© Springer International Publishing Switzerland 2015
Barbara G. Jericho (ed.)Ethical Issues in Anesthesiology and Surgery10.1007/978-3-319-15949-2_1616. Ethics in Research and Publication
(1)
Department of Anesthesiology, Good Samaritan Hospital, 2425 Samaritan Drive, San Jose, CA 95124, USA
(2)
Department of Anesthesiology and Pain Medicine, Department of Biomedical Ethics, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195, USA
Abstract
Medical research and publication serve to promote the scientific integrity and efficacy of the medical profession. The ethical principles of beneficence and nonmaleficence demand that physicians strive to advance medical knowledge so as to improve patient’s lives and avoid harmful or ineffective patient care. The objective of medical research is to seek scientific truths and support these ethical principles. The integrity of clinical investigation involves the just and honest conduct of experimentation, the honest analysis and reporting of data, and then, the fair peer review and publication of these investigations. Research and the publication of research executed dishonestly divert the search for factuality and defile the medical literature. Within the last two decades, several clinical researchers from various specialties whose publications profoundly influenced the practice of anesthesiology were guilty of extensive research fraud and misconduct, and therein, adversely affected the safe practice of anesthesiology.
Keywords
Research and Publication FraudResearch MisconductFabrication and Falsification of DataPlagiarismGhost and Honorary AuthorshipRedundant PublicationEthical Peer ReviewEthical Journal EditorshipPerioperative Beta-BlockadeQuality Performance MeasuresCase Presentation
Your hospital is vigorous in ascertaining compliance to the Surgical Care Improvement Project (SCIP). In fact, the anesthesia record, newly constructed in 2013, has a specific area for confirming adherence to SCIP measures, including perioperative continuation of beta-adrenergic blocking drugs for patients on chronic therapy. A 78-year-old patient is scheduled for a same-day outpatient bilateral laparoscopic inguinal hernia repair. Other than hypertension treated with a beta-blocker (and one other antihypertensive taken at night) and some mild memory loss, the patient has an otherwise normal history with no cardiac symptoms. The patient was instructed by the pre-anesthesia nurse to take her usual evening dose of antihypertensive medications, including metoprolol. However, on the morning of surgery, she admits to having failed to take her nightly medications, attributing this to her forgetfulness and being distracted by concerns over her surgery. Without any anesthetic premedication, she arrives at the operating room alert and moderately apprehensive, with vital signs unchanged from the admission area – pulse 47 and blood pressure 90/68. Your resident judges that she might be overly beta-blocked and does NOT want to administer any beta blockade drugs in the perioperative period unless indicated. Yet, she knows that she then would not be in compliance with the SCIP beta-blockade measure unless a note documenting the reasons for such were placed in the chart. She suggests that it would be easier and prudent to administer 1 mg of esmolol IV in order to satisfy the SCIP requirement. She and most of her department are unaware of the retirement of this SCIP measure by the Centers for Medicare and Medicaid Services and The Joint Commission as of December 31, 2014. You notify the resident that the establishment of the beta-blocking drug quality measure was largely based on two studies [1, 2] from the 1990s that later were found to be insufficient scientifically, and even of greater concern, in one case, likely fraudulent [2].
Introduction
The “social contract” of physicians obliges them to demonstrate that they deserve social trust, authority and reward. Societies expect that a physician’s primary concern is their patient’s well being. Three themes – personal character, interpersonal duty and social responsibility – are recurrent topics of ethical reflection, and constitute the threads that bind medicine and morality. This has come to be known as medical ethics [3].
The ethics of clinical research may best be understood from three disparate perspectives: (1) the process of obtaining new knowledge; (2) the moral use of that knowledge; and (3) the personal ethics of the scientist pursuing this knowledge [4]. This latter element, that of the personal morality of the clinical investigator, deserves particular attention, as the physician researcher is the ultimate guardian of the design, safety, conduct and analysis of the study, the knowledge gained there from, and its dissemination to the medical profession. The personal ethics of a research scientist is a critical element of the moral quality of human research.
