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The 2018 Common Rule, the federal regulations that govern human subjects research, has a compliance date of January 21, 2019. New applications approved on or after this date must comply with the new rule. The IRO has pre-released new versions of the application forms and supplements so study teams can prepare their upcoming applications. Please contact us with any questions. You can learn more about the new rule at HHS.gov.
Please be aware of the submission dates when preparing your applications.
Common Rule training is now available, and will count toward your human subjects refresher training. Please join us in one of the upcoming sessions listed on the Events page (see below). Sign-up now through Hutch Learning.
Guidelines and framework for submitting a new study.
Instructions for submitting annual IRB Continuing Review Reports, or CRRs
Guidelines for reporting changes to plans and processes for ongoing research
View meeting schedules and associated deadlines.
Human subjects training is required every three years for all Fred Hutch personnel involved in the design, conduct or reporting or human subjects research conducted at Fred Hutch or via the Fred Hutch/UW Cancer Consortium.
Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analyzing and reporting of clinical trials. Compliance with GCP provides assurance that the study data are credible and accurate and that the rights, safety, confidentiality and well-being of research participants are protected.