March 18, 2019 - Memorial Sloan Kettering Cancer Center

Dear Dr. Sabbatini:

Thank you for your February 6, 2017 and September 25, 2017 reports in response to our December 29, 2016 and August 31, 2017 requests for information relating to the human research protections program at Memorial Sloan Kettering Cancer Center to evaluate compliance with Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR part 46).  This evaluation was conducted as part of our not-for-cause evaluation program at OHRP. 

During this evaluation, we reviewed multiple informed consent documents, IRB meeting minutes, written IRB policies and procedures, IRB guidelines for investigators involved in human subjects research, and other IRB documents.  Based on the materials we reviewed, we found no evidence of systemic non-compliance with HHS regulations for the protection of human research subjects. 

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.

       Sincerely,

       Lisa Buchanan, MAOM
       Operationally-in-Charge
       Division of Compliance Oversight
cc:
Mr. Roy Cambria, Director, HRPP, MSKCC
Dr. Roger Wilson, Executive Director HRPP Operations, MSKCC
Dr. Michelle Bulls, Director, OPERA, Office of Extramural Research, National Institutes of Health (NIH)
Dr. Pamela Kearney, Director, Division of Human Subjects Research, Office of Extramural Research, NIH
Dr. Adam Berger, Director, Division of Clinical and Healthcare Research Policy, Office of Science Policy, NIH
Mr. Taunton Paine, Office of Science Policy, NIH