Publication Ethics.

INTRODUCTION

“Publish or perish,” has for long been a buzzword for people in academics. Compulsion to publish may at times be a matter of survival for some to remain in the mainstream, for others it may be a matter of sheer ambition, but it is also a duty to publish information which may have larger implications. Published materials represent a record of new knowledge, new perspectives, and new outlooks. The word publication essentially means “the act of making public” such information or content which hitherto has remained private to a group of people or an individual. Therefore, publication entails being responsible to both the author and the reader; the creator of the content of the published material as well as to all potential recipients of such published information. It is the duty of the publishers to ensure that all published material is valid and true to the best of their judgment, obtained through ethical means and also to ensure that due credit is given to all authors in proportion to their contribution, which in effect means making them responsible and accountable. Since knowledge is power, only a valid piece of knowledge can empower us to deal with vagaries of life in times of crises. To fulfil these responsibilities, the publishers have to allow themselves to be regulated by an internal set of rules, evolved, and adopted consensually by the publishing fraternity. This is what Publication Ethics is. They are very important because formal laws do not provide all the answers to issues of concern and leave many grey and gap areas. Various aspects of such ethical principles are being discussed below.

ISSUES IN CONDUCTING RESEARCH

Issues relating to ethical approval of psychiatry research projects

While the general ethical considerations of autonomy, beneficence/nonmaleficence and justice/equality apply to any research on patients with mental illness, there are two key additional issues that are unique to research in psychiatry. First, people with mental illness represent a distinctively vulnerable population; these people may have impairments in several cognitive domains such as attention, executive functions, judgment that interferes with their abilities to make informed decisions about their participation in research. This may potentially violate the fundamental ethical principle of autonomy and calls for better oversight with regards to safeguarding the interests of this group.

Second, the stigma surrounding mental illness often results in marginalization of those affected. Consequently, these individuals have reduced access to sources of support and resources for redressal of grievances; this may violate the cardinal ethical principle of justice/equality. These issues also place greater responsibility on the investigators to protect the privacy and confidentiality of patient data obtained for research purpose.[1]

Table 1 lists ethical concerns in some commonly encountered scenarios and suggests possible solutions to address them.

Table 1

Case scenarios depicting possible ethical issues and solutions

Case scenario	Ethical issues	Possible solutions
Spouse of a person with mental illness who lacks decision making capacity may coerce the patient to participate in a research project that provides financial incentives to its participants	Violation of patient autonomy and principle of nonexploitation[26]	Financial incentives for participation must be a reasonable amount and not excessive so as to be inherently coercive
	Possible conflict of interest for the investigator who has to balance the desire to recruit more study participants against the obligation to act in an unbiased manner[1]	The patient may be asked to frame research advance directives to clarify whether or not he/she would like to participate in research at a later point in time or nominate a surrogate decision maker who may make decisions related to research participation on their behalf
		The decision-making capacity of the surrogate decision maker must also be assessed including their motivation to consent on behalf of the patient and understanding of the benefits of research
The investigator proposes a research question that is not relevant or does not sufficiently add to the state of knowledge in the field or poses risk of harm to the patients (e.g., adverse effects of a drug)	Violates the principle of essentiality in medical research - every proposed research should be deemed to be absolutely essential in order to add to the existing body of work and knowledge in the proposed area[26]	IRB members need to co-opt members with specific expertise in the field when proposals related to mental health are discussed; if the proposed research does not sufficiently advance knowledge in the field, then it must not be approved
	Patients need to be fully apprised about the associated risks and benefits of the study during the informed consent process; they should have the right to terminate the trial at any time during the study period without any prejudice to their ongoing care or treatment in any manner	There must be a provision to monitor patients regularly for adverse effects in any interventional trial and for withdrawal of participants from the study in case of adverse effects
		Any adverse event must be brought to the notice of the IRB immediately
		Provision of DSMB for sponsored clinical trials; this board will monitor data integrity, periodically assess potential risks to participants, and recognize when the study needs to be stopped or revised
“There are no ethics committees in my institution. So, I can proceed without obtaining ethics approval”	The investigator may not know that he/she has other options available for obtaining ethical approval and may proceed to conduct the research assuming that since there is no such committee, no such approval is required	Such investigators may approach independent ethics committees of the nearest appropriate institution or private ethics committees to get their research proposal approved. Note that in both these options, the committees may charge a sitting fee for discussing the proposal
	Serious ethical violations can lead to problems both for the investigator as well as his/her institution	The investigator may also constitute an independent ethics committee in accordance with the guidelines and mandates laid down by the ICMR for the constitution and functioning of ethics committees
“I am doing a research using secondary data (for instance, data contained in publicly available clinical, administrative and national health databases such as cancer registries). Since I am not directly contacting anyone and collecting data, I do not need ethics approval”	The ethical issues involved are of three broad categories – issues related to the individual whose data is contained within the scrutinized records (e.g., privacy/confidentiality/harm); issues concerning the owner of the data (e.g., access and copyright) and finally, issues surrounding the accuracy and scientific validity of the data intended to be used (e.g., completeness, representativeness etc.)[27]	Ultimately, it is the responsibility of every investigator to know what kind of projects require ethical clearance and what kind of projects do not
		When in doubt, it is always safer to approach an ethics committee and get the proposal formally scrutinized
		All medical faculty members of the independent ethics committee as well as aspiring researchers must undergo training in bioethics in order to facilitate a good grasp of ethical issues involved in various kinds of research projects
	Due to the above issues, even such research requires scrutiny by an independent ethics committee

