Showing papers in "Accountability in Research in 2015"

Problems with traditional science publishing and finding a wider niche for post-publication peer review

Abstract: Science affects multiple basic sectors of society. Therefore, the findings made in science impact what takes place at a commercial level. More specifically, errors in the literature, incorrect findings, fraudulent data, poorly written scientific reports, or studies that cannot be reproduced not only serve as a burden on tax-payers' money, but they also serve to diminish public trust in science and its findings. Therefore, there is every need to fortify the validity of data that exists in the science literature, not only to build trust among peers, and to sustain that trust, but to reestablish trust in the public and private academic sectors that are witnessing a veritable battle-ground in the world of science publishing, in some ways spurred by the rapid evolution of the open access (OA) movement. Even though many science journals, traditional and OA, claim to be peer reviewed, the truth is that different levels of peer review occur, and in some cases no, insufficient, or pseudo-peer review takes place. This ultimately leads to the erosion of quality and importance of science, allowing essentially anything to become published, provided that an outlet can be found. In some cases, predatory OA journals serve this purpose, allowing papers to be published, often without any peer review or quality control. In the light of an explosion of such cases in predatory OA publishing, and in severe inefficiencies and possible bias in the peer review of even respectable science journals, as evidenced by the increasing attention given to retractions, there is an urgent need to reform the way in which authors, editors, and publishers conduct the first line of quality control, the peer review. One way to address the problem is through post-publication peer review (PPPR), an efficient complement to traditional peer-review that allows for the continuous improvement and strengthening of the quality of science publishing. PPPR may also serve as a way to renew trust in scientific findings by correcting the literature. This article explores what is broadly being said about PPPR in the literature, so as to establish awareness and a possible first-tier prototype for the sciences for which such a system is undeveloped or weak.

An international study of research misconduct policies.

Abstract: Research misconduct is an international concern. Misconduct policies can play a crucial role in preventing and policing research misconduct, and many institutions have developed their own policies. While institutional policies play a key role in preventing and policing misconduct, national policies are also important to ensure consistent promulgation and enforcement of ethical standards. The purpose of this study was to obtain more information about research misconduct policies across the globe. We found that twenty-two of the top forty research and development funding countries (55%) had a national misconduct policy. Four countries (18.2%) are in the process of developing a policy, and four (18.2%) have a national research ethics code but no misconduct policy. All twenty-two countries (100%) with national policies included fabrication, falsification, and plagiarism in the definition of misconduct, but beyond that there was considerable diversity. Unethical authorship was mentioned in 54.6% of the miscond...

Commentary: Perverse Incentives or Rotten Apples?

Abstract: Around 2% of the investigators admit to have falsified or fabricated data at least once. Also, 34% report to have been guilty to one or more questionable research practices, such as doing many statistical analyses and to publish only what fits their theoretical framework. Prevention of questionable research practices is very important. Universities should ensure that the training is in order and the research culture is adequate, and they should critically look at perverse incentives, such as a too high publication pressure, but also by ensuring proper guidelines, and by having a fair and transparent procedure for suspected violations of scientific integrity.

Research misconduct definitions adopted by U.S. research institutions.

Abstract: In 2000, the U.S. federal government adopted a uniform definition of research misconduct as fabrication, falsification, or plagiarism (FFP), which became effective in 2001. Institutions must apply this definition of misconduct to federally-funded research to receive funding. While institutions are free to adopt definitions of misconduct that go beyond the federal standard, it is not known how many do. We analyzed misconduct policies from 183 U.S. research institutions and coded them according to thirteen different types of behavior mentioned in the misconduct definition. We also obtained data on the institution's total research funding and public vs. private status, and the year it adopted the definition. We found that more than half (59%) of the institutions in our sample had misconduct policies that went beyond the federal standard. Other than FFP, the most common behaviors included in definitions were "other serious deviations" (45.4%), "significant or material violations of regulations" (23.0%), "misuse of confidential information" (15.8%), "misconduct related to misconduct" (14.8%), "unethical authorship other than plagiarism" (14.2%), "other deception involving data manipulation" (13.1%), and "misappropriation of property/theft" (10.4%). Significantly more definitions adopted in 2001 or later went beyond the federal standard than those adopted before 2001 (73.2% vs. 26.8%), and significantly more definitions adopted by institutions in the lower quartile of total research funding went beyond the federal standard than those adopted by institutions in the upper quartiles. Public vs. private status was not significantly associated with going beyond the federal standard.

