HS-IRBs News September 2017

Health Sciences and Minimal Risk IRBs, IRB News/Volume 9, Number 9, September 2017

Upcoming IRBs for Beginners Workshop

The Health Sciences IRBs for Beginners Workshop provides training on the HS IRB's processes, regulatory approval process, resources, and ARROW online application system. The two-hour workshop is held several times each year in the HSLC computer lab (room 2121), and is meant for individuals new to the HS IRBs processes or for those looking for help on how to effectively submit an IRB application. The workshop consists of two sections meant to provide the regulatory framework and technical skills to submit an application. The date and registration link can be found below.

If you have questions, please contact Jake Rome at jarome@medicine.wisc.edu.

Continuing Review Updates

In light of revised institutional policy and forthcoming regulatory changes, the continuing review workflow and form will be changed starting October 2nd, 2017. For studies that meet the criteria outlined in revised policy, the IRBs may decide not to require continuing review and the study will have a "Approved No CR" status in ARROW. Study teams managing these studies will no longer receive continuing review notifications from ARROW but will receive an annual reminder about ongoing IRB requirements. For studies that have expiration dates on or around October 2nd, IRB staff have been in touch with those study teams who appear to have studies that qualify for the exception. New resources, including an FAQ and a Decision Tree, have been developed to help study teams, and revisions have been made to other website documents.

In addition to the new "Approved No CR" status, study teams will notice that the continuing review form has been streamlined. Study teams will see questions that only apply to their type of research, and this will make the continuing review process more efficient and less time-consuming. Specific changes include:

If you have any questions about how the revised continuing review policy may apply to your study, please contact Emily Jenner or Jessie Johnson.

Upcoming Changes to ARROW Application

In partnership with our colleagues in the Vice Chancellor for Research and Graduate Education's IT area, the HS IRBs Office is continually making improvements to ARROW to make the IRB review process easier for study teams. Planned improvements for the September update include:

If you have questions about these updates, please contact askarrowirb@medicine.wisc.edu.

For more information on upcoming changes to ARROW, please see Vice Chancellor for Research and Graduate Education’s ARROW Updates page.

Coming Soon: Revised Common Rule Page

The HS IRBs' website will soon include a page dedicated to upcoming changes to the Common Rule, the federal regulations governing human subjects research. This page will include descriptions of the main changes, how they are being implemented by the HS IRBs, and when information sessions for study teams will be held. The new page will be announced in this newsletter as well as through our listserv.

WIRB Presentation and Q&A

Please join us for a presentation by WIRB on Wednesday, October 11, from 2pm - 3:30pm, HSLC 1345.

Our institutional liaison from Western IRB, Christopher Gennai, CIP, will discuss WIRB submission forms (Initial Review, Change in Research and Continuing Review Report) with special attention to the Promptly Reportable Information requirement. Christopher will continue by diving deeper into protocol deviations and the event surrounding the deviation. The session will also include time for questions and answers.

If you have questions, please contact submitwirb@medicine.wisc.edu.