IRB – Institutional review board; DSMB – Data safety monitoring boards; ICMR – Indian Council of Medical Research

Informed consent

Obtaining informed consent from the patient is a fundamental component of sound ethical research. The process of consenting participants for any medical research has three essential elements:[2]

Information disclosure-about all the potential risks and benefits associated with the research and compensation mechanisms thereof

Competence-referring to the ability of the potential participant to understand the information presented, process the study risks and benefits explained, think rationally, and evaluate the choices; arrive at a reasoned decision; understand the impact of the decision in the context of the patient’s life circumstances and communicate this decision to the treatment team or, in other words, the decisional capacity of the individual[3]

Voluntariness-implying that patient participation in research occurs without coercion.[4]

It has been estimated that only 20%–30% of patients with mental illness lack decisional capacity as a result of impairment in mental faculties.[5] In instances where the patients lack competence, a commonly accepted practice is to obtain informed consent from a legally accepted representative (LAR) who will act as surrogate decision makers on behalf of the patients; in the Indian context, the LAR is usually the spouse or guardian of the patient. This is an ethically proper and appropriate alternative provided the process of obtaining LAR consent meets two primary standards.

First is the principle of “substituted judgment”– this aphorism essentially mandates that the LAR, at all times, exercise the choice that the patient would have exercised if he/she were not impaired and could have exercised their choice; in other words, the LAR has to think like how the patient would have thought and make a decision that is consistent with the patient’s preferences, had he/she been well enough to execute their preferences themselves. The second standard is that of the individuals “best interests”– this means that the LAR exercise his/her choice in the best possible manner that he/she believes would further the interests and well-being of the patient under their care.[67]

An alternative approach is to make use of psychiatric advance directives for research participation if available;[16] these may either be incorporated into the general advance directives or patients can prepare a specific and exclusive advance directive that addresses their preferences for participation in research. Table 2 lists some of the common myths associated with the informed consent process in mental health research and some recommendations.

Table 2

Common myths associated with the process of informed consent in mental health research

