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Human Subjects Division (HSD)

Announcements

eNews re: IRB Review, November 30, 2012

Dec 1, 2012 at 2:32pm

New Required Data Elements for ClinicalTrials.gov

New requirements increase the number of data elements that must be submitted to ClinicalTrials.gov for each initial trial registration.  Effective December 1, 2012 the following data elements will be required to post a new study record:

  • Responsible Party
  • Primary Completion Date
  • At least one Primary Outcome Measure
If you have general questions, please contact the UW Compliance Administrator, Stefan Shipman at sshipman@uw.edu.

Medical Records Review Form Substantially Revised!

The Medical Records Review form has officially been replaced by the Use of Identifiable Biological Specimens/Data form.  HSD will no longer accept the old Medical Records Review form as of December 31, 2012.  Please read the eNews for full details on the use of this new form.

New Metrics Available

The 16th Report of HSD Performance Metrics (for reposting period 4/1/2012 to 9/30/12) has been posted to the HSD website.  This report includes a new metric and analysis of "Minimal Risk" reviews.  Turn-around times are now distinguished by type of application form.

  • The standard application has a median turn-around time of 23 business days.
  • The medical records review form (soon to be replaced by the Use of Identifiable Biological Data/Specimens form) has a median turn-around time of 14 business days.
Information around turn-around times and other kay aspects of the IRB review process can be found in the report along with reports from previous quarters.

2013 Update to the International Compilation of Human Research Standards

The International Compilation of Human Research Standards is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in 104 countries and from several international organizations.  The Compilation is designed for use by IRBs, researchers, sponsors, and others.  Many of the listings embed hyperlinks to the source document.

The 2013 edition is now available, and can be accessed in both Word and PDF formats: http://www.hhs.gov/ohrp/international/index.html. One new country is featured in the 2013 Edition: Ecuador.

As in the past, the new edition updates the human research standards based on information provided by in-country experts.

New and Revised Documents

Please read the eNews for a listing of revised documents for the month of November.

Quick Tips from HSD

This month's quick tips describes how to use the new PDF version of the Use of Identifiable BIological Specimens/Data form to communicate back and forth between researchers, and research coordinators.  Please read the eNews for details.