September 5, 2023
For the Record- September 5, 2023: Consent Templates, HSD Homepage, Zipline Downtime, More
In this Issue:
- New Consent Templates and Guidance
- HSD Homepage Redesign
- Zipline Downtime
- Zipline Updates to the Request a Non-UW IRB Process
- UW eSignatures (DocuSign)
- HSD Guidance for FDA Regulated Research
- FDA Issues Fifth Notice of Noncompliance with ClinicalTrials.gov Results Reporting
New Consent Templates and Guidance
Old Template Not Accepted After October 1, 2023
On June 1st, HSD published new consent materials to support a participant-focused consent process and form. These new tools will assist researchers with designing a consent process that is compliant with the regulatory consent changes implemented in 2018. Full details can be found in the June edition of For the Record. Key points include:
- Designing Consent web guidance that provides information about what must be included in the consent process/form. It may be used to supplement the instructions embedded in the templates or can be used to create a consent process/form without starting from a UW template. It includes a section specific to designing consent for multi-institutional research.
- Consent Templates that will assist researchers with designing a participant-focused consent process and form which emphasizes the key information most likely to influence a subject’s enrollment decision. The templates are flexible so researchers can modify them to suit the needs of their study population.
- Example Consent forms that demonstrate some of the many ways consent may be designed while also satisfying regulatory and UW IRB policy requirements.
Transition period. HSD recognizes that this new approach to consent represents an important but significant change. To ease the transition, HSD will accept consent forms submitted on the old, Standard template until October 1, 2023. However, researchers are encouraged to begin using the new templates and approach as soon as possible.
Questions. Contact email@example.com with any questions about the new materials.
HSD Homepage Redesign
Launched August 31, 2023
The Human Subjects Division launched a new design for our homepage and other major website changes on August 31. 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. Contact firstname.lastname@example.org with any questions or feedback about the changes.
- Streamlined homepage featuring quick access to the most used resources
- New “Getting Started” page targeted to students and other researchers new to working with the IRB
- New “Application Forms” page making it easy to find key forms in one place
- Significantly reorganized “Topic Based Guidance” page, making it easy for you to find all of our resources about notable topics in one centralized location
- Easier access to our “Consent Templates” page
- Significant revisions to our “About Us” page
- Improved search results using the Office of Research site search bar
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.
Effective September 14, 2023
Zipline will be unavailable while we make some minor updates to the e-IRB system the evening of September 14, 2023, from 5 pm until 7 pm. Please remember to save your work and log off before this time.
Most of the updates will be HSD staff-facing. However, researchers who are requesting that a non-UW IRB review their project may notice a few differences. Review the changes in this article.
If you have any questions, please contact email@example.com.
Zipline Updates to the Request a Non-UW IRB Process
The Zipline update on September 14, 2023, will introduce the following changes to the non-UW IRB request process:
Removing researcher edit functionality while submission is in Pending sIRB Review state
Study teams can currently edit the application while it is in the “Pending sIRB Review” state. This is problematic, because HSD is not notified when these edits are made, causing delays in review. After the update, study teams will no longer be able to edit the application while it is in this state. In the rare circumstance that a study team must make changes to the application while it is in this state, please contact firstname.lastname@example.org for instructions.
Removing researcher Finalize Study Updates functionality
The “Update Study Details” pathway for modifying applications allowed the study team to “Finalize” these updates on their own without HSD’s review. This functionality has been removed. Study teams who create study updates using this pathway should continue to email the Reliance Team when updates are ready to be finalized.
Other Changes to Assist the Non-UW IRB Review Process
- Study Scope SmartForm – re-wording of question #4 to aid in clarity
- Funding SmartForm – additional help text and an added option of “No funding administered by the UW” to question #10
- Drugs and Devices SmartForms – additional help text
- Mail letter merge functionality added for generating authorization letters
- NOTE – As a result of this change, study teams will now receive two email notifications from Zipline, One letting them know that the authorization letter has been generated, and one confirming that the application has moved to the “Pending sIRB” state.
If you have any questions, please contact us at email@example.com.
UW eSignatures (DocuSign)
Changes to UW-IT Approval Procedures
UW-IT has revised its process for approving use of UW eSignatures. It is no longer necessary to provide the IRB approval or HSD authorization letter to UW-IT. HSD approval to use UW eSignatures is still required as part of our application process. HSD will no longer cite UW eSignatures in the IRB approval letter though it will remain in our HSD authorization letter to communicate our approval to the reviewing external IRB.
Once IRB approval/HSD authorization to use UW eSignatures has been obtained, the PI or study lead can request a DocuSign “Sender” account from their DocuSign Delegated Administrator. The eSignatures support team can help you identify your department’s Delegated Administrator if you are unsure.
HSD Guidance for FDA Regulated Research
As part of a multi-year project to move Word-based guidance to our website, information from the Word-based SOP FDA Regulated Research and GUIDANCE Applicability of FDA Regulations has been transformed into the web guidance, FDA Regulated Research. This web guidance is designed to help researchers more easily navigate the FDA IRB requirements for investigational drug and device studies.
FDA Issues Fifth Notice of Noncompliance with ClinicalTrials.gov Results Reporting
Know What To Do
On July 19, 2023, the FDA issued its fifth Notice of Noncompliance letter for failure to comply with the requirements for submission of clinical trial results to ClinicalTrials.gov. The Responsible Party (i.e., the study Sponsor or Principal Investigator) has 30 days to submit trial results or face civil monetary penalties up to $13,237 per day.
For UW research, identification of a clinical trial that requires registration and results reporting on ClinicalTrials.gov is made by HSD and communicated to the researcher via Zipline. Researchers who have been identified as the Responsible Party for an applicable clinical trial should ensure they understand the reporting requirements and timelines for submission. Information regarding this can be found on the ClinicalTrials.gov website.
Issuance of a Notice of Noncompliance letter is preceded by a Pre-Notice of Noncompliance letter. Should you receive one of these it is important that you contact HSD at firstname.lastname@example.org right away for guidance. Of course, the best plan of action is to register your study and report your clinical trial results on time and promptly respond to any requests for additional information from the Protocol Registration and Results System (PRS) which manages ClinicalTrials.gov.
If you have questions or need assistance with ClinicalTrials.gov matters, please do not hesitate to reach out to our office at email@example.com.