected from those with all of the following characteristics:
  • Domestic (not international)
  • Studies involving the use of an investigational drug or device, for which the UW researcher has an IND (Investigational New Drug permission) or IDE (Investigational Device Exemption) from the Food and Drug Administration
  • Study is still enrolling or still providing treatment/intervention to the subjects
For more information see the PAVE FAQ on the HSD website, or contact Wendy Brown, Administrator & Monitor for the PAVE program at 206-543-5602 or wbrown3@uw.edu.