Researcher perceptions of ethical guidelines and codes of conduct.

Abstract: Ethical codes of conduct exist in almost every profession. Field-specific codes of conduct have been around for decades, each articulating specific ethical and professional guidelines. However, there has been little empirical research on researchers’ perceptions of these codes of conduct. In the present study, we interviewed faculty members in six research disciplines and identified five themes bearing on the circumstances under which they use ethical guidelines and the underlying reasons for not adhering to such guidelines. We then identify problems with the manner in which codes of conduct in academia are constructed and offer solutions for overcoming these problems.

Rethinking Authorship in the Era of Collaborative Research

Abstract: The size and complexity of research teams continues to grow, especially within the realms of science and engineering. This has intensified already existing concerns about relying on traditional authorship schemes as the way to allocate credit for a contribution to a research project. In this paper, we examine current authorship problems plaguing research communities and provide suggestions for how those problems could potentially be mitigated. We recommend that research communities, especially those involved in large scale collaborations, revisit the contributor model and embrace it as means for allocating credit more authentically and transparently.

Authorship Issues and Conflict in the U.S. Academic Chemical Community

Abstract: A survey on credit issues and related "responsible conduct of research" (RCR) behaviors was conducted with academic chemists in Ph.D. granting institutions in the U.S. Six hundred faculty members responded. Fifty percent of the respondents reported not receiving appropriate credit for contributions they had made to projects the results of which had been published, including when they themselves were students. Thirty percent of these individuals discussed this lack of credit with the "offending" individual, and as a consequence of those discussions, a small percentage of individuals were provided either co-authorship or an acknowledgment. The majority who did not enter into a discussion with the "offending" individual reported two primary reasons for not doing so: that they "could not imagine any good coming from such a conversation" and "I was afraid of being in a compromised situation." A discussion of relationship asymmetry in the academic setting is provided. Confronting one's colleague regarding credit is compared with whistleblowing, and the possible consequences of blacklisting are discussed. A number of recommendations for minimizing authorship disputes are provided.

Analysis of the Nature of IRB Contingencies Required for Informed Consent Document Approval

Abstract: The University of Michigan Human Research Protection Program formed a six-member committee to analyze the nature of Institutional Review Board (IRB) staff and board contingencies for the approval of informed consent documents. Of the 100 studies examined, 87% had one or more informed consent contingencies. "Omissions" in documentation (40%) and "better clarity" (24%) accounted for the majority, while "word-smithing" accounted for only 10%. This is one of the first studies to examine the nature of IRB contingencies as they relate to informed consent documents. Educational efforts targeting completeness in documentation and clarity on the part of study teams, and discouraging "word-smithing" on the part of IRBs, could reduce the number of informed consent contingencies and expedite the IRB approval process.

Social Media, Peer Review, and Responsible Conduct of Research (RCR) in Chemistry: Trends, Pitfalls, and Promises.

Abstract: Over the last two decades, various themes inherent in the responsible conduct of research (RCR) in chemistry have been brought to light through prominent cases of research misconduct. This article will describe a few of these cases especially through the lens of social media such as blogs and Twitter. A case will be made that these wholly novel modalities of online discussion are now complementing, and in some cases even circumventing some of the limitations of traditional peer review in chemistry. We present in detail our evaluation of three recent cases of RCR along with several other social media illustrations. These cases have been selected to be representative and showcase several of the most prominent issues at the intersection of traditional and social-media based peer review. In each case, basic details are presented along with a brief discussion of the underlying issues-readers interested in deeper analysis of each subject are referred to a collection of relevant articles and websites. This perspective focuses on the most important RCR issues that have arisen in the past decade, a time which we believe coincides with the serious participation of the scientific community in general, and the chemistry community in particular, in social media-based, citizen-enabled peer-review. A discussion of important trends in RCR in the age of social media, outstanding developments in this area, and questions of enduring interest for the near future concludes the article.

