Review of Corrective Actions Concerning the Human Subject Research Program

EXECUTIVE SUMMARY:

At the request of the Commissioner of Food and Drugs, we assessed the implementation of corrective actions designed to address problems identified in a clinical study and to prevent future problems in FDA's human subject research program. Our objective was to determine the status, as of October 2005, of the six corrective actions specified in the Commissioner's letter of March 21, 2003. The corrective actions direct FDA's centers and the Office of Science to (1) initiate an inventory and audit of clinical studies, (2) examine research monitoring programs and develop quality assurance programs, (3) establish a policy of accountability to the Commissioner, (4) have the Chief Counsel's Office help ensure appropriate “regulatory schemes,” (5) provide additional funding for oversight, and (6) initiate a mandatory education and certification program. 

FDA undertook several efforts to improve its human subject research program. Some efforts were still underway at the time of this review. Specifically, for each action: (1) The centers conducted inventories and submitted to the Office of Science 71 human subject studies that had not been submitted to the IRB for approval or recorded in the IRB database. The Office of Science then added the 71 studies to the database. From March 2003 to October 2005, FDA audited only 3 of the 297 studies listed in the February 11, 2004, database. (2) Of the four centers that we visited, none had an operational research monitoring program. (3) FDA did not have a written policy setting forth the center Directors' accountability to the Commissioner for noncompliance with clinical research requirements. The Directors of three of the four centers we visited said that they were accountable to the Commissioner. (4) The IRB representative from the Office of the Chief Counsel informed us that she helped ensure that clinical research reviewed by the IRB complied with applicable regulations. (5) The FDA Deputy Commissioner for Operations stated that FDA had not provided any additional funds to the Office of Science to strengthen its oversight function and that the Office of Science had not requested additional funds related to this corrective action. (6) In 2002, FDA began requiring its researchers to complete a course on human subject research issues and to pass an examination to receive a certificate of completion.

We recommended that FDA increase its efforts to accomplish the Commissioner's corrective actions. FDA agreed with our recommendation.