Journal of the National Cancer Institute Advance Access originally published online on December 25, 2007
JNCI Journal of the National Cancer Institute 2008 100(1):7-10; doi:10.1093/jnci/djm300
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© Oxford University Press 2007.
NEWS |
Recent Conference Addresses Research Integrity on Global Scale
The name Jon Sudbø is one that many in the cancer community will not soon forget. In early 2006, Sudbø admitted to fabricating patient data used in a study of nonsteroidal anti-inflammatory drugs and oral cancer risk published in The Lancet. Sudbø's institution, the Norwegian Radium Hospital, promptly appointed a special commission to investigate all his research from the previous decade. The commission found evidence of falsified and fabricated data dating back to Sudbø's Ph.D. project (J Natl Cancer Inst 2006;98:374–6).
The findings prompted the Norwegian government to formally put into place national research ethics committees tasked with proactive, preventive education on research integrity. The government also established a national office chaired by a judge to investigate cases of alleged scientific misconduct, and new legislation on ethics and integrity in research went into effect in July of this year.
The Sudbø case has parallels all over the world: Research misconduct made national headlines and led to a new national policy that defined the concept and set out a course of disciplinary action against future offenders. In September, the European Science Foundation and the U.S. Office of Research Integrity held the first world conference on research integrity to give researchers and policymakers from around the globe a chance to share their experiences in establishing such systems, as well as to discuss what a global framework for research integrity might look like.
The growing globalization of science is a major driving force behind a push to establish a world standard. "We are no longer dealing with single-investigator projects," said Lida Anestidou, D.V.M., Ph.D., of the Institute for Laboratory Animal Research at the National Academies. "We have multicultural, multinational, multi-institutional, multi-investigator, very expensive investigations. Therefore, [the number of coauthors has] risen dramatically, and disputes over credit, over intellectual property, and over patents have all risen dramatically."
One goal of a global policy would be to establish some core standards so that researchers working with scientists in other countries could be assured that their collaborators come from a research culture that fosters integrity. Another would be to help streamline international research misconduct investigations.
To illustrate the difficulties in such investigations, Christine C. Boesz, Dr.P.H., inspector general of the National Science Foundation, described a case that her office recently dealt with. A peer reviewer for a National Science Foundation (NSF) grant proposal recognized ideas and text within the proposal that she had originally written and submitted to a U.K. funding agency. NSF reported its suspicions of plagiarism to the proposal submitter's university. The university and the NSF contacted the U.K. funding agency to get a copy of the original proposal, but the U.K. agency regarded the proposal as confidential and argued that it couldn't be shared. In the end, the university's investigative committee concluded that the NSF investigator had been a reviewer of the U.K. proposal and had plagiarized elements of it. The university fired the researcher, and NSF barred the researcher from receiving any federal funds for 2 years.
"The international challenge was that there was no agreed-upon legal framework to handle the inquiry or investigation; there was no fact-finding structure that goes across international boundaries; and it was totally dependent on personal relationships, ad hoc knowledge, and informal agreements," Boesz said.
Defining Integrity
Before there can be any agreement on something as complex as a structure for international misconduct investigations, however, there needs to be some agreement on basic definitions.
"The easiest part about planning [the world conference on research integrity] is that there is universal agreement on one thing, and that is that standards for integrity in research should be set very high. There should be no compromise," said Nicholas H. Steneck, Ph.D., a consultant with the Office of Research Integrity within the U.S. Department of Health and Human Services and a chairman of the September conference. "There's less agreement, and ‘where it becomes more difficult’ is what we actually mean by integrity."
Definitions of research integrity worldwide may differ slightly, but their central tenets tend to be similar (see sidebar, e.g., the European Science Foundation's definition of scientific integrity. There is less consensus on what scientific misconduct means. However, almost all definitions include falsification, fabrication, and plagiarism (FFP).
Researchers know little about the frequency of FFP. The few studies available suggest that FFP occurs in the scientific literature with a frequency of about 0.1%–1.0%, Steneck said. "The evidence does not support the view that misconduct is rare, ... what the problem is is that most research misconduct is not detected, reported, and investigated," he said.
Beyond FFP are so-called questionable research practices—a term that includes everything from designing a study to bias certain results and not following research protocols to failing to disclose conflicts of interest and using inappropriate statistical methods.
"A colleague of mine said once, ‘Questionable research practice is like low back pain. [A cause is] there, but you cannot detect it,’" said Pieter Drenth, Ph.D., of the All European Academies. "This is a dangerous virus, difficult both to detect and to eradicate."
Brian C. Martinson, Ph.D., of the HealthPartners Research Foundation in Minneapolis, and colleagues conducted a survey in 2002 to try to get at the prevalence of questionable research practices beyond FFP. Fifteen percent of the more than 7,000 NIH-funded early- and midcareer researchers responded that they had changed the design, methodology, or results of a study in response to pressure from a funding source; 12.5% reported overlooking others' use of flawed data; 7.6% reported circumventing certain minor aspects of human-subject requirements; and 6% said that they had failed to present data that contradicted their own previous research. In all, 33% of survey respondents reported that they had engaged in at least one of 10 listed questionable research practices. The implication, the authors wrote in Nature in 2005, is that "scientists engage in a range of behaviors extending far beyond FFP that can damage the integrity of science."
