HS-IRBs News May 2012

Health Sciences and Minimal Risk IRBs, IRB News / Volume 4, Number 5, May 2012

HS-IRBs Office Closed on Memorial Day

The HS-IRBs Office will be closed Monday, May 28th in observance of Memorial Day. The ARROW helpline also will not be staffed on May 28th.

Update: Checking Human Subjects Research Training/CITI Certification

As mentioned in the March and April newsletters, a new activity in ARROW is now available for study teams to check human subjects research training/CITI certifications for all study team members. The new Record Human Subjects Training Snapshot activity lists training expiration dates for all study team members listed in the IRB application. It also will display in the History tab whether any study team members do not have the required training or have expired human subjects research training certification.

Per campus policy, all PIs are responsible for ensuring that study team members have completed the required human subjects research training. Beginning June 4th, study teams will be expected to use this activity before submitting any new applications or personnel changes. If the History tab for a submission indicates that a study team has not used the Record Human Subjects Training Snapshot activity, the study team will be asked to do so via a reviewer note during IRB administrative review or IRB pre-review. For information on how to check training certifications in ARROW, see [Link for document 23550 is unavailable at this time].

NOTE: If a study team member's training information appears to be inaccurate or incomplete in the list generated by the Record Human Subjects Training Snapshot, please email askarrowirb@medicine.wisc.edu. Training information may need to be manually updated by the HS-IRBs Office for study team members who took the training without using their UW-Madison netID and password.

New Guidance Documents on the Scientific Review and IRB Pre-Review Processes Now Available

Two new guidance documents describing what happens to an IRB application during the scientific review and IRB pre-review processes have been posted to the new investigators page of the HS-IRBs website:

Reminder: Keep Your List of Study Members Current

HS-IRBs guidance requires that study teams report the removal of study personnel within one (1) month of the removal of any personnel from the study, regardless of their role.  No additional steps are required for the removal of personnel not affiliated with UW-Madison, UWHC, or Madison VA, or who do not fall under UW-Madison IRB purview. Study team members who leave the UW and who are still listed as study team members often have expired human subjects training certification. These expired certifications can cause delays in processing personnel changes. For more information on when to submit personnel changes, see Principal Investigator Changes and Personnel Updates Guidance .

Coming Soon

Guidance - new or revised - will be forthcoming soon on the following topics and announced in future newsletters:

  • Reporting drug shortages
  • Time frames for submitting changes of protocol
  • Revised HS-IRBs Guidelines for Deferring IRB Review

Information previously provided on this page has been relocated to our new IRB website.

Please visit this page for information about connecting with the IRBs.

Keywords:newsletter, human subjects research training, CITI, snapshot   Doc ID:24399
Owner:Carol P.Group:Health Sciences IRBs
Created:2012-05-18 11:33 CSTUpdated:2015-06-09 15:14 CST
Sites:Health Sciences IRBs
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