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Human Subjects Division (HSD)

Announcements

eNews re: IRB Review, August 30, 2013

Sep 1, 2013 at 9:44am

REVISED Policy about Lapsed IRB Approvals

Effective August 30, 2013

The change: Studies whose IRB approval has lapsed will now be closed approximately 60 days after the approval expires, instead of 90 days. Exceptions may be granted when researchers make other arrangements with the HSD staff person that manages the study for the IRB.

This change will be implemented for all studies whose IRB approval expires on or after August 30, 2013.

When IRB approval has expired, all research involving human subjects must stop except those activities that meet specific subject safety criteria. "All" includes (but is not limited to): subject contact; data collection; and data analysis. Activities that occur without current IRB approval are considered to be non-compliance.

It is the researcher's responsibility to track IRB approval periods and ensure that IRB approval does not lapse. HSD sends reminders as a courtesy, but failure to receive or notice the reminders does not absolve researchers of this responsibility, nor does it change the consequences of a lapsed approval. The HSD reminders are:

  • An email to the lead researcher about 10 weeks before expiration
  • An email to the lead researcher about 6 weeks before expiration
  • An email to the lead researcher at or a few days before expiration
  • A Warning Letter sent by email and printed copy to the lead researcher and the study contact person, about 30 days after expiration

Additional information is provided in a new policy and procedure document called SOP Lapsed Approval, posted to the HSD website on August 30, 2013.

 


 

Research with Children

New section on the Vulnerable Populations supplement

The purpose of the new section is to provide researchers with a way to request a waiver of the requirement to obtain assent from children participants.

Federal regulations require researchers to obtain assent from children. Sometimes it is appropriate to waive this requirement - for example, the children may be too young or may not have the cognitive capacity to provide assent.

Until now, there was no mechanism for researchers to request a waiver of assent and to describe how their request meets the criteria for the waiver. This new section will reduce the need for "back and forth" between the researcher and the IRB about this issue.

See the Protected and Vulnerable Populations Supplement.

 


 

New Performance Metrics Report

Performance metrics are now available for the six month period ending June 30, 2013. The new Report includes the latest turnaround time data for review of initial applications, exempt applications, and modifications.

It also includes a new metric (see below) that will be a regular feature of all future reports.

All of our metrics reports, including this Report #18, are publicly available from the upper right corner of the HSD home page.

HSD has been gratified to receive compliments and inquiries about our metrics reports from IRBs and research administrative offices at other academic institutions. We encourage UW researchers to make use of this metrics information when planning the start-up activities for their research.

 


 

New Metric: Analysis of Turnaround Time

Our latest Metrics Report includes a new statistic that analyzes total turnaround time for IRB approval into two components: (1) IRB work time; and (2) Researcher response time.

Figure 11 on page 15 of the report shows total turnaround time to receive IRB approval for new applications reviewed by the full IRB averaged 59.5 days. Our new analysis shows that:

  • 53% (31.5 days) = IRB work time* (i.e., time on HSD's "desk")
  • 47% (28 days) = Researcher response time (i.e., time on the researcher's "desk")

*IRB work time includes:

  • Intake and assignment to an IRB
  • Pre-reviewing reading and screening
  • IRB member reading and preparation prior to a meeting
  • Scheduling application for IRB meeting
  • Writing and reviewing correspondence
  • Regulatory documentation

We recognize that these are averages, and that individual cases may vary widely from these values. However, we hope that this new addition to our Metrics Report will be of interest and value to researchers.

 


 

HSD Office Closed for Training

The HSD office will be closed so that HSD staff may attend an all-day training session on September 16, 2013. The reception desk will still be open for the Office of Sponsored Programs, and can accept submissions for HSD and the IRBs, but nothing will be processed on that day. If you are aware of any impending deadlines, please take our office closure into account, and plan ahead.

 


 

New and Revised Documents

We generally release and post all new and revised documents on the last Friday of every month. Please see the list of document chagnes on our eNews online.