Myth	Reality	Recommendation
“All patients with mental illness are incompetent to make decisions about participation in research”	Impairment of cognitive faculties due to mental illness occurs on a spectrum and presence of some mental health symptoms is not incompatible with decision making	Assess every patient individually for his/her competence and decision-making ability
		In addition to conversations or interviewing, provide research related information in various ways to the patient such as study information sheet, books, pamphlets, recorded videotapes of study information, and social media links to the study[28,29]
“Competence in decision making is stable over time in mental illness”	Competence in decision making is variable over the lifetime course of mental illness – there may be instances when the same patient is impaired to the extent of being unable to give consent and, at other times, recover sufficiently to regain competence in decision making[9]	Investigators may need to reconsent patients during the course of a study; for instance, if a patient regains decision making ability with treatment during the course of a study, investigators may reconsent the patient although initial consent for the study may have been provided by the LAR. Investigators must note that subjects retain the right to refuse or revoke consent given by the LAR at any later point of time if they regain decisional capacity
		Sometimes, continued consenting of patients may be necessary in situations where new information, that can potentially affect the safety and well-being of study subjects, emerges during the study
“If the patient is not competent to make decisions and there is no LAR to consent on behalf of the patient, such patients may need to be excluded from the study”	Such patients can be included without informed consent but with some caveats	In such cases, the investigator can proceed without obtaining informed consent “provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorized representative”[30]
“If a patient is unable to consent but able to give assent, then obtaining informed consent from LAR is enough to proceed”	Assent of the patient, in addition to consent from LAR is necessary	Clause no 28 of the WMA 2008 guidelines for ethical research states that “When a potential research subject who is deemed incompetent is able to give assent to decisions about participation in research, the physician must obtain the assent in addition to the consent from LAR. The potential patient’s dissent must be respected”[31]

LAR – Legally accepted representative; WMA – World Medical Association

Issues related to data confidentiality

Confidentiality and privacy are deep rooted principles in medical practice and research. It is the duty of every individual conducting research on human subjects to safeguard participant information and uphold confidentiality. It follows that adequate safeguards must be incorporated at every stage of research, the nature of which may vary according to the needs of the research. Box 1 outlines the various types of safeguards that can be implemented by researchers to protect the privacy and confidentiality of research subjects.

Box 1

Types of safeguards to protect data confidentiality in research[8]

Physical safeguards: These refer to steps taken to prevent unauthorized personnel from accessing confidential research data. Examples include securing the research or data room with access control lock, storing data in locked cabinets and keeping data away from common and easily accessible areas

Administrative safeguards: These refer to steps typically taken to specify the people who have access to the confidential research data. Generally, the more the number of people who have access to the private data, the more difficult it is to ensure confidentiality of sensitive participant data. Hence, only the requisite minimum number of research personnel must be allowed to access participant data

Technical safeguards: These involve the use of protective technological safeguards such as the use of firewalls and passwords, data encryption and other measures designed to prevent data hacking, theft and modification

Research design safeguards: These refer to measures that are inbuilt into the research design right from the planning and conceptualization stages to protect privacy of participant data. Examples of such measures include deidentification/anonymization of data, transcribing raw data on the same day or as soon as possible, destroying any paper copies of the data as soon as it is feasible and providing adequate training to data handlers to ensure compliance with these measures

Consent for privileged communication arising out of legal obligation must be obtained beforehand. In addition, the informed consent process must inform participants about the possibility of privacy breaches such as the possibility of data hacking. This may be particularly relevant in this era of electronic health information and online surveys where data are deposited in cloud storage platforms. Investigators must also note that there are special situations where the obligation to protect data confidentiality may be undermined or eclipsed by other considerations such as those outlined below:

If the research design undermines the investigator’s ability to preserve the confidentiality of the collected information – As an example, consider a qualitative study using the methodology of focus group discussion. Typically, in such a scenario, groups of 6–8 participants discuss their perspectives freely and share information with each other. In such a scenario, it is not possible to preserve confidentiality of information shared by one person. Further, though the investigator may take all adequate precautions to protect data confidentiality, it is not a given that other participants will do the same[8]

When there is a legal requirement to report – This could include situations where it is mandated by the law to disclose sensitive information obtained to oversight bodies. An example of this is the necessity to reporting any suspicion of child sexual abuse, obtained during the research process, to the Child Welfare Commission[9]

When the participant wishes to make their personal information known to others– When this happens after the research is underway, it behooves the investigator to respect the patient’s autonomy. However, in all such cases, the investigator needs to go back to the ethics committee to obtain approval to share the confidential information.[8]

RESEARCH MISCONDUCT

Research misconduct is defined as “behaviour by a researcher, intentional or not, that falls short of good ethical and scientific standards.”[10] It extends beyond the traditional fabrication, falsification, and plagiarism, to include several other questionable practices[10] [Table 3]. Research misconduct is important as it wastes resources, damages the credibility of science, and can cause harm (for example, to patients and the public).

