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Federal Research Misconduct Policy

The New Federal Research Misconduct Policy

Panel
The New Federal Research Misconduct Policy
Holly L. Gwin, Chief of Staff and General Counsel
Office of Science and Technology Policy

Peggy L. Fischer, Associate Inspector General for Investigations
National Science Foundation

Managing the Complexities of Implementing OSTP's Research Misconduct Policy at the U.S. Department of Energy
William J. Valdez, Director, Office of Planning and Analysis
U.S. Department of Energy, Office of Science

Federal Research Misconduct Policy from the Public Health Service Perspective
Chris Pascal, Director, Office of Research Integrity
U.S. Public Health Service

The New Federal Research Misconduct Policy
by: Holly L. Gwin
Office of Science and Technology Policy

Our panelists will discuss what the implementation of the new federal research misconduct policy will mean for their agencies and for research institutions. First, I would like to give you a status report on the policy. Some of you may recall, and others may be surprised to learn, that the National Science and Technology Council (NSTC) established a research integrity panel in 1996 to initiate work on this policy.

The original panel included Frances Cordova of NASA, who originally served as the panel chair; Ruth Kirschstein of NIH later assumed that job; Helen Kerch with DOE; Ann Peterson with NSF; Asha Varma, DOE; and Cathie Woteki at USDA. Some of these folks remain in government, and others have gone back to the research community. We are grateful to them for getting us started and look to them for help during the implementation phase.

The panel's report proposed a definition of "research misconduct" and some guiding principles for investigations and agency actions. After the panel completed its report, Sybil Francis continued working with the agencies to bring the policy to the point where we are today. The public part of this policy-making process started last fall. We now have incorporated the public comments on the proposed policy into a draft that was submitted to the NSTC for clearance. We received comments from more than 200 people, some writing as individuals, but most writing as representatives of universities or other research institutions. We even got some of the federal agency comments that way, and some research associations. The comments are a matter of public record, and I'm going to summarize some of the major ones for you in just a minute.

I would like to say that initiation of the final agency clearance process engaged the interest of some agencies that hadn't really paid much attention before now. They have some legitimate concerns about implementation of the policy, which is going to pose some difficulties. I wish they had raised those concerns earlier in the process, but I'm still confident that we're going to get this out this fall.* I'm going to go through the major elements of the policy. I will talk to you about the revisions I think we're going to make, or in some cases will not be making.

Maybe the most important point I'd like to make today is the nearly unanimous support for the policy that we got during the public comment period. Of course, that doesn't mean there weren't a lot of questions and recommendations for improvements, starting with the definition for "research." There were a lot of questions about whether the definition was meant to encompass particular fields. Does it include medicine? Did it include the social sciences? The policy is not intended to exclude any field of research, and we're going to try to make that clear in the final version of the policy.

Our attempt to define each of the main elements of the "research misconduct" definition also elicited a lot of comments. Several comments noted that "fabrication" certainly includes more than making up results. It also includes making up data, and we agree. Several commenters feared that the definition of "falsification" could lead to penalties for researchers who make completely appropriate omissions of data. We think it's important for the policy to cover instances where omission of data misleads the consumers of research. We're probably going to use language in a preamble that will accompany the final publication of the policy to make our intentions clear on that point.

Several commenters also expressed concern that our definition of "plagiarism" tacitly approved the use of information obtained through the confidential peer review process so long as it was properly cited. And we are going to try to fix that. After the definition, the policy describes the requirements for a finding of research misconduct. Several commenters wanted to make sure that practices don't have to be written down to meet the accepted practices threshold. Others noted differences in practices among various fields of research. It is not the intent of this policy to call accepted practices into question or to define what the practices are. We'll continue to depend on the relevant research communities to do that job.

We'll also try to address, in the final policy, the concerns of readers who weren't sure whether we meant to require proof of all three levels of intent or just one. "Intentionally," "knowingly," and "reckless disregard" are mutually exclusive terms. They are already a hierarchy, starting at the worst and going to the least worst, and that also comes into play when the implementers are thinking about the sanctions that they want to apply.

