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Human Subjects Division (HSD)

Announcements

eNews re: IRB Review - July 7, 2014

Jul 11, 2014 at 9:34am

A Table of Contents

Implemented June 19, 2014

"Wow!! This looks AWESOME! Very straightforward order and grouping. I love it!"

HSD received this comment shortly after implementing the new organization and table of contents for our Policies, Procedures, and Guidance. The documents are now organized by topic and subtopic. In addition, links to relevant forms and worksheets are now co-located with the policies and procedures. This should make it significantly easier to find what you need. The alphabetical browse A-Z list and the search function remain available too.

 


Flexibility Initiative: Part 2 of 12

A year-long focus on regulatory flexibility

Did you know that many institutions do not allow IRB office staff to be IRB members? There is no regulatory basis for this policy.

We receive about four new Minimal Risk applications and three new Exempt applications for every one new application that requires full IRB committee review. HSD currently has 12 full time review staff who focus exclusively on doing Minimal Risk and Exempt reviews. Imagine how many additional faculty members would need to join our IRBs if our staff members weren't able to do these reviews! Also, consider the tremendous time pressures our faculty members already face to obtain funding, do research, teach, and (in many cases) treat patients at the UW clinics.

A mental exercise: Twelve staff at 40 hours per week equals 480 hours. If each faculty IRB member contributed four hours per week to Minimal Risk and Exempt reviews, we would need an additional 120 IRB members to maintain our current turn-around times for review and approval.

For well over a decade, the UW has allowed HSD staff to be members of the IRB, primarily for the purpose of doing Minimal Risk and Exempt reviews. To ensure high quality reviews, we hire well qualified staff and put them through a lengthy apprenticeship-style training program. Most of our Minimal Risk staff have advanced degrees and/or significant experience in the fields that they review. We believe this approach ensures the protection of human subjects in addition to protecting the time of our faculty members.

Flexibility Initiative Part 1: A new category of exempt research.

 


 

Status Report Improvement

A time-consuming question has been removed.

Question C.3. has been deleted from the APPLICATION: Continuing Review (Status Report), Renew or Close. The question required researchers to list all modifications, problem reports, and conditional approval responses submitted to the IRB in the past approval period (usually one year), including the HSD number assigned to the item and the date it was approved. The form is used at least once a year by every IRB-approved study.

The question is not required by the regulations, nor does it provide information relevant to the criteria for IRB approval. It was added a few years ago with the intent of making it easier and faster for the IRB members to do the annual re-review of each study; however, it has not had any noticeable effect.

Completing the list required significant time for most researchers. Also, confirming its accuracy has been a major source of "back and forth" between HSD staff and researchers which required additional time. Deleting this question is a "win" for everyone.

 


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 Status Report
Document(s) REVISED: APPLICATION: Continuing Review (Status Report), Renew or Close.
Description Removal of question C.3. - the table asking for all modifications, problem reports, and conditional approval responses sent to HSD in the past year.
Expected impact High
Related changes None
Link for more information See article in this eNews, or document, linked above.
Implementation date June 30, 2014