Table 3

Types of research misconduct

Research misconduct	Examples
Fabrication
Falsification
Plagiarism
Redundant publication	Duplication, salami slicing
Selective or misleading reporting	Spin, hype
Authorship malpractice	Guest/ghost authorship, denying authorship
Funding disclosure	Failure to disclose, misreporting
Informed consent not taken
Ethics committee approval not taken
Miscellaneous	Peer review bias

Fabrication and falsification

Fabrication and falsification of data are considered major scientific misconduct. The Office of Research Integrity defines fabrication as “making up data or results and recording or reporting them,” whereas, 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.”[11] Table 4 summarizes examples of data fabrication and falsification.

Table 4

Examples of fabrication and falsification

Research misconduct	Examples
Fabrication	Manufacturing research data
	Creating datasheets without doing studies
	Creating graphs and images
	Creating informed consents
	Reporting studies that were never done
	Mentioning nonexistent studies in grant applications
Falsification	Alterations in data values
	Omitting outliers
	Image manipulations
	Changing the measurements

Fabrication of data is one of the most difficult to identify, unless a whistle-blower informs about it. However, this is highly damaging to science as other researchers make futile attempts to replicate the study findings. Occasionally, it is possible to identify data fabrication by carefully analyzing the data.

Redundant publications: Duplicate and overlapping publications, salami slicing

If the same content is published as separate manuscripts, it would lead to redundancy in publication. There are several different ways this can happen. If the exact paper is published in two journals, it is duplicate or dual publication. Sometimes, the content is not exactly the same, but there is a substantial overlap between the two, and the new paper does not have sufficient extra information to merit a separate publication. In such situations, it would qualify as an overlapping publication.[12]

At the other end, specifically with large datasets and multiple hypotheses, it may not be possible to include all the findings in a single manuscript. Dividing such data into more than one paper is logical and should not invite criticism. Usually, the published papers are cross-referenced in subsequent publications, thus ensuring transparency. However, if the division of data into small pieces is unwarranted and can be written as a single manuscript, but has been published as separate it is called salami slicing.[12] Just having large amount of data in terms for number of variables is not a defense for salami publications, as not everything that is recorded need to be published in the manuscript. Sometimes, the researchers add some new cases to an existing dataset (not more than half of original data) and publish as a separate manuscript. This is a specific form of salami publication, known as meat extender publication.[12]

The Ingelfinger rule states that a manuscript should be considered for publication if the data has not been published anywhere including reportage by newspapers.[13] The Committee on Publication Ethics (COPE) differentiates between redundant publication and salami publication based on the degree of overlap, i.e., if there is two third overlap in content then it is considered as redundant publication.[14] If there are two separate hypotheses in the same study, they may be published as separate papers and is not considered as salami slicing; however, if the questions are closely related they should be published as a single manuscript. Kumar et al.[15] suggested the following five criteria for redundant publication – ”the number or sample sizes are similar; the methodology is identical or nearly so; the results are similar; at least 1 author is common to both reports; and little or no new information is made available.” All the five criteria should be present to consider a publication as redundant.

The publications with appropriate division of data and duplicate publications lie on a continuum with varying degree of overlap, and salami publication lies somewhere between these extremes. Editors call this kind of unethical publications as “self-plagiarism.” Usually, redundant publications are done with an intent to increase the number of publications by the researcher in order to gain visibility, for promotions or attract funding. Sometimes, novice researchers in their ignorance submit manuscripts to separate journals simultaneously, which may lead to duplication. However, if done with an intent to increase publication counts, it is considered unethical.

Redundant publication increases the burden on peer reviewers and editors and leads to wastage of scarce resources. It also violates the copyright rules, as the published manuscripts become properties of the publishers. It also misleads the readers and may affect decision making based on the reported results.[16] Because of this duplicate publications and salami slicing are considered as a form of publication misconduct. Duplicate publications usually lead to retraction of papers with possible blacklisting of the researchers by the concerned journals. Sometimes the institution in which authors are working are informed regarding the misconduct which can adversely affect the career of the researchers.

