Health Sciences and Minimal Risk IRBs, IRB News / Volume 8, Number 7, 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.
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 email@example.com or 608-890-4399.
If you have questions about these changes to ARROW, please e-mail firstname.lastname@example.org.
New Guidance Documents
Two new documents on KnowledgeBase (KB) have recently been developed by HS IRBs staff and are available for study teams to use:
- 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.
These documents are part of a larger effort to facilitate the IRB process and provide clear information to study teams. Spearheaded by the newly formed Guidance and Standard Operating Procedures (SOPs) Working Group, the Health Sciences IRBs Office is updating current internal and external guidance and SOPs, reducing redundant materials on KB, and drafting new guidance and SOPs. If you have any questions or suggestions for GSWG, please contact Tesha Zimmerman at email@example.com
New VA Research HIPAA Authorization Template
The Madison version of the VA Research HIPAA Authorization has been release and is available here
. If your study uses individually identifiable health information collected for VHA research, please use the updated form with new IRB submissions. For more information, please contact Lynn Tarpey, VA Privacy/FOIA Officer/Records Manager, at 608-256-1901 x11699.
Questions? We're Here to Help!
Whether you have a question about a specific protocol, a general question about the submission process, or need clarification about research policy, we have several ways you can reach us.
- Urgent issues (e.g., subject
safety concerns), please call our main line (608-263-2362) and ask to speak with
the staff reviewer on call for the day. Please do NOT use email for these kinds
- General IRB questions, please call our main line (608-263-2362) to speak with the staff reviewer on call
or email firstname.lastname@example.org. These are the quickest ways to get help with general
- Specific questions regarding the status of your review and/or reviewer notes, please contact the staff reviewer assigned to your application.
- Help with single IRB review and reliance questions, email irbreliance.wisc.edu.
- Assistance with ARROW or technical questions, email email@example.com.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing firstname.lastname@example.org.
- WIRB updates, please sign up for the WIRB listsserv by emailing email@example.com with a request to be put on the list.
- Consultations: For investigators seeking assistance on a specific program or application, HS-IRBs staff are available for individual consultations. To request a consultation, complete the HS-IRBs Presentation and Consultation Request Form.
- Presentations: The HS-IRBs office is available to provide the research community with presentations and trainings on a variety of topics. To request a presentation, complete the HS-IRBs Presentation and Consultation Request Form.