AMA Manual of Style - Stacy L. Christiansen, Cheryl Iverson 2020

Scientific Misconduct
Ethical and Legal Considerations

We should ignore whining about the supposedly awful pressures of “publish or perish” when we have little credible evidence on what motivates misconduct, nor on what motivates the conduct of honest, equally stressed colleagues. Laziness, desire for fame, greed, and an inability to distinguish right from wrong are just as likely to be at the root of the problem.

Drummond Rennie¹

In scientific publication, the phrase scientific misconduct (specifically termed research misconduct by US government regulations and commonly known as fraud) has ethical and legal connotations for researchers, authors, editors, and publishers. A few studies (with limited methods) have estimated the prevalence of scientists who have participated in scientific misconduct to range from 1% to 2%.²^,³^,⁴ In a 2002 survey⁵ of a random sample of 3247 scientists funded by the National Institutes of Health, participating scientists reported engaging in a number of unethical behaviors, including falsifying research data (0.3%), using another’s ideas without permission or credit (1.4%), and inadequate record keeping related to research projects (27.5%). A 2009 meta-analysis⁴ of 18 surveys published between 1987 and 2008 evaluated the frequency with which researchers admitted to fabricating or falsifying data. These surveys included a combined total of 11 647 researchers, primarily from the United States and the United Kingdom; 1 survey was conducted in Australia, and 2 surveys were multinational. In the meta-analysis, a pooled weighted mean of 1.97% of the researchers admitted to having “fabricated, falsified or modified data or results at least once,” and 34% admitted to “other questionable research practices,” such as subtle distortion, selective reporting, and selective publication of data that support one’s expectations, biases, or conflicts of interest. In those surveys that asked researchers about the behavior of their colleagues, 14% responded that their colleagues had fabricated, falsified, or modified data or results.⁴

A 2018 analysis of 10 500 retracted journal articles listed in the Retraction Watch database found that the number of retractions has increased from fewer than 100 annually before the year 2000 to almost 1000 in 2014.⁶ However, this analysis concluded that much of this increase appears to be associated with improved oversight at a growing number of journals. Only about 4 of every 10 000 articles have been retracted.⁶

Although inadequate record keeping and other questionable research practices are not technically forms of misconduct, they could permit misconduct to occur and make investigations of misconduct difficult to conduct. Legal determinations of scientific misconduct in biomedical publication are uncommon, although, when discovered, such misconduct results in serious questions about the validity of scientific research and the credibility of authors and journals. Proven cases of misconduct in the published literature as well as allegations and concerns that do not result in an official finding of misconduct raise important ethical questions and impose duties on authors and editors to protect and correct the literature.

Various definitions of scientific misconduct have been suggested by US and international government agencies, academic institutions, and funders, especially after highly publicized incidents of fraudulent research in the United States in the mid-1970s and early 1980s.⁷^,⁸^,⁹ In 1989, the US Public Health Service released the following definition of scientific misconduct: “fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research.”¹⁰ This definition was considered a practical tool for recognizing and dealing with allegations of scientific misconduct during the manuscript submission, review, and publication processes.¹¹ However, controversy grew over various interpretations of the definition (eg, How narrow or broad should the definition be? Does the definition address intent or levels of seriousness of offense? Can the definition stand up in court? Can the definition serve multiple scientific disciplines?).

In the wake of this controversy, the US Public Health Service appointed a Commission on Research Integrity in 1993. One of the charges of the commission was to develop a better definition of scientific misconduct. In 1995, the commission released a detailed report that included a recommendation that the definition be amended to include offenses that constitute research misconduct: misappropriation, interference, and misrepresentation.¹² This definition replaced the word plagiarism with the broader term misappropriation, replaced the words fabrication and falsification with the term misrepresentation, and added the term interference to address instances “in which a person’s research is seriously compromised by the intentional and unauthorized taking, sequestering, or damaging of property he or she used in the conduct of research.”¹² In this context, property included apparatus, reagents, biologic materials, writings, data, and software.

The commission’s definition was not adopted by the US Public Health Service for many reasons, including protests from scientists and some science groups to which the government responded that it wanted a definition that would work for all governmental departments (eg, both the US Public Health Service and the National Science Foundation, which at the time had different definitions).¹¹^,¹³ In 1996, the National Science and Technology Council, a unit within the Office of Science and Technology Policy responsible for coordinating policy among multiple government research agencies, drafted a common definition, which, after review and comment, was approved and released in 2000.¹⁴ This definition no longer contained a category of misconduct that was in the original 1989 definition, namely, “other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research.”¹⁴

The revised common definition was reviewed again in 2004 and reissued without substantial change in 2005 by the US Department of Health and Human Services (DHHS) (although there were other changes to correct errors and improve clarity in the overall policy).¹⁵

The DHHS common definition of research misconduct remains in effect as follows¹⁵:

Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting research results.

