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Oversight of Research Staff

Oversight of Research Staff by Principal Investigator

Panel
David C. Clark, Director, Research Affairs
Rush-Presbyterian St. Luke's Medical Center

Research Integrity Issues Relevant to the Principal Investigator
Chris Pascal, Director, Office of Research Integrity
U.S. Public Health Service

Ethical Responsibilities of the Principal Investigator
Robert Zand
, Professor, Biophysics Research Division
University of Michigan

Research Integrity Issues Relevant to the Principal Investigator
by: Chris Pascal
U.S. Public Health Service

ORI sponsored, with the University of Arizona, a principal investigators' conference on "How to Manage a Biomedical Research Laboratory," because we recognized that the PIs or the laboratory directors weren't always really in tune with all of the issues, that from our perspective, overlap with the responsible conduct of research. In order to be effective lab directors, and in order to compete for grants and be well published, one has to be able to deal with things like authorship issues and authorship disputes and do a good job of mentoring new students coming in as postdocs and young investigators. So we weaved that into the agenda on lab management.

I understand that Howard Hughes is considering doing a regular course in the area. They have been in touch with our office about it. Also, the University of Arizona has indicated an interest in building into its curriculum for new investigators a regular course on lab management. I don't know if that's happened yet, but I agree there is a need.

I think a small group, like we have here, provides an opportunity for a dialogue. I'd like to make a couple of comments, and then move right into a case study so we can have some interaction about the issues. As Dr. Clark mentioned, we're not just focusing on research misconduct in this session. In addition to the questionable research practices that one should be concerned about, obviously, there are the affirmative activities that the PI and the laboratory can take to promote research integrity, such as providing education on the responsible conduct of research, or establishing procedures in the laboratory such as regular laboratory meetings or policies for reviewing the raw data prior to publication or submission of a grant application. Those sorts of things, I think, are fairly important. So we're not just talking about negative things that could go wrong that the PI has to be aware of. We're talking about what the PI can affirmatively do. I'm sure many of you have your own thoughts and experiences on those issues.

I would like to discuss a research misconduct case, adapted from an ORI case, without any identifiers. I would like for you to think about these questions as we go through the case study. As a PI, how would you have handled the situation and the issues? What other options would there be for responding to a particular situation and how could the institution, such as through its research integrity officer, handle the allegation of scientific misconduct? How could your institution have handled it differently from what actually happened?

This is the allegation. A postdoctoral fellow alleged that a technician falsified data in a grant application. The data looked to be impossibly good and unbelievable. When the lab chief, her mentor, took no action, the individual came directly to ORI (which is not that unusual, but most of our cases do arise at the institutional level, and we only hear about it after the fact, after the institution has decided to conduct an investigation). Then, the mentor "fired" the fellow.

Now, I put the word "fired" in quotes because this person was on a training grant, and actually, the PI had no authority to fire the individual, who ended up being unfired after ORI contacted the institution. What has already happened that went wrong, and how could you respond differently if you were in this situation? Put yourself in the situation of the PI. Or you could be the lab technician or the institutional official. What are some other ways to respond to this?

[Transcription of discussion not usable.]

I'm just going to go through a few more of these slides, then I'll go to the end and tell you what happened just so you know. It was a very interesting case.

When the institution got around to reviewing the allegation, it looked at the data sets and said, "Fine." The mentor also defended the technician's findings. The institutional inquiry concluded the allegation was not supported, so it was going to stop at this point. We didn't let them. ORI looked at the data and found problems. Ultimately, there was a finding of research misconduct on this first allegation. Later, the mentor confronted the technician about a second experiment and the technician admitted falsification and was fired. By the way, this happened in the hallway. There were no witnesses. When we asked, there was no supporting documentation and data that we could use to confirm the admission. Now what do you think is happening?

Is it a matter of the mentor, who is scared now and thinks, "I'm getting in trouble. Should I get rid of the problem?" We don't know. This second case went on for a while, but we sometimes get admissions from institutions that we find deficient and we just can't use. In a different case, we recently had a major institution that found research misconduct, said there was an admission, and when we looked into it, we couldn't sustain it. The individual denied that there was ever an admission. Then the institution went back and reopened the case and found out, "Oops, we don't think there was research misconduct." So I would just say we can't take things at face value all the time. I think that's true for the institutions as well.