There are some situations where duplicate publications are not considered unethical.[16] If the data is published as a conference abstract, it can be published separately as a full paper. It should be mentioned in the manuscript that the data has been shared in a conference and has been published as abstract. Other situations where duplicate publication is accepted is when the manuscript is published in another language which is intended toward a different audience. This should be done with permission from the editor and the publisher, and the original manuscript should be referenced. Sometimes, editors allow duplicate publications of guidelines which are intended toward different specialties.

One way to reduce redundancy in publications including salami slicing is to increase transparency by registering the study protocols in trial registries. It allows the editors, reviewers, and readers to cross check the manuscripts against the published protocols. It is mandated by the journals to confirm that the manuscript or part of it has been published before or has been submitted elsewhere for publication. It is the responsibility of authors to declare about previous publications from the same data during manuscript submissions, so that the editors, reviewers, and readers can evaluate the findings of the study on their merit.[16]

Selective reporting practices

Selective reporting practices includes any addition, deletion or alteration of the planned study elements while writing manuscripts [Table 5]. These are also called spin, and can be defined as “a specific reporting that fails to faithfully reflect the nature and range of findings and that could affect the impression that the results produce in readers, a way to distort science reporting without actually lying.”[17] This is done mostly with the aim to increase chances of publication, though this does not necessarily increase such possibilities. Such practices, however, increases false positives in research and could mislead readers. However, spin could be unconscious and unintentional, and could be legitimate in some contexts. For example, carrying out post hoc exploratory analyses may lead to new insights, however, they should be reported in a transparent manner.

Table 5

Types of selective reporting practices[17]

Selective reporting practices	Description/example
Misreporting the methods
Changing objectives	Change objectives to suit the results
Reporting post hoc hypotheses as if they were prespecified	Add hypotheses after seeing the results
Switching outcomes	Change the outcome measure
Switching analysis	Change the analysis
Masking protocol deviations	Not reporting changes in original protocol
Beautification	Report double-blind, but blinding is not credible
Misreporting results
Selective reporting of outcomes and analysis	Reporting some outcomes or analysis but not others, favoring significant results, ignoring results that contradict the initial hypothesis
P-hacking (selectively choose to report or focus on positive results), cherry picking	Unplanned interim analysis, excluding outliers from analysis, combine or split groups, adjusting covariates, performing subgroup analysis, choosing the threshold for dichotomizing continuous outcomes
Misreporting results and figures	Misleading display of results through choice of metrics and figures (a break in the y axis, not adding statistical uncertainty, alter the images using image-processing software)
Misinterpretation of data
Misinterpretations (HARKing, hypothesizing after results are known or JARKing, justifying after results are known)	Taking strong position based on opinion than actual results, inappropriate inference from a composite outcome, infer causality based on associations, extrapolate results beyond the data to a larger population, setting, or intervention, and provide recommendations for clinical practice
Rhetoric (using persuasive or impressive language)	Inflating the value (first time ever, clear answer, strong evidence), or deflating (inconsistent results, methodological flaws) in absence of evidence
Selective citing of references	To convey a desired message
Hype (inappropriate exaggeration)	Terms such as breakthrough, game changer, miracle, cure, revolutionary in conclusion, describing nonsignificant results as trends, underreporting adverse events, not acknowledging the major errors in study design

Impact of spin

Accurate reporting and interpretation of research results is essential for knowledge translation and has implications for the development of further studies, policies, and clinical practice. Spin can affect researchers, physicians, and even journalists who are disseminating the results, but also the general public, who might be more vulnerable because they are less likely to disentangle the truth. Patients who are desperately seeking a new treatment could change their behavior after reading distorted reporting and interpretations of research findings.

