HS-IRBs News - August 2010
Health Sciences and Minimal Risk IRBs, IRB News / Volume 2, Number 8, 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.
- For information on quick-start training sessions being offered this fall or scheduling an ARROW demonstration for your group, please see the special ARROW edition of the newsletter on Health Sciences IRBs News of the HS IRBs website.
- For information on what going live with ARROW means, please see the [Link for document 17172 is unavailable at this time]
If you have any questions about the final phase of ARROW rollout, please email firstname.lastname@example.org.
- Are you a future ARROW user and curious about the system? A variety of ARROW resources can be found on Health Sciences IRBs ARROW Help
- of the HS-IRBs website, including demonstration videos which provide a good idea of what the system looks like and how it works.
- Smartform Tip: When completing applications in ARROW, please read each question carefully. Many questions are new or phrased differently than those in the current paper applications. Since several questions in ARROW will branch the application to different pages depending on the answer, so making accurate choices will save time during the pre-review process. If you are not sure how to answer a question, please ask for assistance.
- Getting Help: Current ARROW users can get assistance with using ARROW by calling the Help Line (262-0041) from 9-3 Monday through Friday. Questions also can be emailed to email@example.com.
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.
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 firstname.lastname@example.org.
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:
- Only changes of protocol that affect local procedures need to be submitted for review and approval to the HS-IRBs. These include revisions to data transmission procedures, local personnel changes, and changes to information associated with data, images, or samples provided to the UW-Madison or the type of data, images, or samples the UW-Madison will review.
- Copies of revised documents (e.g., study-wide protocol, IDBs) that do not affect the analysis center activities do NOT need to be submitted with the continuing review application. Changes to these documents should instead be described in the continuing review application
The full text of the guidance is also posted on the Policies and Guidance page of the HS-IRBs website.