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Center for Disease Control
and Prevention

February 13, 2004

Re: Protocol #CN-03MGeie-01-H

Leigh Pruncau, Ph.D., R.N.
IRB Administrator
Northern California Kaiser Permanente
1800 Harrison Street, 16th Floor
Oakland, California 94162

Dear Dr. Pruncau:

My office in the National Immunization Program has oversight responsibility for IRB issues related to research sponsored by the National Immunization Program. This letter is to inform you that my office has received reports from the technical monitors that accompanied Dr. Mark Geier and Mr. David Geier on their October 2003 and January 2004 visits to the Centers for Disease Control and Prevention (CDC) Research Data Center) in Hyattsville, Maryland. These investigators were approved by your Institutional Review Board to conduct analyses in our RDC. These reports describe potential breaches in confidentiality and execution of analyses that were not approved in advance. Below is a synopsis of the key issues on these two topics.

From the October 9–10, 2003 Visit to the RDC

Protocol Issues

The approved analysis was to answer the following questions:

  1. Does acellular DTaP increase the risk for acute adverse event (list of 15) within 30 days following vaccination?
  2. Does acellular DTaP increase the risk for chronic adverse event (same list of 15) within 1 year following vaccination?

Instead, the Geiers compared autism rates in those e receiving 100 mg of thimerosal from DTaP to those receiving zero mg from DTaP.

From the January 29–30, 2004 Visit to the RDC

Protocol Issues

The rescarchers asked how to merge datasets across studies to create a composite data file. They were told the files were not set up for such a merger nd that such a merger was not part of the approved analysis. Nevertheless, the researchers ran a program which attempted to merge datasets, and the visit ended with a cancellation of an SAS program that has been running for more than 45 minutes and was intended to have more than 8 million records in it (according to the programmer).

By attempting to merge data files, the researchers would have created a more complete medical records on subjects, and if so, could have increased the risk of a breach of confidentiality.

External researchers are provided with a copy of their SAS programs at the conclusion of their visit to the RDC. On this occasion, the external researchers attempted renaming data files with the ".sas" extension reserved for program files. This would have allowed the external researchers to remove data files from the RDC, contrary to the rules of the RDC. The violation was detected and only the correct files were ultimately released. The programmer stated that the files were created by mistake.

In summary, during the first visit the researchers conducted unapproved analysis on their datasets and on the second visit attempted to carry out unapproved analyses but did not complete this attempt. This analysis, had it been completed, could have increased the risk of a confidentiality breach. Before leaving, the researchers renamed files for removal which were not allowed to be removed. Had it gone undetected, this would have constituted a breach of the rules about confidentiality.

Please note, I have sent copies of this letter to Dr. Jared Rowe, IRB Administrator at Kaiser Permanente Colorado and Dr. Eric France, Principal Investigator for CDC's Vaccine Safety Datalink Project at Kaiser Permanente Colorado as well as Dr. Steve Black and Dr. Henry Shinefield, Co-Principal Investigators for CDC's Vaccine Safety Datalink Project at Northern California Kaiser Permanente. I have also sent copies of this letter to Kristina Borrer, Director of Compliance at the Office of Human Research Protections. I was not able to send a copy to the sponsor of this research as we could not identify the sponsor.

Please inform us of actions, if any, you take in regard to these matters.

Sincerely

/s/

Jeanne Santoli, M.D.
Acting Associate Director for Science
National Immunization Program
Centers for Disease Control and Presention

cc:
Jared Rowe, Pharm.D.
Eric France, M.D., M.S.P.H.
Steve Black, M.D.
Henry Shinefeld, M.D.
Kristina Borrer
Dixie Snider, M.D., M.P.H.
Ann Dellnger, Ph.D., M.P.H.

This page was posted on March 28, 2005,

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