To summarize, on the second allegation, we could not find anything to support it, and so we did not pursue that second allegation. But on the original allegation, after the institution couldn't find anything, we actually sent somebody up on site to help them download the data files, and get the "erased files" from the computer, and we did an analysis of it which we then fed back to the institution. They pursued it and still didn't find research misconduct. But we had found that the technician had used some formula to back-calculate from the desired results to the original "data," and we did find research misconduct in this case.

Furthermore, even though the institution did respond affirmatively to the whistle-blower protection issue when we raised it, we were concerned that their policy was not clear on this point. We asked them to make it explicit in their policy that retaliation was not acceptable, and that individual attempts at retaliation could be sanctioned, and they did that.

Let's review some lessons learned from this case.

One important lesson in this case is it's important to get the evidence up front. The evidence that we got from the technician could have disappeared. Fortunately, it was still available, but sometimes it does disappear. The accused scientist sometimes gets scared and makes up data. If you can collect all the data up front, you might stop them from doing something worse. We just had a case that settled on a 10-year debarment when the major charge, the major proof against the individual, was fabrication of data after the fact in order to give it to the university committee which was investigating the allegation.

In-house expert analysis is often critical. Unfortunately, these cases are not easy. While I have a lot of sympathy with the institutions that try to handle them, if you just take a superficial look at the allegation, sometimes you won't have a clue as to what really happened.

A quick response is important to a whistle-blower. We've had maybe 20 whistle-blower cases in the last seven or eight years, and it makes a big difference if the institution can come in and stop the retaliation and protect the whistle-blower, right away. It can prevent lawsuits. It can prevent tremendous misunderstandings and lots of pain and agony. That's not to say that every whistle-blower deserves protection. There are whistle-blowers who are being laid off because the grant or the contract is ready to expire and then they conveniently come up with an allegation of misconduct or wrongdoing after the decision to let the individual go has already been made. We don't pursue those cases. But there are a lot of legitimate issues raised by whistle-blowers. Quick response by the institution is the best way to resolve it when it is a legitimate whistle-blower protection issue. Once again, the admission is only as good as the proof, witnesses, documents, etc. A bald statement that an admission occurred, without more, is not very helpful.

Case: Falsified Data in Application

Allegation:

A postdoctoral fellow alleged a technician falsified data in a grant application and manuscript because the data was "too good to be true." When the lab chief, her mentor, took no action, the fellow notified ORI. The mentor "fired" the fellow.

Source: Adapted from ORI Case

The Institutional Process

As an institutional official, what do you do now?

Facts from the Inquiry

  • Reviewed data sets provided by the technician.
  • Mentor defended technician's findings.
  • Inquiry concluded allegation was not supported.
  • Mentor confronted the technician about a second experiment and the technician admitted falsification and was fired.

What do you, as the institutional official, do next?

  • Initiate investigation and notify ORI (was done after ORI recommended investigation).
  • Collect and analyze evidence supporting the allegation.
  • Verify that the admission occurred, is supportable, and in writing.
  • If misconduct, take appropriate institutional actions.

Facts after Investigation

  • On original allegation, found data sets supported results and, thus, no misconduct.
  • On second allegation, technician stated he entered data on an existing spreadsheet and it was an honest mistake.
  • The committee concluded that data was entered into research record without a legitimate basis and, thus, constituted falsification.
  • The institution agreed that dismissal was an appropriate sanction on second allegation.

Criteria for ORI Review

  • Review both affirmative and exculpatory evidence.
  • Weight of documentary evidence and testimony.
  • Significance of alleged misconduct for funding, publication, etc.
  • Seniority of investigator, seriousness of misconduct, repetition or pattern of misconduct and impact on public health or others (e.g. clinical trials).
  • Other actions needed, such as correction of literature, data bases, etc.

ORI Oversight

  • On the second allegation, admission of falsification, ORI found:
  • No witness to the admission.
  • Admission not in writing.
  • Technician denied the admission and allegation.
  • Neither the mentor nor institution could provide evidence or data to confirm the allegation.

On the original allegation, ORI:

  • Obtained data files from technician's computer.
  • Identified files which showed false final values had been entered into a spreadsheet and a formula used to back calculate desired "data."
  • Found physical evidence of data falsification/fabrication based on examination of successive spreadsheet files.

