Managing the Complexities of Implementing OSTP's
Research Misconduct Policy at the U.S. Department of Energy
by: William J. Valdez
U.S. Department of Energy, Office of Science
What I want to do today is give you an idea of the complexity of the situation that
we're facing and some of the issues we are grappling with at the Department of
Energy. I am struck by the fact that all of the questions that I have heard today are the
questions we are asking ourselves. The kinds of situations you bring up are the kinds of
situations that we are thinking about as we begin to implement OSTP's research
misconduct policy. And we're much farther along than a lot of the other agencies,
because we have been involved in this from the beginning.
We're involved in a lot of different sciences. We're very big. We have a lot
of money. And so by nature, the complexity of the questions that have come before us are
large and many. Within the department, we have four major business lines. Science is one
of them. But we also deal with environmental quality and national security and energy
resources. And, again, the numbers are big, and the numbers of projects that are funded
are really big.
In addition to various research organizations, which are many, we have many other
offices, ranging from the Office of Inspector General, to the Office of Hearings and
Appeals, to Environmental Safety and Health, to our chief financial officer, down the line
of folks who all have a stake in the implementation of this prolicy. All of them are going
to be involved in this process. Adding to the complexity, as you may be aware, Congress
recently imposed upon us a new National Nuclear Security Administration (NNSA), which has
a separate structure.
By law, you can't have what they call dual hats. So there is a sovereignty issue
currently being debated within the department about whether the Office of Science can even
take the lead on research misconduct, because we have to respect the Congressional wishes
on sovereignty issues regarding NNSA.
If you're familiar with the labs that we have—one of the questions is:
"What falls under this policy?" We have many, many scientific user facilities.
We have many, many national laboratories. The National Synchrotron Light Source is just
one example of our major facilities, where there are about 5,000 users. Those 5,000 users
don't actually do the majority of their research on behalf of DOE. That research
funding and direction comes from NIH, it comes from universities, it comes in from private
sector corporations. And we have to decide, when they use our facility, doing research
that is peer reviewed by us—because we peer review every project that goes in
there—will that fall under our research misconduct policy? The answer is probably,
"Yes." And because we are the home institution, we're the ones who are
going to have to handle the investigation, or the lab where the allegation was made. So it
gets very complex.
The Office of Science alone deals with more than 200 universities. Forty percent of our
research dollars, about $400 million per year, goes to universities. There are a couple
thousand grants per year that goes to different universities.
So we're all over the place. We have all sorts of conflicting and diverse issues
that we have to deal with. So what have we done so far? We were an original representative
on the task force that led to the development of the Office of Science and Technology
Policy's research misconduct policy. We developed a strawman proposal for DOE in
December of 1999, which required a wink/nod by the Undersecretary, who is Ernie Moniz. It
took us until May 2000 to get Ernie to say, "Okay, I've winked and nodded on
it." So this is going to be a process that takes time and will evolve. Ernie was the
originator of the process that led to this. He cares about it, and it took us five months
to get his attention on it.
So now we have a new gang of people coming in, a whole new administration to educate,
to work with, getting their winks and their nods. It's going to be very, very
difficult. We may have the OSTP policy before we have a President. You know, it's
going to be close. We have an R&D councill that brings together all the major offices
that are involved in research. That already has taken place, but we might need to get them
to approve our approach once again. Now we go into the next stages, buy-in, rule-making,
and implementation.
The actual strawman proposal itself was developed around the principles and guidelines
of the OSTP policy you've heard about. A number of other options were considered. We
thought about setting up a separate office. We went to the idea of farming this out to
NSF, NIH. And a number of issues remain unresolved, even today.
For example, we are deciding who within DOE should handle further investigations. We
had a meeting between our Office of Inspector General and our Office of Hearings and
Appeals. Office of Inspector General really likes to do criminal complaints; that's
what they're in business to do. The Office of Hearings and Appeals handles the civil
kinds of complaints and whistle-blower kinds of things. Office of Hearings and Appeals was
interested in doing this. But the Office of Inspector General said, "We think that
there are some classes of research misconduct that we want to be involved in." And we
said, "Well, can you give us an idea of what those classes may be?" And they
said, "No. We just need to see them." And we said, "Well, we have this
problem with timeliness, and we want to make it a fair and open process." And they
said, "Well, we can't help you." And we said, "Let's take a step
back. Can you define the classes?" And they said, "No."
"Okay," we said. "So what if we gave you a 30-day time period to say
that these are the ones that would be something we would like to investigate?" They
said, "Well, we can live with that." So they're going to have a 30-day time
period, and when we were walking out the door, they said, "But we are going to want
the opportunity to intervene in any case." So we're still debating that issue.
