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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