The Division of Investigative Oversight within the U.S. Office of Research Integrity (ORI) is responsible for conducting oversight review of institutional inquiries and investigations of possible research misconduct. It is also responsible for determining whether Public Health Service findings of research misconduct are warranted. Although ORI findings rely primarily on the scope and quality of the institution’s analyses and determinations, ORI often has been able to strengthen the original findings by employing a variety of analytical methods, (...) often computer based. Although ORI does not conduct inquiries or investigations, it has broad authority to provide assistance to institutions at all stages of their reviews of allegations. This assistance can range from providing advice on best practices, to legal assistance, to suggestions for how best to investigate specific allegations. When asked, ORI can also conduct certain forensic analyses, such as a statistical examination of questioned digits or a simple examination of a questioned figure in Photoshop. ORI will not provide opinions or render judgment on such analyses while the institution is still conducting its investigation. Such analyses can be done without knowing much else about the case. (shrink)

BackgroundImplementing responsible conduct of research and monitoring bad practices requires time and tact. In France, it was in 2015 that the wishes of those in charge of research proposed the appointment of research integrity officers (RIOs) in all universities, national higher education schools, and research institutions. Our objectives were to search for information to describe the RI development and to analyze the RIOs’ profiles.MethodsThe OFIS (Office Français de l’Intégrité Scientifique) website lists all public research (...) institutions and universities (RIUs) and their designated RIOs. During the period between 6 and 14 October 2018, and on 2 May 2019 (updating), we entered two keywords (“plagiat” and “intégrité”) into the search engines on the RIU homepages and retrieved the relevant information (including “research” and “scientific” integrity when “intégrité” was entered). We consulted the governance and downloaded the organigram to determine whether the RIO positions and names were mentioned. We searched for the domains of expertise, sex, and age of the RIOs from their CVs (institutional websites), LinkedIn profiles, and various Google links.ResultsThe OFIS website lists 142 RIUs. Searching for the keyword “plagiarism” retrieved 25 RIUs; however, the web information was minimal, and consisted entirely of charters, interviews, and rare training modules. The keyword “integrity” turned up 23 RIUs. Nonetheless, there was little information available beyond notices for seminars, events, and a few training modules. Of the total 142 RIUs, 66.2% (n = 94) had named 96 RIOs. Furthermore, 29.2% RIOs (n = 28) were female and 70.8% (n = 68) were male; 38 RIOs were retired (> 65 years old) 58 were active (< 65 years old), and had a RIO function added to their usual laboratory activities.ConclusionThere is a lack of information about RI on the websites of French universities and research organizations, which may reflect a lack of information and commitment in the institutions themselves. (shrink)

Following its determination of a finding of scientific misconduct the Office of Research Integrity (ORI) will seek redress for any injury sustained. Several remedies both administrative and statutory may be available depending on the strength of the evidentiary findings of the misconduct investigation. Pursuant to federal regulations administrative remedies are primarily remedial in nature and designed to protect the integrity of the affected research program, whereas statutory remedies including civil fines and criminal penalties are designed to deter (...) and punish wrongdoers. This commentary discusses the available administrative and statutory remedies in the context of a specific case, that of former University of Vermont nutrition researcher Eric Poehlman, and supplies a possible rationale for the legal result. (shrink)

Pascal’s paper indicates how far we have come. Now as then, however, there is a need to reflect from outside the cocoon of our agencies, institutions, and disciplines to behold the enterprise that shapes both our behavior and our interpretations of it. For the boundary separating propriety from impropriety continues to move. Just as science, and the knowledge it begets, continues to evolve, so must our collective standards. The lessons of time include this: ORI or biomedical research is no (...) island; each is connected to a body of practitioners who are accountable to a society that is ever-more skeptical of expert knowledge and the institutions entrusted with its development. We are participants in a process of continuous improvement , not occupants of a state of grace. For the good of the enterprise we cherish, it is best that we all remember that. (shrink)

