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Human Subjects Division (HSD)

Announcements

eNews re: IRB Review - June 3, 2014 - Flexibility is Coming to HSD

Jun 4, 2014 at 11:32am

IRB Committee C: Farewell

IRB Committee C held its last meeting on May 15th. It was one of the original UW IRBs, and has operated in one form or another since 1966, for 48 years!

In the past two years, we've revised our procedures to make sure that social/behavioral research is reviewed by a full convened IRB committee only when the research does not qualify for exempt status or Minimal Risk review. This has been extraordinarily successful. The results:

  • Faster approval times for researchers;
  • Shorter IRB Meetings and less work for our IRB members.

To accommodate this fundamental shift in work distribution, we've de-commissioned IRB Committee C, and started a new Minimal Risk team with the HSD staff from IRB C. All studies previously overseen by IRB Committee C are being transferred to a Minimal Risk team, or to one of the two remaining social/behavioral IRBs. Researchers will be contacted about the transfers as they occur. There will be no disruption or delays in the IRB review of new applications, Modifications, or Status Reports.

Thank you to the many, many faculty members and HSD staff who served on or supported IRB Committee C!

 


Flexibility Initiative: Introduction

HSD is pleased to announce the launching of our Flexibility Initiative. Its purpose is to identify areas of flexibility in IRB review that can reduce workload for researchers and/or IRBs and that can be implemented without diminishing human subject protections.

The flexibility projects we will implement during the next year have been identified as "best practices" by a national group called the Flexibility Coalition. The Flexibility Coalition is an informal grass-roots organization that consists of IRB managers that are interested in achieving a more flexible approach to the increasingly burdensome requirements for human subjects research. HSD is one of more than 75 members. The federal IRB oversight agencies and accrediting organizations agree with the Flexibility Coalition's approach and suggestions.

We plan to adopt some highly visible changes that will dramatically affect minimal risk research that is not federally funded. The first Flexibility Project is now complete and was implemented on May 30 (see news item below). Stay tuned for additional Flexibility news, as a regular feature of this newsletter!

 


 

Flexibility Project: Exempt Category 7

Implemented: May 30, 2014

HSD's first Flexibility Project is the implementation of a new category of Exempt research, called Category 7. The qualifications are the same as for Category 2 Exempt status, except that Category 7:

  • Allows the use of tasks, games, priming, and physical actions by a subject, and
  • It is limited to research that is not federally supported.

HSD believes that a significant number of studies will now qualify for Exempt status rather than requiring an IRB application and Minimal Risk review. See the SOP Exempt Determination (Section 8) for more information. The advantages of Exempt research include:

  • Faster review
  • No annual Status Reports and renewals
  • Review of Modifications is not required except in limited circumstances

We will publish metrics about the impact of this first Flexibility Project later in the year. An exciting fact: less than 24 hours after this change, we have already received and approved the first Category 7 Exempt application!

 


 

Past Their Pull Date

Please make sure that you are using the latest version of the APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee. There have been many improvements: the addition of a Genetics Supplement; revision of the Engagement section; removal of the drug and device sections in favor of new Supplements.

HSD will no longer accept older versions of this form as of August 1, 2014.

As always, please don't use forms that you've saved to your computer to begin a new application. Go to our website, and download the latest version. We are always trying to improve.

HINT: If you want to know what has changed on any document, scroll down to see the "Change Notes" on the website landing page.

 


New and Revised Documents

We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We welcome feedback and suggestions. (hsdforms@uw.edu)

Topic Exempt Determination
Document(s) REVISED: SOP Exempt Determination; APPLICATION: Determination, Exempt Status (Word and PDF)
Description SOP and forms revised to include new Exempt Category 7.
Expected impact High
Related changes None
Link for more information See article in this eNews, or documents themselves, linked above.
Implementation date May 30, 2014