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Fred Hutch Status Alert: Details at status.fredhutch.org

Last updated | 6-27-22 11:14 a.m.

During the external IRB endorsement process, the IRO reviews the informed consent documents to ensure the following Fred Hutch institutional elements are included as needed. The external IRB remains responsible for checking that all required and applicable elements of consent are included in each consent form. 

All Consent Forms, even if Fred Hutch is not consenting:

  • Statement that Fred Hutchinson Cancer Center has access to research participants’ records

If Fred Hutch employees are involved in consenting:

  • Statement that Fred Hutchinson Cancer Center has access to research participants’ records
  • Heading includes Fred Hutchinson Cancer Center

If Fred Hutch is the Lead PI on study:

  • Statement that Fred Hutchinson Cancer Center has access to research participants’ records
  • Heading includes Fred Hutchinson Cancer Center
  • Name, affiliation and telephone number of the Fred Hutch principal investigator

HIPAA Authorization

When Fred Hutch is engaged in the research, the HIPAA authorization must include a statement that Fred Hutchinson Cancer Center has access to research participants’ records.

Any HIPAA authorization from outside the Cancer Consortium and any HIPAA language embedded in the study consent requires review by Office of General Counsel. IRO staff will coordinate this review during the screening process.

Industry Sponsored / Other Funding Contracts

If Fred Hutch is a signatory on an industry contract, a copy of the fully executed funding agreement is required.  The Office of General Counsel (OGC) will compare the consent forms with the contract to ensure concurrence. IRO staff will coordinate review by OGC during the screening process.

Last updated | 6-27-22 11:14 a.m.