Assessing Subject Privacy and Data Confidentiality in an Emerging Region for Clinical Trials: United Arab Emirates

Abstract: Pharmaceutical sponsored clinical trials, formerly conducted predominantly in the United States and Europe, have expanded to emerging regions, including the Middle East. Our study explores factors influencing clinical trial privacy and confidentiality in the United Arab Emirates. Factors including concept familiarity, informed consent compliance, data access, and preservation, were analyzed to assess current practices in the Arab world. As the UAE is an emerging region for clinical trials, there is a growing need for regulations related to data confidentiality and subject privacy. Informational and decisional privacy should be viewed within the realms of Arab culture and religious background.

Letter to the editor: Plagiarism screening by the journal: is there still any pitfall?

Abstract: The recent editorial on plagiarism is very interesting (Resnik, 2012). It is important to note the high rate of plagiarism in submitted manuscripts that can be seen in some journals. It is a genera...

Building a more connected DSMB: better integrating ethics review and safety monitoring.

Abstract: Data and Safety Monitoring Boards (DSMBs) have become an increasingly common feature of clinical trial oversight, yet a paucity of legal or ethical frameworks govern these Boards’ composition or operation, or their relationship with other actors with monitoring responsibilities. This paper argues that prevailing structural gaps are impeding harmonized systems for monitoring the ongoing ethical acceptability of clinical trials. Particular tensions stem from DSMBs’ sweeping discretion in deciding whether and when to recommend that a trial should be terminated or amended based on safety and efficacy information. This discretion becomes especially challenging in light of DSMBs’ monopoly over emerging trial data, which prevents Institutional Review Boards, sponsors, and investigators from participating in certain pivotal and ethically charged decisions. To address these disconnects, I advocate for strengthened pre-trial and post-trial communication in addition to innovative strategies to support DSMB decision ...

Ethics in Science: The Unique Consequences of Chemistry.

Abstract: This article discusses the ethical issues unique to the science and practice of chemistry. These issues arise from chemistry’s position in the middle between the theoretical and the practical, a science concerned with molecules that are of the right size to directly affect human life. Many of the issues are raised by the central activity of chemistry––synthesis. Chemists make thousands of new substances each year. Many are beneficial, but others are threats. Since the development of the chemical industry in the nineteenth century, chemistry has contributed to the deterioration of the environment but has also helped to reduce pollution. Finally, we discuss the role of codes of ethics and whether the current codes of conduct for chemists are adequate for the challenges of today’s world.

Tension in Chemistry and Its Contents.

Abstract: This article makes a case for a positive role of tension in the creative process in chemistry. I begin with an argument that there is an inherent tension in what makes molecules interesting—their positioning along various polar axes. One of these, the age-old differentiation between useful (to society and for personal profit) commercialization and pure understanding of molecules and their reactions is characteristic. The question of whether there are any bad molecules then leads me to ethical concerns in chemistry, and a particular working out of these in interactions of chemists in the Middle East. An analysis is made of the special tensions involved in publishing, especially in citation ethics; chemists publish a lot, so this is situation ethics worked out on a daily basis. I then find in the literature of psychology good evidence for the positive value of moderate stress in stimulating creativity. It is obvious that too much tension leads to distress, and there are some institutional aspects of chemist...

Commentary: flawed science delays smelter cleanup and worsens health.

Abstract: For 6,000 years, humans have known about smelter hazards. Yet these metals threats continue. Why? This commentary provides one preliminary answer. It (1) summarizes the history of smelter pollution and (2) suggests that at least 3 problems—especially flawed smelter-polluter science—allow continuing health threats. It (3) illustrates this flawed science by using one of the most dangerous of U.S. former smelters, in DePue, Illinois. There polluters are avoiding violating the law yet trying to minimize smelter-caused health threats, thus clean-up costs, by using two questionable scientific claims. The causality-denial claim denies that smelter metals cause neurodegenerative diseases. The biomagnification-denial claim denies that food-chain biomagnification of smelter metals can put citizens at risk. The commentary shows both claims err, and (4) suggests ways to address flawed smelter science and resulting health harms.

