Last month, David Wright, the director of the federal Office of Research Integrity (ORI), which keeps watch on fraud in federally funded biomedical research, quit in frustration after 2 years. His resignation letter was a scathing critique of what he called the “dysfunctional” bureaucracy at the Office of the Assistant Secretary for Health (OASH). After it was obtained and published by ScienceInsider, it drew national attention to an office that often labors in obscurity. Wright, 68, has since returned to Michigan, where he is a professor emeritus at Michigan State University in East Lansing. He spoke with ScienceInsider earlier this week about his reasons for leaving. The interview has been edited for clarity and brevity.
Q: Did something trigger your decision in February?
D.W.: It was the accumulation of frustrations with the bureaucracy and trying to operate a regulatory office which requires precision, transparency, procedural rigor in an organization that values none of those things.
While the ORI director has a lot of creative capacity and leadership capacity when he or she faces outward to the research community helping institutions better handle allegations or promote the responsible conduct of research, for example, inside the director is essentially treated like a flunky in a kind of backwater bureaucracy.
Q: Did your departure have anything to do with the recent letter from Senator Charles Grassley (R–IA) to ORI asking why it didn’t impose harsher penalties on an Iowa State University AIDS researcher found to have engaged in misconduct?
D.W.: It had nothing to do with the Grassley letter.
Q: How is ORI doing with case management? Are they understaffed?
D.W.: I wouldn’t say we were understaffed in the investigative division. But the number of allegations per year doubled between 2012 and 2013. And that may turn out to be a statistical blip. But previously, allegations came to ORI from a research institution or from complainants that usually had some connection to the research. Now, because of all the online publishing—including high-quality images and the ability of anybody in the world to analyze those using Photoshop-like analytical tools—ORI now gets allegations from people all over the world.
I’d say that ORI is holding its own right now, but if this trend continues, of course it will need more resources. But the problem is in closing the cases.
Q: What is the problem there?
D.W.: ORI has two mechanisms through which it can close cases. One [is] called voluntary settlement exclusion agreements, in which ORI directly negotiates with the respondent and their lawyer. Or if they refuse or it’s a more serious case, ORI asks the HHS [Department of Health and Human Services] Office of General Counsel (OGC) to prepare a formal charge letter, which entitles the respondent to a hearing before an administrative law judge.
Whereas ORI has closed 36 cases through settlement agreements in the last 3 years, OGC has only issued three charge letters in that same period of time [out of 11 cases transmitted by ORI since 2009]. Cases languish at OGC for up to 5 or 6 years. OGC argues that the cases that ORI sends it are inadequately prepared, but were that the case, ORI couldn’t negotiate the voluntary agreements that it does.
I think where all of this is going is that ORI really needs to be an independent agency at HHS. If the ORI director had control of his budget and could hire adequate legal talent, if the director could contract with lawyers directly to generate a charge letter, you’d have one done in a couple months, not years.
Q: Should ORI have more power to investigate on its own instead of relying on institutions’ investigations?
D.W.: There was a time when ORI could conduct its own investigations. That was removed in some of the political to-and-fro-ing into the late 1990s and into the 2000s. I believe that things would work better if ORI had that authority restored. I don’t think it has the resources to conduct its own investigations very often, but I think it would be helpful to have it.
The other thing is that the [education] division that’s supposed to promote the responsible conduct of research is vastly understaffed right now. They have finally hired a new director. That office needs to be staffed up. It has only four people right now and should have eight or 10.
Q: Should the current scientific misconduct definition of FFP (fabrication, falsification, or plagiarism) be expanded?
D.W.: I don’t have a position on that. I brought it up at an April 2012 meeting before a large audience. The Canadians have a much broader definition. They made an argument for why they found it useful. But the American participants in that meeting demonstrated almost no enthusiasm for broadening the definition. It would mean many more cases.
Many universities have a definition that’s broader than FFP. A few institutions have retained the “serious deviation” clause from the old regulation. But lots and lots of people, including me, didn’t like that because it was so broad and ill defined.
Q: Is misconduct increasing? Does it explain the rise in retractions?
D.W.: I don’t think anybody knows. One argument is, it’s not increasing in terms of absolute rate, it’s just easier to detect because of changes in technology and online publishing.
The opposite argument is that as funding rates at NIH [the National Institutes of Health] and other agencies are at or close to all-time lows, and the pressure in the academy to produce to get tenure and that sort of thing increases, there is increasingly pressure to cheat and maybe more people are.
Eventually there will be more research on why people commit misconduct, and there will be some good longitudinal studies at universities that have really good policies and training versus those that don’t to see what the comparative rate of misconduct allegations is. And we may be able to draw some more conclusions.
Q: What were you able to get done at ORI?
D.W.: In 2 years I did everything that I promised to do. We continued to develop the boot camps, which are programs of training for research integrity officers. We started a number of international initiatives; we began working with our Canadian counterparts and talking more to the Europeans.
We had a meeting of leaders in both research misconduct and the protection of human participants in research to talk about how to handle allegations of misconduct in clinical settings and the disharmonies between the two sets of regulations. I wanted to do something about that.
All of those things didn’t require any support or assistance from OASH except to release funds for meetings, which was like pulling hen’s teeth.
Q: Will anybody want to be ORI director now?
D.W.: I don’t know. As I said in my letter, and it was absolutely sincere, the 35% of my time that I got to do what I thought was the whole job when I came there was just wonderful. The rest of it was a nightmare.
There are lots of talented people around and maybe there are people with a higher tolerance for bureaucratic inertia and frustration than I have. There was speculation after I left that they would just find somebody inside, a federal “grinder” as they say, who would do the job, who didn’t necessarily have any experience with the research community or with handling allegations so it would get off the front pages. That would be a disaster.