HS-IRBs News - August 2010

Health Sciences and Minimal Risk IRBs, IRB News / Volume 2, Number 8, August 2010

Printer Friendly Newsletter August 2010

Final ARROW Rollout Coming in November

ARROW (the HS-IRBs new electronic submission and review system) has been rolled out to the research community in phases, with the 3rd and final phase now scheduled for this November. This means that all study teams will begin using ARROW on November 17, 2010.

If you have any questions about the final phase of ARROW rollout, please email askarrowirb@medicine.wisc.edu.

ARROW Updates

HS-IRBs User Survey Closing

The Health Sciences IRBs user survey is closing on August 31st. Thank you to everyone who took the time to provide their feedback. HS-IRBs Office will soon begin reviewing the responses and survey results will be reported in future issues of this newsletter.


WIRB Update

Due to the new ICTR DMC replacing the previous Data and Safety Monitoring Committee at the hospital-based General Clinical Research Center, now the Clinical and Translational Research Core (CTRC) a modification was necessary to the UW/WIRB Consent Template Language and the Required Optional Consent Language Check List text. The only modification made was the removal of the CTRC optional language block.  The removal of this entire block is acceptable since our statement, “Research oversight and research support offices at the University of Wisconsin-Madison…” located under, “Who can see your study records?” covers the Research Subject Advocate. 

The Required Optional Consent Language Check List version #3 will be accepted for initial application submission until August 31, 2010 with the CTRC language optional block marked “No.”  Starting September 1, 2010 version #4 of the check list, see attached, will only be accepted with all submissions.

If you have a WIRB study that utilizes the CTRC please remove the language block from your consent(s) at your next Change in Research (CIR) for the study.  WIRB will not automatically remove this language from your previously approved WIRB consent document; this is the research team’s responsibility to remove the language.

If you have any questions regarding this change please feel free to contact Colette Wagner at 262-7544 or caw@medicine.wisc.edu.

NEW: Guidance for Analysis Centers (Including Fundus Reading and Statistical Data Analysis Centers)

The HS-IRBs Office has issued new guidance for fundus reading centers and other statistical or specimen or image analysis centers for multi-site studies that streamlines the change of protocol and continuing review process. The following guidance is effective immediately:

The full text of the guidance is also posted on the Policies and Guidance page of the HS-IRBs website.