June 14, 2022
For the Record- June 14, 2022: Expanded Requirements for Studies Involving FHCC
In this Issue:
- Expanded Requirements for Studies involving Fred Hutchinson Cancer Center (FHCC)
- Congratulations Karen Moe!
- Zipline Account Creation
- Slower Turnaround Times in July and August
Expanded Requirements for Studies involving Fred Hutchinson Cancer Center (FHCC)
Studies for which FHCC employees or agents will perform certain research activities and that are reviewed by a non-FHCC IRB (such as the UW IRB, Advarra or WCG IRB) must obtain authorization from the Fred Hutch IRO for that IRB review. This applies even when the PI has a primary affiliation with the UW and the majority of the research procedures are conducted by UW employees. HSD’s authorization does not cover FHCC. If both UW and FHCC employees or agents are performing research activities, authorization is required from each institution.
When employees or agents of an institution are involved in conducting research, the institution must keep a record of that involvement to meet its reporting requirements to federal agencies and to confirm that the activities of their employees or agents are covered by appropriate IRB review. This concept is called “engagement”. The institution is engaged when employees or agents:
- Intervene or interact with participants for the research, and/or
- Have access to identifiable private information about the subjects of the research, and/or
- Obtain informed consent of human subjects for the research.
This requirement is not new. FHCC has always required authorization, however due to the merger with Seattle Cancer Care Alliance (SCCA), all previous employees of SCCA are now employees of FHCC which expands the situations in which FHCC employees or agents might be engaging FHCC in research.
Examples of common situations for which authorization might be required:
- Mid-level providers such as PA-C’s employed by FHCC who obtain consent or perform other study procedures such as exams.
- Nursing staff employed by FHCC who administer research infusions.
- FHCC clinic staff abstracting PHI from medical records.
Examples of common situations for which authorization is typically not required:
- FHCC providers informing their patients of the availability of a UW study by giving them a study flyer or copy of the consent form.
- The FHCC lab performing research tests and delivering those results to the UW study team.
- UW employees performing study procedures at FHCC facilities.
See the May 2022 Fred Hutch IRO Newsletter on the Fred Hutch IRO Extranet for more detailed information about the process to obtain FHCC authorization. For questions, contact the FHCC IRO at firstname.lastname@example.org.
Congratulations to Karen Moe!
2022 Recipient of the David B. Thorud Leadership Award
Congratulations to former HSD Director Dr. Karen Moe who was chosen as the 2022 recipient of the David B. Thorud Leadership Award. The award honors those who demonstrate extraordinary leadership through innovation, teamwork, and championing equity and inclusion in the workplace.
In her 15 years as director, Karen led HSD through some challenging periods, fostered an environment based on trust, solved seemingly intractable problems, and worked tirelessly to champion equity and inclusion in human subjects research. Her extraordinary talent for conceptualizing and implementing tangible and ambitious progress is just one part of Karen’s outstanding legacy. Thank you, Karen, for your leadership and congratulations!
Zipline Account Creation
Zipline self-registration was re-implemented the evening of May 31.
This means that most new users can create their own accounts by logging in with their UW NetID and password. New users with a sponsored UW NetID may still need to contact email@example.com to request a Zipline account.
The instructions for new account creation have been updated.
If you encounter any issues or have questions, please contact firstname.lastname@example.org.
Slower Turnaround Times in July and August
The past 2+ years have been a difficult time for all of us. With COVID-19 and travel-related restrictions now lifting, we anticipate many HSD staff will be taking time off this summer to recharge and recuperate. While we will ensure that there is adequate coverage, we anticipate that turnaround times will be slower in July and August. We appreciate your patience and understanding. To minimize the impact to your research, we encourage you to ensure your applications are complete and submitted as early as possible. For any externally imposed urgent deadlines, please be sure to call these out in your submission so we can prioritize accordingly.