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Data Governance has two specific Data House Calls (DHC's) available:
Research Data and AI Support DHC
Data House Calls are short, 20 min calls meant to be topical, focused on solving specific problems or discussing specific topics and function sometimes as a navigation tool to refer people to where they need to go even if we don’t have all the answers.
The Fred Hutch Data Governance team helps investigators navigate data policy and governance resources, such as patient data access, data use agreements, software licensing, and IRB guidance. We also contribute to and facilitate organization-wide initiatives related to data governance such as Cancer Consortium data sharing, connecting patients’ data to research and staff data stewardship literacy. Cancer Consortium members can request access to Fred Hutch resources. This service is hosted by the Fred Hutch Office of the Chief Data Officer and its partners. This page is intended to serve as a guide for available resources and access related to Fred Hutch data systems and tools.
Honest Broker (RADaR) requests
Research Access to Data Review (RADaR) is the process at Fred Hutch also known as an honest broker review. The RADaR process is managed by the Fred Hutch Data Governance team to provide guidance and oversight of use of healthcare data (PHI) for research, and outlines requirements for staff who serve as honest brokers as well as staff requesting the use of healthcare data for research.
Required: For all research uses of PHI, even if the data is already accessible for QA or QI purposes.
Not Required: For QA or QI projects that do not involve generalizable research or external data sharing.
If you have any questions about the RADaR process you can set up a Clinical Data Governance Data House Call or email oncdataaccess@fredhutch.org
Prior to submitting a RADaR review request, please note that RADaR approval confirms eligibility to access research data only and does not include data extraction support.
DASL/OCDO is transitioning to the CARDS translational research platform, and the Translational Data Science team cannot fulfill data extract requests during this period. Even with RADaR approval, you will need to identify another team for data fulfillment.
Interim options include:
- BMT/cIMTX Research Groups:https://centernet.fredhutch.org/u/it/gateway-program/clinical-transitions/consent-management-research-eligibility0.html#reporting
- Operations, patient care, or quality analytics:https://centernet.fredhutch.org/u/clinical-analytics.html
- Epic Reporting Workbench or Leaf cohort discovery:https://redcap.iths.org/surveys/?s=K93KPMJFYF
AI Review Request (AIR)
As new AI systems emerge, in order to ensure we are enabling our staff to use AI in their work, while ensuring we are providing the right guidance regarding responsible use of these systems, our AI policy requires that we maintain an AI Governance Workgroup to support staff in their use of AI in an ongoing way. The AI Governance Workgroup conducts thorough assessments of AI systems and their intended use cases, so staff can confidently use AI enabled tools in their work. Request support through our “Research Data and AI” Data House Call or email dataprotection@fredhutch.org . Please note that AI reviews from Fred Hutch apply only to projects intending to use AI with Fred Hutch data. This does not override or replace any AI review requirements for projects using data from the University of Washington.
cBioPortal Access request
cBioPortal at Fred Hutch is an application for exploring publicly available cancer genomics data alongside your own. It lets you explore genomic and clinical data across multiple studies in a highly visual and interactive way. Our private instance allows for controlled access – meaning only approved users can view & upload data and allows sensitive data – IRB-approved studies with identifiable data can be included and access-limited until you're ready to share. Note: users must have a Fred Hutch affiliation/account to use Fred Hutch cBioPortal.
IRB Pathways for CARDS & CAIA Projects
Below explains how to identify which IRB process applies to adult oncology research that draws on FHCC or UWM data using applications or data from CARDS, projects via CAIA, as well as AI use in these systems.
Key Considerations
- Submit to the proper IRB based on guidance from your primary institution. See Fred Hutch guidance on Selecting the Right IRB and UW guidance on Identifying the Correct IRB (see specifically page about Cancer-Related Research).
- IRB review is always required for research involving human subjects. See Submissions to the IRB (Fred Hutch resource) or Getting Started (UW resource) for more information on IRB submission processes.
- For projects that do not meet the criteria for human subjects research, which might include certain research involving only de-identified data, keep in mind the following nuances around your institution’s NHSR determination process as it relates to CARDS or CAIA projects:
- Fred Hutch: Formal Not Human Research (NHR) determinations are made by the Fred Hutch Institutional Review Office (IRO) for investigators whose primary appointment is at Fred Hutch. See Not Human Research Determinations for more information.
- UW: Policy does allow UW researchers to make the determination themselves using the WORKSHEET Human Subjects Research Determination - UW Research as a guide. However, a formal determination letter is required for CARDS or CAIA projects, study teams should request a determination as outlined at Step 2. Does Your Research Involve Human Subjects? - UW Research.
- Keep in mind if your IRB protocol proposes to use AI, each institution has an AI Governance Ancillary Review which will ask for what tools and under what circumstances will the AI tools be incorporated in your work.
Pathway Highlights and Gatekeeper Requirements
- For CARDS and CAIA data access requests, plan early for IRB documentation as part of the access pathway, even when using de‑identified data (for which a formal NHR or NHSR determination is required).
- All use of CARDS (inclusive of CAIA) requires either IRB approval or a formal Not Human Subjects Research (NHSR)/Not Human Research (NHR) determination from the appropriate IRB or institutional office; self-determinations are not sufficient for access.
- Although UW IRB may allow self-determination for NHSR, investigators requesting CARDS or CAIA access should follow UW guidance to obtain a formal determination letter via the NHSR worksheet process (https://www.washington.edu/research/hsd/getting-started/).
CARDS-Specific
- CARDS data access requires IRB approval letter or a formal not human subjects research determination for all data requests.
CAIA-Specific
- CARDS data access for CAIA requires IRB approval or a formal NHSR/NHR determination letter for all requests.
- CAIA-related projects are part of the CARDS pathway, so CAIA data requests must follow the CARDS process and be directed to the Fred Hutch IRB for NHSR determination.
- Open question pending response: Is Fred Hutch IRB able and willing to review all CAIA-related projects, or was the September 2025 pilot a one-time use case? The answer will determine standard routing guidance.