Just as it's difficult to determine what the prevalence of misconduct is, it's nearly impossible to determine trends. However, there does seem to be a common perception that research misconduct is on the rise. For example, a survey of the All European Academies' 53 science and humanities academies across Europe showed that scientists think there has been an increase in misconduct. The reasons cited were increased pressure to produce and publish, increased commercialization of research results, tougher competition for funds, the diminished prestige of science, increased opportunities to cheat in the Internet age, and the inadequacy of the peer-review system to detect misconduct in complex projects.
"When I first arrived at the NSF, it was my observation that all of the problems were plagiarism problems," Boesz said. "What I've seen the last 4 years is a marked increase in allegations of falsification and fabrication of data. We're trying to understand why we're seeing that—we can speculate, but we don't know why."
Dealing With Misconduct
Many industrialized countries already have a system in place to handle reported cases of scientific misconduct, but they vary widely. Many countries have institution-level committees to deal with reported problems, and other countries, such as Norway, have national-level committees that review individual cases.
"We concluded that no one model is the right model," Nigel Lloyd, Ph.D., of the Natural Sciences and Engineering Research Council Canada, said in summarizing discussions from a workshop last February in Tokyo on scientific integrity. That workshop, held by the Organization for Economic Cooperation and Development Global Science Forum, resulted in a "best practices" document that the group approved and adopted in October. "What is required is to tailor a system to the specific needs of a specific research environment of a particular country. It's the principles that are more important than the particular model."
Many of those national investigative bodies were created in reaction to a particularly egregious case of research misconduct, which can mean that these organizations are set up to deal with misconduct only after the fact. Developing international standards may be a way for countries to think more proactively about fostering scientific integrity and preventing misconduct. "Very often, [national misconduct committees] are problem oriented," the National Academies' Anestidou said. "They espouse the philosophy that a certain behavior is wrong and must be stopped. This way of thinking implies that there is a finite number of ways that one can behave badly, and all of these ways can be defined. I would argue that in reality, it's exactly the opposite. There are very few ways to be ethical about what you do in your work, either science or otherwise, and there are innumerable ways with which to cheat, and they cannot be defined."
International Action
The September conference showed that any global consensus on research integrity is probably a ways off. The varied strengths and complexities in—or the absence of—national systems for research misconduct will make it extremely difficult to appeal to everyone involved.
There was also varied opinion on what form an international statement or directive would need to take, although several speakers highlighted that regulations and policies that are too stringent will do a disservice to science, while anything that's too general will be ineffective.
"This area is a microcosm of society," said Ian Halliday, Ph.D., president of the European Science Foundation. "There's plenty of crime and temptation and retribution in society, and I don't believe this is a whole lot different. Society does not solve these problems by writing guidelines. There's a whole complex set of machinery, and I think we need to think in those terms."
The organizers of the September world conference on research integrity have summarized possible actions from the meeting discussions, and Steneck said he sees the meeting as a good starting point for an ongoing global dialogue on research integrity. Above all, any unified effort needs to be aimed at upholding the integrity of the scientific enterprise, he said. "Research integrity policy has been driven by crises and public pressures, and we need responsibly conducted research studies to react to that and to articulate clear, rational, empirically based policies that can respond to that to maintain public confidence in research."
Spelling Out the Problem: Integrity and Misconduct
Scientific Integrity
The European Science Foundation defined scientific integrity in its 2000 policy briefing, "Good Scientific Practice in Research and Scholarship," with the following: Scientific integrity is at the heart of the trust on which scientific communication and collaboration depend. Scientific integrity demands that those engaging in research and scholarship should at all times, and without exception, adhere to the following basic principles:
- highest professional standards in designing and conducting investigations
- a critical, open-minded approach in conducting research and scholarship and in analysing data
- frankness and fairness with regard to the contributions of partners, competitors, and predecessors
- absolute honesty at all stages in scientific enquiry, in particular, avoiding:
- – any form of fraud, such as fabricating or falsifying data or records;
- – piracy or plagiarism;
- – sabotaging the work, records or protocols of other scientists;
- – breach of confidence as a reviewer or supervisor, and
- – complicity in such actions by fellow scientists.
- – piracy or plagiarism;
- – any form of fraud, such as fabricating or falsifying data or records;
To retain professional and public trust, it is vital that all scientists accept personal responsibility to uphold these fundamental values.
Research Misconduct
The U.S. Office of Research Integrity defines research misconduct with the following:
Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
- Fabrication is making up data or results and recording or reporting them.
- Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
- Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.
- Research misconduct does not include honest error or differences of opinion.
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