Commentary: Flawed Scientific-Evidence Standards Delay Diesel Regulations

Abstract: Of 188 government-monitored air toxics, diesel particulate matter (DPM) causes seven times more cancer than all the other 187 air toxics combined, including benzene, lead, and mercury. Yet, DPM is the only air toxic not regulated more stringently under the Clean Air Act, as a hazardous air pollutant (HAP). One reason is that regulators use flawed standards of scientific evidence. The article argues (1) that DPM meets all six specified evidentiary criteria, any one of which is sufficient for HAP regulation and (2) that regulators’ standards of evidence for denying HAP status to DPM (no DPM unit-risk estimate, inadequate dose-response data, alleged weak mechanistic data) err logically and scientifically, set the evidence bar too high, delay regulation, and allow 21,000 avoidable DPM deaths annually in the U.S.

Ethics and the Responsible Conduct of Research in the Chemical Community: The Unique Role and Challenges of the News Media.

Abstract: Journalists who cover scientific research, including chemistry research, have an obligation to report on alleged cases of research misconduct when knowledge of these surface. New Government definitions of research misconduct, beginning in the late 1990s with the Clinton Administration, have helped scientists, policymakers, as well as journalists sort out and make sense of alleged research misconduct. Journalistic reporting on research misconduct includes many challenges: gathering information from sources who are intimidated or afraid to speak, strict adherence to journalist ethics that take on a new dimension when careers, reputations, and research funding are at stake; efforts by government and institutional bureaucrats to dampen or thwart legitimate news coverage. The Internet, blogging, and social media have added still more complexity and ethical quandaries to this blend. The author, News Editor of Chemical & Engineering News published by the American Chemical Society, provides examples from his own ...

Overview of Research Committees Status in Egypt: Challenges Aspirations and Current Situation

Abstract: We analyze the current situation of clinical research regulatory overview in Egypt to acknowledge the strengths and define the frailties, thus inciting relevant stakeholders to find solutions and bring about change. Uniquely, Egypt possesses favorable factors ideal for a dynamic clinical research market: accessible subjects, a mosaic panel of research areas, and incomparably low cost. Yet, with a majority of participant population needy and illiterate, and in absence of robust legislative constraints, concerns are increasingly being raised, whether ethical pitfalls of clinical research are adequately addressed, and whether the safety and the rights of subjects are constantly prioritized and maintained. In a descriptive explicit literature review, we identify, review, and interpret findings from recent publications backed up by existing data derived from current declared regulations and personal experience in the field. Inferences were made that despite an affiliation to international referential guideline...

Ethics and Responsible Conduct of Research within the Chemical Community. Ideas and Experiences Worth Sharing