ConclusionsPascal’s paper indicates how far we have come. Now as then, however, there is a need to reflect from outside the cocoon of our agencies, institutions, and disciplines to behold the enterprise that shapes both our behavior and our interpretations of it. For the boundary separating propriety from impropriety continues to move. Just as science, and the knowledge it begets, continues to evolve, so must our collective standards. The lessons of time include this: ORI or biomedical research is no (...) island; each is connected to a body of practitioners who are accountable to a society that is ever-more skeptical of expert knowledge and the institutions entrusted with its development.We are participants in a process of “continuous improvement”, not occupants of a state of grace. For the good of the enterprise we cherish, it is best that we all remember that. (shrink)

Personal data protection is an ethical issue. In this study we analyzed how research ethics committees (RECs) and data protection officers (DPOs) handle personal data protection issues in research protocols. We conducted a mixed-methods study. We included heads (or delegated representatives) of RECs and DPOs from universities and public research institutes in Croatia. The participants provided information about data protection issues in research and their mutual collaboration on those issues through structured interviews that contained closed and (...) open-ended questions. Qualitative description was used to analyze open-ended questions. The results showed that 55% of the REC representatives were not aware who was DPO in their institution. Among RECs, 65% never contacted the DPO. There were 61% of RECs who reported that they received no training from the organization on personal data protection. When asked about barriers to personal data protection in their institutions, 26% of REC members highlighted the lack of a clear protocol for assessing personal data protection issues, while 30% of DPOs mentioned lack of knowledge among researchers about personal data. In conclusion, we found that when it came to protecting personal data in research protocols, RECs and DPOs hardly ever worked together. When developing future personal data protection policies for academic and scientific research institutions, it is essential that RECs and DPOs should collaborate and both continue to expand/update their knowledge on personal data protection procedures. (shrink)

This paper looks at the issues and controversies that led to creation of the Office of Research Integrity (ORI) and that dominated its agenda in the early years. The successes and failures of ORI are described and new problems identified. This paper then looks ahead to the future, considering what issues will dominate ORI’s agenda and affect the research institutions, individual scientists, and the scientific community in the next several years.

Institutions receiving federal funding for research from the U.S.Public Health Service need to have policies and procedures to both prevent research misconduct and to adjudicate it when it occurs. The person who is designated to handle research misconduct is typically referred to as the research integrity officer (RIO). In this interview study we report on 79 RIOs who describe how they would handle allegations of research misconduct. Their responses were compared to two expert RIOs. The (...) responses to the allegations in the scenarios demonstrated that RIOs are not uniformly well prepared to handle activities associated with reported allegations of research misconduct. We recommend greater preparation through directed training, use of check lists of possible behaviors necessary to consider when situations arise, being involved in a network of RIOs so one can discuss options, and the possible need to certify RIOs. (shrink)

BackgroundResearch on research integrity has tended to focus on frequency of research misconduct and factors that might induce someone to commit research misconduct. A definitive answer to the first question has been elusive, but it remains clear that any research misconduct is too much. Answers to the second question are so diverse, it might be productive to ask a different question: What about how research is done allows research misconduct to occur?MethodsWith that question in (...) mind, research integrity officers of the 62 members of the American Association of Universities were invited to complete a brief survey about their most recent instance of a finding of research misconduct. Respondents were asked whether one or more good practices of research were present in their case of research misconduct.ResultsTwenty-four of the respondents indicated they had dealt with at least one finding of research misconduct and answered the survey questions. Over half of these RIOs reported that their case of research misconduct had occurred in an environment in which at least nine of the ten listed good practices of research were deficient.ConclusionsThese results are not evidence for a causal effect of poor practices, but it is arguable that committing research misconduct would be more difficult if not impossible in research environments adhering to good practices of research. (shrink)

