WASHINGTON -- According to one observer, events last monthat the Office of Research Integrity (ORI) have had a cripplingeffect on the office within the Department of Health and HumanServices (HHS) that is charged with investigating scientificmisconduct and fraud.

In November, the research integrity adjudications panel of theDepartmental Appeals Board reversed and forcefullycondemned ORI's misconduct conviction of Mikulas Popovic, aresearcher in the National Cancer Institute laboratory of HIVco-discoverer Robert Gallo. Based on that and another reversal,ORI also dropped its charges against Gallo.

ORI had charged that one sentence and seven data points in aseminal 1984 paper in Science about a cell system for culturingHIV had been falsified. The office determined that themisconduct was relatively minor and did not invalidatePopovic's breakthrough research. Gallo was accused offalsifying one sentence in a related paper concerning growingthe HIV virus.

"ORI is pretty well shattered," Daniel Greenberg, editor andpublisher of Science & Government Report and a long-timeobserver of ORI, told BioWorld. "People can come to work anddo their jobs, but the signal that has come out to the scientificcommunity is that these people are pushovers."

But Lyle Bivens, director of ORI, told BioWorld that within thecontext of his agency's overall score, "these are not make-or-break cases.

"Since the office was set up, we've issued 22 findings ofmisconduct; 13 were uncontested. Of the nine that wereappealed, on three of these we have prevailed in theprehearing conference," he said.

Some observers maintain that the ORI, which was consolidatedin May 1992, has been put in the untenable position of tryingto apply scientists' standards of misconduct, which conflict withan appeals board that applies legal standards.

Therefore, instead of having to prove a researcher guiltybeyond a reasonable doubt, ORI passes judgment based on thepreponderance of evidence.

Furthermore, ORI considers a scientist guilty of misconduct ifhe has lied, plagiarized or falsified data, while the appealsboard also requires proof that the scientist intended to falsifyand that such data changed scientific conclusions.

Additionally, ORI would have liked to apply a "should haveknown" standard that would cover gross negligence and lowerthe threshold for finding misconduct, Bivens told BioWorld.

"The (appeals) board is applying the sort of standards youwould apply in a car theft case to matters of scientificbehavior," said Greenberg. "The scientific community has itsown standards, but they don't conform to the standards ofcriminal law."

In the Popovic decision, the appeals board claimed that the ORIdid not even meet its own standards. "Specifically, ORI did notprove that the Science paper contains untrue statements ordata, much less that it contains intentional falsifications."

But even the preponderance of evidence would not haveconvicted Popovic, according to the appeals board's decision.ORI was hardly professional, the appeals board implied in itsdecision; its investigators "were not asked by ORI to conduct afirst-hand investigation. Their information was largely derivedfrom the ORI investigators' understandings, which in someinstances ignored or misrepresented evidence in the record," itsaid.

"ORI has been inexcusably sloppy," Greenberg told BioWorld."In the briefs they prepared, they couldn't even quotecorrectly." ORI quoted the report in Science as saying the cellline had "not been propagated" when the actual wording washad "not yet" been propagated.

ORI's two predecessor agencies were created in March 1989 bythe Public Health Service. One of them, the Office of ScientificIntegrity, was removed from NIH in May 1992 andconsolidated with the other within HHS. Former NIH DirectorBernadine Healy told BioWorld this was done because theoffice's rulings were not viewed as impartial since it residedwithin an agency that funded researchers.

Moreover, there was no due process, she said. "There wereshifting sands with regard to what the allegations were ...documents ... were leaked to the press and yet the accused wasnever afforded the opportunity to have access to those samerecords."

To Healy, preserving due process is the important thing."Someone's life's work is on the line," she said.

-- David C. Holzman Washington Editor

(c) 1997 American Health Consultants. All rights reserved.