Clinical researchers have potentially conflictive roles as scientist, physician and private individual, and each of these roles is commanded by a different value [4].
For science, the value system is truth – knowledge is good in its own sake – and the discovery of “generalized concepts, theories or laws about human physiognomy or disease” [4]. Scientists must rigorously design studies and examine these experiments for their verifiability and falsifiability. “Observations must be accurate, honestly reported, objectively interpreted, subject to peer review, and shared openly with colleagues and the world at large” [4].
For medicine, the value is beneficence toward the patient or patient population – the good of the patient – the helping and healing of human beings. Medicine, therefore, is not purely science, but rather applies science and the truths that science provides for the good of the patient.
For the individual, the primary value likely is self-interest in the form of advancing one’s career, economic gain, and the personal satisfactions of patient appreciation/satisfaction, peer approval and societal acknowledgment. Unfettered, this interest can introduce moral obstacles and obfuscate moral sensitivity. The covenants that the physician (clinical investigator) holds with both the patient (experimental subject) and society serve as the foundation for the moral obligation specific to clinical research. These covenants spring from a trust relationship that despite the oversight of governmental regulations and institutional review boards (IRB), ultimately relies on the good character and moral integrity of the physician investigator.
The manner in which physician scientists address these conflicts in value determines the degree to which society will facilitate or restrict the scientific autonomy necessary for fruitful research. Thus the ethical sensitivity and moral integrity of the clinical investigator is paramount in the quest for medical knowledge. A research project, from design to publication, that is void of scientific integrity places knowledge, truth and humans at risk and violates society’s expectations of science and scientists.
Institutional hubris is another potentially corrosive element. Competitiveness amongst such institutions can potentially lower an IRB’s ethical guardianship, and can, as we shall soon demonstrate, promote overreliance on the supposed moral character of a scientifically prolific or prominent researcher.
Scientific Misconduct [3, 5, 6]
Two prominent ethical principles – beneficence and nonmaleficence – demand that physicians must seek to further medical knowledge with the goal of bettering their patients’ lives while concomitantly identifying harmful or ineffective treatments. The integrity of the process of scientific advancement is more than simply the just and honest conduct of scientific investigation. It also includes honest and truthful analysis and synthesis of the experimental results, appropriate attributions for the submitted product, the integrity of the subsequent peer review, and, last but not least, the unbiased and fair publication of the research.
Publication is an important component of academic medicine as it sets scholarly efforts apart from the actual practice of medicine. As an essential factor for achieving a successful academic career, authorship is integral to receiving credit for one’s research, creative ideas and other educational forays. Publications influence promotions, enhance job searches, and facilitate future research opportunities, including, importantly, funding for such endeavors.
While investigators and authors of scientific papers have primacy over the ethical conduct, analysis, reporting and submission of their studies, there also are important ethical obligations for those involved with the publication process – that is, the reviewers, editors and publishers.
Medicine and Medical Science as Moral Enterprises
Medicine is a moral enterprise, individually and collectively, and physicians are obligated to exercise moral integrity. This behavior, in turn, builds the public trust and serves as a structurally stabilizing and protective force for the medical profession’s interaction with the society it serves. In return, physicians, including researchers, retain considerable authority and privilege to control the critically important aspects of their practice and research. Indeed, medicine’s scientific endeavors necessarily are built upon a foundation of trust: “If science is to flourish and attain its appropriate role in aiding human progress, it is incumbent upon … the scientific community to help provide a research environment that, through its adherence to high ethical standards … will attract and retain individuals of outstanding intellect and character” [7].
Researcher-Author Fraudulent Behavior and Misconduct [3, 5, 6]
Fabrication and Falsification
Among the most ethically troublesome categories of research and publication fraud are fabrication – the invention of false results – and falsification – the manipulation or omission of key data leading to inaccurate representation of the research.