Public Health Service Adjudication

Voluntary agreement, where technician was for two years:

  • Debarred from federal grants and contracts.
  • Excluded from PHS advisory committees.

Institutional Compliance

  • Because of attempted whistle-blower retaliation, ORI requested revision of institutional policies.
  • Policies revised to state explicitly that whistle-blowers would be protected and violators would be sanctioned.

Lessons Learned

  • Importance of gathering all evidence at outset. Respondent's data files needed to prove falsification.
  • In depth analysis often critical to outcome.
  • A "quick response" crucial to protecting whistle-blower.
  • An "admission" of misconduct is only as strong as the supporting evidence. The best evidence is a signed statement of research misconduct and supporting facts.

Ethical Responsibilities of the Principal Investigator
by: Robert Zand
University of Michigan

The question of what are the responsibilities of the principal investigator to the people that they supervise has become an increasingly important concern in both academe, government labs and industry. The days of the hallowed halls of ivy changed with the arrival of Sputnik to the hallowed labs of research grants and contracts. In the academic community, the change in the mission of many universities from one of education and training to one of contract research has imposed many more pressures on the faculty and research staff. I make this distinction for several reasons.

First, in recent years many universities have created a two tier or two track system of the academic professoriat and the research track appointment. Second, the traditional concept of scholarship for the sake of new knowledge and understanding has had constraints imposed on what is "worthwhile" research. Both groups have experienced increased pressures and are subject to the consequences of the pressures. Some of these pressures are driven by ego and the need for peer recognition both by the individual and by the institution.

I would suggest that a more serious driving force creating pressure in the academic and research establishment is the pressure to "show me the money." There is a hierarchy in the present day, research intensive universities that depends upon the input of grant and contract funds to support the research as well as the operation of the institution. The PI is well aware of the consequences of not providing an appropriate level of research and contract funds with their associated overhead contribution.

What are some of these consequences for the PI?

  1. Loss of laboratory space
  2. Loss of access to graduate students
  3. Loss of annual salary increases
  4. Increased teaching loads to compensate for loss of grants
  5. Denial of tenure (for whatever that term means)
  6. Reduced level of publications with concomitant loss of professional recognition

These are a few of the more visible factors that motivate unprofessional and unethical actions of the kind that are not outright fraud and felonies, but fall clearly in the domain of unethical actions or as defined by the National Academy of Sciences as "questionable research practices." The greater the pressure, the greater the temptation to indulge in such action. The penalty for indulging in questionable research practices is generally insignificant. The rewards are quite high.

Scenario 1
A not uncommon situation is the one in which the PI has a theory as to the correct answer to the problem that a student, postdoc or technician is working on. When the experiments do not yield results that agree with the PI's expectations the researcher is told that something is wrong and to go back and repeat the experiments. When the results continue to fail the PI's expectations and the individual doing the experiments feels threatened that they will bear the consequences of this failure to meet the PI's sought for answer, eventually that answer will be provided.

Very often it is the brightest individuals who resort to such fabrication of data believing that they will be long gone with good recommendations before the fabrication is discovered. Here, the PI and the individual who fabricates the data are both responsible for the fraud. Invariably the onus falls upon the student, or postdoc and not the PI. These are situations in which there can be no ambiguity that wrongdoing was committed. These situations usually have a well laid out sequence of steps that result in the punishment of the miscreants.

Scenario 2
The PI runs a large laboratory with some 10 graduate students, six postdocs and one or two technicians. The PI is a very busy individual, serving on committees, study sections, editorial boards etc., and when presented with data obtained by a member of the research team does not have the time to carefully scrutinize the data in order to assess whether it is reasonable or just too good to be true.

What about situations in which there is an abuse of power and where in legal terms no crime was committed but the actions are clearly open to ethical considerations. These fall under the category of questionable research practices. Some institutions have established guidelines and procedures for handling ethical abuses.

Some institutions use the National Institutes of Health or National Science Foundation guidelines and procedures. However, the existence of such guidelines and definitions of rights does not always mean that they are enforced or that redress is possible. Generally these guidelines and procedures are meant for instances where it can be clearly demonstrated that a major legally defined offense has been committed. Some of these areas of misconduct are:

  1. Fabrication of data
  2. Plagiarism
  3. Falsification of research
  4. Publication of misleading material
  5. Abuse of confidentiality
There are other areas where the question of the practice is less well defined. For example, the following scenario was considered by Professor Carl Berger in his presentation at the University of Michigan Sigma Xi Chapter forum on ethics.

