Flaws, Misconduct, Frustration At HHS Noted By Resigning Office of Research Integrity Director

Dr. David Wright

by Jocelyn Kaiser, ScienceInsider: The director of the U.S. government office that monitors scientific misconduct in biomedical research has resigned after 2 years out of frustration with the “remarkably dysfunctional” federal bureaucracy. David Wright, director of the Office of Research Integrity (ORI), writes in a scathing resignation letter obtained by ScienceInsider that the huge amount of time he spent trying to get things done made much of his time at ORI “the very worst job I have ever had.”

ORI, which is part of the Department of Health and Human Services (HHS), monitors alleged research misconduct by researchers funded by the National Institutes of Health (NIH) and other Public Health Service (PHS) agencies. It runs education programs and reviews institutions’ misconduct investigations, each year posting a dozen or so findings of misconduct, defined as fabrication, falsification, or plagiarism. It also recommends PHS sanctions, such as barring researchers from receiving grants. ORI’s visibility has grown recently along with a rise in retracted research papers, some involving misconduct.

Observers lauded Wright’s appointment in December 2011, which ended 2 years in which the office had no permanent director. Wright, a historian of science at Michigan State University in East Lansing, had served as an ORI consultant and came in with plans to beef up training programs. But on 25 February, he fired off a fiery resignation letter to his boss (see below), HHS Assistant Secretary for Health (ASH) Howard Koh. (Wright’s departure has not been formally announced by HHS and was first made public last week by the blog Retraction Watch. HHS spokeswoman Diane Gianelli declined to comment on why Wright left but confirmed his resignation and said that Don Wright, an Office of ASH (OASH) official who is unrelated to David Wright and had previously served as acting director, will resume that position.)

In his letter, David Wright writes that working with ORI’s “remarkable scientist-investigators” was “the best job I’ve ever had.” But that was only 35% of his job; the rest of the time he spent “navigating the remarkably dysfunctional HHS bureaucracy” to run ORI. Tasks that took a couple of days as a university administrator required weeks or months, he says. He writes that ORI’s budget was micromanaged by more senior officials, and that Koh’s office had a “seriously flawed” culture, calling it “secretive, autocratic and unaccountable.” For example, he told Wanda Jones, Koh’s deputy, that he urgently needed to appoint a director for ORI’s division of education. Jones told him the position was somewhere on a secret priority list of appointments. The position has not been filled 16 months later, David Wright notes.

OASH itself suffers from the tendency of bureaucracies to “focus … on perpetuating themselves,” David Wright writes. Officials spent “exorbitant amounts of time” in meetings and generating data and reports to make their divisions look productive, he writes. He asks whether OASH is the proper home for a regulatory office such as ORI, noting that Koh himself has described his office as an “intensely political environment.”

David Wright makes no mention of a recent letter to ORI from Senator Charles “Chuck” Grassley (R-IA), who has complained that ORI was not tough enough on an AIDS researcher at Iowa State University who faked data to obtain nearly $19 million in NIH funding. ORI barred the researcher, Dong-Pyou Han, from participating in PHS-funded research for 3 years, but Grassley has asked why ORI did not make him return federal grant money or impose harsher sanctions (more at Retraction Watch).

David Wright declined to be interviewed by ScienceInsider at this time. His letter indicates that he remains a federal employee until he finishes using leave time by 27 March. After that, he writes, he plans to publish a version of his daily log at ORI to share more of his experiences.

University of Michigan, Ann Arbor, research misconduct expert Nicholas Steneck tells ScienceInsider he hopes there won’t be another long delay before a new ORI director is appointed. “It’s a very important position. ORI needs a permanent director to operate effectively,” he says.

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

2/25

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 I’ve 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 don’t 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 I’m 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.

Sincerely,

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