November 5, 2024
For the Record- November 8, 2024: Slower Response Times, Revised Short Form Consent Policy, Zipline Downtime
In this Issue:
HSD Slower Response Times
November 18-20, 2024
The Public Responsibility In Medicine & Research (PRIM&R) annual human research protection conference will be held in Seattle, WA this year November 18-20, 2024. This presents a unique educational opportunity for many of our staff to attend. While we will ensure that there is adequate coverage, we anticipate that turnaround and response times will be slower the week of November 18-22, 2024. We appreciate your patience and understanding. To minimize the impact to your research, we encourage you to ensure your applications are complete and submitted as early as possible. For any externally imposed urgent deadlines, please be sure to call these out in your submission so we can prioritize accordingly. Feel free to contact your HSD team or write to hsdinfo@uw.edu if you have any questions or concerns.
Revised Short Form Consent Policy
Effective January 1, 2025
In our August 16, 2024, Special Edition Newsletter, HSD shared a draft of its revised policy for use of the short form consent method to enroll participants with a non-English language preference. The changes to the policy were motivated by updated FDA guidance on informed consent as well as the development of our new draft guidance on diversity in clinical trials.
Feedback: HSD received several comments during our open comment period. The final short form consent policy takes into consideration feedback that we received from the UW research community, information from the UW Medicine Language Access and Cultural Advocacy, and is designed to align as much as possible with partner institutions while taking into consideration differences in our institution’s research portfolio. We have put together a summary of the comments that we have received and our responses explaining the final revisions to the policy.
Key points: The most significant changes to the short form consent policy include:
- The new policy will apply to any use of the short form, regardless of when the study was approved.
- Prospective IRB approval to use the short form method is now required for all greater than minimal risk studies and FDA-regulated studies. Existing studies will need to submit a modification in Zipline if they wish to continue to use the short form method. In addition:
- Researchers must notify the IRB after use of the short form consent process and provide a translated consent form as a modification in Zipline within 30 days.
- Study participants must be provided with an IRB-approved translated consent form within 2 weeks of IRB approval. The translated consent form does not need to be signed and does not need to be provided to participants in person. It can, for example, be sent by email.
- In most instances, the required impartial witness must be proficient in the language of the oral consent presentation. However, there is some flexibility in certain circumstances when the interpreter is unable or unwilling to serve as the witness and there is no other impartial adult with sufficient language proficiency available.
- With the above additional requirements, HSD will no longer limit use of short form consent in greater than minimal risk research to only studies that provide the prospect of direct benefit that is not available outside the research.
Thank you! HSD is grateful to the UW Medicine Language Access and Cultural Advocacy for their partnership and to all the UW researchers who provided feedback on the short form policy.
Questions. Please contact hsdinfo@uw.edu if you have questions.
Zipline Upgrade and Downtime
December 5, 2024
On Thursday, December 5, 2024, Zipline will be down for a system upgrade from 6 pm to 8 pm. Please remember to save your work and log off before this time.
While most updates will not impact researchers, there is one new feature that we hope will make the submission of Reports of New Information (RNI) easier.
New Manage Editors Activity
Previously, only the RNI creator could submit or edit the RNI. Now, with the Manage Editors activity, the RNI creator can select additional editors from the Zipline system.
The additional editors will be able to submit and edit the RNI, so take care to only add members of your study team that you wish to have access.
If you have any questions, please contact hsdinfo@uw.edu.
Draft Diversity Plan and Associated Guidance
Update
Thank you to everyone who provided feedback on the proposed new SUPPLEMENT Diversity Plan for Clinical Trials and associated guidance. Our public comment period is now closed. We appreciate the level of engagement from our research community on this important initiative. HSD is busy evaluating all the comments and questions received. We intend to publish a formal response to your feedback with the finalized diversity plan and guidance in our January 2025 newsletter. If you have additional questions or comments, please send them to hsdinfo@uw.edu. Details about other implementation aspects of the initiative may also be found on the UW DCTI website.
Needs Assessment Survey for IRB Reliances
Provide Your Feedback
The UW Human Subjects Division is seeking your feedback to improve support for multi-site studies that are reviewed by the UW IRB (single IRB review) and studies that are reviewed by an external (non-UW) IRB.
Any researchers who have worked on a single IRB or external IRB application are invited to participate. A UW NetID is not required to access the survey.
Please complete the survey to provide your feedback. The survey contains branching logic so you will only see questions that apply to the types of applications you submit. It should take 10-15 minutes to complete.
After completing the survey, you have the option to enter a drawing to receive a coffee gift card as a thank you for your participation. Contact hsdinfo@uw.edu with any questions.