Research and the publication of research executed dishonestly divert the search for factuality and defile the medical literature, ultimately diminishing the quality of care delivered to patients, or potentially even leading to the endorsement of actually harmful treatments. Research fraud also prevents beneficence by dissuading physicians from utilizing beneficial therapies. Moreover, corrupted information can divert other investigators from pursuing a truthful path of scientific research. Fabrication and falsification, when exposed, damage the image of scientific investigation as a noble undertaking. The social contract that physician investigators hold with the society they serve demands a bedrock of honesty and a spirit of selfless service to the public.
How frequent is such misbehavior? Although likely underreported, evidence points to a significant frequency. One study found about one in 50 researchers admitted to at least one episode of fabrication during their career, but of interest, about 14% claimed to know of colleagues who did such [8]. Another survey reported almost 5% of authors admitted to having been participant to research that involved fabrication or misrepresentation, and, again not surprisingly, a larger number (more than one-sixth) claimed to be aware of such behavior in colleagues [9].
Misbehavior in research has been exposed in all specialties. Historically, perhaps the most potentially harmful to society may be the now discredited false claim published in 1998 linking regressive autism and measles-mumps-rubella (MMR) vaccinations [10]. The subsequent MMR vaccine scare later was determined to be based on a deliberate fraud. Appallingly, the researcher’s claims followed his retention by a law firm to assist with lawsuits against manufacturers of the vaccine [11]! The worldwide consequences of this moral and ethical transgression in terms of morbidity and mortality due to arousing scientifically unfounded parental fears of vaccinating their children with MMR vaccine is huge and ongoing 17 years later. Regrettably, the process of reversing such egregious dishonesty, which involves retraction and expunging from the literature, inevitably will be incomplete.
But, we need not wander from anesthesiology to find examples of some of the largest individual research and publication fraud [3, 5, 6]. American anesthesiologist Scott Reuben was found by the medical center in which he conducted his research to have published a number of fraudulent research articles [12]. These studies promoted the routine worldwide clinical administration of “replacement” drugs for postoperative narcotic therapy with theoretically detrimental effects on bone healing in orthopedic patients. The editor-in-chief of the journal Anesthesia and Analgesia (A&A) listed 21 journal articles (ten from A&A and three from Anesthesiology) that had been based on the fraudulent data, and then correctly predicted their retraction [13]. Moreover, research findings from numerous studies that had relied upon Reuben’s articles for their design and comparisons were called into question. The culprit was fined and imprisoned.
Not confined to the United States, extensive cases of scientific fraud in anesthesia and surgery research have been identified in Germany and Japan. German anesthesiologist Joachim Boldt misrepresented major aspects of a published study, involving fabricated data on the deployment of hydroxyethyl starch as a priming agent for cardiopulmonary bypass [14]. Moreover, the researcher failed to seek institutional review board (IRB) approval for his investigations as well as to obtain informed consent from the patients. Unprecedented widespread publication of his ubiquitously published work necessitated an international collaboration of the editors of 16 medical journals to publish a collective letter acknowledging that 88 of his 102 studies had failed to adhere to basic ethical standards for human experimentation [15]. Many of the study files were missing or incomplete, and false data were published in at least 10 of the 91 studies examined, thus further setting the stage for retractions. The researcher had his academic position removed and was subject to both monetary fines as well as imprisonment. In stark contradistinction to the United States, in Germany the state medical association holds jurisdiction over physician misbehavior and misconduct [16].
A Japanese anesthesiologist, Yoshitake Fujii, likely holds a “Guinness-type” world record for the number of fraudulent publications thus far [17]. A retraction of virtually all of his extensive research papers has ensued. Interestingly, an initial question regarding the integrity of his investigations arose a decade earlier [18], but was not pursued in depth [19]. It now has been determined that there was consistent violation of obtaining IRB approval, adhering to ethical standards for human investigation, and veracity of data. Furthermore, for some articles he named co-authors who were unaware of such and whose signatures on submission letters had been forged! Again, there was an international collaboration of editors from prominent anesthesiology journals to prompt investigation of these misdeeds and deception at the host institutions as well as to correct and retract, as much as feasible, the falsified literature. The editors were “completely engaged with the process of coordinating our efforts to identify and reduce research fraud. … It is a team effort. … Everyone is on board” [20–22]. The researcher was fired by his university.