Fabrication is making up data or results and recording or reporting them.

Falsification is manipulating research materials, equipment, or processes or changing or omitting data or results such that the research is not accurately represented in the research record.

Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.

Research misconduct does not include honest error or differences of opinion.

A finding of research misconduct requires that:

there be a significant departure from accepted practices of the relevant research community; and

the misconduct be committed intentionally, or knowingly, or recklessly; and

the allegation be proven by a preponderance of evidence.

None of the definitions of scientific misconduct include honest error or differences in interpretation (see 5.4.6, Retraction and Replacement for Articles With Pervasive Errors). They also do not include or pertain to violations of human or animal experimentation requirements (see 5.8, Protecting Research Participants’ and Patients’ Rights in Scientific Publication), financial mismanagement or misconduct, or other acts covered by existing laws, such as sexual harassment, copyright, confidentiality, libel (see 5.6.3, Copyright: Definition, History, and Current Law; 5.7, Confidentiality; and 5.9, Defamation, Libel), or other concerns, such as authorship disputes, duplicate publication, or conflicts of interest (see 5.1, Authorship Responsibility; 5.3, Duplicate Publication and Submission; and 5.5, Conflicts of Interest).

The DHHS common definition of research misconduct¹⁵ is intended to apply to US government—funded research. Academic and research institutions that accept US government funding must comply with the definition and associated regulations. However, this definition and the associated regulations have become de facto rules for US academic and other research institutions and are applied to any work performed by their employees or under their aegis regardless of the source of funding. These institutions often have other rules that cover “other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research.”¹⁰

Similar definitions have also been accepted by research and funding institutions in other countries, and some have adopted broader definitions. For example, research integrity definitions in other countries include what may be considered questionable research practices. The UK-based Wellcome Trust defines research misconduct as “behaviour or actions that fall short of the standards of ethics, research and scholarship required to ensure that the integrity of research is upheld” including “fabrication, falsification, plagiarism or deception in performing or reviewing research, and in reporting research outputs.”¹⁶ The Canadian National Research Council defines major research misconduct as fabrication, falsification, and plagiarism but also includes other wrongdoings typically covered by other regulations and policies (eg, duplicate publication, invalid authorship or contributions, peer review abuse, and mismanagement of conflicts of interest).¹⁷ The International Committee of Medical Journal Editors (ICMJE) states that scientific misconduct “includes but is not necessarily limited to data fabrication; data falsification including deceptive manipulation of images; and plagiarism.”¹⁸ The ICMJE also notes that “failure to publish the results of clinical trials and other human studies” may also be considered as a serious form of omission-based misconduct.¹⁸ The US Office of Research Integrity (ORI), which has jurisdiction only of US government—funded research, has a list of case summaries in which findings or research misconduct has been found against individuals with active administrative actions.¹⁹ The ORI website also has policies and procedures for detection and investigation of allegations of research misconduct.¹⁹

5.4.1 Misrepresentation: Fabrication, Falsification, and Omission.

Fabrication, falsification, and omission are forms of misrepresentation in scientific publication. Fabrication includes stating or presenting a falsehood and making up data, results, or facts that do not exist. Falsification includes manipulation of materials or processes, changing data or results, or altering the graphic display of data or digital images in a manner that results in misrepresentation (see 5.4.3, Inappropriate Manipulation of Digital Images). Omission is the act of deliberately not reporting specific or selected information to achieve a desired outcome in the report. Data fabrication, falsification, and omission occur when an investigator or author creates, alters, manipulates, selects, or presents selected information or fails to report selected information for a desired outcome that distorts the interpretation of the original data, the research record, or the truth.¹²^,¹³^,¹⁴^,¹⁵

5.4.2 Misappropriation: Plagiarism and Breaches of Confidentiality.

Misappropriation in scientific publication includes plagiarism and breaches of confidentiality during the privileged review of a manuscript¹²^,¹³^,¹⁴^,¹⁵^,²⁰ (see 5.7.1, Confidentiality During Editorial Evaluation and Peer Review and After Publication). In plagiarism, an author documents or reports ideas, words, data, or graphics, whether published or unpublished, of another as his or her own without giving appropriate credit or attribution.¹² Plagiarism of published work violates standards of honesty and collegial trust and may also violate copyright law (if the violation is shown to be legally actionable) (see 5.6.7, Copying, Reproducing, Adapting, and Other Uses of Content). The term self-plagiarism is erroneously included in discussions of plagiarism. The term refers to the practice of an author republishing his or her work or portions thereof without citation to the previous work. However, because this practice does not include misappropriation or theft of another’s work, it is better described as a form of duplicate publication or duplicate submission, and the term self-plagiarism should be avoided (see 5.3, Duplicate Publication and Submission).

Four common kinds of plagiarism have been identified²¹:

1.Direct plagiarism: Verbatim lifting (copying) of passages without enclosing the borrowed material in quotation marks and crediting the original author.

