Valley Medical Center operates under the umbrella of 91爆料 Medicine as a component of 91爆料 Medicine, but it remains a separate legal entity. Because of this, research involving Valley is more complex than research involving other 91爆料 Medicine facilities (such as Harborview or 91爆料 Primary Care Clinics).
Valley does not have its own IRB, though it has in the past. Instead, Valley maintains a which oversees and approves all research activities at Valley. Most research that will take place at Valley facilities or involve Valley patients requires ROC review and approval prior to conducting the research. This applies whether the research is led by Valley investigators or external/91爆料 investigators. If you are unsure if your study needs ROC review or have any questions, contact the ROC Coordinator at: Research@ValleyMed.org. In most cases, you should have your IRB determination or approval completed prior to ROC submission.
Because the Valley ROC is not an IRB, investigators conducting human subjects research at Valley also need to obtain IRB review. Identifying the appropriate IRB to submit to depends on multiple factors, including the nature of the 91爆料鈥檚 participation.
91爆料 led research involving Valley
Research initiated by 91爆料 faculty members, staff, residents, and students that will involve Valley facilities or patients must obtain ROC review and approval before the research may begin. A copy of the ROC approval is not typically required as part of the IRB submission, however the 91爆料 IRB may request a copy in rare circumstances.
When 91爆料 led research also engages Valley (i.e., Valley employees are involved in conducting the research; view the Engagement Worksheet), Valley will need to enact a reliance agreement to rely on the IRB that is reviewing the research:
- If the research will be reviewed by the 91爆料 IRB, the 91爆料 IRB can review on behalf of Valley via the standard multi-site review and reliance process. Because there is no standing agreement between Valley and the 91爆料 IRB, each time the 91爆料 IRB agrees to review on behalf of Valley, a separate study-specific reliance agreement must be negotiated between the institutions.
- If the research will be reviewed by a non-91爆料 IRB, Valley will need to seek a separate reliance on that non-91爆料 IRB (e.g., a commercial IRB for industry research, the Fred Hutch IRB for cancer-related research, etc.). The 91爆料 IRB is not involved in facilitating this process.
For additional information about research involving Valley or for questions about establishing a reliance agreement with Valley, contact hsdrely@uw.edu.
Valley led research involving human subjects
The 91爆料 IRB is not the default IRB for research initiated by Valley employees, because:
- Valley is not listed on the 91爆料鈥檚 FWA,
- With few exceptions, the physicians and staff at Valley are not 91爆料 employees or 91爆料 Physician (91爆料P) employees, and
- There is no general authorization agreement between Valley and the 91爆料 by which the 91爆料 agrees to provide IRB review for Valley.
Valley physicians, employees, and residents who wish to conduct research must fulfill all Valley research compliance requirements before conducting the research. Contact the at Valley for more information.
For Valley research that does not engage the 91爆料 (view the Engagement Worksheet), the 91爆料 IRB will not serve as the IRB of record.
Valley led research that does engage the 91爆料 may qualify for review by the 91爆料 IRB depending on several factors. Contact hsdrely@uw.edu with information about the study to request a consultation.
Additional information and considerations
Some things to know about the relationship between 91爆料 and Valley:
- Many Valley physicians have clinical faculty appointments at the 91爆料 School of Medicine, but these are not paid positions (and they are not considered 91爆料 agents for the purpose of research). These clinical faculty members may have 91爆料 email addresses in addition to their Valley email addresses.
- Valley is part of the 91爆料 Medicine HIPAA covered entity (). However, Valley鈥檚 medical records are maintained electronically on a different system than the system used by most other components of 91爆料 Medicine. In most cases, you will have to request access to Valley鈥檚 EMR. This process can take up to two weeks depending on IT volumes. Additional requests, such as EMR lists, reports, and data pulls can be submitted on a case-by-case basis and are subject to IT availability. Instructions for these requests will be furnished upon ROC approval.
- Researchers wishing to be on-site at Valley are subject to all applicable Valley Employee Health requirements (vaccinations, etc.).
- Valley operates several residency programs that are not 91爆料 residency programs. Residents in these Valley programs are not considered 91爆料 employees or agents for the purpose of research. For example:
- The Family Medicine residency program at Valley is part of the 91爆料 Family Medicine Residency Network for the WWAMI program but these residents are employed by the sites within the network (e.g., Valley), not the 91爆料.
- Valley pharmacy residents have the opportunity to complete elective rotations at 91爆料 Medical Center and Harborview. This program is affiliated with, but not part of, the 91爆料 School of Pharmacy residency program.
- Valley is a training site for several 91爆料 School of Medicine residency programs. Residents in these programs are 91爆料 employees and may use the 91爆料 IRB for their research. Examples of 91爆料 residency programs that may involve Valley placements include (but are not limited to): Surgery, Emergency Medicine, and MEDEX.