We've made that much progress...
Quote of note:
The study also steered clear of the controversy of whether the NIH study complied with Good Clinical Practices (GCP), a sweeping set of record-keeping and patient protections that NIH says it is requiring its researchers to follow.
The IOM panel said GCP was voluntary and that it remained confident the researchers for the study were in "substantial compliance" with the federal guidelines they were obligated to follow some of which were tougher than the GCP conditions. [P6: emphasis added]
Panel: AIDS Study OK Despite Violations
- By JOHN SOLOMON, Associated Press Writer
Thursday, April 7, 2005
(04-07) 16:28 PDT WASHINGTON, (AP) --
Controversial U.S. research in Africa that violated federal patient protection rules was nevertheless conducted well enough to support its conclusions that the AIDS drug nevirapine could be used safely to protect babies, an expert scientific panel has concluded.
"The committee finds that there is no reason based in ethical concerns about the design or implementation of the study that would justify excluding its findings from use in scientific and policy deliberations," the Institute of Medicine panel said in a report first obtained by The Associated Press.
The report, released Thursday, will have implications in both Africa, where medical officials are debating whether to withdraw the drug, and in the United States, where investigators are examining whether U.S. research is complying with federal law.
The report was be welcomed as good news at the National Institutes of Health, the federal agency that funded the nevirapine study in Uganda and which has been engulfed in months of controversy but has insisted the drug is safe.
