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Human Subjects Division (HSD)

Announcements

Effective July 1: Industry-sponsored clinical trials and significant changes concerning Western IRB

Jun 17, 2009 at 12:48pm

WIRB (Western IRB)
Significant Changes to Submission Process

Effective:  July 1, 2009

Relevance:       This applies only to industry-initiated-and-sponsored clinical trials, which are generally reviewed by Western IRB (WIRB) for the UW IRB.

Purpose of the changes:  

  • 1. Reduce HSD screening time, by:
  • Allowing the use of email to send documents to HSD, and to return documents from HSD to the researcher
  • Reducing the "back and forth" between WIRB, HSD, researchers, and sponsors about certain sections of consent documents
  • 2. Enhance compliance oversight

Description of the changes.  The Human Subjects Division (HSD) has always provided an authorization for WIRB's review, by requiring researchers to fill out and submit a UW / WIRB Cover Sheet.  HSD reviews the Cover Sheet, signs it, and returns it to the researcher.  The researcher includes the Cover Sheet with the application packet that he/she sends to WIRB.  The changes in this process are:

  • Electronic transmission. All documents for this process (except Confidentiality Agreements) may now be sent to and from HSD electronically (by email).
  • The UW / WIRB Cover Sheet has been revised to include some additional questions.
  • New required attachments to the Cover Sheet. All of these attachments are parts of the application packet required by WIRB. Researchers will simply be providing a copy to HSD; there are no new forms to complete.
  • The Compensation for Injury section of the consent form template has been revised, to ensure compliance with UW policies and to provide researchers & sponsors with suggested language.
  • Screening of consent forms and HIPAA Authorization forms. HSD will screen and evaluated the consent form(s) and HIPAA Authorization form. After screening is completed, HSD will stamp the consent forms and UW HIPAA Authorization form, to signify to WIRB that the Injury Compensation for Injury language in the consent form and the HIPAA language are acceptable and follows UW policies. The stamped versions must be submitted to WIRB together with other WIRB-required documents.

UW / WIRB Cover Sheets submitted to HSD using old versions of forms and procedures will not be accepted after July 1, 2009.