HS-IRBs News July 2016

Improving IRB Processes for Researchers

As part of our continuing series on how the HS IRBs Office is working to improve IRB processes for researchers, we want to highlight the work of the Informed Consent Working Group (ICWG). ICWG’s overall goal is to enhance the quality of the informed consent process by improving the HS IRBs’ consent-related tools and guidance. ICWG’s first project has been to develop new tools to help research teams create informed consent forms that are clear, concise, and easier for research participants to read.

ICWG is now piloting these new informed consent templates and model consent language to test their usability and effectiveness. Eleven regulatory personnel have agreed to use the materials in new submissions to the HS IRBs.  The regulatory personnel, along with HS IRBs staff who review the pilot consent forms, will provide feedback about clarity of instructions, ease of use, formatting, and more. Thank you to all the research teams who have agreed to participate! 

ICWG will use the feedback from the pilot to make the consent templates as effective and easy as possible for research teams to use, with a goal of reducing the number of consent form modifications required during HS IRBs review process.  We will share the results of the pilot in a future newsletter when the new informed consent tools are finalized and posted on the HS IRBs website. If you have any questions, please contact ICWGquestions@medicine.wisc.edu. 

ARROW Updates

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. Changes coming at the end of July include:

• Improvements to Form Navigation: The existing grey links at the top of pages in IRB applications will be reformatted to display as distinct buttons to enhance visibility and make navigating forms easier.
• Earlier and More Frequent Pre-Submission Notifications: ARROW currently sends an email notification to study teams to remind them that an application has been in pre-submission for 90 days and has not yet been submitted to the IRB office. Later this summer, this notification will be sent to study teams twice - at 14 and 30 days - to help researchers better manage pending IRB submissions
• Good Clinical Practice Monitoring: The human subjects training snapshot activity in ARROW will begin monitoring for Good Clinical Practice (GCP) training data starting July 30th. Study teams engaged in research involving drugs, devices, biologics, or radiation will be required to take GCP training every 3 years. If you have any questions about this requirement, please contact the Office of Research Policy at hrpp@research.wisc.edu  or 608-890-4399. 

If you have questions about these changes to ARROW, please e-mail askarrowirb@medicine.wisc.edu.

New Guidance Documents

• Washout Period or Withholding/Postponing Standard Treatment Guidance: If a study requires washout of medications taken by any or all subjects or the withholding or postponement of standard treatments or medications, study teams should refer to this guidance. Highlights of this guidance include: a question-by-question walk-through of the washout/withholding section in ARROW, examples of when the guidance does and does not apply, and links to additional information. 

• Vulnerable Populations Guidance: Because specific regulatory requirements must be met if a study involves a vulnerable population, such as children, pregnant women, fetuses, or prisoners, this new guidance explains how to describe the inclusion of these populations in research studies. Specifically, it outlines the difference between "targeted" and "incidental" inclusion, includes details on justifying enrollment of such populations, and provides links to additional information.