Interestingly, to identify falsified data, statistical techniques to identify unusual patterns of categorical and continual variables have been developed. As a result, in addition to earlier methodology to detect plagiarism [23], editors now have substantial technology to detect research and publication dishonesty [24, 25].
Plagiarism
Plagiarism is the “appropriation of someone else’s words and/or ideas as one’s own” [5]. Because science and scholarship involve new knowledge and creative ideas, the wording utilized might be less important than the ideas that the words convey for the determination of whether a scientific thesis has been plagiarized. Plagiarism is an ethical violation because it harms the true authors by not giving them credit and not recognizing their work. But, plagiarism also damages the reader by deception and obfuscation of the pathway taken in the development of an idea. Furthermore, trust of the body of work of the plagiarist inevitably surfaces. In 1998, it was determined that complaints (likely underreported) involving medical authorship such as the plundering of non-credited work of junior faculty had risen precipitously, and moreover, appeared to disproportionately involve females and non-United States citizens as victims [26]. Perhaps the most infamous example of scientific plagiarism involved the unauthorized acquisition of Rosalind Franklin’s unpublished research on DNA – as well as her confidential research progress report – by Watson and Crick. The latter of these famed biologists later acknowledged that the double helix model was based on her data, by which time Franklin, tragically, was deceased [27, 28].
Plagiarism is antithetical to the principles of nonmaleficence and justice. Nonetheless, identifying plagiarism is difficult. Editors now have within their armamentarium reliable methodology to detect plagiarism. This notwithstanding, words, when compared with ideas, do not in every circumstance hold equal weight in determining originality [29].
“Ghost” Authorship and “Honorary” Authorship
The International Committee on Medical Journal Editors defines an author as someone who has made a substantial contribution to a scientific publication. This would include participating in all of the following arenas of the scientific project: concept, design and acquisition of data, drafting or critical revision of the publication, and final approval of the version that is published.
“Ghost” authorship involves the acceptance of credit for a publication written by another (“ghost”) individual. Industry, for example, often provides a professional writer (the “ghost” who is not identified or acknowledged) to compose a substantial portion of a publication to which is attached the name of an “author” who did not actually write the piece. “Honorary” authorship constitutes the assignment of credit to an individual (usually a senior academic or industry leader, or even government regulator or administrator) who did not participate to a meaningful degree in the research, analysis, review and/or synthesis of ideas upon which the publication is based. Both of these behaviors are commonplace, particularly in industry-financed publications [30, 31].
Such dishonest attribution of authorship is deleterious to the publication process in several ways. The attachment of the name of a well-respected researcher or prominent policy-maker to a paper might falsely give more significance and credibility of an investigation. Ghostwriters can conceal conflicts of interest that could influence the credibility of a publication as, for example one extolling the value of a new drug or medical device. Identification of the true author(s)/researcher(s) is key with respect to accountability and the ability to retrospectively investigate data of past publications that may have come into question. Pure and simply: authors who knowingly permit their name to be attributed to a publication in which they did not participate are engaging in fraud.
Redundant Publication
Redundant or duplicative publication is publication of the same results of one research project in more than one journal, or publishing a review of such results nearly at the same time in another journal, or the deliberate division of results from one study into several publications. This practice spuriously inflates academic “achievements,” but unfortunately, is commonplace [32]. Inflating an already oversized medical literature and publication process is disingenuous and misleading. Self-plagiarism is a form of duplicative publication.
Ethical Duties of Peer Reviewers [5, 6]
As a fundamental segment of the process of medical publications, appropriately conducted peer review is, in the end, a major determinant for safe, quality patient care. Peer review determines whether research has been properly and ethically designed and conducted, and also accurate in its analysis, discussion and conclusions. It therefore affirms and confirms research as being a credible origin of new scientific information. Review articles as well as research also fall under the protective canopy of peer review.
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