HS IRBs News February 2019

Health Sciences and Minimal Risk IRBs, IRB News/Volume 11, Number 2, February 2019

Revised IRB Fee Policy

A revised IRB fee policy is now available and is effective as of January 1, 2019. The most significant change is that fees will no longer be charged for most studies that are NOT industry-sponsored. Questions about the IRB fee policy can be directed to vcrge@research.wisc.edu.

New Exemption Web Page

To make it easier for researchers to find information about exemptions, the HS IRBs website has been revised and now includes a page focused on exemptions. Highlights of this new page include:

  • Guidance on each new exemption category per the revised Common Rule
  • Sections on projects that do not involve human subjects or research, including a link to the not research decision tree
  • Information on when changes and reportable events may need to be submitted

New Single IRB (sIRB) Application in ARROW

To better accommodate studies involving four or more sites for which UW-Madison will serve as the reviewing IRB, ARROW now includes a special application for sIRB studies. Key features include:

  • A protocol-based, shorter initial review application for the overall study
  • Site-specific forms to collect site-specific information, including consent and authorization documents
  • Ability to add multiple sites at the same time

Study teams are strongly encouraged to contact the HS IRBs Reliance Team before using the sIRB application to discuss any reliance agreements as well as any questions about the sIRB application itself. For more information, see the “Introducing the New Single IRB Application” or email irbreliance@wisc.edu.

New Workshop Coming Soon: Understanding the Common Rule and the HS IRBs Submission Process

This new workshop provides an overview of the regulatory requirements for conducting human subjects research at the UW and the IRB submission process for projects requiring review by the Health Sciences IRBs. The current one-hour workshop is held several times each year and workshop attendance is encouraged for those new to the HS IRBs process or looking for help on how to effectively submit an IRB application. The focus of the workshop is on Common Rule requirements, the ARROW application system, and resources available to assist researchers with their submissions. This workshop replaces the previous IRB for Beginners Workshop series.

The next workshop is scheduled for Tuesday, March 5th from 2-3 PM in room 1325 of the Health Sciences Learning Center (HSLC). Registration for the workshop is available here. If you have any questions or issues registering please contact Jake Rome at rome2@wisc.edu.

Reminder: Updated Informed Consent Templates

To address the requirements of the revised Common Rule, we have updated our informed consent templates. The most noticeable changes relate to the “concise and focused presentation of key information” and clinically relevant research results. For lengthy consent forms (more than 10 pages), our templates address the concise presentation requirement by adding a brief introductory section based on our familiar Study Summary template. To address clinically relevant research findings, the updated consent templates add a new section to describe how research results will be handled. Additional changes to instructions and model language throughout the consent form templates are designed to comply with the revised Rule and institutional requirements.

Keywords:revised common rule, common rule, exemption, sirb, single irb, consent, template, fee, workshop   Doc ID:89482
Owner:Monica E.Group:Health Sciences IRBs
Created:2019-02-05 08:41 CSTUpdated:2019-03-27 11:43 CST
Sites:Health Sciences IRBs
Feedback:  0   0