December 1, 2017 - Fred Hutchinson Cancer Research Center

Dear Dr. Gilliland:

Thank you for your March 11 and April 22, 2016 reports in response to our February 23 and March 28, 2016 requests for information related to our evaluation of the Fred Hutchinson Cancer Research Center system for protecting human research subjects. This review took place as part of our program to evaluate human subjects protection programs of institutions that receive Department of Health and Human Services (HHS) support for research.

Recommendations:
We recommend that you add the location of the various checklists and flow charts referenced in your Policies and Procedures.  For example, the “Minimal Risk Application for Expedited Review Flow Chart” and “The Study That May Require IRB Review More Often Than Once A Year” checklists are two documents for which the locations could be provided.

At this time, there should be no need for further involvement by our office in this matter.  We appreciate your institution’s continued commitment to the protection of human research subjects.

Please do not hesitate to contact me should you have any questions.

Sincerely,

Lisa Buchanan, MAOM
Operationally-in-Charge
Division of Compliance Oversight
Email: lisa.buchanan@hhs.gov

Kemnique Ramnath, MHA
ORISE Fellow
Division of Compliance Oversight
Email: kemnique.ramnath@hhs.gov

cc: 
Ms. Karen Hansen, Director, Institutional Review Office, FHCRC
Dr. Brenda Sandmaier, Chair, FHCRC IRB #1
Dr. David Maloney, Chair, FHCRC IRB #2
Dr. Mark Thornquist, Chair, FHCRC IRB #3
Dr. Margaret Madeleine, Chair, FHCRC IRB #4

Dr. Joanne Less, FDA
Ms. Bridget Foltz, FDA
Dr. M. Khair ElZarrad, Office of Science Policy, NIH
Dr. Michelle Bulls, Director of OPERA, Office of Extramural Research, NIH