2.Mosaic: Borrowing the ideas and opinions from an original source and a few verbatim words or phrases without crediting the original author. In this case, the plagiarist intertwines his or her own ideas and opinions with those of the original author, creating a “confused, plagiarized mass.”

3.Paraphrase: Restating a phrase or passage, providing the same meaning but in a different form without attribution to the original author.

4.Insufficient acknowledgment: Noting the original source of only part of what is borrowed or failing to cite the source material in a way that allows the reader to know what is original and what is borrowed.

The common characteristic of these kinds of plagiarism is the failure to attribute words, ideas, or findings to their true authors, whether or not the original work has been published. Such failure to acknowledge a source properly may on occasion be caused by careless note taking or ignorance of the canons of research and authorship. The best defense against allegations of plagiarism is careful note taking, record keeping, and documentation of all data observed and sources used. Those who review manuscripts that are similar to their own unpublished work may be especially at risk for charges of plagiarism. Reviewers who foresee such a potential conflict of interest should consider returning the manuscript to the editor without reviewing it. This recommendation may be stipulated in the letter that accompanies each manuscript sent for review (see 5.5.6, Requirements for Peer Reviewers, and 6.0, Editorial Assessment and Processing). Some have reported that the internet and subsequent rapid and widespread dissemination of findings and publications have resulted in an increase in plagiarism; however, text-based plagiarism software provides editors and publishers with tools to detect plagiarism and inappropriate duplication in submitted papers²²^,²³ (see 5.3, Duplicate Publication and Submission).

5.4.3 Inappropriate Manipulation of Digital Images.

Image-processing software, such as Adobe Photoshop, has made it relatively easy for authors to manipulate images to highlight a specific outcome or feature by cropping; deleting items; adjusting color, brightness, or contrast; or cloning/copying images. These same applications can be used by journal staff to screen digital images for evidence of inappropriate manipulation and fraudulent manipulation.²⁴^,²⁵ Some enhancements to figures, such as cropping or adjusting color of the entire image, may be appropriate if such manipulations do not alter the interpretation of the original data or omit or obscure important data. However, any manipulation that results in a change in how the original data will be interpreted or that selectively reports, omits, or obscures important data (such as adding or altering a data element or adjusting tone or compression of an image to make it appear as a uniquely different image) is considered scientific misconduct.²⁴^,²⁵ Authors should indicate any changes or enhancements that have been made to digital images in the legend that accompanies the image (see also 4.2.10, Guidelines for Preparing and Submitting Figures). These same principles apply to images included in video files.

Journals that regularly publish digital images should have policies and procedures in place for screening these images.²⁴^,²⁵ If resources are limited, screening can be reserved for those images that are included in papers that have been accepted for publication. The Journal of Cell Biology has a policy and guidelines for authors that are a good model for other journals.²⁶ During a 3-year period of screening images in all manuscripts accepted for publication, the Journal of Cell Biology had to revoke acceptance of 1% of papers after detecting “fraudulent image manipulation that affected interpretation of the data.”²⁴ In addition, 25% of the accepted manuscripts had at least 1 figure that had to be remade because of inappropriate manipulation that did not affect the interpretation of the data but that violated the above guidelines.

The JAMA Network journals have the following policy on image integrity in all journal Instructions for Authors.²⁷

Preparation of scientific images (clinical images, radiographic images, micrographs, gels, etc) for publication must preserve the integrity of the image data.

Digital adjustments of brightness, contrast, or color applied uniformly to an entire image are permissible as long as these adjustments do not selectively highlight, misrepresent, obscure, or eliminate specific elements in the original figure, including the background.

Selective adjustments applied to individual elements in an image are not permissible. Individual elements may not be moved within an image field, deleted, or inserted from another image.

Cropping may be used for efficient image display or to deidentify patients but must not misrepresent or alter interpretation of the image by selectively eliminating relevant visual information.

Juxtaposition of elements from different parts of a single image or from different images, as in a composite, must be clearly indicated by the addition of dividing lines, borders, and/or panel labels.

When inappropriate image adjustments are detected by the journal staff, authors will be asked for an explanation and will be requested to submit the image as originally captured prior to any adjustment, cropping, or labeling. Authors may be asked to resubmit the image prepared in accordance with the above standards.

5.4.4 Editorial Policy and Procedures for Detecting and Handling Allegations of Scientific Misconduct.

Detection of scientific misconduct in publishing has often been the result of the alertness of coworkers or other authors of the same manuscript and less commonly detected by editors, peer reviewers, or general readers. However, postpublication forensic statistical analysis and other replication techniques have begun to be used by peers and other experts to identify and expose scientific misconduct in published reports.

