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Wanted: Fraud-buster with political antennae

Susan Notes:

A mild-mannered man's fiery resignation leaves a troubling vacancy at the world's largest office for investigating scientific fraud.

HHS official tells government to take this job, shove it in resignation letter--Fox News

HHS official pens a caustic resignation letter--Washington Post

The Office of Research Integrity (ORI)has not been mentioned in the New York Times since 2012. The only David Wright they mention is a baseball player. Likewise, the only David Wright in the Wall Street Journal is a baseball player.

by Colin Macilwain

When David Wright leaves the Office of Research Integrity (ORI) at the US Public Health Service later this month, everyone will know just why he is walking out of the door. Wright̢۪s resignation letter to the assistant secretary of health, leaked last week, is unusually direct. "I'm offended as an American taxpayer that the federal bureaucracy -- at least the part I've labored in -- is so profoundly dysfunctional," he tells his former boss, in a note decorated with choice cuts of bureaucratic hubris. In one example, Wright says, he sought an evaluation of the support services available to the ORI, only to be told that "that had been tried a few years ago and the results were so negative that no further evaluations have been conducted".

Wright, a science historian and former research-integrity officer at Michigan State University in East Lansing, signs off with a cheery promise to publish a version of the daily log he kept at the ORI, "to share my experience and observations with my colleagues in government and with members of the regulated research community". That would be you, dear reader.

Anyone who has dealt with Wright professionally will be taken aback to see the guy nailing his colours to the mast in this way. He just isn't the rocking-the-boat type: a more courteous and polite official it would be difficult to meet. There is a profound feeling in circles interested in research misconduct that he is one of the good guys.

"A lot of us are wondering where we go from here," says Mark Frankel, head of the Scientific Responsibility, Human Rights and Law Program at the American Association for the Advancement of Science in Washington DC. As well one might, when the directorship of the world's largest and best-established research-misconduct office -- which lacked a permanent director for two years before Wright's appointment in 2012 -- has just imploded.

The ORI was established 22 years ago in the wake of the David Baltimore case, in which allegations of fraud (later dismissed) rocked the laboratory of one of America's most eminent biologists. The agency's 25 staff are supposed to educate tens of thousands of researchers on proper research conduct, as well as overseeing investigations into misconduct by researchers funded by the US National Institutes of Health (NIH), the world's largest research agency. But it was built to deal with the handful of cases that it was assumed would arise. According to research published last December by Daniele Fanelli at the University of Edinburgh, UK (D. Fanelli PLoS Med.10, e1001563; 2013), the proportion of allegations the ORI receives that are investigated and closed has halved over 20 years. Wright's resignation letter blows wide open long-standing doubts about its capacity to deal with a caseload that, the available evidence suggests, should have expanded with the growth of the NIH itself.

"The position must be filled promptly by someone respected by both ethicists and health researchers."

The administration of US President Barack Obama needs to get a grip on this before an explosive high-profile case -- such as that of Andrew Wakefield and MMR vaccines in the United Kingdom -- turns up and the ORI can't cope. If the administration doesn't do this, Congress just might. Senator Chuck Grassley (Republican, Iowa) demanded in February that the ORI explain its lenient treatment of Dong-Pyou Han, a physician at Iowa State University in Ames, who was banned from seeking NIH funding for three years after falsifying data in AIDS vaccine trials that cost the agency US$19 million.

It is not known how much Grassley's strident demand for answers contributed to Wright's departure. But attention from one of the most feared and respected voices on Capitol Hill can only intensify the political hot-house atmosphere that his resignation letter blames for the ORI's troubles.

These troubles go back a long way. The ORI sits under the assistant health secretary, instead of being properly independent like the inspector generals who keep an eye (imperfectly) on scientific fraud at the National Science Foundation (NSF) and other agencies. Its enforcement remit (of fabrication, falsification and plagiarism, or FFP) is too narrow, and its budget too small.

Canada has already shown the way. In 2011, it set up the Tri-Agency Framework: Responsible Conduct of Research. It has a relatively large staff of eight, for a research system one-tenth the size of that of the United States, a remit that reaches far beyond FFP, and it is led by Susan Zimmerman, a tough lawyer unlikely to put up with dodgy academics whimpering about their "creativity".

Wright's resignation comes as a panel chaired by Robert Nerem, a bioengineer at the Georgia Institute of Technology in Atlanta, is in the final stages of the first National Academy of Sciences study on research integrity in 20 years. The report may recommend beefing up the ORI, broadening its remit beyond FFP and aligning its approach with that of the NSF and other agencies. But with the ORI leaderless, the academy report may be even more prone than usual to gathering dust.

I have been an optimist on misconduct: some 18 months ago, I wrote that the global community was starting to get a handle on it. Wright's appointment was progress, and his departure is a setback. His position must be filled promptly by someone respected by both ethicists and health researchers. They will also need the skills to build bridges with Congress: a peripatetic master, perhaps, but one who can prevent the ORI from getting kicked around.

