'Assessing the Need for a Research Ethics Remediation Program' by James M DuBois, Emily E Anderson and John Chibnall in (2013) 6(3)
Clinical & Translational Science 2009
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With supplement funding to the Washington University CTSA, the Restoring Professionalism and Integrity in Research (RePAIR) program was developed at Saint Louis University to meet the remediation needs of institutions nationwide regarding investigators who violate research regulations. With the aim of determining the frequency and kinds of wrongdoing at leading research institutions in the United States, as well as institutional responses and levels of interest in a formal remediation program, an online questionnaire was distributed by email to a research integrity officer (RIO) and institutional review board (IRB) chair at all medical schools and comprehensive doctoral institutions in the United States (N = 194). One hundred sixty-one individuals responded (44%) representing 66% of institutions. For those institutions that had both RIOs and IRB chairs responding, 96% had investigated at least one case over the past 2 years; the modal individual response was 3–5 cases, with a range from 0 to more than 16 cases. The most common forms of wrongdoing were violations of procedure, informed consent, research integrity (fabrication, falsification, plagiarism), privacy, and conflict of interest policies. Most RIOs and IRB chairs expressed interest in the RePAIR program, despite concerns about costs and faculty resistance.
The authors note that
A recently developed taxonomy of wrongdoing in research identifies 14 primary kinds of violations of professional standards for researchers, including research misconduct (which is federally defined as falsification, fabrication, or plagiarism—FFP), informed consent failures, privacy/confidentiality violations, improper care of animals, conflict of interest violations, and others.
Some forms of wrongdoing appear to be quite common. While determining the frequencies of FFP is controversial, it is probably the most studied domain of wrongdoing. A recently published meta-analysis of survey data on this topic estimates that almost 2% of scientists have admitted fabricating, falsifying, or modifying data at least once and, when asked about colleagues’ behavior, over 14% of scientists surveyed reported knowing of data falsification. Applying a conservative rate of 1.5% to the 155,000 researchers supported by the US National Institutes of Health, Titus, Wells, and Rhoades estimated 2,325 cases of FFP per year occur that deserve investigation. FFP is just one of 14 categories of wrongdoing in research. When asked about a much broader set of research ethics violations and questionable practices, 33% of researchers self-reported questionable behavior5 and 84% reported observing questionable behavior among colleagues.
Wrongdoing in research causes significant problems for multiple stakeholders. Research misconduct or FFP impedes research progress, undermines public trust in research, and wastes public dollars by introducing false information into the scientific literature, distorting meta-analyses, and straining the scientific publication system as it forces editors to take special effort to detect misconduct. The infamous Tuskegee syphilis study chillingly demonstrates how improper exposure to risk and consent violations can harm participants and negatively impact trust in clinical research.
Although few data on recidivism (or repeated wrongdoing after getting caught) are available in the domain of research, in other professions once violations of professionalism occur, the risk of recidivism is high. For example, while less than 1% of physicians with no sanctions from 1994 to 1998 received a sanction during 1999–2002, more than 20% of physicians receiving moderate/severe sanctions in the first period recidivated in the subsequent time period. Our ongoing study of high-profile cases of wrongdoing in research indicates that many investigators have offended in more than one environment; oftentimes, earlier offenses are only made public once an investigator is caught at another institutions and these offenses are publicly reported.The confidentiality (or secrecy) of institutional responses to wrongdoing often appears to enable further wrongdoing.
Why would an institution choose to refer an investigator for intensive professional remediation education rather than terminate employment? First, termination has downsides, including: The loss of an investigator in whom the institution, and often funding agencies, have heavily invested; the loss of research funding and oftentimes research staff working in the lab of the terminated investigator; and potential for legal actions. Second, remediation may present a reasonable way of achieving a variety of goals: preventing recidivism; restoring trust; and managing risk by having a reasonable response plan in place.
For physicians who experience lapses in professionalism in medical care, excellent remediation education programs exist. In these programs, participants meet in small groups for several days and engage in exercises that address some of the root causes of unprofessional behavior. Outcomes appear promising: Physicians demonstrate marked improvement in skills and peer evaluations on multiple behavioral measures. Until recently, no such program existed for researchers.
Moreover, a small but growing body of evidence gathered across the past two decades indicates that most current instruction programs in the responsible conduct of research (RCR) are not effective in improving ethical decision making or behavior; in fact, for reasons that are currently poorly understood, RCR training may be associated with worse professional behavior.
We recently received funding from the National Institutes of Health to develop a research ethics remediation program, “Restoring Professionalism and Integrity in Research” (RePAIR). Information on the RePAIR program can be found at http://www.repairprogram.org. The RePAIR program is not an ethics course, but rather an intensive professional development program that is based on best available evidence regarding the nature of wrongdoing in research and the factors that predict poor ethical decision making. While a full description of the curriculum and the evidence-base supporting the curriculum is beyond the scope of this needs assessment paper, data indicate that problems in the conduct of research arise in part due to self-serving biases, faulty mental models for research, stress, and the failure to forecast long-term consequences of actions, including especially consequences to others. The development team includes industrial-organizational, clinical, experimental, and developmental psychologists, as well as lawyers, researchers, research administrators, and research ethics educators. The program consists of assessment, online training when knowledge deficits are identified, and a 3-day onsite education program aimed at reducing levels of self-serving bias in research, fostering ethical decision-making skills, teaching stress management and work management skills, and developing individualized professional development plans that will be tracked across the following year.
As a first step in the development of the RePAIR program, we conducted a survey of all comprehensive doctoral institutions and allopathic medical schools in the US to assess their needs for a research ethics remediation program. This paper presents details on that survey and explores the implications of our findings.