October 3, 2023
For the Record- October 3, 2023: New Consent Templates, Study Participant Payment, UW Face Covering Requirements, Audio Recording Requirements
In this Issue:
New Consent Templates and Guidance Implemented
We No Longer Accept New Forms Submitted on the Old Template
On June 1st, HSD published new consent templates and updated web guidance to support a participant-focused consent process and form. This approach emphasizes: (1) providing prospective study participants with the key information most likely to influence their enrollment decision, (2) using plain language, and (3) presenting the information from the participants’ perspective. As of October 1st, this approach to consent is required for all new forms.
Use the following materials to design consent processes and forms.
Requirements.
- The old consent template does not meet our participant-focused approach to consent so we will no longer accept new forms submitted on the old template.
- For studies that are ongoing, you do not have to convert existing consent forms. However, any new forms that are submitted with a modification will not be accepted on the old template.
- The new consent templates are designed to help researchers create participant-focused consent forms. HSD does not require use of the new templates. Consent forms that do not use the new templates will be accepted provided they satisfy requirements for participant-focused consent forms.
Adjusting to the change. HSD recognizes that this new approach to consent represents an important but significant change that is in line with the regulatory consent changes implemented in 2018. This is why we have allowed a lengthy lead-in time. Learning and implementing this revised approach will be a process. HSD staff and our IRBs look forward to working in partnership with the UW research community to improve research consent at the UW.
Questions. Contact hsdinfo@uw.edu with any questions.
Study Participant Payment Processing in Workday
Update
On September 29, 2023, UW Procurement issued a Campus News Flash with an update on additional measures they have taken to improve the participant payment process in Workday. These changes are to address concerns regarding privacy and are outlined below:
Social Security Required Field: The social security field is no longer a required field for Zelle and/or checks to individuals in the business process. However, the Social Security Number (SSN)/Individual Taxpayer Identification Number (ITIN) is required if the payment is $600 or more or if the cumulative total to an individual within a calendar year is $600 or more. It will be the researcher and department’s responsibility to assess this and collect SSN/ITIN when the threshold is met.
Required Fields for Zelle Payments: Banking account information and payee address have been removed from the required fields for the Zelle payment business process for research study participants. Only email or phone number are required for this payment method. The participant will need a bank account to receive funds but a bank account and routing # are not required by UW to process payment.
Routing: Payments to individuals for participation in research studies will no longer route to Accounts Payable (AP) for processing. Under the new approval flow, requests will be routed to the cost center manager and the shared environment only. Payment requests will only be routed to AP when payments are $600 or more or if the cumulative total to an individual within a calendar year is $600 or more. These payments require action by the Tax Office as there are tax implications for payments to individuals that meet this threshold.
UW Enterprise Services continues to work on a long-term solution for bulk upload payment requests. The Enterprise Interface Builder (EIB) is currently available for eligible users to process bulk requests. However, this tool is only available to limited security roles in Workday. Interested units will need to work with their Shared Environment to process payments via EIB.
Coming Changes to UW Face Covering Requirements
Updated September 27, 2023
UW Environmental Health & Safety has updated their face covering webpage, and is revising the COVID-19 Face Covering Policy. High quality face masks (e.g., N95, KN95, surgical) are currently required to be worn in certain higher risk patient care settings (e.g., oncology patients on active radiation or chemotherapy treatment). UW healthcare facilities will return to requiring masks in all patient care settings when certain respiratory virus transition (e.g., COVID-19, flu, RSV) metrics are reached. Signs will be posted in UW healthcare facilities indicating when masking is required.
Researchers and study participants must abide by any face covering requirements imposed where the in-person research activities will occur.
Consent Requirements for Audio Recordings in Washington State
New Guidance Published October 2, 2023
When an audio recording, or video recording that includes audio, will capture a private communication or conversation between two or more individuals, Washington State law requires that consent must be obtained from all individuals who will be recorded.
The law applies if any participant in the conversation or communication is in Washington State at the time of recording. Its requirements differ from the consent requirements for human subjects research.
The Washington State consent requirement for audio recording may be satisfied using written consent, recording verbal consent, or recording an announcement that the conversation is being recorded. Unlike in human subjects regulations, the statute includes no provision for a waiver of the consent requirement.
For more information:
- Refer to HSD’s Consent Guidance which has been updated to include a section about the consent requirements for audio recordings in Washington State.
- UW Medicine recently published a policy and FAQ on audio recordings in a UW Medicine clinical setting. This policy requires approval from the applicable UW Medicine entity’s Chief Executive Officer or Executive Director when audio recordings will be made for research purposes in a UW Medicine clinical setting.
Questions?
Contact the Human Subjects Division at hsdinfo@uw.edu.
New Survey About the Zipline Online Help Library
Provide Your Feedback to Help Us Improve
Last fall, the Human Subjects Division launched a survey about user preferences for Zipline support. The survey results indicated that many users like having step by step written instructions with screenshots in the Zipline Online Help Library but have some difficulty in navigating and locating the information that they need.
HSD is currently planning a project to make improvements to the Zipline Online Help Library, and we are seeking your feedback in a very short (2 minutes or less) survey available in the Zipline Online Help Library. You can also send questions or comments to hsdinfo@uw.edu. Thank you for taking the time to help us improve Zipline support.