HS-IRBs News May 2017

Health Sciences and Minimal Risk IRBs, IRB News / Volume 9, Number 5, May 2017

HS IRBs Office Closure

The HS IRBs office will be closed Monday, May 29th, in observance of Memorial Day.

Upcoming 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. Upcoming dates and registration links can be found below.

SMART IRB Update

As mentioned in previous newsletters, the Health Sciences IRBs office is helping lead the NIH-funded SMART IRB initiative to enable single IRB review for multisite studies. SMART IRB is a flexible, national IRB reliance agreement as well as complementary tools and resources to help streamline the IRB review process. Over 200 institutions across the nation have now signed on to the SMART IRB agreement. In addition, the SMART IRB online reliance system is now live in a beta phase. If you are interested in learning more about how SMART IRB and the online reliance system may be useful for your research, please contact the Reliance Team (irbreliance@wisc.edu).

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 June update include:

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

New Interim Guidelines for Use of Commercial IRBs Participating in SMART IRB

The HS IRBs are seeing an increasing number of requests from researchers to use commercial IRBs with which the UW does not yet have a contract and/or for studies that are not industry-sponsored. Although the UW is in the process of establishing contracts with a range of commercial IRBs, these arrangements will take some time to finalized. Consistent with its support for researchers to take advantage of single IRB review models, however, the HS IRBs will allow expanded use of commercial IRBs in limited situations. These interim guidelines will be in place until contractual arrangements between the UW and additional commercial IRBs are complete and revised criteria for use of these IRBs are finalized. These guidelines apply only to studies that are NOT industry-sponsored and for which the UW is not the lead site or coordinating center. These studies may qualify for review by a commercial IRB if all the criteria listed in the guidelines are met. If you have any questions about these interim guidelines, please contact the Reliance Team (irbreliance@wisc.edu).

Limitations on Use of Vanity Emails for Research Purposes

In March 2017, the HS IRB’s Office released new email guidance intended to assist study teams who want to use email for recruitment, scheduling initial study visits, and study participation. The guidance advises against using vanity email addresses that contain specific disease or diagnoses. If study teams are currently using these types of vanity emails under an IRB-approved application, they should contact the HIPAA Privacy Officer, Amanda Reese, amanda.reese@wisc.edu, for resources to change to a generic email. Please note, the IRB will need to be notified of the new email address via a change of protocol. If you have any questions or suggestions regarding the email guidance in general, please contact Tesha Zimmerman at tmzimmer@medicine.wisc.edu.