FDA Warning Letter Cites IRB for Data Collection Deficiencies

Posted 15 August 2012 | By

A warning letter sent to an institutional review board (IRB) by the US Food and Drug Administration (FDA) accuses the New York-based board of failing to document many of its activities in violation of federal regulations.

FDA's 3 August warning letter to the Center for the Improvement of Human Functioning International (CIHFI) notes "objectionable conditions" at the IRB's facilities. IRBs are charged with protecting human subjects by overseeing the design and general conduct of clinical trials.

Deficient Data Collection

FDA charged that the company was negligent in its duties to protect human subjects because of numerous deficiencies, primarily related to its collection of basic data.

For instance, FDA said its inspection revealed that the company had failed to maintain any written procedures for the IRB's functions and operations. Under normal circumstances, procedures should be established for reviewing research, determining the timelines for review, receiving changes to the trials' procedures, ensuring prompt reporting and approving changes.

But beyond not taking of stock of what it should do, FDA said the IRB also failed to document what it did do in at least three cases. In the case of one particular study, FDA said it was unable to find copies of any consent forms required to be filled out by patients and kept on file by the IRB. In a similar case, FDA said it was unable to find any meeting minutes from the IRB's meetings since 1997 despite assurances from the IRB that it met on average twice per year. Other assorted correspondence, including letters detailing serious adverse event reports, were not kept by the IRB, and FDA said it would require the IRB to submit a Corrective and Preventive Action (CAPA) plan detailing preventive actions to be taken by the company to ensure future compliance.

Mystery Men

FDA also said it was unable to determine whether the members of the IRB were suitable to be on the board. During FDA's inspection, it said it was unable to find any listing of the IRB's members since 2007, and even the 2007 member list did not include the titles, affiliations or qualifications of the IRB's members.

All of the deficiencies together were indicative of systemic problems that are to the detriment of patient safety, FDA explained. "As noted in the citations above, the IRB lacks procedures to define how it operates, and has failed to maintain adequate documentation of its activities," FDA explained. "Such information helps to ensure that the rights, safety, and welfare of human subjects are protected."

FDA said it did, however, appreciated the cooperation shown to its investigator during the inspection. Such positive points are rarely contained within warning letters.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles