HS-IRBs News February 2015

Health Sciences and Minimal Risk IRBs, IRB News / Volume 7, Number 2, February 2015

New: Replacement Application Guidance

Campus policy requires new IRB applications be submitted for ongoing studies every five years, except in certain cases. These replacement applications should be submitted as a new initial review application in ARROW and at least 3 months (for non –VA studies) or 5 months (for VA studies) prior to expiration of the original application. To assist study teams in complying with this policy, a new guidance document on How to Complete a Replacement Application in ARROW is now available

This guidance document clarifies that replacement applications need to include a document called the Study Status Summary. Beginning March 2, 2015, a study status summary will be required for all replacement applications. To assist with review of the replacement application, this document will need to describe the following key aspects of study progress:

  • Proposed changes (if any) being made to the protocol, consent documents, or other study documents
  • Completed study activities that will not continue under the replacement application
  • Enrollment information for both completed and planned ongoing enrollment
  • Significant events in the study’s history that affected study progress (e.g., halted enrollment, funding loss)
  • Any reportable events (e.g., unanticipated problems, noncompliance, unresolved subject complaints) that occurred since the last continuing review for the study being replaced

As always, if you have any questions about this new guidance, please do not hesitate to contact us via any of the avenues noted below.

Update on HS-IRBs Quality Improvement Project

As announced in the October newsletter, the HS IRBs office launched a pilot quality improvement project.  The goal of this project is to reach out to study teams whose applications may be stalled in the review process.

Since beginning the project, nearly 300 emails have been sent to study teams and approximately 30% of study teams have responded to these outreach efforts. Although this is fairly high response rate, the HS IRBs office encourages any study team receiving these emails to be in touch with us. Knowing about unforeseen delays study teams are experiencing (e.g., funding delays, workload issues, etc.) during the IRB review process helps the HS IRBs office manage its review load more efficiently and improve turnaround times. We also are happy to assist study teams who encounter difficulties during the pre-review process and to provide guidance on next steps.

If you have any questions about this project, please email asktheirb@medicine.wisc.edu.

New Dates for IRB for Beginners Workshops

The HS IRBs office is again offering the IRB for Beginners Workshop. The 90-minute workshop is held in the HSLC computer lab and gives participants a first-hand look at resources available on the HS-IRBs website as well as tips for working with the ARROW submission system. The workshop also introduces participants to the IRB review process. This workshop is designed to help people who are new to the HS-IRBs review process.

This workshop is scheduled for the following dates:

Monday, March 23rd from 10-11:30 AM (HSLC Room 2121)
Thursday, March 26th from 3:00-4:30 PM (HSLC Room 2121)

Registration is required and space is limited. Please email asktheirb@medicine.wisc.edu to reserve your spot and include any questions or topics you would like addressed during the workshop.

ARROW Outage February 28th

ARROW will be unavailable Saturday, February 28th from 1PM to 5PM for upgrades and maintenance. We apologize for any inconvenience. 

Upcoming ARROW Improvements

ARROW will soon be updated to include the following important improvements:
  • New Help Links: Help links are being added throughout the initial review application to link to guidance documents on the HS-IRBs website. These links are being added to provide quicker access to guidance documents that may assist study teams in completing the application.
  • Revised Documents Tab: The current documents tabs in the main study workspace will be combined to create a single combined tab. The new study documents tab will include currently approved versions of the study protocol and consent documents as well as previously approved versions of these documents. This change is being made to provide easier access to previously approved documents.
  • Continuing Review Form Update: The continuing review form is being updated to allow study teams to select which consent documents they wish to have reapproved from a list of currently approved consent documents. This change is being made to help make this part of the continuing review process easier for study teams and the IRB alike.

Coming Soon: New Post-Approval Monitoring Program

The Office of the Vice Chancellor for Research and Graduate Education will be launching a Post-Approval Monitoring Program in March 2015. The Post-Approval Monitoring Program will expand the efforts of the Human Research Protection Program (HRPP) in providing education and guidance for investigators who have received Institutional Review Board (IRB) approval. The PAM Program is designed to improve the quality of research on campus and maximize protections for participants. The PAM Program is separate from the IRB offices on campus.

Under the PAM Program, active, non-exempt studies may be selected randomly for routine monitoring. After a study has been selected for monitoring, the PAM Program will notify the study team and schedule an initial visit.  At this initial visit, the monitor will go over the study with the study team and provide an opportunity to ask any questions about the review process. During the monitoring visit, the monitor will review study materials and be available to the study team for questions. Study teams will then receive a report of observations from their monitor.

If you have questions about the PAM Program, please contact Ryan Moze (ryan.moze@wisc.edu).

Questions? We're Here to Help!

Whether you have a question about a specific protocol, a general question about the submission process, or need clarification about research policy, we have several ways you can reach us.

  • For urgent issues (e.g., subject safety concerns), please call our main line (608-263-2362) and ask to speak with the staff reviewer on call for the day. Please do NOT use email for these kinds of questions.
  • For general IRB questions, please call our main line (608-263-2362) to speak with the staff reviewer on call or email asktheirb@medicine.wisc.edu. These are the quickest ways to get help with general questions.
  • For assistance with ARROW or technical questions, email askarrowirb@medicine.wisc.edu.
  • To receive the newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
  • To receive updates about WIRB, please sign up for the WIRB listsserv by emailing submitwirb@medicine.wisc.edu with a request to be put on the list.
  • Consultations: For investigators seeking assistance on a specific program or application, HS-IRBs staff are available for individual consultations. To request a consultation, complete the HS-IRBs Presentation and Consultation Request Form.
  • Presentations: The HS-IRBs office is available to provide the research community with presentations and trainings on a variety of topics. To request a presentation, complete the HS-IRBs Presentation and Consultation Request Form.

Keywords:newsletter, listserv, post-approval monitoring, PAM, replacement application, continuing review. documents   Doc ID:46853
Owner:Carol P.Group:Health Sciences IRBs
Created:2015-02-04 20:19 CDTUpdated:2015-06-09 16:14 CDT
Sites:Health Sciences IRBs
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