Another issue is who should be the deciding and debarring officials? The deciding
official is the one who ultimately decides if there has been a finding of misconduct. The
debarring official is the one who says, "You have been bad, and here's the
penalty." Because of the NNSA issue, we have a question about who actually will do
that. And then, of course, there are a number of other issues involved with NNSA. One of
the issues we are grappling with is the long lead time.
Given the diversity of the program offices and other associated performers, we have no
DOE policy in place. But the research performers are not operating in a vacuum. For
example, we fund a lot of the same people that you guys fund. So what have they done in
the absence of a policy from the Department of Energy? They've adopted the National
Science Foundation policy. For example, Pacific Northwest National Labs, up in Washington
State, adopted the National Science Foundation policy just wholesale. Well, it's
completely inappropriate for a national lab, the way they adopted it. But that's the
way they are currently handling their policies.
Implementation is raising a lot of issues, and I'll briefly go through them.
Amnesty is a real interesting issue. When you come out with a notice to your performers
that you are going to have a research misconduct policy, you want to give them time to
come clean, right? So our labs and our university performers have not had a requirement,
to this point, to tell us that there are instances of misconduct at their institutions. So
we expect there is going to be a bubble, that people are going to come up and say,
"Well, we're not quite sure if this qualifies as misconduct. We think we
actually are in the middle of a misconduct investigation, and we want to tell you about
that."
The reason it's a question of amnesty is that there is going to be an absolute
requirement that they notify us if they have an allegation of misconduct, using our
dollars. So in the absence of that absolute requirement in the paat, we need to give them
a time period when they can come clean.
The appeals process is complicated, and we haven't been able to come to a good
answer on that. We have an appeals process with our Office of Hearings and Appeals, but
whether it's appropriate to research misconduct is another question. Due process. You
know, I mentioned the Office of Inspector General clouds the issue. What is the threshold
that we're going to investigate? We haven't come to a decision on that. Then
there is this whole issue of assurances. We're going to ask our research performers
to assure us, like they do NSF and NIH, that they have a research policy in place
that's consistent with what we need as an agency; the form that that assurance will
take; and what happens if they don't actually have a policy in place after they have
assured us that they have one are open questions.
Then, finally, the infrastructure considerations are not inconsiderable. Training was
mentioned. We agreed that there needs to be training. But look at the number of performers
we have. This is going to require extra staff, and currently we don't have a lot of
money for extra staffing, enforcement, investigation, hearings, etc. So, real quickly,
that's what we're dealing with, and if you're one of our research
performers, get ready for a wild ride.
I would just note that during the past five years, at least, there has only been one
serious allegation of research misconduct that the Department of Energy has been involved
in, and that was out at Berkeley National Laboratory. We did an informal survey of our
national laboratories and said, "If there was a research misconduct policy in place
and you had to tell us about cases, how many would you bring to us each year?" And
the total out of our labs was about five to 10 cases where they would just notify us that
something was happening. But most of them we think wouldn't really rise to the level
of research misconduct. They would just give us an advisory that this is happening.
I'm not saying that we don't have research misconduct, but I don't think we
have had the drivers that NSF and NIH have had in the past to develop such a formal
system. We agree it's a good thing to have, but we don't think we're going
to have the volume of business that NSF and NIH have had.
One last comment. We're committed to completing rule-making within the next year,
max two years, depending on the diversity of the comments that we get. But you can look at
the OSTP process as an example. They began this four years ago, and this is not something
you do lightly. This is not something you do quickly, because you can make a lot of
mistakes. So we are not going to rush into it, and we're going to do it right the
first time.
Federal Research Misconduct Policy from the Public Health Service Perspective
by: Chris Pascal
U.S. Public Health Service
The federal agencies should try to have common implementation of the policy where they
can, and the Office of Science and Technology Policy (OSTP) is going to help us with that
by having an implementation group. Just quickly, I'd like to go through ORI's
view of the impact of these changes.
The policy establishes a common definition that should help the institutions and the
scientists, because the definition will be applied across disciplines and federal
agencies, so there will be one standard to implement at the institutional level. It should
increase confidence in the scientific community, because the policy has gone through a
public comment process, getting the community's input on the definition. It should
also simplify administration by research institutions. If you have six grants from
different federal agencies, you will now have a common standard to apply. I think it will
increase awareness of misconduct and, possibly, the number of allegations handled by the
institutions because the definition and policy will apply to a greater number of research
projects across a range of disciplines. The institutions may not see that as positive; but
nevertheless, I think that's an impact, and it could be a positive for the agencies,
in the sense that it should increase expertise by the institutions in handling
allegations.
