HS-IRBs News November 2011
Health Sciences and Minimal Risk IRBs, IRB News / Volume 3, Number 11, November 2011
In observance of the Thanksgiving holiday, the HS-IRBs office will be closed on November 24th. The office will be open from 9AM to 3PM on November 25th and resume normal hours on November 28th.
Please note that the ARROW helpline will not be staffed November 24th and November 25th.
Western IRB Holiday Coverage and Closings
The HS-IRBs office will have no WIRB coverage on November 24th and 25th. WIRB offices also will be closed on November 24th and 25th in observance of the Thanksgiving holiday.
Important: ARROW Helpline Changes Coming in December
Beginning December 5th, 2011, all calls to the ARROW helpline will be directed to voicemail only.â IRB staff will monitor voicemails from 9AM to 3PM Monday through Friday and will return all calls received before 3PM on that same day. Calls received after 3PM will be returned the next business day.
This change is being made for several reasons, including a continuing decrease in the number of calls received by the helpline in recent months. Moving to voicemail only also will allow the HS-IRBs office to better allocate staff resources and provide more effective triage for incoming helpline calls.
The askarrowirb email help system will continue unchanged. The ARROW Guidance page of the HS-IRBs website also contains a variety of help materials, including FAQs and brief instructional videos.â ARROW consultations and in-services continue to be available by request and study teams are encouraged to request training as needed. All training requests should be emailed to firstname.lastname@example.org.
Uploading Revised Documents in ARROW
When uploading revised documents in ARROW, please keep the following in mind:
- Always use the Upload Revisions button to upload revised documents. Do
NOT delete the current version of the document and/or upload
new documents. Please see Working with Revisions to
Consent and Authorization Documents in ARROW for more information.
- Always upload ONLY a tracked changes version of the revised
documents. Do NOT upload a clean copy in addition to the
tracked changes copy and do NOT upload a copy of the previous
version of the document.
Reminder: What Does NOT Qualify as an Expedited Change of Protocol
When deciding whether to submit an expedited or full change of protocol, please review the Expedited Change of Protocol Guidance . Selecting the expedited change option when the change requires full IRB review may cause additional delays in the IRB review and approval process. The following are examples of types of changes that CANNOT be reviewed under expedited procedures:
- Significant changes to study design, including adding or eliminating study arms or phases
- Study-wide increase in number of subjects enrolled
- Changes that adversely affect the risk/benefit ratio
- Changes to inclusion/exclusion criteria that require assessment by a medical
ARROW Tips: What “Copying Original Version” Means
When a new study is approved in ARROW or when a study team opens a change of protocol, ARROW creates a copy of the application. When this process is happening, the status of the application will display as Copying Original Version. Depending on the amount of traffic on ARROW, the normal copying process can take several minutes or even more than 1 hour. Although it may look like an application is stuck in the copy mode, this is often not the case if the copy process has been ongoing for less than a couple hours.
Some applications can become stuck in the copy mode, however, and the HS-IRBs office can restart the copy process for these applications. Restarting the copy process will not save time, however, if the original copy process was working properly. As a result, study teams are advised to keep the following in mind when they see Copying Original Version as the status for an application:
- For initial reviews, study teams should allow at least 1 hour before contacting the helpline to report that an application appears stuck in the copy mode.â This is especially important the mornings after an IRB meeting, when several staff reviewers may be approving applications at the same time. This can cause the system to take additional time when copying an application and this is not typically an error in the system.
- For changes of protocol, study teams should allow at least 30 minutes before contacting the helpline to report that an application is stuck in the copy mode.