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A Question of Integrity

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TIMES SCIENCE WRITER

For more than a decade, federal officials and university administrators have struggled to handle allegations of scientific misconduct without stigmatizing those who rightfully raise questions about a colleague’s research or destroying the careers of those who are wrongly accused.

Now, for the first time, those federal officials who are responsible for the integrity of about $12 billion annually in biomedical research have calculated the consequences--in derailed careers, damaged reputations and missed research opportunities--to those guilty of nothing more than doing the right thing.

In two comprehensive studies, the federal Office of Research Integrity explored the experiences of researchers who became whistle-blowers and, in unrelated cases, of scientists who were accused but exonerated of any wrongdoing.

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The studies confirm what many have long suspected:

* Despite federal regulations designed to protect them, whistle-blowers frequently faced significant hardships as a result of their efforts, with many suffering “devastating consequences.” Some lost promotions and pay increases. Others were ostracized or threatened.

* At the same time, those on the other side of that human equation--scientists who were accused but eventually exonerated of misconduct--weathered equally trying experiences, even though federal regulations are meant to protect them as well. Some reported that they lost research funding. Others had grants delayed or had problems getting new research papers published.

Office of Research Integrity experts said the findings are significant because they offer the first systematic assessment of the personal impact of misconduct investigations, which can run the gamut from relatively routine administrative hearings taking a few days to legal imbroglios taking years to resolve.

By pointing out weaknesses in how such cases are handled, the studies will help federal officials further fine-tune a system that has already been overhauled several times in the last decade to ensure its fairness.

It is an article of faith among scientists that honest research errors will be weeded out as others routinely try to duplicate published experiments. But the question of researchers who may deliberately fabricate data in publicly funded research projects has drawn increasing attention in recent years.

Despite more than a decade of scrutiny, however, no one knows just how serious or extensive a problem misconduct in science may be.

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Indeed, federal officials and research agency regulators have not been able to agree even on a uniform definition of misconduct.

Of the estimated 1 million researchers working in the United States, fewer than 200 are reported for alleged misconduct in any given year, according to historian Nicholas H. Steneck of the University of Michigan. Since the current regulations went into force in 1989, Office of Research Integrity officials and other public health investigators have opened 351 investigations.

But that may be a misleading measure of the situation. Steneck said that an unofficial check of about 150 research papers picked at random showed technical errors in at least half of them. No one knows whether those errors are the result of honest mistakes or cupidity.

“There are reasons, significant reasons, to be concerned. [But] there is very little factual information,” Steneck said. “There have been very few studies of what the average researcher is doing.”

Although misconduct investigations are underway, universities and research labs are under a special obligation to ensure that no scientists suffer undue consequences simply because the integrity of their research has been questioned.

Indeed, federal regulations urge that the identity of the accused be kept confidential during an investigation and, if the accusations are unfounded, that actions be taken to restore the researcher’s reputation.

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The schools and federally funded laboratories are under a similar obligation to protect researchers and faculty who, in good faith, report misconduct or help in an investigation.

In all, a study team from the Research Triangle Institute, which conducted the surveys for the Office of Research Integrity, talked at length to 68 whistle-blowers whose allegations were upheld and 54 researchers who, in separate cases, had been exonerated of misconduct charges.

More than two-thirds of the whistle-blowers reported that they experienced some consequences as a result of their actions.

Whistle-blowers fared worst in high-profile cases arising from the basic sciences, in which institutional officials and funding agencies appear to put the interests of their organization above those of the whistle-blower, the study found.

“This pattern definitely suggests a failure in mechanisms to protect vulnerable whistle-blowers from retaliation,” the study team reported.

The researchers also found that:

* Two in five whistle-blowers were pressured to drop the allegations or were confronted with countercharges of misconduct. Problems were most likely to arise during the investigation, not after the case was resolved.

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* One in four were ostracized by colleagues and one in five lost research support. A few whistle-blowers lost their jobs or were denied promotions.

* Three-fourths of those who suffered retaliation for their actions, however, said they would not hesitate to report misconduct again.

In all, about 70% of the misconduct cases that come to the attention of the Office of Research Integrity result in exoneration, federal officials said.

Looking at those cases, the study team found that three out of five scientists who were cleared of misconduct said they suffered some harm in their careers, professional activities and personal lives.

Nonetheless, the overall effect on their lives was probably neutral, a majority of the scientists said.

But 39% said the allegations hurt their career and a sizable minority--17%--said they had been seriously affected by the accusations, even though investigators determined they were baseless.

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Their problems ranged from lost jobs to missed promotions and lack of pay increases.

Among the findings:

* One in five said they were ostracized by their colleagues. One in six said they had lost research funding or had grant applications delayed. Several said they had trouble getting their research manuscripts cleared or were no longer invited to present their findings at research meetings.

* Almost all of those who reported serious consequences from the allegations said the problems started during the investigation, at a time when they should have been presumed to be innocent and their identities should have been protected. More than three in five said the problems continued well after they were exonerated.

* Fewer than half were satisfied with how their cases were handled or believed that their institution did all it could to maintain confidentiality. And barely one-quarter were satisfied with the efforts to restore their reputation.

“These findings suggest there is substantial room for improvement in restoring the reputation of those exonerated of scientific misconduct,” the study team concluded.

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Researchers and Responsibility

The Office of Research Integrity polices federally funded biomedical research carried out through about 30,000 grants at 2,000 institutions.

Here is a sample of cases federal officials have investigated.

Case: A senior cancer researcher at St. Luc Hospital, Montreal, fabricated patient data in multicenter clinical studies on breast and bowel cancer.

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Punishment: Pleaded guilty to 13 counts of committing “acts derogatory to the honor anddignity of the medical profession” and was barred from receiving federal funds for eight years.

Case: A pediatrics researcher at the University of Wisconsin admitted making up medical records in research on Parkinson’s disease.

Punishment: Banned from receiving federal grants for three years and required to submit to special supervision to ensure integrity of work.

Case: A psychologist a Dartmouth College admitted fabricating animal research records and results of surgical experiments.

Punishment: Banned from receiving federal grants for three years.

Case: A senior researcher in the School of Dental Medicine at the University of Connecticut falsified data in nine studies on the brain.

Punishment: Banned from receiving federal grants for three years and ordered to retract studies published in four technical journals.

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Case: A genetics researcher at the University of Michigan falsified data in his dissertation and its eight research papers on the genetics of leukemia and cancer.

Punishment: Banned from federal grants for three years and ordered to retract all the fabricated papers.

Case: A research coordinator at Johns Hopkins University admitted making up data in studies of breast cancer patients.

Punishment: Banned from receiving federal grants for three years and required to submit to special supervision.

Source: Office of Research Integrity

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