June 4, 2024
For the Record- June 4, 2024: Key Information Draft OHRP/FDA Guidance, Zipline Updates, New Human Subjects Training
In this Issue:
OHRP/FDA draft guidance, “Key Information and Facilitating Understanding in Informed Consent”
New Draft Federal Guidance and Associated Edits to UW IRB Resources
The Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) recently issued joint draft guidance (March 2024) on how to comply with the Revised Common Rule requirement that consent information “begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.”
The draft federal guidance is generally in agreement with existing published UW IRB resources. We have made some minor edits to our Key Information guidance and Separate Key Information Consent Template to incorporate some of the recommendations in the draft guidance.
These edits primarily include formatting changes to the Key Information section of the template and additional instructions for researchers who are conducting investigational drug and device studies.
Key Information
The Key Information should be unique for each study because it is intended to be the information that is most likely to assist the specific participant population with making an enrollment decision.
Researchers are responsible for identifying the Key Information for their studies and may benefit from reading publications about participant preferences and/or consulting with disease-focused non-profit groups, patient interest groups, or other researchers with experience with the study population.
Presenting Key Information
The Key Information requirement applies to the consent process as a whole which means there is flexibility in how the presentation of Key Information is structured so long as it is provided first and is organized and presented in a way that facilitates comprehension for the prospective participants.
Generally, information that is fully described in the Key Information section does not need to be repeated later in the process or form. Though there may be some limited situations when intentional repetition of information could improve comprehension or clarify complex concepts (e.g., certain risks, alternatives, uncertainty about direct benefits). Even when there is repetition, information should be briefly mentioned in the Key Information with a note that complete information can be found later in the form (e.g., provide a hyperlink or page number reference).
The UW IRB provides two optional templates for researchers.
- Separate Key Information Consent Template. This template has a distinct Key Information section at the beginning of the form. It should be used for complicated, higher risk studies that require the consent form to be more than 2,000 words in order to explain that complexity. The separate Key Information section helps prospective participants focus up-front on the information that is most likely to influence their decision. The rest of the form fills in additional details and provides other information that may be of interest and/or is regulatorily required.
- No Separate Key Information Consent Template. This template is for simpler studies, studies with few procedures, minimal risks, and/or that require 2,000 words or less to explain. The UW IRB considers these shorter forms to be concise and focused enough that they don’t require a distinct Key Information section.
If you have questions about the guidance or changes to UW IRB resources, contact hsdinfo@uw.edu.
Zipline Downtime
June 25, 2024
Zipline will be unavailable while we make some minor updates to the e-IRB system the evening of June 25, 2024, from 5 pm until 8 pm Pacific Time. Please remember to save your work and log off before this time.
Zipline changes. Most of the changes will not be noticeable to researchers, but we have made several updates based on user feedback including:
- The Modifications Required to Secure Approval letter for follow-on submissions will now automatically include the parent study number, for faster study identification.
- The Continuing Review notification email will now contain a direct link to the Status Report form, enabling researchers to quickly locate and download the form.
- As part of the Zipline Help Library redesign: the Zipline Help Center will be streamlined to direct users to the main Help Library page; unnecessary help bubbles will be removed from the Workspace and SmartForms; all affected URLs will be updated.
If you have any questions, please contact hsdinfo@uw.edu.
Zipline Website Redesign
Launching June 25, 2024
The Human Subjects Division is excited to announce a new design for our Zipline landing page and associated help materials launching on June 25. The goal of this project is to improve site navigation by providing clear pathways to the most needed information for all types of researchers, from students working with the IRB for the first time to experienced study staff. Our Zipline landing pages and Zipline Help Library will be under construction on June 25 and it may be more difficult to find materials that day as we make updates. Contact hsdinfo@uw.edu if you have any questions or need assistance.
Changes will include:
- Streamlined Zipline landing page featuring quick access to the most used resources
- Updated process overview pages designed to give new and infrequent users a high level overview of common actions such as applying for review
- Flattened structure in the Zipline Help Library with curated information to make it easier to find step by step instructions for common tasks such as updating the study team in Zipline
- Updated Zipline FAQs to address the most common questions about using Zipline
Thank you to all the members of our campus community who participated in interviews and provided in-depth feedback about our draft designs. Your insights helped to ensure that our final design is better suited to the needs of the UW research community.
Human Subjects Protections Training for Community Partners
New Offering
The Human Subjects Division is offering a new human subjects protections training option specifically for community partners.
CIRTification: Community Involvement in Research Training is designed by the University of Illinois Chicago Center for Clinical and Translational Science (UIC CCTS) especially for community partners who are involved in activities such as recruiting research participants, obtaining informed consent, or collecting data. This training is not for UW researchers who need to satisfy the NIH training requirement. They should take training offered through the CITI Program.
Visit the HSD website to learn more about this new human subjects protections training, including how to register. Contact hsdinfo@uw.edu with any questions.
HSD Administrative Fee Increase for Industry Clinical Trials
Reminder
Effective July 1, 2024, HSD’s administrative fee will be increasing from $1933.70 to $2060.06. This one-time fee only applies to industry-sponsored-and-initiated clinical trials reviewed by a non-UW IRB where the contract was negotiated by UW’s Office of Sponsored Programs (OSP). This fee is charged because this type of research has an indirect cost rate that does not cover HSD’s costs for performing necessary administrative and regulatory oversight activities. The rate increase reflects updated costs for HSD to perform these activities. It is common for universities and research institutes to charge these fees for industry research.
Applicable external authorization requests submitted in Zipline on or after the effective date will have the new rate applied.
Contact hsdrely@uw.edu if you have any questions.