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Human Subjects Division (HSD)

Announcements

eNews re: IRB Review, May 13, 2013 Special Mid-May edition

May 13, 2013 at 12:05pm

NEW WIRB Service

For researchers who want personalized service and faster turnaround time for their industry trials

WIRB has a Clinical Pharmacology Unit (CPU) that offers faster and more personalized services for industry-sponsored clinical trials of drugs, for a somewhat higher fee than the standard process. This service is already in use by several UW investigators for research that is especially sensitive to trial start-up times. The following information has been posted to the WIRB pages of the HSD website:

 

NEW UW-WIRB Process Flow Chart

To provide a snapshot overview of the UW process for industry clinical research that will be reviewed by WIRB

HSD is revising and consolidating the information and procedures for researchers who are planning to submit an IRB application to WIRB for industry-sponsored research. The revisions will be posted within the next two months. In the meantime, this one-page high-level flow chart provides a snapshot overview of the process - including information about the timing of contract negotiations and budget preparations.

 

NEW Standard Operating Procedures (SOPs)

This trio of SOPs is the first of many new or revised SOPs that HSD will be posting during the next five months. They describe policies and procedures for researchers, the IRBs, and HSD staff.

IRB Actions

This SOP describes the meaning, procedures, and criteria for the basic actions that the IRB can take: approval; conditional approval; deferral, disapproval; suspension; and termination.

Modifications

Among other things, this SOP describes the factors that influence the HSD decision about whether a modification:

  • Should instead be submitted as an application for a new study.
  • Is a "minor change" and therefore can be reviewed by the expedited ("Minimal Risk") process instead of the full IRB committee.

Continuing Review

This SOP describes everything you might want to know about Status Reports, including:

  • The criteria used to review and approve Status Reports.
  • The factors the IRB considers when deciding the duration of your IRB approval period.
  • The factors the IRB considers when deciding whether to require verification of information in the Status Report, from sources other than the researcher.
  • The consequences of lapsed IRB approval.