Fostering Integrity in Research (2017) / Chapter Skim
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7 Addressing Research Misconduct and Detrimental Research Practices: Current Knowledge and Issues
7 Addressing Research Misconduct and Detrimental Research Practices: Current Knowledge and Issues
Pages 105-146
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From page 105... ...
Addressing detrimental research practices may involve even greater challenges than does addressing misconduct. ADDRESSING RESEARCH MISCONDUCT Chapter 4 provides a broad overview of how the U.S.
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From page 106... ...
In addition, as discussed in Chapter 10, while most experts and practitioners believe that RCR education is necessary and worthwhile, perhaps particularly in discouraging detrimental research practices, the evidence of its effectiveness is limited. This issue is discussed in more detail in Chapter 10 and in Appendix C
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From page 107... ...
According to the current federal research misconduct policy Agencies and research institutions are partners who share responsibility for the research process. Federal agencies have ultimate oversight authority for Federally funded research, but research institutions bear primary responsibility for prevention and detection of research misconduct and for the inquiry, inves tigation, and adjudication of research misconduct alleged to have occurred in association with their own institution.
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From page 108... ...
Another analysis examined cases of research misconduct as well as cases of other misconduct -- such as failure to follow rules governing human subjects or laboratory animal protection -- and medical practice misconduct (e.g., undertaking unnecessary procedures)
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From page 109... ...
The importance of increasing transparency is a key theme of this chapter and underlies several of the committee's recommendations intended to prevent or reduce misconduct and detrimental research practices (DRPs) and to more effectively detect the misconduct that does occur.
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From page 110... ...
Chapter 5 discusses the existing evidence on the incidence of research misconduct. Surveys of researchers on their own behavior and on the behavior of colleagues whom they have observed or heard about generate much higher estimates of the incidence of research misconduct than is reflected in the findings of research misconduct investigations reported by NSF-OIG and ORI.
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From page 111... ...
In these cases, journal editors are advised to be persistent and to contact the funder or national research integrity office if the institutional response is inadequate. In some countries, institutions do not have a formal responsibility to investigate research misconduct or report it to sponsors, and there may be no national research integrity organization.
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From page 112... ...
To be sure, the legal authorities and implementing regulations that govern how FDA exercises its responsibilities have evolved separately from the federal research misconduct policy and related regulations, so it is not surprising that they might be out of synch in some areas. As indicated in this discussion, not much is known about how these policy frameworks interact in practice and what sorts of changes or adjustments might be needed.
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From page 113... ...
The topic of knowingly false allegations is discussed below. Journal editors need to exercise judgment in evaluating the credibility of expressions of concern and accusations they receive, and anonymity deprives them of important information in making an evaluation.
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From page 114... ...
federal research misconduct policy and its implementation in agency regulations place the primary responsibility for investigating research misconduct allegations on research institutions (HHS, 2005; NSF, 2002; OSTP, 2000)
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From page 115... ...
In addition, ORI undertakes programs to train institutional research integrity officers (RIOs) and maintains a Rapid Response for Technical Assistance program to help institutions with advice, referrals, and assistance with forensic tools related to investigations.
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Different Approaches to Plagiarism As noted in Chapter 4, the U.S. federal research misconduct policy defines plagiarism as "the appropriation of another person's ideas, processes, results, or words without giving appropriate credit" (OSTP, 2000)
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Later communication between the university's research integrity officer and Norris indicated that ORI had "not taken an interest in the past in disagreements between investigators at the same institution" (Rosenberg, 2011)
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From page 118... ...
Still, some themes and lessons emerge from the information that is available. Unevenness in institutional policies and capacity to investigate and address research misconduct allegations is an important challenge examined by the committee.
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New allegations uncovered during the course of the investigation might not be followed up properly. ORI also sponsored several surveys of research integrity officers aimed at learning more about the knowledge and preparedness of these institutional officials.
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Less than half reported discussing all four topics with those considering making an allegation. The report pointed out that it would be helpful for RIOs to discuss this issue with potential complainants because many of those who come forward with research misconduct allegations have reported experiencing retaliation or other adverse consequences (Lubalin et al., 1995)
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From page 121... ...
Additional information about how institutions address research integrity issues more broadly has emerged via administration of the Survey of Organizational Research Climate (SOURCE) , reported as part of the Project on Scholarly Integrity (PSI)
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From page 122... ...
The occasional surveys supported by ORI have shed light on important aspects of institutional responses, but additional research to assess aggregate trends and needs could yield valuable insights that would enable the entire system of investigating research misconduct in the United States to operate more effectively. Taking Corrective Actions Corrective actions may be taken in response to research misconduct findings, and these take several forms.
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From page 123... ...
A federal effort to bring about greater consistency between agencies in the implementation of the research misconduct policy could address this issue, as could other initiatives such as reconciling differences in the handling of plagiarism allegations. However, it is not obvious how implementation should be made consistent.
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From page 124... ...
It is important to note that the standard of proof in criminal prosecutions -- proof "beyond a reasonable doubt" -- is significantly higher than the "preponderance of the evidence" standard that prevails in institutional research misconduct investigations and federal oversight of these investigations. In recent years, there have been calls for research misconduct to be treated as a crime more frequently than it has been up to now (Smith, 2013)
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From page 125... ...
