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Human Subjects Division (HSD)

Announcements

eNews re: IRB Review - November 26, 2013

Dec 4, 2013 at 10:18am

New Questions on the Main IRB Application Form

Implementation date: November 22, 2013

In the past few months, some new questions have been added to the main IRB application form. The purpose of these questions is to provide the IRB with additional information that will help make the review process smoother and more efficient. The new questions include:

  • Section V. Type of New Submission. The purpose of this new section is to enable the assignment of new applications to a specific (consistent) IRB based on department/college/school and specific types of research, in place of the previous random assignment method.
  • Question IX.B.5. This section summarizes the required Supplements that may be needed for the application. It includes three new supplements, for research involving devices; drugs, botanicals, or biologics; or the Department of Justice.
  • Question IX.H.6. This question is used to identify research that is required to comply with federal regulations that apply to research on students or student records.
  • Question IX.H.11. This new question serves to remind researchers about a new requirement concerning billing subjects or subjects' health insurance for research related procedures.

 


 

Clinical Trials Registration: Impact on Billing for Research Procedures

Implementation date: January 1, 2014

For the past several years, most clinical trials have been required to register with a national database called ClinicalTrials.gov (see http://clinicaltrials.gov). This includes investigator-initiated trials. A new federal requirement states that the clinical registration number must now be provided as part of the billing process, when research subjects or their health insurers are billed for the cost of research-related services, procedures, and facilities fees for most clinical trials. Question IX.H.11 has been added to the main IRB application form, to remind researchers about this new requirement.

For more information about this new requirement, contact the UW Clinical Research Budget and Billing (CRBB) office:

For more information about how to register a clinical trial:

 


 

HSD Personnel News

Shannon Sewards has been promoted from Assistant Director to Associate Director. In addition to recognizing her many important contributions to HSD and the IRB, this promotion acknowledges her role of taking on the responsibilities and authority of the Director when the Director is unavailable or out of the office.

The HSD Compliance Team has been reconfigured and expanded to include additional regulatory responsibilities. It is now called the HSD Regulatory Team. The Regulatory Team consists of:

  • Assistant Director of Regulatory Affairs Maria Savage (mcsavage@uw.edu), who came to HSD in 2013 from the IRB at UC Berkeley.
  • Compliance Analyst Jean Kang (kangjj@uw.edu), who came to HSD in 2013 from the IRB at Pepperdine University.
  • Compliance Analyst Laurie Berger (lberger@uw.edu), who was previously an HSD Minimal Risk Administrator.

 


 

IRBshare Reminder

The Human Subjects Division (HSD) has teamed up with the Institute of Translational Health Sciences (ITHS) to bring you IRBshare: a centralized, electronic joint IRB review model for federally-funded multi-site studies that accelerates the review process by enabling a temporary reliance between member IRBs for initial review while maintaining UW IRB oversight for all subsequent aspects of a study (such as Status Reports and Modifications).

For the first year, the UW will use IRBshare to rely on other institutions (rather than allowing others to rely on us). This means that at least one IRBshare member institution must have performed its IRB review and uploaded the review materials into the secure IRBshare server.

See the HSD webpage on IRBshare or contact Shannon Sewards, Associate Director for Biomedical Operation (ssewards@uw.edu; 205-543-2254). Your study coordinating center may also have information.

 


 

HSD Campus Presentation Recording Available

For those that were unable to attend, and those that would like to review, a recording of one of the HSD campus presentations from earlier this month is now available on our website.

Click here to view.


 

Email Size Limits

UW-IT has limited the size of email messages at the UW to 25 MB in preparation for an upcoming migration to "UW Exchange Online". If you need to email a document(s) to an HSD staff member that is larger than 25 MB, please compress the item, break up the item into multiple emails, or contact hsdinfo@uw.edu for assistance.

 


 

New and Revised Documents

We generally release and post all new and revised documents on the last Friday of every month. Please see our newsletter online for a full description of the changes. We welcome feedback and suggestions. (hsdforms@uw.edu)