Abstract: This open-access issue of Accountability in Research is intended to serve as a special resource. There is little need to justify providing resources that can be useful in the instruction of scholarship in Responsible Conduct of Research (RCR) for readers of Accountability in Research. At present, there are no specific, detailed, line-by-line RCR requirements for institutions that apply for research grants from the U.S. National Science Foundation or the National Institutes of Health. Both NSF and NIH have implemented Section 7009 of the American Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science Act (42 U.S.C. 1862o-1) (Federal Register, 2009; National Institutes of Health (NIH), 2011). For example, “the Act requires that ‘each institution that applies for financial assistance from the Foundation for science and engineering research or education describe in its grant proposal a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research project’” (Federal Register, 2009). For the past several years, I have given lectures on RCR at a number of academic institutions around the world, including RCR workshops in my own university. Sometimes, my lectures are part of the institution’s mandated RCR training program. Other times, I speak about my own research in RCR (House and Seeman, 2010; Seeman and House, 2010a,b) and history and sociology of chemistry as they relate to RCR (for example, see Seeman, 2007). While there are many valuable resources available for use in RCR educational programs, including a number of excellent texts (Beach, 1996; Committee on Assessing Integrity in Research Environments, 2002; Panel on Scientific Responsibility and the Conduct of Research, 1992; Panel on Scientific Responsibility and the Conduct of Research, 1993; Lock and Wells, 1996; Macrina, 2014; Resnik, 1998; Seebauer and Barry, 2001; Shamoo and Resnik, 2015; Steneck, 2007), there is only one that specifically focused on the chemical community—the book The Ethical Chemist: Professionalism and Ethics in Science (Kovac, 2004). More than coincidentally, this book was written by one of the authors of an article in this project. My idea was to publish a single, permanently open-access issue of Accountability in Research with articles written by chemists and articles devoted to ethics and RCR in chemistry. However, the articles were also intended to provide meaning and useful information throughout the research communities. In addition to speaking to the most controversial areas of RCR (i.e., fabrication, falsification and plagiarism), the articles were to make clear that “RCR is simply good citizenship applied to professional life” (Steneck, 2007). True, this special issue of Accountability in Research was designed to serve as a resource in chemistry departments to meet the federally-mandated education in RCR referred to above. Nonethelesss, the articles were to be of interest and value to the broadest range of readers, from the general public to government policy makers to those professionals who work in the fields of RCR and ethics. I proposed this idea to Professor Adil E. Shamoo, Editor in Chief, who immediately and enthusiastically said “yes.” The Innovative Project Grant Program of the American Chemical Society approved my grant proposal to fund the issue’s open access feature. And a number of chemists agreed to and have provided their articles. The articles in this special issue are: “Ethics in Science: The Unique Consequences of Chemistry” by Jeffrey D. Kovac (Department of Chemistry, University of Tennessee) “Tension in Chemistry and Its Contents” by Roald Hoffmann (Department of Chemistry and Chemical Biology, Cornell University) “Authorship Issues and Conflict in the U.S. Academic Chemical Community,” by Jeffrey I. Seeman (Department of Chemistry, University of Richmond) and Mark C. House (Giant Steps Research, Gainesville, FL) “Social Media, Peer Review, and Responsible Conduct of Research (RCR) in Chemistry: Trends, Pitfalls, and Promises,” by Ashutosh S. Jogalekar (Cambridge, MA) “Ethics and the Responsible Conduct of Research in the Chemical Community: The Unique Role and Challenges of the News Media” by William G. Schulz (Chemical & Engineering News, American Chemical Society) The titles and authors of these five articles illustrate another goal of the project: to obtain a wide diversity of subjects, written by authors who are themselves researchers and experts in the subjects covered. I thank the authors for participating in this project and the Division of Professional Relations of the American Chemical Society (Dr. Joseph Stoner, Chair) for supporting the proposal and encouraging this project. Time will tell whether we––all the authors and many others who participated in the project, as well as the American Chemical Society—have provided a resource that is used by students of RCR and ethics within and outside the chemical community. We hope so.

Open Access, Open Business, Closed Fairness!

Abstract: A strong trend to move from print to online publication is largely perceived in scientific and nonscientific fields. A growing number of publishers increasingly opt for online publication as an option or a compulsory alternative. From readers’ perspective, this is a highly appreciated facility, but from the author’s, things are different mainly because of excessive article processing charges (APC) that make the open access system sometimes as a hindrance for many authors but a lucrative enterprise for many shareholders, enticing the most traditional and conservative publishers.

Factors influencing parental consent in a hypothetical pediatric vaccine trial in a developing country setting: a questionnaire study.

Abstract: Clinical vaccine trials have been lacking in the pediatric population due to lower consent rate of the parents. We assessed characteristics of the parents, and motives and barriers underlying the decision process. The results of the questionnaire were evaluated by multivariate analysis. Parents who opted in were younger and more often employed than the parents who opted out. The most important motives were receiving detailed information about trial and benefits to human health. The qualified education of medical community and public about the rationale and benefits of trials is essential for opt-in.

Playing, Sitting Out, and Observing the Game: An Investigation of Faculty Members’ Perspectives on Political Behavior in Ethical Decision Making

Abstract: Ethical dilemmas are inherently ambiguous, complex, and ill-defined. Additionally, these dilemmas involve multiple stakeholders. These characteristics may induce political behavior as a resolution tactic. Thus, the goal of the present effort was to investigate perspectives on politics among researchers in an ethical decision-making context. A qualitative analysis of interviews with university faculty members revealed that faculty members’ perspectives on political behavior in an ethical decision-making context fall into a number of categories, including positive, negative, and realistic views of political activity. The implications of these varying perspectives on ethical decision making are discussed.

Research ethics committee: dominance and accountability.