If an allegation of scientific misconduct is made in relation to a manuscript under consideration or published, the editor has a duty to ensure confidential and timely pursuit of that allegation, but the editor is not responsible for conducting the investigation.²⁸ This recommendation is supported by the ICMJE,¹⁸ the World Association of Medical Editors,²⁹ the Council of Science Editors,³⁰ and the Committee on Publication Ethics (COPE).³¹ COPE has a set of useful flowcharts and retraction guidelines to help editors address allegations of scientific misconduct that involve submitted or published papers.³² In addition, the Council of Science Editors has a list of retraction resources that includes links to guidance and other information related to the handling of retractions.³³

A 2012 study³⁴ of 399 high-impact journals in 27 biomedical categories found that only 35% of journals had a publicly available definition of scientific misconduct and 45% had publicly available policies that described procedures for handling allegations of misconduct. In this study, the prevalence of misconduct policies was higher in journals that endorsed any type of policy from professional editors’ associations, the US ORI, or professional societies compared with those that did not refer to adherence to policies of these organizations. Editors have a duty to develop and follow a policy on handling allegations of scientific misconduct and retractions. Thus, the recommendations in this section are intended to help editors with such policies.

An editor’s first step after receiving an allegation of falsified, fabricated, or plagiarized work published in her or his journal is to attempt to assess the validity or rationale for the allegation by requesting supporting documentation from the person who has made the allegation while maintaining confidentiality. If the allegation then appears to have merit, the editor should consider contacting the corresponding author, depending on the circumstances, to request an explanation while maintaining confidentiality. This initial contact can be made by telephone or email marked confidential (see 5.7.2, Confidentiality in Allegations of Scientific Misconduct). If the explanation received from the author is satisfactory and if guilt is admitted, the editor should request a letter of explanation and formal retraction from the author (preferably signed by the author and all coauthors); the editor should also notify the author’s institution and inform the author of this notification.²⁸ If the explanation allays any concerns about misconduct, the editor may inform the person making the allegation that no misconduct has occurred. If the explanation received is not satisfactory or leads to additional concerns or if no explanation is received, the editor should contact the author’s institutional authority to request a formal investigation and should notify the author of this plan.

The responsibility to conduct an investigation lies with authorities at the author’s institution where the work was done (eg, dean, president, or ethical conduct/research integrity officer), with the funding agency, or with a national agency charged to investigate such allegations, such as the US ORI or the Danish Committees on Scientific Dishonesty. Many countries do not have such national agencies to investigate allegations of scientific misconduct or enforce regulations. In such cases, the journal editor must pursue an author’s local institution for an appropriate response.²⁸^,³⁵ Editors should expect a prompt acknowledgment of their notification of an allegation of misconduct from institutional leaders.³⁶^,³⁷ The acknowledgment should include a plan for the inquiry or investigation into the matter and a timeline that specifies when the editor will be informed of the outcome. A checklist developed by a working group (comprising university and institutional leaders and research integrity officers, government officials, researchers, journal editors, journalists, and attorneys representing respondents, whistle-blowers) can be used by institutions to follow reasonable standards to investigate an allegation of scientific misconduct and to provide an appropriate and complete report following the investigation.³⁷ The editor cannot conduct the investigation because he or she does not have the appropriate institutional access or authority or an employment relationship with the author or other relationship, such as that between the author and a governmental funding agency. If the editor does not receive a satisfactory or timely reply (eg, within 2 months) from the investigational authority, the editor should consider contacting the authority again to request follow-up information. The US DHHS policy recommends that institutions complete their initial inquiry to determine whether an official investigation is warranted within 60 days of its initiation unless circumstances clearly warrant a longer period.¹⁵

The editor should take great care to maintain confidentiality during any communication about the allegation. However, the editor needs to identify the person or persons about whom the allegation is made when contacting the relevant institutional, funding, or governmental authority to request an investigation. This is best done by a telephone call or a brief formal letter sent by mail or attached to email and marked confidential. During such investigations, editors should avoid including details of the cases in emails that can be widely circulated and should avoid posting details, even if rendered anonymous, in email discussion forums or blogs (see 5.7.2, Confidentiality in Allegations of Scientific Misconduct). Journal editors should keep information about manuscripts, authors, and blinded reviewers confidential; however, if there is clear evidence that shows that articles in other journals may have been subject to the same misconduct, it would be acceptable for editors of these journals to discuss the matter in a confidential manner.

5.4.5 Retractions and Expressions of Concern.

After receiving confirmation from the author or authors and/or a report from the author’s institution or other agency indicating that fabrication, falsification, or plagiarism has occurred, the journal should promptly publish a retraction. Preferably this retraction will be a signed letter from the corresponding author and all coauthors. If none of the authors will agree to publish a signed retraction, the editor may request such a retraction from the investigating institution, or the editor may issue a retraction on behalf of the journal. In each case, the editor should inform the author(s) and institutional authority of the plan to publish a retraction. See Boxes 5.4-1 and 5.4-2 for examples of retraction notices.