Colin Macilwain writes about science policy from Edinburgh, UK

Here is the text of David Wright's letter, provided to ScienceInsider by an anonymous source:


Dr. Howard Koh, M.D.
Assistant Secretary for Health

Dear Howard:

I am writing to resign my position as Director, Office of Research Integrity, ORI/OASH/DHHS

This has been at once the best and worst job I've ever had. The best part of it has been the opportunity to lead ORI intellectually and professionally in helping research institutions better handle allegations of research misconduct, provide in-service training for institutional Research Integrity Officers (RIOs), and develop programming to promote the Responsible Conduct of Research (RCR). Working with members of the research community, particularly RIOs, and the brilliant scientist-investigators in ORI has been one of the great pleasures of my long career. Unfortunately, and to my great surprise, it turned out to be only about 35% of the job.

The rest of my role as ORI Director has been the very worst job I have ever had and it occupies up to 65% of my time. That part of the job is spent navigating the remarkably dysfunctional HHS bureaucracy to secure resources and, yes, get permission for ORI to serve the research community. I knew coming into this job about the bureaucratic limitations of the federal government, but I had no idea how stifling it would be. What I was able to do in a day or two as an academic administrator takes weeks or months in the federal government, our precinct of which is OASH.

I believe there are a number of reasons for this. First, whereas in most organizations the front-line agencies that do the actual work, in our case protecting the integrity of millions of dollars of PHS-funded research, command the administrative support services to get the job done. In OASH it's the exact opposite. The Op-Divs, as the front-line offices are called, get our budgets and then have to go hat-in-hand to the administrative support people in the "immediate office" of OASH to spend it, almost item by item. These people who are generally poorly informed about what ORI is and does decide whether our requests are "mission critical."

On one occasion, I was invited to give a talk on research integrity and misconduct to a large group of AAAS fellows. I needed to spend $35 to convert some old cassette tapes to CDs for use in the presentation. The immediate office denied my request after a couple of days of noodling. A university did the conversion for me in twenty minutes, and refused payment when I told them it was for an educational purpose.

Second, the organizational culture of OASH's immediate office is seriously flawed, in my opinion. The academic literature over the last twenty-five years on successful organizations highlights several characteristics: transparency, power-sharing or shared decision-making and accountability.If you invert these principles, you have an organization (OASH in this instance), which is secretive, autocratic and unaccountable.

In one instance, by way of illustration, I urgently needed to fill a vacancy for an ORI division director. I asked the Principal Deputy Assistant Secretary for Health (your deputy) when I could proceed. She said there was a priority list. I asked where ORI's request was on that list. She said the list was secret and that we weren't on the top, but we weren't on the bottom either. Sixteen months later we still don't have a division director on board.

On another occasion I asked your deputy why you didn't conduct an evaluation by the Op-Divs of the immediate office administrative services to try to improve them. She responded that that had been tried a few years ago and the results were so negative that no further evaluations have been conducted.

Third, there is the nature of the federal bureaucracy itself. The sociologist Max Weber observed in the early 20th century that while bureaucracy is in some instances an optimal organizational mode for a rationalized, industrial society, it has drawbacks. One is that public bureaucracies quit being about serving the public and focus instead on perpetuating themselves. This is exactly my experience with OASH. We spend exorbitant amounts of time in meetings and in generating repetitive and often meaningless data and reports to make our precinct of the bureaucracy look productive. None of this renders the slightest bit of assistance to ORI in handling allegations of misconduct or in promoting the responsible conduct of research. Instead, it sucks away time and resources that we might better use to meet our mission. Since I̢۪ve been here I've been advised by my superiors that I had "to make my bosses look good." I've been admonished: "Dave, you are a visionary leader but what we need here are team players." Recently, I was advised that if I wanted to be happy in government service, I had to "lower my expectations." The one thing no one in OASH leadership has said to me in two years is 'how can we help ORI better serve the research community?' Not once.

Finally, there is another important organizational question that deserves mention: Is OASH the proper home for a regulatory agency such as ORI? OASH is a collection of important public health offices that have agendas significantly different from the regulatory roles of ORI and OHRP. You've observed that OASH operates in an "intensely political environment." I agree and have observed that in this environment decisions are often made on the basis of political expediency and to obtain favorable "optics." There is often a lack of procedural rigor in this environment. I discovered recently, for example, that OASH operates a grievance procedure for employees that has no due process protections of any kind for respondents to those grievances. Indeed, there are no written rules or procedures for the OASH grievance process regarding the rights and responsibilities of respondents. By contrast, agencies such as ORI are bound by regulation to make principled decisions on the basis of clearly articulated procedures that protect the rights of all involved. Our decisions must be supported by the weight of factual evidence. ORI's decisions may be and frequently are tested in court. There are members of the press and the research community who don̢۪t believe ORI belongs in an agency such as OASH and I, reluctantly, have come to agree.

In closing, these twenty-six months of service as the Director of ORI have been a remarkable experience. As I wrote earlier in this letter, working with the research community and the remarkable scientist-investigators at ORI has been the best job I've ever had. As for the rest, I'm offended as an American taxpayer that the federal bureaucracy--at least the part I've labored in--is so profoundly dysfunctional. I'm hardly the first person to have made that discovery, but I̢۪m saddened by the fact that there is so little discussion, much less outrage, regarding the problem. To promote healthy and productive discussion, I intend to publish a version of the daily log I've kept as ORI Director in order to share my experience and observations with my colleagues in government and with members of the regulated research community.

I plan to work through Tuesday March 4, 2014 and then use vacation or sick days until Thursday March 27 (by which time I will have re-established health care through my university) and then end my federal government service.


— Colin Macilwain


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