Health Sciences and Minimal Risk IRBs, IRB News / Volume 5, Number 3, March 2013
The HS-IRBs office has implemented a new process for notifying study teams that a study or protocol is subject to the campus Five Year Policy. This policy requires a new initial review application be submitted to replace a study or protocol that has been open for 5 years unless it qualifies for an exception as described in the HS-IRBs Exceptions to Five Year Renewal Policy. For such studies/protocols, no further continuing reviews can be submitted unless the study or protocol qualifies for an exception.
The HS-IRBs office currently includes a notification about the five year policy in the continuing review approval letters for protocols that have been open for 5 years and that do not appear to qualify for an exception. Although this process will continue, the HS-IRBs office will now also email a copy of any continuing review approval letter that includes a notification about the five year policy to the protocol Principal Investigator and all points of contact. This is being done as a courtesy to study teams to ensure they have ample time to prepare to submit a replacement application, if needed, by the required deadlines. Replacement applications must be submitted no later than 90 days prior to expiration of IRB approval for non-VA studies/protocols and 150 days prior to expiration of IRB approval for VA studies/protocols.
NOTE: The HS-IRBs exception policy is currently being revised. The revisions will be announced in a future newsletter.
Faye joined the HS IRBs Office in February and was previously the Operations Program Associate for the Division of Mental Health and Substance Abuse within the Wisconsin Department of Health Services. One of Faye’s major duties is working with IRB fees. Any questions about fees can be directed to her. Faye is a wonderful addition to the HS IRBs Office, and comes to us with great experience and a penchant for problem-solving. She can be reached at 263-4922 or email@example.com. Welcome, Faye!
Study teams may have noticed that an IACUC tab has recently appeared in the study team workspace. This is in preparation for the Research Animal Resources Center (RARC) going live with ARROW in 2014. ARROW uses the same workspace for all study teams, so the IACUC tab will be visible to all study teams regardless of the type of research they do.
A revised version of the Expedited Change of Protocol Guidance has been posted to the HS-IRBs website. Several revisions have been made and a tracked changes version of the revised guidance also has been posted. To assist study teams with determining whether a change may qualify for expedited review, a new table with examples of common types of changes also has been posted.
The campus database that tracks human subjects research and other training certifications has been updated to include a netID icon. After clicking on the details link in the campus lookup database, a netID icon now appears next to the training course name if the person took human subjects research training using a netID. This is important because if people take training without using a netID, their training data will not automatically updated in ARROW. If training is taken without using a netID, please refer to the instructions for connecting a UW-Madison CITI account with a UW-Madison netID.