Methods to reduce spin

This ranges from raising awareness, registration of protocols, following reporting guidelines, and stringent peer- and editorial review[17] [Table 6]. Prospective registration is currently a mandatory requirement in all trial registries, including Clinical Trials Registry- India. This is a mandatory requirement for all the journals that follow the 2005 International Committee of Medical Journal Editors (ICMJE) policy.[18]

Table 6

Methods to reduce spin in research[17]

Methods	Description
Spin should be considered as a form serious research misconduct	Researchers, institutions, editors, and funders should recognize this as serious
	Increase awareness on misrepresentation or distortion of research in published reports
	Training of researchers to detect and avoid spin in published reports early in their research career
Protocol registration	Essential information on study design, methods, statistical analysis plan should be part of all research protocol
	All protocols must be registered in trial registry and accessible to public
	Protocols should be registered before the start of data collection, i.e., prospective registration
Data availability	Data should be made available in data repositories or from the researchers on request
	Raw data can be used to verify the results against the statistical analysis plan available in the protocol
Reduce bias	Although new findings including unexpected results are welcome, one must be aware of the following bias
	Apophia, i.e., the tendency to see patterns in random data
	Confirmation bias, i.e., the tendency to focus on evidence in line with expectations
	Hindsight bias, i.e., the tendency to see an event as being predictable only after it has occurred
Reporting guidelines	Reporting guidelines developed by EQUATOR network (www.equator-network.org) helps in complete, accurate, and transparent reporting
	Minimum set of information that should be systematically reported by authors for specific studies
	Endorsed by editors who require adherence to the guidelines for research publications
Peer-review	Peer-review of manuscripts is a safeguard against spin
	Specific peer-reviewer training may enhance the ability of novice reviewers to detect spin
	Tools may be made available to peer-reviewers and editors to facilitate the detection of spin
Editors	Editors should be held accountable for the content of a published manuscript
	The published research should be monitored regularly for spin through postpublication reviews as letters to the editors
Changing the reward system	The number of publications and the journal impact factor, against which researchers are evaluated is fraught with problems
	Transparent and open research which are more collaborative, than competitive, may reduce spin

EUAQTOR – Enhancing the Quality and Transparency of Health Research

ISSUES IN AUTHORSHIP

Background

A person who works to give shape to an original research work and takes pain to get it published would like to get credit of authorship in the published work. Apart from this simple and obvious reason, requirements for authorship may arise due to various reasons-promotions, improving academic credentials, to get better projects and so on. With increase in collaborative work, the days of single authors are a thing of the past. A research work these days involves a collective effort of several researchers right from conceptualization to funding, data collection, analysis and preparing the manuscript. Several individuals may get involved at various stages of research thus having varying contributions to the research. Apart from this, issues of “ghost authorship” and “gift authorship” have complicated the issue of authorship even further. In this background, the scientific community felt the need to clearly define what constitutes authorship (and obviously, what does not!).

Criteria for authorship

Although there are several criteria delineated across various journals to define authorship, most of the biomedical journals follow the recommendations of the ICMJE.[19] According to ICMJE, “authorship is based on the following criteria:

Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND

Drafting the work or revising it critically for important intellectual content; AND

Final approval of the version to be published; AND

Agreement 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.”

It is important to note that only those who fulfil all the 4 criteria should be designated as authors. Similarly, individuals fulfilling the criteria should not be deprived of due credit of authorship. Those who fulfil some but not all criteria should be acknowledged in the published paper.

Corresponding author

The corresponding author has to take the responsibility of communicating with the journal across all phases of publication including fulfilling submission requirements (conflict of interest [COI], ethical consent), addressing reviewer comments, fulfilling prepublication nitty gritties, and even answering postpublication queries and demands. He serves as the main source of communication on behalf of all authors with the editorial team. However, due to disputes arising at various stages, it is considered desirable if the journal sends a copy of their communication with the corresponding author at each stage to all the authors. This ensures greater transparency and accountability of all authors.

Order of authorship

It is desirable that the number of authors and the order of authorship including the extent of contribution expected from each author at various stages of work be decided at the beginning of the research work. Subsequent modifications, again based upon varying contributions of each, may be made prior to submission, based on mutual agreement. If change in authorship has to be made (including addition or removal of author) after submission or publication, then all the authors may submit a statement about their mutual agreement in the process (including the author whose name is to be added or removed). The editor of the journal is not expected to make a decision on disputes arising out of authorship issues. If the authors can’t reach an agreement, the issue is referred to the Head of the Institution where the work was carried out. The first author is usually the one who has made maximum contribution to the entire work. It is the most lucrative order of authorship because the work is often cited in the name of the first author. The corresponding author is often an administrative requirement of the journal editorial team. However, various promotion criteria in academic positions require contribution either as a first author or as a corresponding author. Hence, many consider this position important. Regarding the last author, it is often reserved for a senior author who plays a mentoring and supervisory role. However, the team of authors must ensure that even this position is not a result of “gift authorship” but be granted after fulfilling the required criteria for authorship.

