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

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"?

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.

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.