HS-IRBs News June 2015

Health Sciences and Minimal Risk IRBs, IRB News / Volume 7, Number 6, June 2015

HS-IRBs Staff Updates

A Final Farewell: Sherry Holcomb, MR IRB staff reviewer, has been working part-time for the HS-IRBs Office remotely since relocating in July 2014. Sherry will bid a final farewell to the office at the end of June.  We want to thank Sherry for all of her hard work over the years. Sherry has been an invaluable member of the HS IRBs Office and we wish her all the best.

Filling In: With Sherry's departure, Monica Esquibel will be taking over the review of exemptions previously covered by Sherry. Questions about any items that Sherry previously reviewed can be directed to Gretchen Anding (263-4170).

New: HS IRBs Informed Consent Working Group Wants to Hear from You!

HS IRBs staff are working to revise and improve the informed consent form templates and informed consent-related guidance for the research community. We need your suggestions and ideas so we can create templates and guidance that are most helpful for you. Please provide your feedback and suggestions by emailing asktheirb@medicine.wisc.edu. Please include "informed consent feedback" in the subject line.

Tips for Handling Personnel Leaving or Joining UW-Madison

Since summer is often a time of transition on campus, please keep the following tips in mind for handling study team members leaving or joining UW-Madison:

  • Per the HS IRBs' Principal Investigator Changes and Personnel Updates Guidance, study team members leaving UW-Madison must be removed from the IRB application within 1 month of departure from the study team.
  • If personnel leaving UW-Madison will continue to be engaged in human subjects research for a study, please remember that the HS-IRBs cannot automatically remain the IRB of record for these personnel.   Please contact the HS-IRBs Reliance Team to discuss what additional steps may need to be taken to ensure these personnel continue to have appropriate IRB oversight for their study activities.
  • Any change in principal investigator (PI) requires a full change of protocol and must be submitted at least 14 business days prior to the current PI's departure. Please see How do you change the responsible principal investigator (PI)? for more information.
  • New personnel should be added to the IRB application via a personnel change prior to or at the time when the new personnel will engage in human subjects research. Please see the Personnel Change Guidance linked to above for more information, including limited exceptions to this time frame.
  • Personnel joining UW-Madison may be able to receive credit for human subjects research training completed at another institution. Please see Instructions for Linking Previous CITI Training to Your NetID for more information.

Continuing Review and Checking Training Certifications

To assist the campus human research protection program in ensuring that all study team members have current human subjects research training certification, HS IRBs staff are reviewing study team training certifications at the time of continuing review. If study team members are found to have expired training, the study team will be asked to request that they renew their training or remove them from the study team via a personnel change. Study teams also can help with monitoring training certifications by doing the following:

  • Use the Record Human Subjects Training Snapshot activity in ARROW to check the current training certifications for your study team. Please see [Link for document 23550 is unavailable at this time] for more information.
  • If the snapshot indicates someone has expired training certification and you wish to remove this person from the study team, please submit a personnel change to do so. Personnel changes can be submitted at the same time as a continuing review. For more information on submitting personnel changes, please see [Link for document 19971 is unavailable at this time]
  • In future, ARROW will be able to check for personnel with expired netIDs and study teams will be requested to remove anyone with an expired netID from the study team. In anticipation of this and consistent with Principal Investigator Changes and Personnel Updates Guidance , please keep lists of study team members current by submitting personnel changes whenever someone leaves the study team.

ARROW Outage in June

Due to upgrades and maintenance, ARROW will be unavailable June 27th from 1PM to 5PM. We apologize for any inconvenience.

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, listserv, leaving, personnel, continuing review, informed consent, templates   Doc ID:51942
Owner:Carol P.Group:Health Sciences IRBs
Created:2015-06-04 12:17 CSTUpdated:2017-05-30 09:16 CST
Sites:Health Sciences IRBs
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