Acknowledgment

Individuals who do not meet all the criteria for authorship but have otherwise made important contributions to the research work need to be mentioned in “Acknowledgment” separately. Such nonauthor contributions include getting funds for the project, performing statistical analysis, supervision of data collection, proofreading and so on. Since the acknowledged person may later be held responsible for certain parts of the work, it is desirable to have the written permission of the person concerned before including his name in acknowledgment.

Gift authors

Those authors whose names are included though they do not fulfill the criteria for authorship. This is either done on the basis of the individual’s power and authority (head of the department), to gain favor (publication in reputed journals based on position/contact of the person) or with the understanding that he will return the favor by extending gift authorship in his publications.

Ghost authors

Sometimes professional writers help in drafting and proofreading manuscripts against payment. Such writers are usually not acknowledged but it should ideally be done because they may have conflicts of interest. Ghost authors also refer to individuals who have contributed significantly to the study and fulfill authorship criteria but are not included in the list of authors. The second group is also known as “orphan authors.”

Best practice to prevent authorship disputes

For researchers

The research team must initiate discussion about authorship right at the beginning of research

The final list of authors, including the order of authorship, must be finalized before writing the research article

It is advisable to have a written agreement with signature of all authors.[20]

For journals

The journal must ask for a signed statement wherein all authors shall confirm to what extent they have participated in each aspect of the research work. This has been recommended by ICMJE

The corresponding author must be made to inform the journal regarding any previous submission in another journal, any subsequent change in authorship, use of any professional editorial services, or any other undisclosed COI

The journals should commit to use of Contributor Roles Taxonomy wherein the authors’ contributions across various roles are included in journal metadata. If this is coupled with ORCID ID, it becomes easy to track the contribution of each author across publications.

When to suspect authorship issues?

The list of authors is unusually too long or too short

The language of the manuscript does not match that of the cover letter

The article does not match the author’s area of expertise

Unusually prolific author

Authorship changes without notification during revision stages

Industry funded study with no author from Sponsor Company

Questionable roles of contributors

The corresponding author seems unable to reply to reviewer’s comments

Tracking in manuscripts show that authors have been added or removed

Similarity check shows that the work is derived from a thesis where the original researcher has not been included.

How to handle authorship disputes?

Authorship disputes may arise pre- or post-publication. If the issues are minor involving request for change of spellings of name or affiliation, it may be resolved at the editor’s discretion in communication with the corresponding author. However, it is desirable to get the signature of all authors agreeing for the desired change. Requests for change in terms of addition or removal of authors or change in order of authors should be entertained after proper justification along with a signed statement from all authors. Disputes regarding suspicion of ghost/gift authorship or omission of individuals from list of authors should be addressed as per the COPE Flowcharts.[21] It is desirable to hold the publication of an article till the authorship issue is resolved in case of prepublication disputes. If postpublication disputes can’t be settled at the level of the authors, it is better to refer it to the Head of the Institution in which the research was conducted. Rarely, the journal ombudsman may be asked to intervene.

PLAGIARISM

What is plagiarism?

World Association of Medical Editors define plagiarism as, “The use of others published and unpublished ideas or words and or other intellectual property without attribution or permission, and presenting them as new and original rather than derived from an existing source”.[22] The COPE defines plagiarism as, “Plagiarism ranges from the unreferenced use of others’ published and unpublished ideas, including research grant applications to submission under “new” authorship of a complete paper, sometimes in a different language. It may occur at any stage of planning, research, writing, or publication. It applies to print and electronic versions.”