Box 5.4-1. Examples of Hypothetical Published Retraction Notices

Retraction Notices From Authors

Notice of Retraction: Falsification of Data in “Effects of Low-Fat Diet on Risk of Breast Cancer” (J Med Res. 2016;242[1]:135-139)

To the Editor.—We write to retract the article “Effects of Low-Fat Diet on Risk of Breast Cancer,”¹ published in the January 3, 2016, issue of the Journal of Medical Research. Two participants in the low-fat diet group were intentionally misclassified as not having breast cancer by one of us (J.S.). Had the reporting of these 2 cases not been falsified, our multivariate analysis would not have shown statistically significant results. We regret any problems our article and actions may have caused, and we retract the article from the literature.

John Smith

Jane Doe

Medical University

Chicago, Illinois

1.Smith J, Doe J. Effects of low-fat diet on risk of breast cancer. J Med Res. 2016;242(1):135-139.

Notice of Retraction: Plagiarism in “Effects of Low-Fat Diet on Risk of Breast Cancer” (J Med Res. 2016;242[1]:135-139)

To the Editor.—We regret that the first 3 paragraphs in the Discussion section of our article, “Effects of Low-Fat Diet on Risk of Breast Cancer,”¹ published in the January 3, 2016, issue of the Journal of Medical Research, were taken from another source without proper attribution. We should have cited the following article as the original source of the information contained in those paragraphs: Scott RB. Low-fat diets and cancer risk. J Med Nutr Diet. 2015;20(8):1450-1455. We regret any problems our article¹ may have caused, and we retract it from the literature.

John Smith

Jane Doe

Medical University

Chicago, Illinois

1.Smith J, Doe J. Effects of low-fat diet on risk of breast cancer. J Med Res. 2016;242(1):135-139.

Retraction Notice From Institution

Notice of Retraction: Falsification of Data in “Effects of Low-Fat Diet on Risk of Breast Cancer” (J Med Res. 2016;242[1]:135-139)

To the Editor.—An official investigation conducted by the Research Integrity Review Panel of Medical University of the data reported by John Smith and Jane Doe in the article “Effects of Low-Fat Diet on Risk of Breast Cancer,”¹ published in the January 3, 2016, issue of the Journal of Medical Research, has confirmed falsification in the reporting. Two participants in the low-fat diet group were intentionally misclassified as not having breast cancer by one of the authors (J.S.). As a result, we retract this article from the literature. The review panel’s investigation did not reveal any additional research misconduct in either author’s previously published works.

Joan Brown

Dean

Medical University

Chicago, Illinois

1.Smith J, Doe J. Effects of low-fat diet on risk of breast cancer. J Med Res. 2016;242(1):135-139.

Retraction Notice From Journal Editor

Notice of Retraction: Falsification of Data in “Effects of Low-Fat Diet on Risk of Breast Cancer” (J Med Res. 2016;242[1]:135-139)

We have received confirmation from the Research Integrity Review Panel of Medical University that data reported by John Smith and Jane Doe in the article “Effects of Low-Fat Diet on Risk of Breast Cancer,”¹ published in the January 3, 2016, issue of the Journal of Medical Research, were falsified. Two participants in the low-fat diet group were intentionally misclassified as not having breast cancer by one of the authors (J.S.). As a result, we retract this article from the literature. The review panel’s investigation did not reveal any additional research misconduct in either author’s previously published works.

Mary Frank

Editor, Journal of Medical Research

1.Smith J, Doe J. Effects of low-fat diet on risk of breast cancer. J Med Res. 2016;242(1):135-139.

Expression of Concern From Journal Editor

Expression of Concern: Falsification of Data in “Effects of Low-Fat Diet on Risk of Breast Cancer” (J Med Res. 2016;242[1]:135-139)

In the January 3, 2016, issue of the Journal of Medical Research, we published “Effects of Low-Fat Diet on Risk of Breast Cancer,”¹ by John Smith and Jane Doe. On March 15, 2016, we received information that cast serious doubt on the validity of several cases that were reported in Tables 1 and 2 and that prompted us to alert the author and the author’s institution and to request a formal investigation. An interim report from the Medical University’s Research Integrity Review Panel, received on April 10, 2016, indicates that “data were falsified for two participants in this study” and that a formal investigation is under way. We have requested formal retractions from the authors and a final report from the university’s review panel, including information about the validity of the authors’ previous publication in the Journal of Medical Research. In the interim, we publish this expression of concern to alert our readers to the serious concerns raised about the validity of the data, interpretations, and conclusions of the article published in January 2016.¹

Mary Frank

Editor, Journal of Medical Research

1.Smith J, Doe J. Effects of low-fat diet on risk of breast cancer. J Med Res. 2016;242(1):135-139.

