Research Misconduct

There are some indications that research misconduct occurs only rarely. In 20 years, the federal government found an average of about 10 cases of research misconduct per year; that is, about 1 case per year for every 10,000 researchers. However, there are many barriers to accurately quantifying the extent of research misconduct; cases may go unreported and institutions may be biased against finding misconduct. The actual rate of research misconduct could be as low as 1 in 100,000 or as high as 1 in 100. (Steneck, 2000)

In the past 20 years, numerous serious cases of alleged misconduct have been widely publicized. In many cases, the allegations were borne out by subsequent investigation. It is noteworthy that in these cases both whistleblowers and those accused of wrongdoing paid a price whether the allegations were ultimately sustained or not.
 

Whistleblowing

The details of how research is conducted are often known only to those actually working on a project. This relative secrecy is driven by many different factors, from sheer practicality, to protection of credit or intellectual property rights, to worries about the possible misuse of preliminary data. Where there is this secrecy, however, misconduct will only come to light if someone close to the project blows the whistle.

Unfortunately, the evidence is compelling that whistleblowers, not just the accused, suffer adverse consequences. Based on self-reports, over 60% of whistleblowers suffered at least one negative consequence, such as being pressured to withdraw their allegation, being ostracized by colleagues, suffering a reduction in research support, or being threatened with a lawsuit. Approximately 10% noted significant negative consequences, such as being fired or losing support. However, fewer than 18% of those suffering the most severe impact on their careers reported that they would be unwilling to come forward with allegations again. (Research Triangle Institute, 1995) This potential for adverse consequences makes it problematic to place an obligation for whistleblowing on scientists in training, such as postdocs, graduate students, or undergraduate students.

Scientists do not all agree regarding if, when, or how to report misconduct. There is a considerable range of opinions among scientists about how to respond to perceived misconduct -- and an even greater difference between scientists and administrators. [Wenger et al. (1999)] Yet, as a 1995 publication of the National Academy of Sciences advises, 'someone who has witnessed misconduct has an unmistakable obligation to act.'
 

Rules and Regulations

Research Misconduct

In an effort to harmonize activities among the federal sponsors of research, the Office of Science and Technology Policy in the White House published the Federal Policy on Research Misconduct (OSTP, 2000). At present the following agencies or departments have implemented the new federal policy: Department of Health and Human Services, Department of Transportation, Department of Labor, the Environmental Protection Agency, National Aeronautics and Space Administration, and the National Science Foundation. The remaining eight departments report that their policies have been drafted and are undergoing internal review: Agriculture, Commerce, Defense, Education, Energy, Interior, Justice and Veterans Affairs.

Some, but not all, categories of questionable conduct are covered under the federal policy on research misconduct and the specific regulations implemented by departments and agencies. Under the older regulations, research misconduct was (and in some cases still is) defined as: fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. The most significant changes in the new federal policy restricts the definition of research misconduct to fabrication, falsification, and plagiarism. In the OSTP policy, 'research misconduct' is defined as: fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.

Minimally, for something to count as research misconduct it must be committed intentionally, knowingly, or recklessly, and there must be a significant departure from accepted practices of the relevant research community.

Other abuses of the research process do not fall under the definition of research misconduct. These are dealt with through other mechanisms. Examples include but are not limited to: mismanagement of research funds, conflict of interest, problems involving animals or humans in research, sloppy research design or technique, disagreements between collaborators, etc.

Sponsor specific regulations and procedures for responding to allegations of research misconduct can usually be found in the Code of Federal Regulations (NASA, 2004; NSF, 2005; PHS, 2000b). Eventually all the agencies and department will have modified their regulations to adhere to the single federal policy announced in December of 2000 (OSTP, 2000). The existing and proposed definitions both make it clear that federal agencies and research institutions have a shared responsibility for the research process and, therefore, for responding to allegations of research misconduct. There are a range of circumstances under which institutions must report allegations to federal authorities (see italicized section below); in other circumstances, allegations of research misconduct are initially in the purview of individual institutions.

Research institutions are required to notify the appropriate federal agency if an allegation of research misconduct involves federally funded research; if the institution's inquiry finds that an investigation is warranted; if there is an immediate health hazard involved; if there is an immediate need to protect federal funds or equipment; if there is an immediate need to protect the interests of the whistleblower or of the subject of the allegations; if it is probable that the alleged incident is going to be reported publicly; if there is a reasonable indication of possible criminal violation. (42CFR50.104(b); PHS, 2000b)

To foster fair and timely responses to allegations of research misconduct, both current and proposed regulations include safeguards for informants and for the subjects of allegations, an expectation of objectivity and expertise, adherence to reasonable time limits, and respect for confidentiality.

Whistleblowers

Whistleblowers are protected under rulings from both the state and federal governments. The first amendment to the Constitution, guaranteeing free speech, gives whistleblowers legal protection from retaliation. The federal False Claims Act is more far-reaching (US Code, 1986). Originally developed to protect the federal government from fraudulent contractors during the Civil War, the Act provides that any individual with primary knowledge of fraudulent use of federal funds can bring charges. If a defendant in a False Claims case is found liable, then the whistleblower can be awarded 15-30% of the resulting settlement. The False Claims Act also specifically calls for significant remedies for any discriminatory action that can be shown to have been taken to retaliate against an employee who has presented a case under the Act.

