HS-IRBs News March 2013

Health Sciences and Minimal Risk IRBs, IRB News / Volume 5, Number 3, March 2013

New Process for Five Year Renewal Notifications

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.

Welcome to the Health Sciences IRBs Office's New Office Manager

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 flevine@medicine.wisc.edu. Welcome, Faye!

ARROW Update: New IACUC Tab in the Study Team Worskpace

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.

Revised Expedited Change of Protocol Guidance

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. 

Improvements to the Campus Training Database

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.

New IRB Consultations Followup Process and Feedback Surveys

The HS-IRBs office has been offering in-person consultations to study teams for several years. To help ensure that the HS-IRBs consultation service is benefiting study teams as much as possible, a new followup process has been developed.  After a consultation, IRB staff reviewers are providing study teams with a short brochure listing additional HS-IRBs resources. The HS-IRBs office also now sends a followup email to study teams after their consultation that includes a link to a short survey asking for feedback about their consultation experience. Feedback from study teams on the consultation service is very helpful and we thank everyone who has taken a few moments to complete the survey so far.

Questions? We're Here to Help!

Whether you have a question about a specific protocol, a general question about the submission process, or need clarification about research policy, we have several ways you can reach us.

  • For 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 of questions.
  • For general IRB questions, please call our main line (608-263-2362) to speak with the staff reviewer on call or email asktheirb@medicine.wisc.edu. These are the quickest ways to get help with general questions.
  • For assistance with ARROW or technical questions, email askarrowirb@medicine.wisc.edu.
  • To receive the newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
  • To receive updates about WIRB, please sign up for the WIRB listsserv by emailing submitwirb@medicine.wisc.edu with a request to be put on the list.
  • Consultations: For investigators seeking assistance on a specific program or application, HS-IRBs staff are available for individual consultations. To request a consultation, complete the HS-IRBs Presentation and Consultation Request Form.
  • Presentations: The HS-IRBs office is available to provide the research community with presentations and trainings on a variety of topics. To request a presentation, complete the HS-IRBs Presentation and Consultation Request Form.

Keywords:newsletter, replacement, five year, 5, expedited change, consultations,   Doc ID:28980
Owner:Carol P.Group:Health Sciences IRBs
Created:2013-03-07 09:02 CDTUpdated:2015-06-09 16:14 CDT
Sites:Health Sciences IRBs
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