Doctoral programs at U.S. universities play a critical role in the development of human resources both in the United States and abroad. This volume reports the results of an extensive study of U.S. research-doctorate programs in five broad fields: physical sciences and mathematics, engineering, social and behavioral sciences, biological sciences, and the humanities. Research-Doctorate Programs in the United States documents changes that have taken place in the size, structure, and quality of doctoral education since the widely used 1982 (...) editions. This update provides selected information on nearly 4,000 doctoral programs in 41 subdisciplines at 274 doctorate-granting institutions. This volume also reports the results of the National Survey of Graduate Faculty, which polled a sample of faculty for their views on the scholarly quality of program faculty and the effectiveness of doctoral programs in preparing research scholars/scientists. This much-anticipated update of such an essential reference will be useful to education administrators, university faculty, and students seeking authoritative information on doctoral programs. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Office of Scientific IntegrityDavid P. Hamilton (bio)For most of the 1980s, the specter of scientific fraud popped into public view every few years, usually only to submerge again. Faced with several well-publicized cases of scientists who blatantly faked their data—among the best-known being Harvard cardiologist John Darsee (whose colleagues watched him forge data) (Broad and Wade 1982, p. 14) and Sloan-Kettering Institute immunologist William Summerlin (who painted (...) black spots on white mice to simulate tissue grafts) (Broad and Wade 1982, p. 155)—the scientific community as a whole tended to dismiss the phenomenon as the work of a few deviants. Called in 1981 to testify before then-Representative Albert Gore Jr.'s subcommittee on investigations and oversight, Philip Handler, then-president of the National Academy of Sciences, told the panel that science was perfectly capable of regulating itself, and that the problem of scientific fraud had been "grossly exaggerated" by the press (Broad and Wade 1982). The message was clear: Congress should stick to its knitting, and science would take care of itself.Now, however, scientists are faced with a very different situation: a permanent federal bureaucracy, known as the Office of Scientific Integrity (OSI), devoted to the investigation of alleged scientific wrongdoing. The transition from the days of laissez-faire, when universities were entrusted with all investigations unless they were handled so badly that the federal government was forced to take notice, has been an uncomfortable one for many researchers. Lately, this discomfort has taken shape as a vocal protest against OSI. Largely as a result of this protest, federal officials recently promoted a plan to restructure OSI and change some of its operating procedures, a move with unpredictable consequences for universities and researchers alike.OSI was born largely because of investigations by two influential congressmen: Representatives John Dingell of Michigan and Ted Weiss of New York. While both claimed they acted mainly to make sure taxpayer dollars were not spent on fraudulent research, both also maintained a strong interest in protecting "whistleblowers," the often vulnerable, and usually junior, scientists who first raise questions about bad research. And Dingell seemed to take special pleasure in pointing up the deficiencies of investigations run by universities and by the National Institutes of Health (NIH) itself. (For reasons that are not well understood, [End Page 171] biomedical research seems far more prone to fraud than any other field of science. As a result, NIH, which funds most biomedical research in the United States, has held ultimate responsibility for most prominent cases of fraud.) Plagued as they often were by conflicts of interest, shoddy methodologies, and, in some cases, a willingness to believe any excuse by the accused, no matter how far-fetched, these investigations made easy targets. And the notion that science could "govern itself" grew harder to sustain.In late 1988, Dingell and other congressmen began circulating draft bills that would have created a new office for investigating scientific fraud. Dingell would have placed such an office under the aegis of the Inspector General of the Department of Health and Human Services, raising the possibility that scientific fraud might be probed by the same criminal investigators who unravel Medicare fraud. Unsettled by this vision of the "science police," NIH officials moved quickly to pre-empt Congress. On March 16, 1989, they published a notice in the Federal Register announcing the creation of OSI, an office with responsibility for ensuring thorough university investigations of misconduct and the authority to conduct its own investigations when necessary.From the beginning, OSI took an unusual approach to its work. For one thing, the office had a broad mandate: Although located within NIH, it was responsible for research funded throughout the entire Public Health Service, including the Food and Drug Administration, the Alcohol, Drug, and Mental Health Administration, and the Centers for Disease Control. Furthermore, it was not restricted to scientific fraud. Departmental lawyers, wishing to avoid the legal connotations of the term "fraud"—in particular, a requirement that fraudulent actions not only mislead others but also cause them noticeable harm—decided instead to adopt the term "scientific misconduct," defined as "fabrication, falsification, plagiarism, or other practices that deviate... (shrink)

