June 6, 2023
For the Record- June 6, 2023: Consent Revision Project Phase 2, Short Form Consent, New Fred Hutch Requirement, Changes to HSD Fee
In this Issue:
Consent Revision Project – Phase 2
New consent templates and guidance published June 1st
Obtaining informed and voluntary participant consent is one of the most fundamental and important activities for conducting ethical and compliant human subjects research. With the goal of designing consent from the participant perspective, HSD has been working for several years on a major overhaul of its consent-related policies, requirements, SOPs, guidance, and templates.
Phase 1 of the project (implemented October 2021) included publication of our main Consent guidance. Within that guidance are HSD’s five high-level Consent Considerations which must be part of creating a meaningful consent process and form.
Phase 2 of the project provides UW researchers with the tools necessary for designing a participant-focused consent process and form:
- Designing Consent web guidance. The guidance 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. HSD has published two new templates that will assist researchers with designing a participant-focused consent process and form. The templates are flexible so researchers can modify them to suit the needs of their study population.
- Example Consent forms. The examples demonstrate some of the many ways consent may be designed while also satisfying regulatory and UW IRB policy requirements.
Important concepts.
- Key Information. When developing consent, researchers must think carefully about identifying and emphasizing the Key Information that is most likely to influence the enrollment decision for the particular subject population. Consent forms with >2,000 words are required to have a separate key information section.
- Facilitating informed decision-making. This includes using plain language, familiar terms, an appropriate reading level, and presenting information in a logical sequence that allows for real-time discussion. It also includes using reader-friendly formatting such as bulleting, tables, subject-focused headings, adequate spacing and sufficient font size.
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.
If you’d like to know more about the regulatory requirements and best practices that informed this project check out this 1hr 45min tutorial from the Office for Human Research Protections (OHRP).
Questions. Contact hsdinfo@uw.edu with any questions about the new materials.
Thank you! To the UW researchers and IRB members who provided feedback on the draft materials and who agreed to let us post their IRB-approved consent materials as examples. Your feedback and willingness to collaborate has improved the published versions and will help other researchers visualize some of the many ways to design an effective consent process.
Short Form Consent – New HSD Policy and Translated Short Form Templates
Published June 1st
Regulations and Policy
The regulations allow use of short form consent for the infrequent and unanticipated enrollment of an individual with limited English proficiency in a study: (1) for which no consent form in the subject’s language has been prepared; and (2) there is insufficient time and opportunity to obtain a written translation of the IRB-approved English consent form.
In addition to these regulatory requirements, it is now HSD policy that:
- The short form method may only be used when an appropriately qualified interpreter is available to the subject throughout their participation in the research;
- For greater than minimal risk research, the short form method may only be used for studies that provide a direct benefit that is not available outside the research context.
HSD’s new policies apply to all studies reviewed by the UW IRBs (including to non-UW institutions relying on the UW IRB’s review) as well as to research reviewed by a non-UW IRB for which UW investigators are obtaining consent using the short form method.
New Templates
A pre-approved English version of the short form, as well as translations in twenty languages, are posted on the HSD website [ Consent Templates]. If the language you need is not posted, contact hsdinfo@uw.edu.
New HSD Requirement for Fred Hutch led studies reviewed by the Fred Hutch IRB
Reminder and New Information
As introduced in our May 2, 2023 newsletter, beginning July 1, 2023, all new studies that are:
- Led by a Fred Hutch PI, and
- Reviewed by the Fred Hutch IRB, and
- Which engage UW in the research activities,
must obtain authorization from HSD for review by submitting a request in Zipline prior to the Fred Hutch IRB issuing its approval for the portion of the research engaging UW.
After HSD has reviewed the request in Zipline, it will issue a letter to the study team to document this authorization. The Fred Hutch IRB will proceed with its review of the overall study but will hold final approval until it receives a copy of this letter from the study team.
Why is HSD authorization required?
Due to the single IRB mandates, there is an increased need for tracking the engagement of UW to ensure UW is complying with federal regulations.
Additionally, UW and Fred Hutch recently renegotiated their longstanding cooperative agreement, and this is a term of the agreement.
What is HSD doing to assist study teams?
New Information: Fred Hutch employees can now obtain a UW NetID and gain access to Zipline by:
- following the instructions at UW to login via their Fred Hutch account to obtain a UW NetID, then
- self-registering in Zipline by logging in with the new UW NetID and selecting “Fred Hutchinson Cancer Center” as their department.
Detailed instructions for this process are now on the Account Creation for Fred Hutch Employees webpage.
New Information: In consultation with the Fred Hutch Institutional Review Office and Clinical Research Support, HSD has developed enhanced webpage guidance for cancer-related research along with:
- A two-page worksheet tailored to Fred Hutch led research to assist study teams with identifying UW engagement
- A quick reference guidewith specific instructions for and FAQs about Zipline submissions for Fred Hutch led studies
For questions about this new requirement, contact hsdrely@uw.edu.
Changes to HSD Fee for Industry Clinical Trials
Reminder and New Information
Initially announced in our April 4, 2023 newsletter, this is a reminder that effective July 1, 2023, HSD is making the following changes to our industry clinical trials fee:
- Fee Increase: All new authorization requests to use a non-UW IRB submitted on or after this date will be charged $1933.70. HSD anticipates that this fee will modestly increase on an annual basis commensurate with HSD’s costs.
- Change in Billing Process: GCA will no longer be involved in billing the fee. Instead, HSD will work with the Office of Research to charge the fee using a researcher-provided worktag, which is the new equivalent of a budget number in Workday. You will be solicited for this information in a new section of the REQUEST External IRB Review HSD will begin its review without a worktag, however final authorization will not be provided until a worktag is received.
What should researchers do to prepare?
It is important to ensure you have a worktag (budget #) if you intend to submit a request for authorization on or after July 1st. The easiest way to do this is to request an advanced budget # under the current system no later than June 13th. This advanced budget # will be converted over to the appropriate study worktag with UW Finance Transformation (UW FT) Workday go-live (on or after July 6th).
NOTE – After June 13th it will not be possible to obtain an advanced budget # due to UW FT and the need to freeze current processes to transition over to the new one. This means anyone without an advanced budget # by June 13th will have to wait until UW FT goes live on July 6th to request a worktag, which may take several weeks to obtain.
For questions about these changes, contact hsdrely@uw.edu.
HSD is Hiring!
Open Positions
HSD has 2 open positions to come work as part of our team as an IRB Administrator – Req #22503 and Req #22504
Individuals may work at the HSD office on the UW Seattle campus, 100% remotely, or a combination (hybrid). We also offer flexible scheduling.
See the listings on UW Hires for more information and how to apply.