As illustrated by the discussion above of clinical trials where an FDA investigation found significant problems such as falsification of data, but where the research was published with no indication of a problem and there is no record of a research misconduct finding, there appear to be shortcomings in how information flows between the two regulatory and compliance systems. Another area where human subjects protection regulations overlap with research misconduct regulations is in education, since human subjects protection is included as one of the nine core areas of responsible conduct of research (RCR)
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From page 126... ...
Another area of regulation that has some relationship with research misconduct policies involves the requirements for disclosing and managing possible financial conflicts of interest in research. Conflicts-of-interest reporting is an issue currently in flux, with many differences between existing policies, which are not uniform between agencies, and compliance generally does not raise issues of overlap with research misconduct policy.
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From page 127... ...
Although journals are not equipped to investigate allegations of research misconduct, they may have strong evidence of misconduct developed through the use of software that detects image manipulation or through other technological tools. In the absence of a finding of misconduct or a request by an institution to retract an article, a journal might hesitate to move forward.
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From page 128... ...
In at least one case, ORI has treated sabotage of experiments as research misconduct. In a case from several years ago, Vipul Bhrigu, a postdoc at the University of Michigan Medical School, was found to have tampered with the experiments of Heather Ames, a graduate student in his lab, which caused false results to be reported in the research record (HHS, 2014a; Maher, 2010)
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From page 129... ...
As described below, agencies follow a variety of approaches toward making information about research misconduct investigations public. Despite the understandable focus on NSF-OIG and ORI, other federal agencies that perform and/or support research are also obliged to implement the federal research misconduct policy.
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From page 130... ...
Although a detailed review of how all agencies are implementing the research misconduct policy is beyond the scope of the study, examining several examples serves to illustrate that efforts to assess and improve performance by federal agencies would contribute to fostering research integrity within the federal government and beyond. Part of the context is the scientific integrity initiative that the Obama administration undertook during its first term, described in Chapter 3.
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. The VA's Program for Research Integrity Development and Education oversees training and credentialing in areas related to human subjects protection.
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From page 132... ...
DOE's research misconduct policy was adopted in 2005 and specifies that research misconduct allegations should be referred to "the DOE Element responsible for the contract or financial assistance agreement" (10 CFR Parts 600 and 733; 48 CFR Parts 935, 952, and 970)
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From page 133... ...
The sum total of these negative impacts may be greater than the harm done by research misconduct. Some detrimental research practices related to authorship that do not constitute misconduct, such as honorary authorship, are discussed below in a section focused on authorship issues and challenges.
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From page 134... ...
Discouraging, reducing, and eliminating DRPs will support and strengthen the effective operation of science's self-correcting tendencies. An example from high-energy physics illustrates the value of good research practices in the process of reporting results, identifying and correcting errors, and confirming findings.
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From page 135... ...
(OSC, 2015) Strengthening Standards and Ensuring Transparency Detrimental research practices and some amount of failure to reproduce research results are not new problems.
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The sharing and reuse of data have become central to research practices in HLT. Advances in the field have led to products that are widely used today, such as Apple's Siri and Google Translate.
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. For clinical trials, sharing data at the time of publication is aspirational.
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federal government and by most other countries. For the most part, other categories of authorship credit misallocation are considered detrimental research practices for
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From page 139... ...
In cases where work is fabricated or falsified, questions are raised about the responsibilities of coauthors whose contributions may or may not have merited authorship. The stem cell case at Seoul National University and the University of Pittsburgh, described in Appendix D, discusses these issues.
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From page 140... ...
In these latter cases, ghost authorship also becomes a type of honorary authorship. While the immediate motivation for this form of ghostwriting is to hide the financial interest of the sponsor and ghost authors in the work, it has also been associated with other detrimental research practices such as selective reporting and suppression of some findings.
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From page 141... ...
. All of the authorship abuses described above undermine research integrity.
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From page 142... ...
In 1989, the PHS definition of research misconduct was "fabrication, falsification, plagiarism, or other serious deviations from commonly accepted research practices." None of the specific terms was further defined. Authorship misrepresentation other than plagiarism is clearly not included in the definition of falsification specified in the current U.S.
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From page 143... ...
Another practical difficulty in addressing authorship credit misrepresentation other than plagiarism through the research misconduct policy framework involves the sheer scale of the phenomenon. Suppose that the study cited above is correct and more than 20 percent of biomedical research articles have honorary and/or ghost authors (Wislar et al., 2011)
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From page 144... ...
illustrates the vulnerability of whistleblowers, even in situations where there was no retaliation on the part of the accused or the institution. Providing effective protection for whistleblowers is a key element in addressing research integrity going forward (Kornfeld, 2012)
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From page 145... ...
One option would be to create standards for institutions as part of the research misconduct policy, without making whistleblower retaliation part of the misconduct definition. HHS published proposed standards for protecting research misconduct whistleblowers in November 2000 (HHS, 2000)
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From page 146... ...
146 FOSTERING INTEGRITY IN RESEARCH Even whistleblowers acting in good faith may not be very sympathetic figures, alienating colleagues and administrators. Apprehension about possible retaliation is certainly reasonable and can be expected to deter those who observe misconduct to come forward.
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