February 7, 2023
For the Record-February 7, 2023: New Guidance on Reasonably Foreseeable Risks, Revisions to Human Subjects Research Determination Materials
In this Issue:
New Guidance on Reasonably Foreseeable Risks
Available Now
The regulations require that a description of any reasonably foreseeable risks or discomforts to the subject be presented as part of the informed consent process but does not define what this means nor offer guidance for researchers on how to pragmatically determine what to include in a consent form. This is particularly challenging for those doing interventional drug or device trials. The result is that we often end up with long, unwieldy consent forms that include every possible risk and occasionally situations where key risk information has been left out of consent forms.
HSD has developed new guidance for researchers that defines what reasonably foreseeable risks means and describes how to pragmatically ensure those risks that a reasonable person would find meaningful to their decision to participate in the research are included in the consent form.
This guidance was informed by FDA draft guidance, SACHRP recommendations, and input from multiple stakeholders including:
- IRB Chairs and members
- HSD staff
- HSD leadership
- Researchers (held two virtual focus groups in October 2022)
- Research leadership (e.g., department chairs, vice deans for research)
- Peer institutions (i.e., Seattle Children’s, Fred Hutch)
We want to thank everyone who provided thoughtful commentary and feedback.
Revisions to the Human Subjects Research Determination Materials
Worksheet Changed from PDF to Word and Content Reorganized
The WORKSHEET Human Subjects Research Determination and SOP Human Subjects Research Determination are often used by UW researchers to think through the question of whether their project is research and whether it includes human subjects according to the regulatory definitions. Researchers may also use these materials to make a self-determination that their project does not need IRB review and approval because it does not fit into these definitions.
On January 26th HSD posted revisions to these materials. The motivation for these revisions was to make it easier for UW researchers to access the materials and to improve the usability of the content.
The changes include:
- The worksheet was converted from PDF to Word format. Researchers often experienced technical difficulties when downloading the PDF from the website. Additionally, HSD is in the process of converting all our worksheets from PDF to Word to improve accessibility of our materials.
- The FDA definitions now come before the Common Rule definitions. While FDA regulations do not apply to most UW research, reviewing the FDA definitions first ensures appropriate consideration of whether a project meets the requirements for IRB review. The FDA section is much shorter than the Common Rule section.
- The website now provides researchers with instructions for making the determination and the SOP describes only HSD staff procedures. Researchers can find instructions on the webpages, Step 1: Is Your Project Considered Research? and Step 2: Does Your Research Involve Human Subjects?
If you have any questions about making a determination, please contact us at hsdinfo@uw.edu for assistance.
Zipline Contains Embedded Help Text
Did You Know?
Did you know that Zipline contains embedded help text to help you answer questions in the online portion of the IRB application? Simply select the embedded question marks as you proceed through Zipline to find relevant context, useful guidance, and suggested links to get more information.
