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.
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. We use this newsletter to alert you to those new documents. We welcome feedback and suggestions. (firstname.lastname@example.org)
NEW SOP Lapsed Approval, REVISED SOP Continuing Review
||A new standard operating procedure (SOP) describes the change in the lapsed approval closure window from 90 to 60 days
||Reminder emails, and warning letter templates
|Link for more information
||See the articles in this eNews and the SOPs, linked above.
August 30, 2013
Quick Tips from HSD
The Health Sciences shuttle bus lurched with the heavy traffic, causing some of the researcher’s coffee to slosh unexpectedly out of the “no spill” lid onto her lap.
"Darn this trip back and forth to Harborview," she muttered, wiping ineffectively at the small puddle with the plastic wrapping from her half-eaten sandwich.
The shuttle bus lurched again, but this time she was ready. With the sheaf of paper she had tucked under her arm, she covered the lid.
"Ack! That's my Modification Form!" She cried, as the realization of what she'd done hit her.
"Should have put that in an evelope instead of delivering it in person." Her always-helpful colleage was travelling to the main campus to attend a seminar; he sat right next to her.
"Thanks," she replied dryly. "I really want to get this into HSD! I think one of the IRBs is going to review my initial application next week, and I just realized that the number of subjects I requested wasn't enough..." The researcher trailed off as the sudden sound of a rattling newspaper, and cough, sounded behind her. "Sick people should just stay home..." she muttered under her breath.
"Ahem," the newspaper rustled again. "You should be glad you spilled coffee on that Modification Form."
"Excuse me?" The researcher turned fully around, only to see a giant headline announcing the problems with the Highway 99 tunnel dig.
"Yes, unless the IRB has already approved your application, you really shouldn't be sending in a Modification. There's nothing to Modify, because nothing has been approved. Instead, you should send in that Modification right after you receive your approval." The voice squeaked out from behind the paper.
She asked. "I wish I'd known that before coming over here from Harborview." The bus pulled up to the curb at one of the shuttle stops.
"And here's a napkin." A hand holding a compostible napkin from UW Food Services snaked out from behind the newspaper.
"Thank you." The researcher smiled, but before she could turn fully around, the stranger was out the open shuttle door and gone.
"Oh well," said her colleague. "You'll always have the Health Sciences Express."
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