Inspections, Compliance, Enforcement, and Criminal Investigations
Oak Lawn Institutional Review Board Response Letter
September 25, 2003
Jean Toth-Allen, Ph.D.
Director Office of Compliance Center
for device and Radiological Health
Division of Biological Monitoring
Program Enforcement Branch II (HFZ-312)
2098 Gaither Road
Rockville Maryland 20850
Dear Dr. Toth-Allen
This letter responds to a letter dated September 17, 2003 from Timothy A. Ulatowski, Director Office of Compliance, regarding an inspection of the Oak lawn Institutional Review Board that took place during the period of May 5 through May 23, 2003 that was conducted by Ms. Lisa Hayka.
The protocol and informed consent form for [redacted] study to evaluate the [redacted were reviewed at the IRB meeting on [redacted]. The minutes documented that the investigators were not approved at the meeting because the investigator list had not been finalized and no C-V’s were submitted; however, IRB approval letters to clinical investigators are dated [redacted].
The C-V’S were sent to the Oak Lawn IRB after the [redacted] meeting. When the C-V’s were received a letter and a periodic/annual report form went out approving each investigator at the date of the original approval as long as the investigator met the qualification criteria. The Oak Lawn IRB through our inspection discussed the rationale of corresponding to the investigator at the date of the approval and not the date of the original IRB approval meeting. These changes have been integrated into the Oak Lawn procedural manual. All letters will be dated at the time of correspondence.
The Oak Lawn IRB has previously conducted its consent revisions with signatures of the IRB members. The copy of the informed consent with signatures of the IRB members was never lost and is attached to this letter. The IRB comprehends the climate that investigative business is now operating. Since 1979 IRB protocol and consent verification has undergone ever changing evolution. The Oak Lawn IRB has purchased a stamp in March of 2003 to date, stamp and place signatures on the consent form. The Oak Lawn IRB has also created a signature page so that Oak Lawn IRB member’s signatures could be verified.
The Oak Lawn IRB has previously operated under the guidelines, which has been reviewed by the FDA during past inspections, when an approval of a protocol pending the submission of information was granted, the submission of corrected information or deficient information was sufficient for approval when the information was of minimal risk or consequence. The Oak Lawn IRB understands that each revision of a protocol will require a separate response submitted to the sponsor and investigator. The Oak Lawn IRB will change its operating procedure to reflect this change.
The Oak lawn IRB has instituted in its manual to review and document the risks to children participating in clinical investigations before the clinical proceeds. The Oak Lawn IRB will make several determinations concerning the risks and document subject risks. The Oak lawn IRB additionally will specifically identify which of the four risks categories will apply to pediatric subjects in a clinical investigation. The risk determination will be divided into clinical investigations not involving greater than minimal risks, clinical investigations involving greater than minimal risks but presenting the prospect of direct benefit to individual subjects, clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects disorder or condition, or clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. The Oak Lawn IRB will require permission by parents or guardians and for assent by children. The Oak Lawn IRB has conducted a review meeting on June 10, 2003 to address subpart D, additional safeguards for children in clinical investigations. The Oak Lawn IRB also sent letters to each of the investigators notifying them of the information. The minutes of that meeting and a letter to the investigator is included for your review.
In the past the Oak Lawn IRB requested summaries from the protocols in review and if no adverse reactions were documented, the submission of the summaries to the IRB members were considered as sufficient to continue the investigation until its next schedule review. The Oak Lawn IRB is committed to full compliance with the law and the FDA regulations. The Oak lawn IRB has conducted a meeting to review both studies data and will continue to review all protocols at the intervals that the FDA stipulates in the Federal Registry. This information will also be documented in the IRB minutes.
Due to the late start up of the [redacted] the progress report was assumed to be scheduled for submission six months after the initiation of the study. The approval letter was dated [redacted], although the final revised protocol was dated [redacted]and the bulk of the patients were not enrolled until November/December. A letter was sent to the study monitor on [redacted]approving the advertising language of patient recruitment. The IRB decision was to wait until sufficient data could be analyzed in order to review the progress of the investigation. Progress/Final report was sent to each investigator with the original investigator approval letter and is included for your review. On [redacted] the six month summary was submitted by the study monitor. Using the November/December initiation date the IRB notified each investigator with the progress/final report form dated [redacted] as the yearly progress report. An additional letter was sent [redacted] to investigators who had not submitted a progress report stating that if a report was not sent to the IRB by [redacted] the investigational site would be closed. The Oak Lawn IRB learned through our inspection that the FDA requires the time table of reporting to start at the approval date and not at the initiation of subjects enrollment. The IRB will change its time table to reflect the FDA guidelines.
Due to the time you have committed to review and critique the Oak Lawn IRB SOP’s, the Oak Lawn IRB manager has begun to review and rewrite the IRB SOP’s. The manager is using the July 11, 2002 “Guidelines on written IRB procedures” as a template for the new SOP’s. We will send you the revised Oak Lawn IRB SOP’s as soon as they are written no later than February 1, 2004.
The Oak Lawn IRB appreciates the opportunity to respond to the inspectors concerns and have the opportunity to correct the procedural deficiencies. The Oak Lawn IRB views the agency’s communicating its views as constructive. The partnership through the inception of the IRB program has always been a learning experience. The Oak Lawn IRB is committed to adhere to all the legal requirements and ethical standards.
Irwin Septow, O.D., F.A.A.O.