There is a significant difference of opinion on the appropriate burden of proof. Some reviewers find "preponderance of the evidence" acceptable. I'd say more reviewers urged us to go with "clear and convincing evidence," but I think we will be sticking with the standard of "preponderance of the evidence."

We did receive comments on the three remaining elements of the policy, but most of those are going to have to be addressed during the implementation phase rather than through modification of the policy. Time lines, for instance, will be established on an agency-by-agency basis. That's also true for measures that ensure confidentiality or that protect whistle-blowers from retaliation.

I would like to note that there was, again, near unanimous support for agency referral to a home institution whenever possible. We'll be keeping that in the final policy.

We're going to try to clarify some issues about the finality of certain decisions. For instance, we need to make it clearer than it was in the proposal that agencies will be making the final decisions on whether there will be an agency finding of research misconduct; and they'll consider that after the institution is through; and an agency decision cannot be appealed back to the research institutions.

We'll also present a more comprehensive, but still non-inclusive, list of corrective actions based on the reviewer's comments, and we're going to recognize a role for agency inspectors general in research misconduct cases. We worked very hard to get inter-agency consensus on this policy, but when it's final, as we have been discussing, it's going to be up to each agency to implement the policy through mechanisms that best suit its needs. Some agencies will need to revise existing policies and regulations. That's true for the National Science Foundation and for Health and Human Services. Some agencies will need to implement the new policy from scratch. That includes the Department of Energy, and they're just waiting for us to get our work done before they go forward. Some agencies will go through formal rule-making, and others will implement through administrative mechanisms.

But in all cases, the implementation process is going to be a very public process. Regardless of whether they use rule-making or some other mechanisms, they will be publishing their proposed policies and rules for public review before they are finalized. And the Office of Science and Technology Policy will stay involved in this issue throughout the implementation phase. We established an implementation working group that had its first meeting last July. I think it will meet again in conjunction with publication of the final policy.

The agenda will include a discussion of areas where there can be consistency among the agencies in implementation of the policy. We will also ask for a preliminary reading on whether agencies will be using rule-making or some other mechanism. And we're going to probably ask agencies to go ahead and identify their investigations offices and their decision-making officials. That's a quick summary of where we are on the policy.

News Release Announcing New Federal Research Misconduct Policy

Research Misconduct: A New Definition and Guidelines for Federal Research Agencies

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

  1. How are "questionable research practices," such as conflicts of interest and authorship disputes, handled under the policy?
  2. Is misconduct in human subjects research covered?
  3. Is failure to obtain "informed consent" research misconduct? (Multiple Choice)
    1. No, under federal policy
    2. Yes, under some institutional policies
    3. Falsified signature might be misconduct under federal policy
    4. Violations of informed consent are covered under human subjects regulations (OHRP)
    5. All of the above
  4. Is omission of data research misconduct?
  5. Is use of author's manuscript obtained during peer review of a journal article misconduct?
  6. True or False? If an allegation of falsification of data involves federal funding, you must conduct a formal investigation.
  7. True or False? Due to retaliation, most whistle-blowers regret having made the allegation.
  8. True or False? A substantial number of "bad faith" allegations are made against innocent scientists.
  9. When should you take possession of the research data? (Multiple Choice)
    1. When the respondent finishes cleaning out his office.
    2. After the investigation is completed.
    3. When the research integrity officer finishes her golf game.
    4. Immediately after it is determined the allegation deserves an inquiry.
  10. Who finds the misconduct investigation extremely difficult? (Multiple Choice)
    1. The whistle-blower.
    2. The respondent.
    3. Witnesses who are asked to testify.
    4. The research integrity officer who manages the investigation.
    5. The support staff who work for the RIO.
    6. Scientists who work on the investigation committee.
    7. Members of the laboratory where the accused is located who worry about their reputation and funding.
    8. All of the above.

Answer Key

  1. Not covered; handled by institution or separate process.
  2. Yes.
  3. E. All of the above.
  4. It depends. Need to determine whether a significant departure from the community standard (acceptable scientific practice). Deliberate omission to deceive would be falsification.
  5. Yes, it may constitute plagiarism during the "review" of research.
  6. 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.
  7. False. Whistle-blowers report they would make the allegation again.
  8. 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.
  9. D.
  10. H. All of the above.

 

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