Health Sciences and Minimal Risk IRBs, IRB News / Volume 3, Number 6, June 2011
Newsletter Format Change
With the migration of the HS-IRBs website to a new platform, the newsletter will no longer be issued in PDF format and will be available only through the website. A link to each month's new newsletter will be sent to listserv subscribers. For those who want a paper copy, the online newsletter can be printed via both Firefox and Internet Explorer. If you have questions or suggestions regarding the newsletter, please contact Carol Pech (firstname.lastname@example.org).
Important: Using Preview Final Documents
A new activity - called Preview Final Documents - is now available in ARROW. Preview Final Documents generates a PDF preview of what uploaded consent and assent documents will look like after they have been approved and stamped in ARROW. This allows study teams to check the documents for any formatting errors before those documents are formally stamped in ARROW. This is important because the only way to correct a formatting error in a consent document after it is approved in ARROW is to submit an expedited change of protocol. Note that formatting errors are a result of coding differences between Microsoft Word and Adobe PDF, and not generated by ARROW itself.
Beginning immediately, study teams will be responsible for using the Preview Final Documents activity to check their uploaded documents for formatting issues. If study teams find an error in the previewed documents, they will need to revise the document so that the formatting is correct after the document is stamped. Basic formatting guidelines are posted on the HS-IRBs website: Working with Consent Documents. Study teams should contact email@example.com or the ARROW helpline (262-0041) if they need assistance with the reformatting a consent document.
Instructions and additional information on the Preview Final Documents activity is now posted on the ARROW page of the HS-IRBs website: [Link for document 18856 is unavailable at this time.]. Please note that after August 1, 2011, study teams that do not use the Preview Final Documents activity may incur IRB fees if an expedited change of protocol is required to fix a formatting error in an approved consent document.
HS-IRBs Guidance Now Searchable!
The Policy and Guidance page of the HS-IRBs website has been migrated to the new platform. This means that HS-IRBs guidance documents are now searchable. We hope that this will make guidance documents more accessible and useful for study teams. The main search engine on the website searches by keywords, so please use the advanced search function to search the full text of guidance documents.
Please note that HS-IRBs policies are developed by the campus' Human Research Protection Program (HRPP). The HRPP has not migrated to the new website platform, so these are not yet searchable via the HS-IRBs website. A link to the full index of HRPP policies is posted on the Policy and Guidance page.
ARROW Training Update
Until further notice, ARROW training for study teams will be available by request only. The following types of training are available for study teams:
ARROW Consultations: For individuals or small groups needing a refresher or assistance with specific issues, ARROW consultations are available by appointment at the HS-IRBs Office.
ARROW In-services: Study teams who would like training for larger groups of people should request an in-service.
Please email all requests for training to firstname.lastname@example.org. Please put consultation or in-service in the subject line and include the number of people in your group.
Glossary Now Available on the HS-IRBs Website
A searchable ARROW glossary is now available on the HS-IRBs website. The glossary includes brief definitions for most states and activities in ARROW. If you are not sure what an activity like Submit Issues Response does or what happens in a state like IRB Administrative Review, please check the glossary for more information.
Your Feedback Needed on HS-IRBs Documents!
With the migration of the HS-IRBs website to a new platform, study teams are able to provide feedback on many HS-IRBs documents, including ARROW FAQs, multisite research pages, informed consent information, and much more. At the bottom at many pages, study teams can let the HS-IRBs Office know if they found a document to be helpful or not as well as leave more detailed feedback. If you have ever found a document posted on our website to be confusing or to not quite answer your question, this is your chance to let us know. Website feedback is reviewed regularly, so please let us hear from you!
A technical upgrade was made to ARROW on June 23rd. The upgrade includes improvements for behind-the-scenes technical issues, but study team will also notice a couple changes:
Text search for personnel: When entering study team members in the IRB application, study teams can search for individuals by first or last name in a text box and do not need to use the pop-up (although this is still available).
Faster page loading: Pages in ARROW no longer load all at once, but rather in parts. This new form of page loading is faster, but it may mean that study teams may need to wait a couple additional seconds for all the information on a page to load. For example, when opening the My Home page, inbox and other tabs will appear but it may take additional seconds for the full the list of studies will appear.
Revised timeout notification: When study teams are working on an IRB application, ARROW will send a timeout notification if no activity has occurred (e.g., no saving, no data entry) for 60 minutes. At this 60 minute point, the screen will be shaded grey. ARROW will ask if you wish to refresh your session or exit. Choose the refresh option if you wish to continue working on the application. Please remember that is important to save your work regularly.
If you have any concerns regarding these changes, please contact the ARROW helpline or email email@example.com.
Coming in August: Guidance on How to Version Study Documents
New guidance on how to version documents is being developed and will be featured in the August newsletter.
Reminder about Selecting Study Team Members in ARROW
When adding study team members to the IRB application in ARROW, please check that the correct individual is being selected. The directory includes a large number of people and several individuals with very similar names may appear in the search results. The search results do display each individual's email address, so we recommend double-checking the email address to ensure that you do not select the wrong person from the list.
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
General IRB questions, please call our main line (608-263-2362) to speak with the staff reviewer on call
or email firstname.lastname@example.org. These are the quickest ways to get help with general
Specific questions regarding the status of your review and/or reviewer notes, please contact the staff reviewer assigned to your application.