HS-IRBs News December 2017

HS IRBs Office Closure

The HS IRBs Office will be closed the following days in December and early January:

• December 25th: The office will be closed in observance of the Christmas holiday with no coverage, including for ARROW. WIRB Offices will also be closed.
• January 1st: The office will be closed in observance of the New Year's holiday. WIRB offices will also be closed.

Revised Common Rule Webpage and Presentation

On October 7, 2017, the Department of Health and Human Services requested a one year delay of the general implementation of the revised Common Rule but requested three unidentified provisions outlined in the new rule to be implemented as of January 19, 2018. As of the date of this newsletter, no further announcements have been made regarding whether the implementation of the revised Common Rule will be delayed, in whole or in part. The University of Wisconsin-Madison continues to revise policies, guidance, and forms to address implementation of the revised Common Rule to applicable human subjects research approved on or after January 19, 2018. 

To learn more about these changes, please sign up for our upcoming information session:

• Friday, January 12th: 3:00pm - 4:30pm, HSLC 1325 - register to attend here

The HS IRBs' website also includes a new page dedicated to revisions to the Common Rule. We will regularly update this page to help study teams to stay informed about the impact the revised rule may have on their research.

Coming January 2018: Improved Ceded Review Process

ARROW will be updated in January to include a revised application and review process for studies ceded to an external IRB. A primary reason for this change is to reduce administrative burden for researchers by streamlining the review process for ceded studies, regardless of the type of external IRB reviewing the study. Highlights include:

• Streamlined application form for all types of ceded review
• Determination letters from the IRB regarding ceded review decisions
• After studies have been ceded, ability to update cede review applications to add new funding source or study team members

Collaborative Research and Single IRB Review is being updated to include a FAQ on the improved ceded review process as well as other resources for researchers. If you have questions about these changes, please contact the HS IRBs' Reliance Team.

Requirements for Relying on an Independent IRB

Starting 1/20/18, the UW-Madison Health Sciences IRBs Office will be implementing an updated submission process for using an independent or commercial IRB, including Western IRB (WIRB). Please join us for an overview of the process as well as time for Q&A.

• Monday, January 8th: 11am - 12pm, HSLC 1335 - register to attend here.

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

Education Needs Assessment Survey

A cross-campus education working group has been working to expand the educational offering to UW-Madison researchers. A survey was created to gauge the training needs of our research community. Your input will help us to prioritize the creation of these new opportunities. If you have not yet had a chance to complete this survey, it can be accessed here. The deadline to complete the survey is January 1st.

If you have questions, please contact Travis Doran at the Office of Research Compliance.

Updated Guidance Documents

The Guidance and SOP Working Group (GSWG) has updated the following recruitment guidance documents:

• Initial Recruitment Contact and Screening Guidance
• Document 50278 is unavailable at this time.
• Completing the Subject Identification and Recruitment Section

The documents provide new information regarding who can make first contact when recruiting subjects through a clinical setting as well as other minor updates.

If you have any questions or suggestions for GSWG, please contact Tesha Zimmerman.