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Why This Matters

  • If Fred Hutch, as an institution, is engaged in human research, IRB review is required. 
  • In addition, Fred Hutch is required by federal regulation to track all research in which we as an institution are engaged.
  • If your collaborating site is engaged as an institution in your research, they will also require IRB review. To determine if engaged sites should be reviewed by a single IRB (sIRB) see How to Determine When a Single IRB (sIRB) is Required.

Concept of Engagement

Fred Hutch would be is considered engaged in your human research if it meets the criteria for “engagement” under the guidance provided by the federal Office of Human Research Protections (OHRP). Engagement is a federal regulatory concept that simply means that an institution is (or is not) engaged in conducting human research. It is not solely based on the physical location of the research procedures.

This applies to non-exempt human research that involves multiple institutions. 

Definition of engagement

Fred Hutch is considered to be engaged if it meets any of these criteria:

  1. Fred Hutch is directly receiving funding for the research (including any funding for salary support) through a grant, contract or cooperative agreement.
    • It does not matter whether some or all of the human research activities will be carried out by another organization.
    • “Directly” does not include a subcontract, pass-through, or flow-through funds from an organization that is the prime recipient of the federal research support.
  2. Fred Hutch employees are involved in the research by doing any of the following:
    • Performing research procedures with subjects
    • Manipulating the environment of subjects for research purposes
    • Interacting with subjects for any research purpose
    • Obtaining informed consent from the subjects
    • Obtaining for research purposes any identifiable private information or biological specimens, from any source, even if there is no direct interaction with the subjects.

Documentation of Non-Engagement

If you need assistance in determining if Fred Hutch is engaged in human research per OHRP guidance, please contact The IRO does not currently have a formal process for engagement determinations but can provide a letter certifying non-engagement if required by the funding agency/sponsor.

If it is determined that Fred Hutch is not engaged, keep a copy of the communication with the IRO for your records; this documentation may be necessary for future funding verification requests.