eNews re IRB Review

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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. We use this newsletter to alert you to those new documents. We welcome feedback and suggestions. (hsdforms@uw.edu)

 

Topic Regulatory Affairs
Document(s) NEW: SOP Data Collected Without IRB Approval; NEW: SOP Federal Reporting, REVISED: SOP Over-Enrollment
Description New and revised SOPs to help clarify what is, and is not, non-compliance.
Expected impact Medium
Related changes Removed old guidance document on over-enrollment.
Link for more information See documents linked above.
Implementation date November 22, 2013

 

Topic Vulnerable Populations
Document(s) NEW: SOP Pregnant Women; NEW: CHECKLIST: Pregnant Women 
Description New SOP and checklist to document and track the regulatory requirements involved in using pregnant women as a target or as an incidental population. 
Expected impact Medium
Related changes None
Link for more information See the documents linked above.
Implementation date

November 22, 2013

 

Topic Main Application for Human Subjects Review
Document(s) UPDATED: APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee
Description Added reminder questions for COPPA, PPRA, FERPA, and registration with ClinicalTrials.gov.
Expected impact Medium
Related changes None
Link for more information See the eNews article above, and the application linked above.
Implementation date

November 22, 2013

 

Topic Other Federal Regulations
Document(s) NEW: SOP Children and the Internet (COPPA); NEW: SOP Research Involving Students
Description New SOPs regarding other federal regualtions to take into consideration: COPPA, FERPA, and PPRA.
Expected impact Low
Related changes Added reminder questions to the APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee, APPLICATION: Specimen or Data Use, Identifiable, APPLICATION: Modification, Approved Project and SUPPLEMENT: Protected and/or Vulnerable Populations.
Link for more information See documents linked above.
Implementation date November 22, 2013

 


 

light bulbQuick Tips from HSD

"An-ti-ci-pay-ay-shun..."

Here at QuickTips we've gotten used to that feeling. You may remember way back in 2011, the federal Department of Health and Human Services (HHS) announced that they were proposing major changes to the rules regarding the protection of human research subjects, aka the "Common Rule".

The ambitious proposal, titled "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay and Ambiguity for Investigators" sought to strengthen and streamline the human subjects research protections that have been in place since 1991.

But, things happen, and the whole proposal seems to have slipped quietly to the background. The HHS department has been a bit pre-occupied with other projects lately.

ketchup commercial

Don't worry, QuickTips and the HSD newsletter will keep you up-to-date when any new developments occur. So don't dismiss the possibility that we may someday have a modernized version of the "Common Rule"! Like for ketchup or Cat Stevens, we'll keep waiting!

 


 

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November 26, 2013

IN THIS ISSUE

New Questions on Main Form

Clinical Trials Registration

Personnel News

IRBshare Reminder

Presentation Recording Available

Email Size Limits

New and Revised Documents

Quick Tips

 

 


IRBshare is open for business! See the HSD website for more information.


 

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