Turmoil at Federal Agency Threatens Oversight of Biomedical Research

(The Washington Post) -

A small government office that monitors misconduct in biomedical research is in turmoil, jeopardizing oversight of billions of dollars in grants to universities and other institutions around the country.

Six of the eight investigators in the federal Office of Research Integrity have signed a letter hinting that they may leave, a move that could hobble federal efforts to detect data manipulation and other misconduct by laboratory researchers. The office’s new head has filed personnel actions against the two division directors she inherited and installed a new deputy to supervise the entire staff.

In a letter to Karen DeSalvo, acting assistant secretary for health at the Health and Human Services Department, the six investigators wrote: “We need your help. We request that [your office’s] leadership investigate the situation … before there is further deterioration of staff morale and all or most of the investigators need to be painstakingly replaced.”

Falsification, fabrication and modification of data remain an ongoing problem for the scientific community. In a 2009 study in the journal PLOS One, about 2 percent of scientists admitted they had committed one of those three acts, and as many as 33.7 percent said they had used other “questionable research practices.” In surveys that asked about their colleagues’ behavior, scientists reported much higher rates of misconduct, according to the article.

The consequences of such deceit can be magnified when subsequent research builds on published articles that contain false data.

The conflict at ORI, first reported in Science magazine, appears to stem from the arrival Dec. 28 of Kathryn M. Partin to head the office, which had been without a permanent director for about two years. Partin and her staff members, many of whom have been there for years, almost immediately began to clash. One of the issues they disagreed about was Partin’s suggestion that investigators spend more time looking into allegations of plagiarism, which had previously not been a major focus of their work, said John Dahlberg, who retired as a deputy director of ORI last year and has been following the controversy.

“The disagreement is not in whether it should be done or could be done, it’s in how much attention is going to be paid to meeting the legal requirements,” Dahlberg said. From there, Dahlberg and others said, the conflict has mushroomed into an ongoing personality clash that pits Partin against the investigative staff members and the members of the office’s other unit, who educate researchers about responsible biomedical research.

“She doesn’t like for anyone to tell her that they disagree with her,” said one person in the office, who like everyone besides Dahlberg requested anonymity out of fear of retaliation. “We’re not angry. We’re afraid.”

A spokeswoman for the office said that Partin and DeSalvo declined to comment on what are primarily personnel issues because of limitations imposed by the federal Privacy Act.

ORI investigators are the forensic sleuths of the arcane world of biomedical research. They scrutinize images, pull information off hard drives and pore through notebooks hunting for misconduct that was committed intentionally, knowingly or recklessly by researchers who sometimes use subterfuge to produce the results they want.

The investigative craft takes years to learn well, said Dahlberg, who spent 23 years in the office. All eight investigators — six staff members and two contractors — hold Ph.D or MD degrees. One is 85 years old.

While the 24-year-old unit is an obscure part of the vast HHS, it is responsible for all the biomedical research grants handed out by the eight agencies that constitute the U.S. Public Health Service. Most of the money is distributed by the National Institutes of Health, which gave out nearly $24.5 billion in fiscal year 2015. But the Centers for Disease Control and Prevention also handed out $618 million in research grants during the same fiscal year, and agencies such as the Substance Abuse and Mental Health Services Administration support research as well.

Nicholas Steneck, an expert on research integrity, said that despite its small size, ORI is recognized around the world as the most important oversight agency of its kind, mainly because of the huge amount of money it oversees.

ORI publishes its findings, including the names of scientists who have engaged in “research misconduct” in the Federal Register and online. The office’s reports can be a death sentence for the careers of scientific researchers, who often rely on grant money to do their work. And because the investigators typically must prove deliberate or reckless misconduct, the legal standards they must meet are high. The office relies on preliminary investigations by integrity officers stationed at institutions that receive the grants, but often must review and redo their work, Dahlberg said.

The work is slow and painstaking, but the investigators have caught some elaborate trickery. Working with the medical school, they reported earlier this year that a researcher at Albert Einstein College of Medicine in New York used Photoshop to falsify 38 images. The work had been supported by money from the National Heart, Lung, and Blood Institute.

In one of ORI’s better-known cases, a Vermont researcher was sentenced to a year and a day in prison in 2006 for falsifying information in 15 federal grant applications and as many as 10 journal articles.

“People out there are misusing federal money and deceiving the scientific community, and we’re the only ones who can stop them,” one ORI investigator said.

But the office has been criticized for inefficiency – it closes only 10 to 15 cases a year – and has suffered some setbacks. A case against the laboratory of high-profile scientist David Baltimore was overturned in 1996, and an accusation against Robert Gallo, co-discoverer of the virus that causes an immune deficiency disorder, was dropped in 1993 after a four-year investigation.

Plagiarism, however, has not been a major part of ORI’s work. Although it does look into some plagiarism cases, it hasn’t made a plagiarism finding since 2013. Partin told Science magazine that “comments from the research community” endorse her idea of taking “a fresh look” at plagiarism.

ORI made news in 2014, when David Wright, the director at the time, quit and blasted the HHS bureaucracy in a resignation letter that called it “profoundly dysfunctional.” In the letter, obtained by ScienceInsider, Wright called his post “the very worst job I have ever had” and said the bureaucracy left him “offended as a taxpayer.”

It’s not clear whether Partin was brought in to clean house at ORI and how far the conflict extends beyond the typical difficulties that can arise when a new chief takes over an organization full of established staff members. Partin arrived after a long tenure as a research integrity officer at Colorado State University and brought her acting deputy, Scott Moore, over from the National Science Foundation.

In their May 10 letter, the investigators said they were shocked that “Partin has in such a short time apparently concluded that she cannot work with either” or that she “believes it likely and possibly best that they both leave ORI.”

One of the division heads declined to discuss the situation and the other did not return telephone calls to her office.

Partin told Science magazine that researchers and integrity officers from other organizations find the office’s staff accessible but would like cases closed more quickly, and need more “guidance on some technical issues related to their investigations of allegations of research misconduct.”

It would take some time to replace the expertise of staff members if there were a major exodus, said Steneck, an emeritus professor of history at the University of Michigan and founder of the World Conferences on Research Integrity.

“I know what’s going on,” said Steneck, who also has worked as a contractor at ORI. “I know a lot of the people and it’s a very unfortunate situation. I wish they could get together and work their way through this and keep on with the experience they have.”