What I heard that day would, like that picture of the OPRR police that was yet to appear a few years later, leave a lasting impression.
It was not more than about a year later when just before a meeting of the Partners Research Council was about to convene that the suspension by OPRR of Duke's multiple project assurance came across the wire.
After the death of Ellen Roche, a volunteer in an asthma study at Johns Hopkins University, the OPRR
suspended human subject research at that university (ABC News, 2001).
The FHCC has posted a copy of the letter on its website along with one from the OPRR
stating that "although there was room for improving procedures of informing the Institutional Review Board (IRB) of research outcomes during the course of IRB-approved research, there was no material failure to comply" with US policy for the protection of human beings.
Although the OPRR currently maintains records concerning the incidence and types of allegations of scientific misconduct it investigates and the deposition of each allegation, we simply do not know the proportion of alleged or actual incidents of wrongdoing in relation to the totality of scientific research.
Further, allegations of misconduct can halt important studies, as noted in the rash of OPRR actions in 1999 and early 2000, and they may tarnish reputations for years, even if the allegations are later found to be false.
The institution fulfills that assurance to OPRR by setting up institutional review boards (IRBs) to review research proposals before they begin.
NBAC commissioners, the Inspector General's report, and OPRR officials--despite their worries about systemic weaknesses--all credit the culture of the American medical profession with an outstanding sense of ethics.
is concerned with the definition of a human subject.
The initial response from the Clinton administration was to move OPRR
from a low-level office within the National Institutes of Health to the departmental level at DHHS.
With a full-time staff of four people in charge of assuring compliance with research rules, OPRR
can hardly be expected to keep a close watch on the thousands of experiments involving humans going on at any one time.
A salute to OPRR
and to the Poynter Center is appropriate.