HS-IRBs News October 2014
Health Sciences and Minimal Risk IRBs, IRB News / Volume 6, Number 10, October 2014
Important Update to Study Team Workspace In ARROW
In early November, ARROW will be updated to streamline what tabs display in the study team workspace. The IRB Inbox tab will no longer display separately and will instead become part of a single IRB tab. This change is being made to simplify the number of tabs in the study team workspace now that additional research compliance areas are using ARROW. If you have questions about this update, please email firstname.lastname@example.org. A view of the updated workspace is below.
Study Team Workspace
New Outreach Event: Reportable Event Refresher Session
The HS IRBs office is offering a new outreach event for study teams, a one-hour Reportable Events Refresher session. This event will be held on Tuesday, November 25th from 11AM to noon in CSC G5/119. Topics will include:
- What types of events need reporting and when
- What determinations the IRB makes regarding unanticipated problems and noncompliance
- Understanding corrective action plans
- Tips for what to include in your reports
We also will have plenty of time for your questions.
Registration is required for this session. To register or to let us know that you would like to participate but are unable to attend the November 25th session, please complete this short form: http://tinyurl.com/od7go24/. Please note that this session is for study teams NOT in the UWCCC; a separate session will be held for UWCCC study teams on November 11th.
New Quality Improvement Outreach Initiative
In a continued effort to assist study teams with using ARROW and navigating the IRB review process, the HS IRBs office will soon initiate a pilot quality improvement project. This project will involve IRB staff monitoring ARROW for initial review applications that may be stalled in the review process (e.g., those automatically withdrawn by ARROW or that have pre-review issues outstanding for more than 2 weeks). IRB staff will then reach out to these study teams to determine whether any additional assistance with the review process is needed or if an application is being withdrawn. The hope is this initiative will be especially helpful for new investigators who may be unfamiliar with ARROW or the IRB review process. If you have any questions about this project, please email email@example.com.
Email Recruitment Reminders
Several recruitment emails have been sent out recently that do not comply with institutional or federal requirements for recruitment materials. To help address some of these issues, here are some reminders about email recruitment:
- Use of email as a recruitment method as well as the content of the email must be specifically approved by the IRB. Proposals to use email to recruit must be included in the IRB application at initial review or submitted later as a change of protocol.
- Only “wisc.edu” emails should be used to send out recruitment emails and for any responses expected via email. This is to ensure an adequate level of security. Use of gmail, Hotmail, or other accounts outside the UW generally is not permitted.
- No protected health information should be requested via email because email does not meet the security protections required under federal privacy regulations.
- The subject line of the email should clearly state that it is an advertisement for a research study, such as: Seeking participants for a research study or Information about a Research Opportunity.
- The text of the email should clearly identify the source of the email list, such as “You are receiving this email because you are a student at UW-Madison. Your email address was obtained from the UW-Madison Division of Information Technology (DoIT).”
- If the study is a clinical trial, the use of the phrase “free treatment” is not allowed under FDA regulations.
For additional information, see [Link for document 18872 is unavailable at this time] .
Reminder: IRB for Beginners Workshop Dates
The last IRB for Beginners workshops for 2014 have been scheduled. The full schedule and registration information is available on the HS-IRBs website.
ARROW Outage November 1st
ARROW will be unavailable Saturday, November 1st from 1PM to 5PM for upgrades and maintenance. We apologize for any inconvenience.