The federal office responsible for guarding against misconduct in biomedical research is so hampered by bureaucratic turf wars that it has been unnecessarily losing cases against suspect scientists, the unit’s departing director said on Monday.
“Right now there’s no accountability” at the Office of Research Integrity, said David E. Wright, who stepped down last month from ORI after serving two years. “That’s a huge problem.”
Mr. Wright last month returned to his post as emeritus professor of community sustainability at Michigan State University with the publication of a caustic letter, first reported by Science, setting out his complaints to the leadership of the Department of Health and Human Services, ORI’s parent agency.
While the letter broadly described his frustrations over bureaucratic hassles such as long meetings and billing disputes, Mr. Wright set out details in an interview with The Chronicle that pinpointed a central grievance: an inability to spend the ORI’s own budget, especially to hire the legal expertise needed to win court cases.
ORI, with an annual budget of about $9-million, is responsible for detecting and punishing misconduct by scientists who carry out more than $30-billion a year in research financed by several federal agencies, including the National Institutes of Health.
In many instances, those accused of fraud or misconduct accept ORI’s findings and the corresponding penalty, usually several years of ineligibility for new federal money. But in other instances, the accused decline to settle and are entitled to a letter setting out the charges so that they can prepare a court defense.
In those instances, Mr. Wright said, the Department of Health and Human Services insists on using its own lawyers. And that becomes a problem, he said, because the department’s lawyers often are insufficiently conversant with the subject matter.
The result is an “incredibly slow and inefficient” process, with cases that can languish for five or six years, sometimes too long to be effectively pursued, Mr. Wright said. Instead, ORI should be allowed to choose its own lawyers, which it would be able to do if it were really treated as an independent authority, as it was envisioned in the 1993 law creating it, he said.
The situation not only prevents ORI from catching and deterring scientists involved in misconduct, but also hinders ORI in its central mission of helping to keep as accurate as possible the public record of research discoveries, Mr. Wright said.
The Department of Health and Human Services, asked for a response, issued a single-sentence written statement: “ORI serves an important and valuable role in ensuring responsible conduct of Public Health Service research activities and functions in a manner consistent with its legal mandate.”
Overwhelmed by Allegations
Mr. Wright said he hopes Congress will step in. Sen. Charles E. Grassley, an Iowa Republican long active on issues of integrity in federally sponsored science, said he believes ORI “should have the authority to carry out its role.” In a written statement, Mr. Grassley added, “I’m looking into Dr. Wright’s concerns, and HHS should look into them if it isn’t already doing so.”
Aside from the bureaucratic issues, Mr. Wright acknowledged other possible conflicts in ORI’s operations. One stems from the general expectation that a university is the primary agent for investigating alleged misconduct by one of its employees. ORI does double-check any findings by the university, though he pointed out that there are limits to how thoroughly it can dig.
Also, university compliance officers typically lack tenure or some other bottom-line assurance of their authority to make a thorough and unvarnished review of the facts, Mr. Wright said. “My estimate is only about a third of them have some kind of meaningful employment protection,” he said.
ORI can also be simply overwhelmed, especially as new technological tools give people around the world the ability to detect signs of possible fraud. Last year, Mr. Wright said, ORI received about 425 allegations and produced 13 findings of misconduct.
“We’re constantly pushing the envelope” of being able to keep up, he said.
One solution is to encourage even greater cooperation with universities, Mr. Wright said. Turning away from ORI’s original image as a “draconian regulator,” he began a program of three- to four-day “boot camps” at which ORI helps train university compliance officers, with the idea that institutions come to see self-enforcement as ultimately in their own interest. ORI hopes eventually to turn control of the program over to an outside professional organization, Mr. Wright said. “That is, in many ways, much more successful than aggressive oversight and compliance work,” he said.