Abstract: Sir, the recent report entitled “Medical Dominance within Research Ethics Committees” is very interesting (Humphreys et al., 2014). Humphreys et al. noted for influence of the medical profession in shaping ethics review (Humphreys et al., 2014). The theory of Freidson can be well used for explaining the observation (Coburn, 1992). In fact, dominance is not a problem. However, the problem can be expected in case of overacting (Guillemin et al., 2012). “Poor relations and mistrust between ethics committees and researchers” are important issues to be addressed (Guillemin et al., 2012, p. 38). Bias and double standardization that might relate to the dominance can be the big problem. In the present day, the important consideration is the lack of a good system to check the accountability of the Research Ethics Committees. International regulation of ethical committee is required and should be the topic for further discussion (de Lecuona, 2013).

Paving the road to negligence: the compensation for research-related injuries in Spain.

Abstract: The planned reform of the regulation of clinical trials in Spain has reopened the debate over how to regulate research-related injuries. Act 29/2006 and Royal Decree 223/2004 regulate the insurance of research-related injuries, and they include a general clause requiring mandatory insurance and imposing a no-fault compensation system; they also contain an exception clause enabling clinical trials to be carried out without insurance under some conditions, and an exclusion clause excluding compensation when there is no causal connection between injuries and a clinical trial. National legislation is under review, affecting the requirement of mandatory insurance and paving the road to a liability system based on negligence, which will affect the level of protection of the persons enrolled in clinical trials because it would not ensure compensation. Regulatory texts on individuals' participation as research subjects should include not only mandatory insurance, but also a no-fault compensation system for cases when voluntary research subjects are injured, irrespective of negligence.

Historical Model for Editor and Office of Research Integrity Cooperation in Handling Allegations, Investigation, and Retraction in a Contentious (Abbs) Case of Research Misconduct

Abstract: Cooperation between a journal editor and the federal Office of Research Integrity (ORI) in addressing investigations of research misconduct, each performing their own responsibilities while keeping each other informed of events and evidence, can be critical to the professional and regulatory resolution of a case. This paper describes the history of one of ORI’s most contentious investigations that involved falsification of research on Parkinson’s disease patients by James Abbs, Professor of Neurology, University of Wisconsin, published in the journal Neurology, which was handled cooperatively by the authors, who were the chief ORI investigator and the Editor-in-Chief of Neurology, respectively.

Letter to the Editor: Self-Plagiarism, Textual Recycling, and Conceptual Plagiarism

Abstract: Sir, the recent report (Bruton, 2014) on “self-plagiarism and textual recycling” is very interesting. Bruton (2014) discussed “textual recycling” and mentioned the ethical problem on this practice....

Defining the research category in pediatric Phase I oncology trials.

Abstract: Clinical research studies in children are classified by risk into three major categories. These are as follows: a) minimal risk studies, b) more than minimal risk studies but with benefit, and c) studies with minor increase over minimal risk but with no benefit.Pediatric Phase I oncology trials, which are conducted in a highly vulnerable population of severely ill children with cancer, are designed to establish safety and to determine the maximum tolerated dose (MTD), as well as establish dose limiting toxicity (DLT). These types of studies can be associated with significant risk. The research design of such high- risk studies, which comprise short-term treatments with varying doses, is generally not associated with any clinical benefit. Classification of the research category in these pediatric studies poses a special problem for the Institutional Review Board (IRB) with major implications for the consenting process. The challenges associated with the classification of such studies are discussed in this ...

Book Review: A Review of Research Misconduct Policy in Biomedicine: Beyond the Bad-Apple Approach

Abstract: This commentary provides a review and critique of the book Research Misconduct Policy in Biomedicine: Beyond the Bad-Apple Approach by Professor Barbara Redman.

The Middle East-North Africa region: a cocoon for clinical trials.

Abstract: Increasingly, pharmaceutical companies have been turning to global markets to conduct clinical trials. Likely reasons for this are i) regulators in the US can scrutinize easier drug trials carried ...

Letter to the Editor: Retraction and Coauthorship in Problematic Publication

Abstract: Foo and Tan (2014, p. 198) reported a very interesting report on fraudulent publications. They mentioned the “use of coauthorship as a strategy for publishing fraudulent work.” Based on this report...