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UWCCC HS-IRBs News June 2014
The Health Sciences IRBs Cancer Center Newsletter for June 2014
Welcome to the new UWCCC HS-IRBs Newsletter. This is our inaugural newsletter specifically for UW Carbone Cancer Center researchers. The HS-IRBs will be issuing a newsletter every-other month to the UW Carbone Cancer Center (UWCCC) that will include updates and reminders on policies and procedures that are pertinent to human subjects research being done in the UWCCC. This newsletter also will provide UWCCC study teams with consistent and important information related to human subjects protection policies, regulations and guidance. These newsletters will be archived on the HS-IRBs website so that they will be searchable for future reference. If there is a topic that you would like addressed in a future newsletter, please send a detailed description of the topic to firstname.lastname@example.org.
Note that in addition to the UWCCC HS-IRBs listserv, the HS IRBs host two other listservs: one for general updates and announcements (including a general HS-IRBs newsletter), and one for people who use Western IRB (WIRB).
To be added or removed from the listserv for this newsletter, individuals should submit a request to the HS-IRBs office by emailing email@example.com with the subject ‘UWCCCIRBNews Add/Remove’.
Have a question? The HS-IRBs Office Can Help
- General questions: The fastest way to get answers to general questions is to email askTheIRB@medicine.wisc.edu or call 263-2362 to speak with the IRB staff point of contact. If asking about a specific study, please provide the study ID number in the message.
- Urgent issues: If you need assistance from the IRB office with an urgent issue (e.g., reportable event, subject safety concerns), please call 263-2362 and ask to speak with the point of contact. Please do NOT email these questions to asktheirb or other IRB office staff.
- Questions about responding to reviewer notes: If you have questions about how to respond to a Reviewer Note in ARROW, contact the staff reviewer assigned to reviewing your application. Individual contact information can be found here.
- IRB Consultations: If you would like to request a meeting with an IRB staff reviewer to discuss specific questions about an upcoming study, complete the HS IRBs Consultation Request Form.
- ARROW assistance: If you need technical assistance with ARROW, email your question to firstname.lastname@example.org
Using the NCI Central Institutional Review Board (NCI CIRB)
Information about UW-Madison requirements and procedures for using the NCI CIRB is available on the HS IRBs website. Updates related to CIRB procedures will also be announced through this newsletter. Jennifer Fenne on the HS IRBs staff is the UW’s primary contact for the NCI CIRB. If you have questions about using the CIRB, please contact Jennifer at email@example.com or 263-8914.
Reportable Events: What to Report and When?
The HS-IRBs office frequently gets questions from UWCCC researchers about what events need to be reported to the HS-IRBs office and when. The HS-IRBs office provides a resource to help researchers know what adverse events, noncompliance, unanticipated problems, and new information need to be reported and the timelines for reporting these events to the HS-IRBs office. The HS-IRBs Reporting and Submission Timeframes table can be found here. Additional information about reportable events can be found on the Adverse Event and Other Incident Reporting page on the HS-IRBs website. Contact the HS-IRBs office at 263-2362 if you have questions about what needs to be reported.
A Note on Version Dates
Documents that will be used by a study team in the conduct of a study must have a version, whether provided by the sponsor or the study team. Such documents include, but are not limited to, the following: study protocol, consent and assent documents (including information sheets), authorization forms, data collection forms, recruitment materials, phone screening scripts, and questionnaires and similar survey tools.
Study documents provided by a sponsor or cooperative group do need to be versioned. If the documents already include a version date and/or number, the UW study team does NOT need to provide any additional versioning. If a document provided by a sponsor or cooperative group does not include a version date and/or number, the study team will be asked to add a version date.
The version date can be located anywhere in the document except for the lower right-hand corner (which is where ARROW stamps certain documents). If the document has multiple pages, the version date should be included on each page.
Additional information about how to work with version dates for study documents can be found in the How to Version Study Documents guidance on the HS-IRBs website. Remember to use the Preview Final Documents Activity in ARROW to see what the final, stamped, documents will look like after they are approved in ARROW.
A Reminder about Review Timelines
If your application has a 90-Day Review Deadline or other deadline, this should be noted in the comment box of the Submit activity form in ARROW. In the note, make sure to specify the deadline date. If the study team forgets to include a review timeline request in ARROW when submitting the application, the study team must contact the assigned IRB staff reviewer via email to communicate the request. Determinations about review priority are made at the discretion of the IRB Office. Guidance on Submitting Changes with a 90-Day Review Deadline can be found here.
Future IRB for Beginners Workshops
The upcoming IRB for Beginners Workshop dates have been posted. Check out the Health Sciences IRBs website for future dates and information about how to register.