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Human Subjects Division (HSD)

Announcements

eNews re: IRB Review - May 1, 2014

May 5, 2014 at 2:00pm

Additional Minimal Risk Staff

Minimal risk and exempt reviews have been the largest and fastest growing part of HSD's work for the last few years. There has been a significant concurrent decrease in applications requiring review by a full convened social/behavioral IRB. HSD believes that this represents a fundamental and permanent shift in our work that will continue to grow.

HSD was previously unable to increase Minimal Risk staff to keep pace with this change. Consequently, Minimal Risk approval turnaround times have increased. We are now happy to announce some long-awaited relief for our dedicated and over-worked Minimal Risk staff. Within three months, we will have:

  • Three new Minimal Risk administrators
  • One new Minimal Risk review coordinator

This is being accomplished by re-distributing staff and vacant positions within HSD. One of the social/behavioral IRBs will be discontinued as of June 30, and the staff associated with that IRB will joining Minimal Risk teams.

Next month's e-Newsletter will have more information about theses changes. We expect the transition to be smooth and to require no extra work for those researchers whose studies will eventually be transferred from the discontinued IRB to another social/behavioral IRB.

 


WIRB-Related Documents and Tools

HSD previously announced the availability of two significantly revised Standard Operating Procedure (SOP) documents that consolidated the dozens of previous, outdated documents about sending industry trials to Western IRB (WIRB) for IRB review.

Brecken Cardinal, HSD's Clinical Trials Administrator, has now completed revising or developing the suite of documents and tools about using WIRB for IRB review. Note the inclusion of two new items below. We hope that this suite of documents will greatly assist study coordinators and their principal investigators.

The completed suite includes:

SOP WIRB Review - Research Procedures Implemented 2/28/14
SOP WIRB Review - HSD Procedures Implemented 2/28/14
UW/WIRB FAQs and Frequent Errors NEW 3/28/14
UW WIRB Initial Submission High Level Process Diagram Revision 2/28/14
UW/WIRB Initial Submission Detail Level Process Diagram NEW 3/28/14
REQUEST AUTHORIZATION: UW/WIRB Revision 2/28/14
TEMPLATE: Consent Form, UW/WIRB Revision 4/25/14
TEMPLATE: Consent Form, UW/WIRB Clinical Pharmacology Unit (CPU) Revision 4/25/14
WIRB Fee Schedule 2014 Revision 2/14/14
WIRB Clinical Pharmacology Unit Fee Schedule Revision 5/10/13
WIRB Clinical Pharmacology Unit Services Brochure Revision 5/10/13

 

Feel free to contact Brecken with questions or comments, through hsdinfo@uw.edu or 206-543-0639. She is also available to meet with you or your research group, at your facility, to review the WIRB process and how to make it as efficient as possible for your group. Thank you, Brecken!

 


 

Research with Native Populations

Respect for Persons, Beneficence, and Justice. These are the three ethical principles of the Belmont Report: the document that underlies today's federal regulations on research with human subjects. The Belmont Principles address the rights, risks, and benefits for individual subjects but they have been criticized for paying little attention to the rights, risks, and benefits for groups of subjects. This is most likely to be an issue for research that involves distinct and identifiable groups in specific locations, such as Native populations.

Though federal human subjects regulations do not require it, the UW IRB believes that it is important to consider group rights, risks, and benefits of research with Native populations. The National Congress of American Indians (NCAI) Policy Research Center has published a Research Regulation Toolkit - a comprehensive set of tools and resources intended to support tribal leaders and their communities in regulating research. These tools also provide thoughtful insights for researchers working with tribal communities.

The toolkit includes documents on policy and practice considerations, a guide to reviewing research studies and an excellent guide on Community-Based Participatory Research in American Indian and Alaska Native Communities.