6-item 483 received by IRB for consent and correspondence records.(IRBs)(Institutional Review Board)(Report)

Stanislaus Surgical Hospital Institutional Review Board, Modesto, CA, was the recipient of a six-item 483 for failing to keep accurate minutes for informed consent, and did not keep correspondence directly through the IRB and principal investigator in a medical device study, according to FDA records.

Investigators Marie Kinkade and Thomas from the Alameda, CA, District Office conducted the investigation.

The 483 stated: "In general, minutes failed to signify what informed consent form had been approved. The chair stated that all consent forms approved by the IRB were received from the sponsor, and the IRB had not requested any modifications." Through its approval letter to the principal investigator, the IRB granted blanket approval of all consent forms used at the Modesto study site, FDA noted.

The consent forms did not include a statement that one purpose of the study was to determine safety and efficacy of the study device. The consent also failed to provide a specific contact for answers to pertinent questions about the research subject's rights.

Also, "consents lacked the name of the individual to contact for questions about the research, research-related injury or subject's rights," the EIR reported.

The EIR also stated: "it cannot be determined what protocol or consent form was approved for use by the clinical investigator at any given time. The IRB appeared to approve all consent forms of the principal investigator, even those yet to be written."

Next, "correspondence required to be direct between the IRB and principal investigator was sent through a third party--the sponsor of the research. This includes submission of research proposals, informed consent forms, adverse reaction and progress reports. No correspondence from the principal investigator was available for review during our inspection."

Other missing information, according to the 483, was noted in a letter from the IRB to the principal researcher that referred to information the doctor had provided about the progress of the investigation, current assessment of risks, benefits and the appropriateness of the approved consent form.

Also noted in the 483 were meeting-minute flaws. The agency wrote that minutes of meetings were not written in sufficient detail to describe what the members reviewed and approved. "This first annual review of the study gave no indication whether or not a consent form was reviewed by the IRB. It did not indicate what version was approved for continued use. There was no discussion regarding a missing progress report from the investigator."

Another example noted in FDA documents was where the board of the IRB gave retroactive approval of a consent form. However, there appeared to have been no discussion of the fact that two different consent forms were used at the Modesto study site.

Further, a revised consent form was approved by the IRB at a meeting, but the IRB failed to discuss and approve the form the sponsor had requested in a letter to the IRB. No approval letter was sent to the principal investigator or sponsor to report the authorization of this new consent form.

Regarding SOPs, the 483 stated that the IRB was deficient because the document was undated and only three pages that included a checklist for the review of study protocols and consent forms.

These procedures fail to meet federal requirements for conducting continuing review of research; determining which projects require more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review; ensuring prompt report to the IRB, institutional officials and FDA of any unanticipated problems involving risks to human subjects and others; ensure continuing review of research on an annual basis; and ensuring IRB determination of significant risk or nonsignificant risk for investigational devices.

The EIR added: "From the records at hand, we could not resolve whether principal investigator, Wesley Kinzie, M.D., agreed to accept responsibility for the IRB approvals. In fact, no correspondence whatsoever was on file from him."

Also, the IRB did not require progress reports from the principal investigator. The IRB received annual reports from the sponsor which were so vague with respect to the locations of sites involved that it could not be determined if any adverse events or protocol deviations occurred at the Modesto site.

The EIR further noted that the IRB lacked five members on the board and was short a community member, a scientist medical doctor and diversity of membership. Stanislaus Surgical Hospital Institutional Review Board, Modesto, CA, 12/16-23/04, Doc. 115385, $13 plus retrieval.

Stanislaus Surgical Hospital Institutional Review Board, Modesto, CA, Alameda, CA, District

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