HS-IRBs News November 2016

Health Sciences and Minimal Risk IRBs, IRB News / Volume 8, Number 11, November 2016

Upcoming Workshop: Post-IRB Approval Submissions and Post-Approval Monitoring

A new workshop for researchers is being offered by the campus Post-Approval Monitoring (PAM) program in partnership with the Health Sciences IRBs office. This session will begin with HS IRBs staff discussing the what, when, and how of IRB submissions that occur after IRB approval (i.e., continuing review, change of protocol, closure, and reportable events). PAM representatives will give an overview of the program and discuss the most common findings from PAM Reviews.

  • Tuesday, December 6th - 11 AM to 12 PM, CSC Room G5/113 - Registration available here.

HS-IRBs Office Closures

The HS IRBs Office will be closed or have limited coverage the following days in November:

  • November 24th: The office will be closed in observance of the Thanksgiving holiday with no coverage, including for ARROW.

  • November 25th: The office will be closed. Limited coverage for urgent HS-IRBs and ARROW issues will be provided from 9AM to 3PM only by email via asktheirb@medicine.wisc.edu.
  • WIRB offices are closed both November 24th and 25th. No WIRB coverage will be provided by the HS-IRBs those days.

HS IRBs Office Staff Updates

The HS-IRBs Office is welcoming some new and returning staff members:

  • Welcome: Amy Neeno-Eckwall has joined the HS-IRBs Office as a full-time staff reviewer who will be supporting both the HS and MR IRBs. Amy has a JD and an MD, and she looks forward to using her analytical ability and research experience to help study teams. 
  • Welcome Back: Curtis Ryals previously served as an IRB staff reviewer and is returning to the office on a part-time basis. He will be focusing primarily on full changes of protocol for the HS-IRB Board as well as helping with NCI-CIRB and WIRB studies.

Updated Investigator Responsibilities Guidance

Research teams are responsible for ensuring language in IRB-approved consent documents for their studies regarding provisions for medical care or other services for research-related injuries is consistent with the wording in the contracts and funding agreements supporting those studies. This requirement applies regardless of the IRB that reviews the study (e.g., a UW IRB or IRB external to the UW) and has been in place for studies reviewed on behalf of the UW by the Western IRB since 2008. We are now clarifying that ensuring the consistency of consent forms and contracts/funding agreements applies to all studies. The Summary of Investigator Responsibilities document has been updated to reflect this requirement.

ARROW Updates

In partnership with our colleagues in the Vice Chancellor for Research and Graduate Education's IT area, the HS IRBs Office is continually making improvements to ARROW to make the IRB review process easier for study teams. Planned improvements include:

  • More Information about the Status of Applications: Study teams can monitor where their application is in the IRB review process by looking at the labels in the upper left-hand corner of the main protocol workspace. Previously, these labels just had a title (e.g., Issues Pending, IRB Pre-Review, Assigned to Meeting). New labels will now provide additional information and indicate when next steps need to be taken. For example, the Issues Pending state will now read: "Action Required. Respond to IRB reviewer questions and submit for review." This information is being added to make it easier for study teams to see where their applications are in the review process.
  • New Path for Completed Exemptions: Projects that have been determined to be exempt and have not been extended by the study team at the five-year mark will now go to a new Exemption Completed state. This will clarify for study teams the status of their exempt projects as well as options for extending or archiving those applications. Please our guidance for additional information. 

Please contact the ARROW Help Desk Team at askarrowirb@medicine.wisc.edu with any questions about these changes or improvements you would like to see.

ARROW Email Sync and Listserv Update

The Vice Chancellor for Research and Graduate Education's IT have conducted an email sync to link the email addresses in ARROW with those listed in the Human Resources System (HRS). Those affected should have already been contacted via email from the ARROW Support Team, and further updates have been posted on the ARROW homepage. The sync occurred on November 15th. At this point, study teams are no longer be able to edit their email addresses within ARROW. If study teams wish to change their contact information, please follow the guidance available here to change a business email address.

At the end of November, the HS IRBs Office will update its general announcements listserv. Key regulatory personnel as well as PIs and points of contact on current, active ARROW applications will remain on the list. All other email addresses will be removed so as to improve deliverability rate and reduce unwanted messages. If removed in error, study teams can email join-hs_irbs_announcements@lists.wisc.edu to receive the newsletter and other IRB updates. After this first update, it is expected that further updates will occur on a semi-annual basis. 

Please contact the ARROW Help Desk Team at askarrowirb@medicine.wisc.edu with any questions about this process. 

Improving IRB Processes for Researchers

As part of our continuing efforts to improve processes within the HS IRBs Office, we will be changing our process for stamping consent forms in January. Starting at that point, the stamps of IRB approval for consent forms, information sheets, and assent forms will not include an expiration date or the IRB FWA number.

These study documents will no longer expire on an annual basis, and study teams will not need to update their consent documents at every continuing review. Instead, documents will be stamped upon initial approval, re-stamped with changes that involve a revision to the consent document, stamped if new consent documents are added, and stamped with 5-year replacement applications. If study teams need to know what version to use, the most recently approved consent document(s) can be found in the Study Documents tab of the main study workspace in ARROW.

For any questions or concerns regarding this, please contact Peter Johnson in the Office of Research Policy at 608-890-1241 or peter.johnson3@wisc.edu.

Keywords:newsletter, listserv, states, exemptions, email, investigator responsibilities, contracts, consent   Doc ID:68473
Owner:Monica E.Group:Health Sciences IRBs
Created:2016-11-08 13:37 CSTUpdated:2016-12-20 09:40 CST
Sites:Health Sciences IRBs
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