Allentown, PA, May 1 (OHRP)
It was alleged that the Lehigh Valley Hospital (LVH) IRB did not review and approve protocol changes and enrolled a complainant's husband into a research project even though he was ineligible due to treatment with the anti-arrhythmic medication digoxin.
OHRP determined that there was no proven violation of HHS regulations regarding this allegation because, as the hospital's report stated, "digoxin does not possess any of accepted classes of Vaughan-Williams antiarrhythmic properties and as such is not traditionally classified as an anti-arrhythmic."
Further, the report noted, "The specific purpose of this exclusion criterion was to ...