April 5, 2022
For the Record- April 5th, 2022: COVID Requirements, FHCRC-SCCA Merger
In this Issue:
- COVID Related Requirements for Human Subjects Research
- FHCRC-SCCA Merger
- New Zipline Help Links Available
- New Regulatory Affairs Manager
COVID Related Requirements for Human Subjects Research
In line with state, local and UW health policies, most UW-imposed restrictions on human subjects research have been lifted effective March 28, 2022.
For research conducted in WA State, researchers and study participants must continue to wear masks in indoor healthcare settings, correctional and jail facilities, and on public transportation and in transportation hubs.
Researchers and study participants must also abide by any other requirements imposed where the in-person research activities will occur (e.g., institutional or facility requirements, local government, or public health agency).
Check the HSD COVID webpage for details on existing requirements and answers to frequently asked questions.
Effective April 1, 2022, Fred Hutchinson Cancer Research Center (FHCRC) and Seattle Cancer Care Alliance (SCCA) have merged to become the Fred Hutchinson Cancer Center (FHCC).
The existing FHCRC federalwide assurance number (FWA00001920) will remain in place after the merger is complete under the new legal name, Fred Hutchinson Cancer Center. SCCA’s current FWA number (FWA00000334) will be deactivated and all current SCCA components will move under the new FHCC FWA.
All active IRB reliance agreements between the UW and FHCRC will automatically transfer to the merged FHCC entity.
Like Fred Hutch and SCCA, the new FHCC will be an independent, private, not-for-profit, tax-exempt organization dedicated to the continuation of Fred Hutch’s scientific mission, including translating scientific discovery into the prevention, diagnosis, treatment and cure of cancer and related diseases. With respect to personnel, all SCCA and FHCRC-employed principal investigators and staff will become employees of FHCC and any prior contacts for scientific, administrative, and fiscal matters will remain the same.
Contact firstname.lastname@example.org (UW) or email@example.com (FHCC) if you have any questions.
New Zipline Help Links Available
Find The Most Popular Instructions Fast
Did you know that HSD has an extensive online help library for Zipline, our eIRB system? To make it easier to find the most commonly used instructions, we’ve added them to the sidebar on the HSD homepage. The quick links include:
- Tips for Filling Out Zipline Applications
- Assign PI Proxy
- Edit Submission and Respond
- Modify Approved Studies
- Submit Faculty Advisor Review
- Researcher Guide Home
New Regulatory Affairs Manager
Beginning March 15, 2022
We are pleased to announce Jean Kang as the new HSD Regulatory Affairs Manager. In that role she will oversee the HSD Regulatory Affairs team, which includes our compliance and post-approval monitoring programs. For the past 9 years Jean has been a Compliance Administrator on the HSD Regulatory Affairs team. In that role she has been responsible for reviewing Reports of New Information, making formal regulatory determinations, and managing IRB reviews and federal reporting. She has resolved complex research inquiries and complaints; project managed a major overhaul of HSD’s compliance policies and procedures and provided invaluable guidance and support to HSD and the research community. Prior to the UW Jean was Manager of the IRB at Pepperdine University for 7 years. She also served as a Research Subject Advocate at the UC Irvine General Clinical Research Center. Jean has a BS in Biopsychology and Cognitive Science from the University of Michigan and has been CIP certified since 2011.