New federal regulations have been proposed by the Department of Health and Human Services (2000) to protect whistleblowers from retaliation. The proposed regulations are intended to place obligations on institutions both to prevent and to remedy retaliation against whistleblowers. In addition to federal regulations, most states and/or institutions typically have specific protections for whistleblowers. Additionally, most institutions, and many professional societies and journals, offer guidelines to support the role of the whistleblower. Guidelines can have as much or more importance than the regulations in reducing the chance of adverse outcomes.
 

Principles

The integrity of science depends on the integrity of research. Science is predicated on trust -- without confidence in the integrity of their peers, scientists would be unable to trust one another's work. The demands of ethical and responsible conduct may not always seem expedient.

The integrity of research depends in part on self-policing. Just as peer review operates to assure the legitimacy of published reports, self-policing operates to assure the legitimacy of research at a deeper level. This means that scientists should be familiar with definitions of research misconduct and procedures for dealing with it, regardless of whether they are actually party to allegations. Self-policing also demands that scientists attempt to communicate with one another to foster an environment in which responsible research is explicitly discussed and encouraged.

A witness to possible misconduct has an obligation to act. Many people will find it difficult to be silent about wrongdoing, particularly if it could result in harm to patients or subjects, a waste of scarce resources, or publication of misleading findings. Others may be inclined to report misconduct because they would not want to risk that an independent discovery of the misconduct could implicate them for complicity or could at least lead to questions about why nothing had been said earlier. Finally, the sponsors of research have the right to expect that recipients of the funding will address serious deviations from good research practice.

Not all concerns about research conduct should result in an allegation of research misconduct. Even when a strong argument can be made for action, making an allegation of research misconduct should not be a first step to remedy questions or concerns. Impressions should be validated before making serious charges, and many apparent problems can be resolved by other means.

Allegations, once made, should be handled at the institutional level. Once an allegation has been made, it is not the whistleblower's task to investigate misconduct or mete out justice. Procedures for responding to allegations of research misconduct are designed to protect the integrity of science, rather than to address real or perceived grievances on the part of a whistleblower. If a whistleblower does have specific grievances, then those should be handled separately by whatever procedures are appropriate within the institution.
 

Guidelines

Documentation
A failure to keep good records can have serious consequences for the progress of a research project, but can be particularly devastating for someone involved in an allegation of misconduct. Whether one is making the allegation or accused of misconduct, clear documentation of who did what and when they did it will provide the best chance for a fair and timely resolution.

As with good research, an allegation of misconduct should be sustained or rejected based on adequate documentation. An allegation of research misconduct is one of the most serious charges that can be made against a scientist. As such, it is essential that a charge be sustained only if justified by documentation and other relevant evidence. Correspondingly, it would be unusual to have an allegation of misconduct based solely on a disputed testimonial account.

Rules and procedures
Although institutions receiving federal funds need to meet a common set of minimal requirements, individual institutions are granted substantial leeway in the rules and procedures for handling of allegations of misconduct. Especially if you become involved in an allegation of misconduct, it is in your best interest to familiarize yourself with all relevant institutional procedures. It is important to determine who is to be apprised of the allegation, what constitutes evidence for or against the allegation, how the evidence is to be obtained, who will review the allegation, what her or his role will be in the process, and what will be the time course for reviewing the allegation.

Institutional channels are preferable to public channels.
The pace of the process for dealing with alleged misconduct may be frustrating. In such circumstances, it can be tempting to discuss the case publicly. Placing a complex, unresolved issue into the public arena can produce unpredictable results, however, which can be harmful to the people involved and to the scientific community as a whole. Publicity may compromise the integrity of an ongoing inquiry and the privacy of parties to the investigation. Moreover, an attempt to circumvent the institutional process may prejudice those charged with reviewing the allegation.

Perspective
Note that not all instances of misbehavior amount to research misconduct. Some aspects of conduct are too new or poorly defined to allow for a simple answer about what is appropriate conduct. Other behavior that stems from bad manners, honest error, or differences of opinion may be 'bad' in some sense without being research misconduct.

Because of the serious consequences of an allegation of misconduct, it is important to be clear about the allegation. This concern is particularly relevant for someone with relatively little experience in research or in a specific area of research. Some actions that appear to be serious deviations from good research practice are due only to misunderstanding or to differences between accepted standards in different research disciplines. To avoid the mistake of an inappropriate allegation, begin by asking questions and seeking perspective. Depending on circumstances, it may be appropriate to talk to peers, to more senior members of the research group, to someone in an ombudsman program, or to the individual whose conduct is in question.

Dispute resolution
Many potential allegations of misconduct are issues that would be better resolved by other means. There are often options between the extremes of doing nothing and of lodging a formal allegation of research misconduct.