Listing of a Retraction Notice in the Table of Contents

Letters

Notice of Retraction: Plagiarism in “Effects of Low-Fat Diet on Risk of Breast Cancer” (J Med Res. 2016;242[1]:135-139)—J Smith, J Doe

Box 5.4-2. Citations of Published Retraction Notices and Expressions of Concern

Retraction Notices From Authors

Ahimastos AA, Askew C, Leicht A, et al. Notice of retraction: Ahimastos AA, et al. Effect of ramipril on walking times and quality of life among patients with peripheral artery disease and intermittent claudication: a randomized controlled trial. JAMA. 2013;309(5):453-460. JAMA. 2015;314(14):1520-1521. doi:10.1001/jama.2015.10811

Acharya CR, Hsu DS, Anders CK, et al. Retraction: Acharya CR, et al. Gene expression signatures, clinicopathological features, and individualized therapy in breast cancer. JAMA. 2008;299(13):1574-1587. JAMA. 2012;307(5):453. doi:10.1001/jama.2012.2

Poehlman ET. Notice of retraction: final resolution. Ann Intern Med. 2005;142(9):798.

Poehlman ET. Retraction of Poehlman et al. Journal of Applied Physiology. 1994;76:2281-2287. J Appl Physiol. 2005;99(2):779.

[Note: In the following 2 retractions, the coauthors signed the retraction, but the author responsible for the misconduct did not.]

Cooper PK, Nouspikel T, Clarkson SG. Retraction of Cooper et al. Science. 275(5302):990-993. Science. 2005;308(5729):1740.

Warloe T, Aamdal S, Reith A, Bryne M. Retraction of: Diagnostics and treatment of early stages of oral cancer. Tidsskr Nor Laegeforen. 2006;126(17):2287.

Retraction Notices From Editors

Bauchner H. Notice of Retraction: Wansink B, Cheney MM. Super bowls: serving bowl size and food consumption. JAMA. 2005;293(14):1727-1728. JAMA. 2018;320(16):1648. doi:10.1001/jama.2018.14249

DeAngelis CD, Fontanarosa PB. Retraction: Cheng B-Q, et al. Chemoembolization combined with radiofrequency ablation for patients with hepatocellular carcinoma larger than 3 cm: a randomized controlled trial. JAMA. 2008;299(14):1669-1677. JAMA. 2009;301(18):1931. doi:10.1001/jama.2009.640

Horton R. Retraction—Non-steroidal anti-inflammatory drugs and the risk of oral cancer: a nested case-control study. Lancet. 2006;367(9508):382.

Expressions of Concern From Editors

McNutt M. Editorial expression of concern. Expression of Concern on Brantley et al. Science 2011;333(6049):1606-1609. Science. 2014;344(6191):1460. doi:10.1126/science.344.6191.1460-a

Bauchner H, Fontanarosa PB. Expression of Concern: Kiel et al. Efficacy of a hip protector to prevent hip fracture in nursing home residents: the HIP PRO randomized controlled trial. JAMA. 2007;298(4):413-422. JAMA. 2012;308(23):2519. doi:10.1001/jama.2012.14079

A study that included a search of the internet to locate copies of 1779 retracted articles (identified in MEDLINE) that were originally published between 1973 and 2010 found that copies of retracted articles were publicly available on nonpublisher websites (ie, external to the journals that originally published the articles).³⁸ These nonpublisher websites provided 321 publicly accessible copies for 289 retracted articles. Of these, 304 (95%) were copies of the publishers’ versions and 13 (4%) were final manuscripts. However, only 5% of these article copies included the relevant retraction notice. Moreover, studies have found that retracted articles continue to be cited in the literature, also without indication of their retracted status.³⁹^,⁴⁰ Editors are encouraged to follow the procedures outlined below to ensure that readers, researchers, authors, and librarians are aware of the status of retracted articles.

A retraction should include a complete citation to the original article and should indicate the reason for retracting the original article. The retraction, whether a formal letter or notice, should be labeled as a “Retraction,” be listed in the table of contents, be published in a section of the journal (eg, the Correspondence/Letters or Editorial section), and be published in a format that will permit a formal citation so that it can be identified easily by indexers and included in bibliographic databases (see 3.11.15, Retractions and Expressions of Concern). If there is a lengthy delay until the schedule for publication of a retraction in a formal issue, consideration should be given to publishing the retraction notice online first or before subsequent publication in a specific issue. The US National Library of Medicine (NLM) will index the retraction as long as it clearly states that an article in question is being retracted or withdrawn, whether in whole or in part, and is signed by an author, the author’s legal counsel or institutional representative, or the journal editor.⁴¹ Online versions of journals and bibliographic databases should provide reciprocal links to and from the notice of retraction and the retracted article. Retractions should be made freely available and accessible on a journal’s website (ie, readers should not have to pay an access fee to see the retraction notice).¹⁸^,³⁵ A retracted article should be properly labeled or watermarked as retracted in online and PDF versions of journals and should not be removed from the online journal or archive. Such labeling may include the words “Retracted Article” or “This Article Has Been Retracted” placed prominently at the top of the online article and on each page of a PDF file of the article. These labels can be hyperlinked to the published retraction. Copies of retracted articles deposited in public repositories and other databases should also be labeled prominently as retracted and should link to the published retraction notice.

