eNews re IRB Review

A special edition for UW researchers who do industry-sponsored studies that are reviewed by Western IRB (WIRB)

Comparing the contract, budget, and consent form

  • Current UW policy requires HSD to compare the contract, budget and consent form for consistency and key regulatory issues before signing the UW/WIRB Cover Sheet that allows UW studies to be reviewed by Western IRB (WIRB).
  • Effective immediately, this requirement has been eliminated for industry sponsored clinical trials that will be performed under a Master Clinical Trials Agreement (MCTA or "master agreement/contract").
  • The presence of a Master Agreement assures HSD that the relevant issues have already been addressed with the sponsor.
  • The UW Office of Sponsored Programs (OSP) maintains an up-to-date list of Master Agreements at: http://www.washington.edu/research/main.php?page=clinicalTrials. Please contact OSP with questions about Master Agreements.

 

When should the UW/WIRB Cover Sheet Packet be submitted to HSD?

  • We strongly encourage you to submit your UW/WIRB Cover Sheet Packet to HSD during contract negotiations.  It is not necessary to wait until after the contract is done.
  • HSD cannot sign and return the UW/WIRB Cover Sheet until certain issues and documents have been reviewed.  However, most of our review work can be done in parallel with the contract negotiationsWhen this has occurred, we can complete the review process very quickly once the contract is finalized, by doing the last review step* of comparing the contract, budget, and consent form.

*As noted in the first news item, this last step is not required for studies performed under a Master Agreement.

 

Mandatory Revisions to UW/WIRB Consent Form Template

Effective immediately, the UW/WIRB Consent Form Template has been revised and is posted to the UW Human Subjects Division website at http://www.washington.edu/research/hsd/docs/468.

The changes are summarized in the same order as they appear in the template:

  • COST. Includes new language for subjects whose health insurance is the Medicare Advantage Plan.  This section has been reviewed and approved by the UW Attorney General's Office; it cannot be revised.
  • CONFIDENTIALITY AND PRIVACY. Includes new language required by the Food and Drug Administration (FDA) about registering clinical trials with ClinicalTrials.gov.  This language is mandated by law and may not be changed.
  • COMPENSATION FOR INJURY.  Revised language about the sponsor's obligation to report to Medicare if the sponsor pays for research related injuries.  This language is preferred by major sponsors.
  • SOURCE OF FUNDING.  Includes new language for device studies.  Medicare/Noridian will not pay for a clinical trial device without this language.

It is not necessary to revise currently approved consent forms solely to incorporate these changes. However, these changes should be incorporated if a currently approved consent form is being changed for other reasons (such as adding a new research procedure).

 

Please contact the UW Human Subjects Division Clinical Trials Administrator, Arna Elezovic, at elezovic@uw.edu or 206.543.0639 with questions about any of the information in this newsletter.

 


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July 18, 2011

IN THIS ISSUE

Comparing the contract, budget, and consent form 

Mandatory Revisions to UW/WIRB Consent Form Template




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