One of the things that ORI has noticed is, except for a few institutions that have a
lot of cases, most institutions don't have enough volume to develop a level of
expertise or maintain that level of expertise at the institution, and these are difficult
cases to investigate. By broadening the definition and policy to all federal research, it
could improve the quality of institutional response. The proposed policies and procedures
retain the existing framework for institutions, as the National Science Foundation
mentioned. It's basically the same approach as taken previously.
A big point that is not really commonly understood is that the institutions have the
authority to have a broader definition of "research misconduct," and to have
other policies on other types of misconduct. Frankly, some institutions, even when they
don't find federal research misconduct, impose sanctions or discipline the
researcher. As the employer of scientists within their institution, they have that
authority. That flexibility for institutions is retained under the new structure, and
certainly it highlights the need for agencies to work together in interpreting and
implementing the federal policy, as was mentioned.
In Health and Human Services (HHS), we have anticipated these changes because we were
involved with the OSTP work group and knew what was being proposed. Therefore, we have
already made some changes to be consistent with the new policies. The intramural programs
in the Public Health Service will now be doing their own investigations. That's new.
That's consistent with the structure in the new federal policy - that the intramural
program is treated like an extramural institution in the sense that it will have authority
for its own investigations.
HHS has now assigned the authority for investigations to the Office of Inspector
General. However, ORI is going to rely heavily on the institutions, as we have in the
past. Over 95 percent of investigations since 1995 have been done at the institution. So
far, ORI has not referred a single case to OIG. ORI will continue to do oversight in order
to separate the investigative process from the decision-making process. The Assistant
Secretary for Health, for the past several months, has been making decisions on research
misconduct. ORI makes a recommendation. He makes the final decision. We have had maybe
four or five cases like that since we've instituted this new process. The
Departmental Appeals Board will handle the appeals process. That is consistent with the
way we have done it previously.
HHS will have new regulations to implement the new federal definition of
"misconduct" and the federal policies and procedures that are generally
described as guidelines in the federal policy. It will have a separate whistle-blower
regulation, which is currently before the Office of Management and Budget for approval.
(Subsequently published as an NPRM at 65 Fed. Reg. 70830; November 28, 2000). That's
a statutory requirement, so it's being issued as a separate regulation, but it will
be part of our overall regulation when that is finalized. ORI plans to put the HHS appeals
process into a regulation and update our current regulations and cover the intramural
programs. That's all I have on the federal policy.
Authors Note: Below is a quiz presented by ORI on the application of the new
Federal Policy and Definition of Misconduct. An answer key is provided following the quiz.
Quiz on Federal Policy and Definition
- How are "questionable research practices," such as conflicts of interest and
authorship disputes, handled under the policy?
- Is misconduct in human subjects research covered?
- Is failure to obtain "informed consent" research misconduct? (Multiple Choice)
- No, under federal policy
- Yes, under some institutional policies
- Falsified signature might be misconduct under federal policy
- Violations of informed consent are covered under human subjects regulations (OHRP)
- All of the above
- Is omission of data research misconduct?
- Is use of author's manuscript obtained during peer review of a journal article
misconduct?
- True or False? If an allegation of falsification of data involves federal funding, you
must conduct a formal investigation.
- True or False? Due to retaliation, most whistle-blowers regret having made the
allegation.
- True or False? A substantial number of "bad faith" allegations are made
against innocent scientists.
- When should you take possession of the research data? (Multiple Choice)
- When the respondent finishes cleaning out his office.
- After the investigation is completed.
- When the research integrity officer finishes her golf game.
- Immediately after it is determined the allegation deserves an inquiry.
- Who finds the misconduct investigation extremely difficult? (Multiple Choice)
- The whistle-blower.
- The respondent.
- Witnesses who are asked to testify.
- The research integrity officer who manages the investigation.
- The support staff who work for the RIO.
- Scientists who work on the investigation committee.
- Members of the laboratory where the accused is located who worry about their reputation
and funding.
- All of the above.
Answer Key
- Not covered; handled by institution or separate process.
- Yes.
- E. All of the above.
- It depends. Need to determine whether a significant departure from the community
standard (acceptable scientific practice). Deliberate omission to deceive would be
falsification.
- Yes, it may constitute plagiarism during the "review" of research.
- False. An inquiry is required, but if there is insufficient evidence that misconduct
could have occurred, the institution can close the case after the inquiry is completed and
not report it to the federal agency.
- False. Whistle-blowers report they would make the allegation again.
- False. ORI receives very few reports of bad faith allegations. An allegation that is not
proven or is incorrect is not considered in bad faith.
- D.
- H. All of the above.
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