First, good conflict resolution skills may be enough. Scientists' training in conflict resolution tends to be poor, but much can be gained from a few basic principles. Deal with the problem as early as possible. Begin by defining points of agreement and then work on areas of disagreement. Emphasize the problem rather than the person. Give and ask for clear communication about what is most important to each of the interested parties.

Second, a respected third party can sometimes help with mediating a dispute. The goal of mediation is to help clarify issues in a way that permits the best possible agreement or compromise. When other avenues of communication have failed, then parties to a dispute might be convinced to put their cases before an arbitrator for review and a binding decision. Some institutions have formal mechanisms in place for conflict resolution, mediation, or arbitration; absent such mechanisms, finding a solution to a dispute may require some creativity. That creativity is rewarded, however, if the problem can be resolved.

Goals and role of the whistleblower
If the facts of a case warrant making an allegation of research misconduct, then two issues need to be kept in mind.

First, a whistleblower should be well aware of the potential for difficulty. Although the possibility of explicit or implicit retaliation should not automatically deter a good faith allegation of research misconduct, it is unfortunate when a whistleblower comes forward unaware of potential consequences.

Second, in presenting an allegation and supporting documentation, a whistleblower should clearly distinguish between facts and speculation. It is easy to fall into the trap of inferring motives on the part of others. By sticking to the facts of the case, a whistleblower (or the accused party) will reduce the risk of a loss of credibility. In short, a whistleblower, as well as his or her case, will be best served by asking questions rather than drawing conclusions.
 

UAF Specific Information

All UAF employees are protected against reprisal due to good faith allegations as required by state and federal regulation. Students are protected against reprisal based on good faith allegations by institutional policy.

University of Alaska Misconduct Policy: Misconduct in Research, Scholarly Work and Creative Activity in the University is covered in UA Board of Regents Policy and Regulations (10.07.06).

Whistleblower Protections

  • Students are protected from reprisals arising from good faith reporting under Board of Regents Policy and Regulations (09.01.09).
  • Employees are guaranteed protection from reprisal due to good faith allegations by the Alaska Whistleblower Act (AS 39.90.100-150) - see chapter 39.90 Miscellaneous Provisions, Article 2, "Protection for Whistleblowers".

Allegations of misconduct may be made verbally or in writing to any UA or UAF Officer. Internal processes are handled by the UAF Research Integrity Officer (Director, UAF ORI) and UA General Counsel. The order of events is 1) notification, 2) inquiry, 3) investigation, and 4) decision. UAF is required to notify all involved sponsors whenever an investigation is initiated and to provide a final report describing the outcome. UAF also files an annual report to the Federal Office of Research Integrity providing information about allegations, inquiries, and investigations involving Public Health Service sponsored research (PHS includes the National Institutes of Health).
 

Works Cited

  • Department of Health and Human Services (2000): Public Health Service Standards for the Protection of Research Misconduct Whistleblowers. Notice of proposed rulemaking. Federal Register November 28, 2000 65(229): 70830-70841

  • National Academy of Sciences, National Academy of Engineering, Institute of Medicine (1995): On Being a Scientist: Responsible Conduct in Research. National Academy Press.
    http://www.nap.edu/readingroom/books/obas

  • National Aeronautics and Space Administration (2004): Investigation of Research Misconduct. Federal Register July 14, 2004 69(134): 42102-42107.

  • National Science Foundation (2002): Research Misconduct. Federal Register March 18, 2002 67(52): 11936-11939.

  • Office of Science and Technology Policy (2000): Federal Policy on Research Misconduct: Notification of Final Policy. Federal Register December 6, 2000 65(235): 76260-76264. http://www.ostp.gov/html/001207_3.html

  • Public Health Service (2000a): Sec. 50.102 Definitions. Subpart A. Responsibility of PHS Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science. Part 50--Policies of General Applicability. Chapter I--Public Health Service, Department of Health and Human Services. Title 42--Public Health. 42CFR50.104, p. 168.

  • Public Health Service (2000b): Section 50.104 Reporting to the OSI. Subpart A. Responsibility of PHS Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science. Part 50--Policies of General Applicability. Chapter I--Public Health Service, Department of Health and Human Services. Title 42--Public Health. 42CFR50.104, pp. 170-171.

  • Research Triangle Institute (1995): Consequences of whistleblowing for the whistleblower in misconduct in science cases. Report submitted to Office of Research Integrity
    http://ori.dhhs.gov/multimedia/acrobat/final.pdf

  • Steneck N (2000): Assessing the integrity of publicly funded research: A background report for the November 2000 ORI Research Conference on Research Integrity.
    http://ori.dhhs.gov/multimedia/acrobat/backg_int.pdf

  • US Code (1986): False Claims Amendments Act of 1986. 31 USC Sections 3729-3731.
    http://uscode.house.gov/title_31.htm

  • Wenger NS, Korenman SG, Berk R, Honghu L (1999): Reporting unethical research behavior. Evaluation Review 23: 553-570.

  • Gunsalus CK (1998): How to blow the whistle and still have a career afterwards. Science and Engineering Ethics 4: 51-64. This article is made available online via the website for the Poynter Center for the Study of Ethics and American Institutions, Indiana University, at http://poynter.indiana.edu/links.shtml1#SEE.