KPNC Warning Letter re: Dr. Mark Geier


April 15, 2005

KAISER FOUNDATION
RESEARCH INSTITUTE
1800 Harrison Street
Oakland, CA 94162

February 25, 2004

Mark Geier, MD
Principal Investigator
The Genetic Centers of America
14 Redgate Court
Silver Springs, MD 20905

Re: A Series of Studies to Analyze the Vaccine Safety Database

Dear Dr. Geier:

On February 19, 2004, the Kaiser Permanente Northern California (KPNC) Institutional Review Board (IRB) suspended your research project pending the following:

  • Submission of a response from you to the attached letter, which the Centers for Disease Control and Prevention recently sent to the IRB notifying it of reports received from the technical monitors who accompanied you on visits to the CDC Research Data Center (RDC)

Please note: The ITB views with great concern the reported attempt to breach confidentiality and your attempts to merge data and conduct analyses which were not in accord with CDC procedures.

Also note: as a result of this suspension, you and your co-investigator are prohibited, until notified otherwise, from accessing VSD data derived from Colorado Kaiser Permanente and Northern California Kaiser Permanente institutional officials.

Federal regulations and KPNC/IRB policy prohibit conduct of research that has been suspended by the IRB. The IRB is required to report, and will proceed to report, the suspension of this study to the CDC and Kaiser Permanente institutional officials.

The following actions are required:

  • You must immediately cease all activities which involve Kaiser Permanente data, as it is required by federal regulations and KPNC IRB policy.
  • You must inform the IRB of any research-related activity continued beyond this notification of study suspension, providing the reason(s) for continuation.
  • You must provide written notification of study suspension and the required cessation of all research activities to the co- and sub- investigators, if any, participating in this research within five business days of receiving this notification.

The IRB requires that you provide your response to the CDC’s letter to KFRI via e-mail to KPNC IRB on Lotus Notes, or KPNC.IRB@kp.org, or by U.S. Mail by noon on March 8, 2004, for review at the March 18, 2004 IRM meeting.

Sincerely

Leigh Pruneau, PhD, RN
KPNC/IRB Administrator

This page was posted on April 15, 2005,