Navy Investigates Unapproved Medical

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The good news is their investigating and talking about it.

Navy Investigates Unapproved Medical Research Protocol

By National Naval Medical Center Public Affairs

BETHESDA, Md. (NNS) -- The National Naval Medical
Center (NNMC) is currently investigating a research project by
its Orthopedic Department that did not follow the appropriate
approval procedures.

The inquiry looks at a research protocol conducted over a
two-year period involving diagnostic studies on 48 patients with
shoulder injuries. The protocol had not obtained proper prior
administrative approval by the Institutional Review Board.

"This hospital upholds a standard of excellence in caring for its
patients and conducting research," said Rear Adm. Donald
Arthur, NNMC commander. "This is an isolated occurrence of
not following well-prescribed research protocols; it is being fully
investigated and reviewed to determine the cause of the oversight to prevent recurrence."

The intent of the research was to determine which of two imaging
studies would give surgeons the best assessment. Patients who
agreed to participate in the study were to undergo two separate
evaluative procedures, both of which involved the injection of a
contrast dye followed by magnetic resonance imaging of the
shoulder.

Both of these procedures are currently used by surgeons
throughout the United States who choose one procedure or the
other, but not both. Both procedures were performed in a
manner that met all standards of care for normal practice.

This NNMC research protocol has been suspended.

The NNMC staff have notified patients and asked them to come
in for evaluations at no cost to the patients. Command-wide
training of research protocols is currently being conducted.

For related news, visit the National Naval Medical Center Navy
NewsStand page at www.news.navy.mil/local/nnmc.