I present a review of the top management teams (TMTs) of the largest public corporations in the U.S. and Scandinavia (one thousand in total) to identify corporations that have a TMT position with “corporate social responsibility” (CSR) or a “CSR synonym” like sustainability or citizenship explicitly included in the position title. Through this I present three key findings. First, I establish that a number of CSR TMT positions exist and I list all identified corporations and associated position titles. Second, I (...) show that Scandinavian corporations are significantly more likely than U.S. corporations to have such CSR TMT positions. This finding serves as evidence that the U.S. may have been surpassed by a subset of Europe, i.e., Scandinavia, in at least one relevant measure of explicit CSR, whereby this study may serve witness to a noteworthy juncture post Matten and Moon’s (Academy of Management Review, 33(2):404–424, 2008) “Implicit & Explicit CSR” article. And third, I show that corporations with a CSR TMT position are three times more likely to be included in the Dow Jones Sustainability Index (DJSI) than corporations with none. A range of further research opportunities stemming from these findings include exploring whether explicit attention to CSR by the corporation is indicative of a longer term trend that has to do with attention to responsible business and whether a move away from the expression ‘CSR’ toward the expression ‘sustainability’ is underway and what this may entail. (shrink)

OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had a mean number (...) of 12 members, requested a mean of six complete dossiers and nine additional copies of the protocol with a mean deadline of 14 days before the meeting. All applications were approved except three (two of the three were open-label long-term safety trials rejected by the same committee), which were approved by the other committees involved. The mean time from submission to approval was 64 days. The mean time from submission to arrival of the approval document at our offices was 85 days. Twenty-five committees raised queries for 38 of the 97 finally approved applications. Impact of evaluation fee, number of members, queries raised and experience of committees on timings were not statistically significant. CONCLUSION: Obtaining ethical approval is time-consuming. There is much diversity in the research ethics committees' performance. A remarkable delay (> 20 days) exists between the decision and the arrival of the written approval, suggesting administrative or organisational problems. (shrink)

The Office of Research Integrity found in 2011 that Vipul Bhrigu, a postdoctoral researcher who sabotaged a colleague’s research materials, was guilty of misconduct. However, I argue that this judgment is ill-considered and sets a problematic precedent for future cases. I first discuss the current federal definition of research misconduct and representative cases of research misconduct. Then, because this case recalls a debate from the 1990s over what the definition of “research misconduct” ought to (...) be, I briefly recapitulate that history and reconsider the Bhrigu case in light of that history and in comparison to other cases involving tampering. Finally, I consider what the aim of a definition of research misconduct ought to be, and argue that the precedent set by the reasoning in this case is problematic. (shrink)

BACKGROUND: The offer of return of research results to study participants has many potential benefits. The current study examined the offer of return of research results by analyzing consent forms from 2 acute lymphoblastic leukemia studies of the 235 institutional members of the Children's Oncology Group. METHODS: Institutional review board (IRB)-approved consent forms from 2 standard-risk acute lymphoblastic leukemia studies (Children's Cancer Group [CCG] 1991 and Pediatric Oncology Group [POG] 9407) were analyzed independently by 2 reviewers. RESULTS: The (...) authors received replies from 202 of the 235 institutions that were contacted (85%). One hundred eighty-one institutions had CCG 1991 (n = 96) or POG 9905 (n = 85) protocols that were approved by an IRB. Most institutions provided contact information for the principal investigator (n = 175; 97%) and a member of the institution's research services office (n = 154; 85%). Only 5 (2.8%) institutions provided an indication of a participant's right to receive a summary of research results; most of these institutions provided details on how (n = 5) or when (n = 5) this was to occur. All of these institutions (n = 162; 89.5%) provided a specific statement offering new information that might affect a participant's decision to continue to participate in a study. Only 2 institutional consent forms offered participants the option to receive research results, and only 10 (5.5%) consent forms contained an unambiguous, specific statement offering to provide new information after the study was closed. CONCLUSIONS: Few institutional review board-approved consent forms explicitly indicate the right of research recipients to receive a summary of the results of the research in which they have participated. (shrink)

This article contributes to the project of historicizing the emergence of printed books as a mass cultural form in the 20th century and after, in addition to exploring the political-economic struggles both occasioning and occasioned by their constitution as such. In doing so, it both models and reflects on what a possible historiography of technology "after social constructionism" might look like. More specifically, it attempts to account for the behind-the-scenes or "back office" processes through which commodification takes place in (...) the sphere of book distribution, and it does so by focusing principally on communication and information technologies such as the international standard book number (ISBN) and machine readable bar codes. This history, overall, complements the more hopeful narratives of mass culture's democratizing potential, by telling a story about how increased opportunities for middle class social advancement depend on intensified - and intensely technological - work processes for those employed in the sphere of commodity distribution. This essay demonstrates, moreover, how dominant metaphors and frameworks that have guided Social Construction of Technology (SCOT) research (e.g., "actor-networks," "seamless webs," and so forth) must be amended to account better for power, contradiction, and antagonism within the history of technology. (shrink)

