FDA Warning Letters - IRBs

This list will be updated as new letters are posted

Commercial IRBs

OHRP Letters of Determination

IRBs do not have an obligation to report SAEs to FDA; the study sponsor does this. However, IRBs are required to report an IRB's termination or suspension of its approval of an investigator's study to FDA. IRBs who do not terminate investigators who fail to comply with 21 CFR 312 or 812 or the IRB's requirements and are putting subjects at risk, may have their authority to approve studies suspended by FDA. [see Crittenton & Huntsville Hospital]

Wheaton Franciscan Healthcare IRB    1-24-2007 CBER Warning Letter
FDA recommended that the IRB record the number of votes on each of the action taken by the IRB and avoid recording the votes as a block voting.

Washington Regional Medical Center IRB    12-8-2006 CDRH Warning Letter
The IRB was operating without any type of written procedures. Minutes for the [redacted] meeting could not be located and produced during the inspection. In addition, the minutes covering continuing review approval for protocol [redacted] for 2003, 2004, and 2005 could not be located.

St. Joseph's Healthcare IRB     11-7-2006 CDRH Warning Letter
The 2006 FDA inspection went back to 2001. A failure to vote and keep good records of the votes were problems. Unusual, in this case, the IRB was cited for failure to approve a protocol that the hospital president approved. It looks like an emergency situation and the IRB was not available to review it. It was referred to as a "compassionate use/emergency" approval. These uses are distinctively different so I can't comment on what it really was.

Oklahoma Blood Institute IRB     7-10-2006 CDER Warning Letter
Full IRB review by a quorum of members, notice of study approval and timely continuing reviews were the problems.

Vail Valley Medical Center IRB     6-23-2006 CDRH Warning Letter
There were multiple problems with IRB reviews and records of their reviews.

St. Johns Medical Center IRB     6-23-2006 CDRH Warning Letter
There was evidence of investigator non-compliance in reports to the IRB; however, the IRB took no action to correct the problems nor did it terminate study approval and report the termination to FDA.

Galesburg IRB    6-22-2006 CBER Warning Letter
Same problems as Vail Valley Medical Center IRB plus inadequate written procedures and consent form problems.

MD Anderson Cancer Center IRB     6-15-2006 CDER Warning Letter
This was a Radioactive Drug Research Committee (RDRC). There were problems with consent and safety risks for the pediatric subjects.

Human Investigation Committee of Houston, Texas     1-23-2006 CDER Warning Letter
This IRB approved the study done by Dr. Fabre in which a Vietnam war hero died. I've seen a report that the IRB received an FDA warning letter in 1992 saying it had conflicts of interest. It was run by Fabre himself. Members include his business partner, psychiatrist Stephen Kramer, and his lawyer, Bruce Steffler. The letter is not in the FDA archives and the FDA 1-23-2006 letter does not mention it so I'm not sure there was a 1992 letter. This was a Warning Letter, not a suspension like Huntsville and Crittenton whose letters referenced an earlier warning. A prior Warning Letter is not required before going to a suspension even though it looks that way.

The FDA said in it's January 2005 letter to Dr. Fabre that the consent form he gave Polsgrove "failed to describe clozapine's risk of fatal myocarditis," the disease that killed him.The IRB failed to ensure that a description [from the drug's labeling] of any reasonably foreseeable risks or discomforts to the subject were included in the informed consent documents. Boxed warning information needs to be included in the consent form.The IRB failed to ensure that the ICDs disclosed appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.

The IRB approved protocols in which the monitoring frequencies for WBC counts were not adequate to ensure that risks to subjects were minimized.

While the IRB's written procedures did mention reporting to the IRB, they did not contain a procedure for ensuring prompt reporting to FDA of any unanticipated problems involving risks to human subjects or others. A statement is needed in the approval letter sent to the investigator.

Baltimore City Health Department 12-15-2005 CBER Warning Letter
There were no records in the IRB's file to show that the IRB conducted continuing review of six studies at intervals appropriate to the degree of risk, but not less than once per year. These new studies, which were approved as renewals and amendments incorrectly, should have been reviewed at least annually as required by the regulation.

The minutes of the IRB meetings do not show the actions taken and the members voting for, against, and abstaining. The IRB failed to establish a majority of members at four meetings. The IRB allowed non-members to vote on research projects.

One study involved more than minimal risk, in that it used an invasive procedure, and was therefore not eligible for the expedited review approval process.

Huntsville Hospital     8-1-2005 CDRH Suspension 4-11-2003 CDRH Warning Letter
Re the 8-1-2005 letter: As a result of the IRB's continued noncompliance with FDA regulations, FDA will withhold approval of new studies that are reviewed by your IRB. In addition, we direct that no new subjects are to be admitted to ongoing studies. These restrictions will remain in effect until you are notified in writing by FDA that the IRB's corrective actions are satisfactory.

There is good information in this case regarding SR and NSR determinations.

St. John Hospital IRB     6-23-2005 CDRH Warning Letter
The primary problem here involved incoming reports from investigators reflecting non-compliance with the protocol and IRB requirements; the IRB did not act on these reports in a timely manner.

Crittenton Hospital Medical Center 1-19-2005 CDRH Suspension 11-7-2002 CDRH Warning Letter
The IRB granted retroactive reapproval to two FDA-regulated studies after approximately two months of lapsed approval. For FDA-regulated studies, with the exception of activities necessary to ensure the welfare of the study subjects, no study-related activities are to occur during an approval lapse.

The [redacted] is a significant risk device study hence requiring review quarterly, however, the study approval letter required only annual progress reports.

As a result of the IRB’s continued non-compliance with FDA regulations, we are directing that no new subjects be added to on-going FDA-regulated studies until we have evidence of adequate corrective actions. Therefore, under 21 CFR 56.120(b)(2), we are directing that you immediately inform the clinical investigators for these studies that no new subjects may be added to their on-going FDA-regulated studies.