If an author of a fraudulent article, or any institutional authority, refuses to submit an explanation for publication as a retraction, the editor may be able to leverage the authority and influence of his or her position and that of the journal to compel an appropriate response, keeping in mind the journal’s obligation to publish a retraction.²⁸^,³⁵ If, however, the editor is unable to receive a satisfactory or timely response from an author or the investigating authority on the merit of the allegation, the editor may publish a notice of Expression of Concern to alert readers, librarians, and the scientific community that there are concerns that an article may include fabricated, falsified, or plagiarized work and follow this later with a formal retraction. An Expression of Concern from journal editors may also allow for timely notification while awaiting a formal investigation. This notice of concern should follow the same publication format as recommended for notices of retraction. If evidence of misconduct is sufficient and the editor cannot obtain a retraction letter from the author and is awaiting the results of an official investigation, the editor may choose to publish an expression of concern and follow this with a formal retraction once the institution has completed its investigation.

The validity of other work published in the journal by the authors responsible for the misconduct should also be questioned. The ICMJE recommends that editors ask institutions to provide assurance of the validity of earlier work published in their journals or to retract those as well. If this is not done, editors may choose to publish a notice or expression of concern stating that the validity of such previously published work is uncertain.¹⁸

Box 5.4-1 shows examples of retraction notices from authors, an institution, and an editor and a listing in the table of contents. Examples of recent retractions in the literature are given in Box 5.4-2. Some authors may not want to explain the reason for the retraction in a forthright manner. Editors should work with authors or their institutional authority to make these notices as accurate as possible. In some cases, publishing an author’s evasive or incomplete statement might be better than publishing nothing from the author; in such a case, the journal can also publish an explanatory note from the author’s institutional authority or the editor.

When an article is retracted, the original article should not be removed from a journal’s website or other online archival publication. However, it should be made clear to all users of online archival material that the article has been retracted and should not be used or cited. This requirement includes clear labeling of retracted articles and 2-way linking between retraction notices and the original articles. The NLM does not remove the citation of a retracted article; the citation is updated to indicate that the article has been retracted, and links between the original citation and the citation to the retraction notice are added.⁴¹

5.4.6 Retraction and Replacement for Articles With Pervasive Errors.

Retractions may also be used for articles that are seriously and pervasively flawed because of honest, inadvertent error that is not a result of fabrication, falsification, or plagiarism.²⁸^,⁴²^,⁴³^,⁴⁴^,⁴⁵ However, retraction of an article because of serious and pervasive errors should be used cautiously. Indeed, Sox and Rennie³⁵ have called for retractions to be reserved solely for cases of scientific misconduct. Retractions should never be used for typical errors; in these cases, a correction is appropriate⁴⁶ (see 5.11.10, Ethical and Legal Considerations, Editorial Responsibilities, Roles, Procedures, and Policies, Corrections [Errata]).

A study⁴⁷ of 395 articles retracted during the years 1982 through 2002 found that 107 (27%) reflected scientific misconduct and 244 (62%) represented unintentional errors (another 44 [11%] represented other issues or provided no information about the reasons for the retractions). Another study⁴⁸ of 1112 retracted articles, based on notifications of retraction in PubMed between 1997 and 2009, found that 55% were retracted for misconduct. Twenty percent of these retractions were attributable to some type of error, such as problems with the data (10%); error in the methods, analysis, or interpretation (7%); and problems with the sample (3%). A review³⁹ of 2047 retracted articles with retraction notifications in PubMed from 1977 through 2012 found similar results: 21% of the retractions were attributable to error, whereas 67% were attributable to fraud or suspected fraud and 10% were attributable to plagiarism; duplicate publication (14%) and miscellaneous or unknown reasons accounted for the remaining retractions.

The NLM does not differentiate between articles that are retracted because of serious but unintended error and those that are retracted because of scientific misconduct.⁴¹ A pervasive error in a published article could result from a human or programmatic coding problem or a miscalculation, and this could cause extensive inaccuracies throughout an article (eg, abstract, methods, results, discussion, conclusions, tables, figures, and supplemental information).⁴² Inadvertent publication of pervasive incorrect data that does not affect the results, interpretations, or conclusions of an article can be managed with a formal Correction notice, perhaps with a Letter of explanation from the authors published with the Correction notice and correcting the article online⁴⁵ (see 5.11.10, Corrections [Errata]). However, inadvertent pervasive errors that result in a major change in the direction or significance of the results, interpretations, and conclusions is a serious matter.⁴² In such a case, the editor should request the authors to thoroughly review the published article, all underlying data, and all analyses to check for any additional errors and provide the following:

■Complete explanation for how the errors were discovered

■An itemized listing of all errors and corrections

■A marked-up copy of the original article identifying all errors and corrections (Note: A tracked-changes version of the original text of tables and figures is helpful.)