We are reporting on how involved the mentor was in promoting responsible research in cases of research misconduct. We reviewed the USPHS misconduct files of the Office of Research Integrity. These files are created by Institutions who prosecute a case of possible research misconduct; ORI has oversight review of these investigations. We explored the role of the mentor in the cases of trainee research misconduct on three specific behaviors that we believe mentors should perform (...) with their trainee: (1) review source data, (2) teach specific research standards and (3) minimize stressful work situations. We found that almost three quarters of the mentors had not reviewed the source data and two thirds had not set standards. These two behaviors are positively correlated. We did not see convincing evidence in the records that mentors were causing stress, but it was apparent in the convicted trainees’ confessions that over 50% experienced some kind of stress. Secondary data, while not created for this research purpose, allows us to look at concrete research behaviors that are otherwise not very researchable. We believe it is important for mentors and institutions to devote more attention to teaching mentors about the process of education and their responsibilities in educating the next generation of scientists. This becomes a critical issue for large research groups who need to determine who is in charge educating, supervising and assuring data integrity. (shrink)

Education in the responsible conduct of research (RCR) in the United States has evolved over the past decade from targeting trainees to including educational efforts aimed at faculty and staff. In addition RCR education has become more focused as federal agencies have moved to recommend specific content and to mandate education in certain areas. RCR education has therefore become a research-compliance issue necessitating the development of policies and the commitment of resources to develop or expand systems for educating (...) faculty and staff and for assuring compliance. These changes implied the need to develop a program evaluation model that could be applied to institutional RCR education programs, which were expected to differ from traditional academic credit-bearing courses targeting trainees. Information gleaned from the examination of corporate compliance models was analyzed in order to create a program evaluation module that could be used to document and assess educational programs focused on teaching RCR. A programmed series of questions for each of the nine RCR content areas identified by the United States Office of Research Integrity was created based on a performance-monitoring evaluation model. The questions focus on educational goals, resources provided to support the educational efforts, educational content, content delivery, educational outcomes, compliance requirements and feedback. Answers collected in response to the questions could be used to both document and continually improve the quality of RCR educational programs through on-going formative assessment and feedback. (shrink)

As the research integrity officer at my university for two years, I handled eight allegations of plagiarism. These eight cases show that initial appearances can be mistaken, that policies for handling allegations of research misconduct cannot cover every contingency, and that many cases can be resolved collegially without resort to formal procedures.

: Dr. Smith is an internist in private practice who works at an inner city clinic affiliated with a university hospital. He is also a member of the university faculty. Many of Dr. Smith’s patients have type 2 diabetes mellitus and struggle with health care and other costs. Thinking about opportunities to better serve his patients and advance his career, Dr. Smith considers conducting clinical research in his office. ACME is a respected pharmaceutical company that for decades has (...) engaged in research, development, and production of widely used drugs. Several of ACME’s oral agents for type 2 diabetes will soon go off patent. In an effort to retain its market share in this class of drugs, ACME wants to complete clinical trials expeditiously and obtain approval for its new oral hypoglycemic medicine. The company approaches Dr. Smith to be a coinvestigator in its multicenter clinical trial. (shrink)

Organizations continue to show renewed focus on managing their ethics programs by developing organizational infrastructures to support their ethics implementation efforts. An important part of this process has been the creation of an ethics officer position. Whether individuals appointed to the position are successful in the role or not may depend on a number of factors. This study presents a suggested framework for their effectiveness. The framework includes a focus on personal, organizational and situational factors to predict performance in the (...) role. The study examines the complex nature of the role. These include task complexity, low task visibility, role conflict, and role ambiguity. Personal, organizational and situational factors that can serve as buffers against the complexities associated with the role are presented. The study suggests that individuals with certain competencies and orientations may be better suitable for the ethics position, and firms need to consider key organizational and situational issues critical to the performance of an ethics officer. The research and practice implications of the study are given. (shrink)