A graduate student leaves the university. A set of data still exists in the student's computer account that is paid for by the grant under whose auspices the data was obtained. This data requires a password to be accessed. The data is needed to complete the research for which the grant was awarded. We are faced with the following questions:

  1. What should the professor do?
  2. What are the professor's responsibilities to the university?
  3. What are the professor's responsibilities to the file "owner"?
In other instances the questionable practice is less well defined. Some situations in this category are:

At a faculty lunch table there is a discussion about how to proceed with a particular research problem. A colleague recognizes that this approach can effectively be applied to a different problem and uses it, without informing the other colleague, to apply for a grant. Does he owe his colleague any acknowledgment for his contribution to the research?

A junior faculty member agrees to collaborate with the chair of the department, with each individual providing their own unique expertise. The research problem is based on ideas initially contributed by the junior faculty member. At a particular stage of the research there is sufficient data to warrant a publication. This is prepared and the chair decides to place all authors in alphabetical order. Since the chair's name begins with "A" and the junior faculty member's name begins with "S," that individual's name appears last. When the manuscript appears in print the chair informs the junior faculty member that the collaboration is ended since he no longer requires the expertise contributed by the junior faculty having learned what was needed in the initial effort. The continuation of the research can proceed without further collaborative efforts. Does the junior faculty have any recourse in this situation?

These are questions and problems that arise every day in the offices and laboratories in academia and industry. The floors in the Halls of Ivy are often full of ethical sink holes. Are these simply matters of political concern, or do they fall under the umbrella of ethical considerations?

Beating the System
A faculty member publishes the same research result in three different journals in order to enhance his list of publications.

  1. Is this practice ethical?
  2. Suppose the research is germane to three different research areas. The PI then argues that in order to give his work the distribution that it warrants he needs to publish it in diverse journals that are read by practitioners of those disciplines and not by the practitioners in other research disciplines.
Does this justify the practice? See K. McDonald article in the Chronicle of Higher Education, June 5, 1985.

The last scenario I propose is the following: In a given department, a major consideration for merit pay increases and for promotion depends on the number of citations the PI receives in the Citation Index. In order to increase this number, the PI, who has done an excellent study with excellent data, decides to deliberately interpret the data in a way that, although not immediately obvious, is incorrect. The research of the study is in a very important and highly visible area, and soon a multitude of investigators have written papers that do not challenge the data. However, the interpretations is challenged and the paper is cited a multitude of times. Is the PI ethical in doing this? If not, how should the matter be handled?

As I bring my presentation to an end, I want to raise the question of the difference between unethical actions and bullying-like behavior. I believe that the distinction between these terms is primarily semantic rather than demonstrating a difference in behavior. The ultimate consequence of such actions is intimidation. The principal investigator functions as a team or group manager. Department chairpersons function as managers of the principal investigators. Deans function as managers of the department chairpersons. Thus, there is a hierarchy of responsibility to ensuring ethical behavior. This responsibility is frequently neglected.

T he effective mentoring of students, lab assistants, junior faculty and researchers by managers and administrators depends on the development of mutual respect between all parties. To give managers and administrators, who lack people skills, supervisory power without built-in controls leads to the abuse of power and the erosion of respect for the institution. The antagonism that can develop can result in a loss of research credibility.

Data can be manipulated and modified to fit preconceived concepts or expectations of the PI or granting sources. The occurrence of abuses of power by faculty and administrators in academic institutions cannot be denied. What controls can the institution provide to ensure that abuses are kept to a minimum? What redress can be pursued without incurring additional penalties to the aggrieved? I have no simple solution to the problem. But, given the current rewards for those who successfully get away with unethical, but not illegal, actions, this kind of behavior will increase.

Not dealing with the problem in a meaningful way will surely promote an increase in such behavior to the detriment of the education, scholarship and research components of the university's mission. Willie Sutton, the bank robber, when asked why he robbed banks rather than small enterprises that were less dangerous replied "because that is where the big money is." Unethical behavior at universities occurs because the rewards are sufficiently great to warrant the risk. In banks there are alarms and guards to deter most thieves. No such meaningful barrier is normally present in most academic settings to impede unethical, but not illegal, activities.

 

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