■Confirmation that there are no additional errors.

■Indication of whether the errors change the statistical direction of the results, interpretations, and conclusions

■Letter of explanation summarizing all the above from all authors to be considered for publication

The editor should then re-review the published work, authors’ explanation, and marked-up copy of the original article identifying all errors and corrections. This review may include additional external peer review or statistical review. If the editor then determines that the science of the article is still reliable and important, a formal Notice of Retraction and Replacement as a Letter from the authors may be published. The JAMA Network journals and The Lancet journals have published such notices and have replaced or republished the original article along with online supplements that include a version of the original retracted article showing the original errors and a version of the replacement article showing what was corrected.⁴²^,⁴³^,⁴⁴^,⁴⁵ This option provides authors who have made inadvertent pervasive errors that have resulted in changes to results of published articles with a mechanism to retract the erroneous article without the “do not use” stigma associated with retractions that are reserved for acts of fabrication, falsification, and plagiarism. The ICMJE supports this option.¹⁸

In these cases, online versions of journals and bibliographic databases should provide reciprocal links to and from the Notice of Retraction and Replacement (or Republication) and the retracted and replaced (or republished) article. In addition, a prominent notice should appear on the online and PDF versions of the article. See the following examples:

Lopes AC, Greenberg BD, Pereira CB, Norén G, Miguel EC. Notice of retraction and replacement. Lopes et al. Gamma ventral capsulotomy for obsessive-compulsive disorder: a randomized clinical trial. JAMA Psychiatry. 2014;71(9):1066-1076. JAMA Psychiatry. 2015;72(12):1258. doi:10.1001/jamapsychiatry.2015.0673

Kessler RC, Duncan GJ, Gennetian LA, et al. Notice of retraction and replacement: Kessler et al. Associations of housing mobility interventions for children in high-poverty neighborhoods with subsequent mental disorders during adolescence. JAMA. 2014;311(9):937-947. JAMA. 2016;316(2):227-228. doi:10.1001/jama.2016.6187

5.4.7 Allegations Involving Unresolved Questions of Scientific Misconduct.

Cases may arise in which an allegation requires the journal editor to have access to the data on which the manuscript or article in question was based. Following the recommendations of the ICMJE, JAMA’s authorship statement includes the following language for all authors:

I agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved; and

If requested, I shall produce the data or will cooperate fully in obtaining and providing the data on which the manuscript is based for examination by the editors or their assignees.

For discussion of reasonable time limits for which authors should keep their data, see 5.6.1, Ownership and Control of Data.

If an author refuses a request for access to the original data or if the author or the author’s institution refuses to comply with the journal’s request for information about the allegation, the journal and its editor may be left in a precarious position. The ICMJE and COPE recommend that journals publish an Expression of Concern detailing the unresolved questions regarding an allegation of scientific misconduct in their publications (see 5.4.5, Retractions and Expressions of Concern).¹⁸^,³¹

5.4.8 Allegations Involving Manuscripts Under Editorial Consideration.

In the case of a manuscript under consideration that is not yet published in which fabrication, falsification, or plagiarism is suspected, the editor should ask the corresponding author for a written explanation. If an explanation is not provided or is unsatisfactory, the editor should contact the author’s institutional authority (ie, dean, director, ethical conduct/research integrity officer) or governmental agency with jurisdiction to investigate allegations of scientific misconduct to request an investigation. In all such communications with authors and institutional authorities, the editor should take care to maintain confidentiality and should follow the same procedures described in 5.4.4, Editorial Policy and Procedures for Detecting and Handling Allegations of Scientific Misconduct. If the author’s explanation or institutional investigation demonstrates that the misconduct did not occur, the editor should continue to consider the manuscript on its own merits. If the author’s explanation or a formal investigation demonstrates misconduct, the editor should then reject the paper. However, rejecting and returning to an author a manuscript associated with suspected or confirmed misconduct without addressing the possible misconduct issues is inappropriate because it may result in the work being published elsewhere.³¹

Principal Author: Annette Flanagin, RN, MA

Acknowledgment

I thank the following for review and helpful comments: Howard Bauchner, MD, JAMA and JAMA Network; Carissa Gilman, American Cancer Society, Atlanta, Georgia; Timothy Gray, PhD, JAMA Network; Iris Y. Lo, JAMA Network; Ana Marušić, MD, PhD, Journal of Global Health and University of Split School of Medicine, Croatia; Chris Meyer, JAMA Network; and Fred Rivara, MD, MPH, JAMA Network Open and University of Washington, Seattle.

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AMA Manual of Style - Stacy L. Christiansen, Cheryl Iverson 2020

Scientific MisconductEthical and Legal Considerations

Scientific Misconduct
Ethical and Legal Considerations