March 8, 2022
For the Record – March 8, 2022: Reconsent; E-Consent
Expanded Consent Guidance
Reconsent and Ongoing Subject Communication
After subjects are enrolled, they may need to be informed about new information. They may also need to be reconsented as a result of that new information. HSD has added a new section to the web-based consent guidance titled, Reconsent and Ongoing Subject Communication. The guidance provides four possible methods by which new information can be communicated to subjects as well as examples of situations when each method might be appropriate. The new Tip Sheet Reconsent and Ongoing Subject Communication provides a summary of the main points from the Guidance page.
FHCRC-SCCA Merger, FHCRC Funding Changes, and HSD
Fred Hutchinson Cancer Research Center (FHCRC) and Seattle Cancer Care Alliance (SCCA) are intending to merge and become the Fred Hutchinson Cancer Center (FHCC). The merger is still in negotiation and not finalized but if successful, would become effective April 1, 2022.
In anticipation of this merger, Grant and Contract Accounting & the Office of Sponsored Programs posted an announcement on February 17, 2022, advising researchers that all FHCRC incoming and outgoing awards/subawards will be terminated on March 31, 2022 and new awards reissued from/to the new FHCC entity. For more information regarding this process, read the full announcement here.
For open-active studies impacted by this change, you will need to update your funding information in Zipline. You may do this at your next opportunity (e.g., Continuing Review, study modification). There is no need to immediately submit a modification for this change alone. Zipline will be updated to add FHCC as a ‘Funding organization’ after April 1, 2022.
Effective February 15, 2022
Minor updates were made to Zipline, the eIRB system on February 15, 2022. Notable changes include:
- Update to the SmartForm question on the Study Scope page regarding research with minors. Language was added to clarify that interaction with minors means: “minors who will be human subjects”.
- Updated Ancillary Review notification to assist faculty advisors with signing off on studies led by students and residents. A link to the Faculty Advisors Guide was added to the email notification templates to help advisors quickly locate instructions for completing the review.
- Help text for the new Site Search field has been updated to include use of the term “Projects” when searching, in order to avoid search results that include unused templates.
- Application forms. Documents linked in Zipline have been updated to the most current versions.
The Release Notes describing the changes to Zipline in more detail have been posted on the Zipline Release Notes page.
New Tutorial on E-Consent
Interested in implementing electronic consent for your study but unsure what to consider or where to begin? In approximately 15 minutes, HSD’s new interactive tutorial will walk you through the basics of electronic consent. The tutorial includes:
- Using UW ITHS REDCap and UW DocuSign for e-consent;
- Special considerations for HIPAA, using an external IRB, and studies that include non-UW sites, including international research; and
- Common scenarios involving e-consent.
If you have any questions or concerns about the tutorial, please contact firstname.lastname@example.org.