Relevant IRB Policies and Procedures
- IRB Training (Policy 2.20)
Federal policies require that people involved in human subjects research receive training. At Fred Hutch, everyone involved in certain aspects of the Human Research Protection Program must complete required training. The training requirements described here reflect Fred Hutch's commitment to the protection of research participants and the conduct of scientifically valid and reproducible research.
There are two areas of required training:
Look up your or others' Human Subjects Protection (HSP) and GCP training status.
Are you new to Fred Hutch? Have you recently changed to a new position?
Whether or not you need training depends on your level of involvement with research participants and the type of research you are involved in. Go to Hutch Learning and complete the IRO Training Form to find out what training you need. You can also access learning options in Hutch Learning.
(Fred Hutch faculty and staff only.)
Meeting the Training Requirements
New Fred Hutch employees have 60 days to complete required training. Once completed, Human Subjects Protection (HSP) and Good Clinical Practice (GCP) training is good for 3 years; personnel must renew ("refresh") their training often enough to keep it current as long as they are in a position that requires such training.
Failure to meet training requirements is a significant issue. Individuals whose training expires will be contacted and prompted to complete training as soon as possible. The individual’s Senior VP, PI, or supervisor may also be contacted, as appropriate.
If the lead investigator of a study fails to meet the training requirements, IRB approval may be withheld and could result in a lapse of IRB approval. Studies can be reapproved when the lead investigator completes the training requirements.
If your primary affiliation is with an institution other than Fred Hutch, do you need to meet the Fred Hutch training requirements?
If you are the principal investigator on a study submitted to the Fred Hutch IRB, or you are relying on the Fred Hutch IRB through an IRB Reliance Agreement, you need to meet the Fred Hutch training requirements.
Other non-Fred Hutch investigators and study staff should meet the requirements of their own institution; the PI is responsible for ensuring all study staff have met the relevant institutional requirements. Refer to IRB Policy 2.20 Training for more information.