Easy availability of electronic journals, pressure to publish more in a short span of time, and the inherent “easy way out” through “copy-paste” are some of the factors which are responsible for increase in plagiarism among young researchers. Sometimes, lack of adequate knowledge also leads to plagiarism because many young authors feel that “lifting” portions of published work is fine as long as the source is cited.

Types of plagiarism

Based on intent-It can be “intentional plagiarism” when large portions of the text are deliberately copied without citation or referencing with an intent to deceive. “Unintentional plagiarism” may occur due to inexperience leading to copying of large portions of text without proper acknowledgement. The distinction becomes obvious if the authors cite the source but copy large portions verbatim without proper paraphrasing or using quotation marks. However, if the source is not cited at all, the distinction becomes blurred.

Based on nature of plagiarized portion

Plagiarism of text – This is the most common form of plagiarism when a portion of the text, including sentences and paragraphs are copied “intact” from another source with or without citing the source

Plagiarism of ideas – It is often difficult to prove as the idea stolen is not something, which is amenable to “obvious detection.” For example, if a reviewer borrows an idea from a submitted article (which does not get published somehow) and goes ahead to make his own research paper out of it without acknowledging the original source

Patchwriting or “mosaic plagiarism” – This involves copying portions of other people’s works and rewriting them by changing important words, phrases, or sentences. The author claims the work to be his own and it is difficult to detect by using the plagiarism-check software. However, a careful analysis often reveals the “pattern of lifted portions”

Self-plagiarism deals with copying of one’s own work without citation. This has been discussed in detail elsewhere in the chapter.

Important factors to be considered after detecting plagiarism

There are different factors, which are to be considered before determining how serious the plagiarism is.[23] It does not depend only on the length of text.

Extent – Copying of entire paragraphs word for word without citation would constitute major plagiarism whereas copying a string of words or phrases with proper citation should be dealt with by asking the authors to change the plagiarized portion by proper paraphrasing

Originality of the copied material should also be considered and not just the extent

Position/context – This is of utmost importance. The methodology section of research papers may have similar ways of describing certain research designs. This will not constitute plagiarism as long as it remains the best way to describe a research methodology. Similarly, references cited in the bibliography section may show similarity with previously published references. This will also not constitute plagiarism. However, similar portions in introduction, results and discussion section should be taken more seriously

Referencing – If the “similar text” has been referenced, it is considered lesser offence than a text which has not been attributed

Intention – The intent to deceive is a much greater offence than a careless mistake. However, it may be difficult to establish because when caught with plagiarism, many authors justify their act as “unintentional”

Seniority – A senior and experienced author will be more liable to be rebuked for an act of plagiarism because he can’t justify it as an “unintentional act” arising out of inexperience

Language – It often becomes difficult for a researcher writing in another language (which is not his native language) to look into the subtle aspects of “similarity in text”. The editors often give due considerations in such cases. Another important aspect of plagiarism involves translation into another language without citing the sources. This type of plagiarism will usually not be detected by the plagiarism detection software which is programmed to detect similarity in texts of same language.

How much of similarity in text will constitute plagiarism?

A typical similarity score that is quoted by most authorities is 15%. It is deemed ideal to keep the similarity score below that. However, as discussed previously, the similarity in text should not account for overlaps in methodology and reference sections. Thus, the abstract, introduction, results and discussion/conclusion sections are to be assessed more carefully. Standard plagiarism detection software highlight the similar portions in various colors, each color denoting a particular source. One has to check manually whether the highlighted portions have been adequately cited or put under quotation marks. Otherwise, those areas either have to be adequately cited, paraphrased, or put in quotation marks. Thus, the overall score is an indication but lower similarity score does not mean that plagiarized portions do not exist in the text or these should be ignored.

How to avoid plagiarism in scientific writing?

Whenever in doubt, it is better to cite a source

Do not copy text verbatim even if you are citing the source; learn to paraphrase the idea or comment and then cite the source

If you have to copy text word for word (in case of definitions, for example), always put them under quotation marks and then cite the sources

It is always advisable to put your manuscript through plagiarism check software and taking appropriate corrective measures before submitting it to a journal.

Steps to be taken when Plagiarism is detected in a submitted/published manuscript

According to the COPE Guidelines, major plagiarism involves “unattributed copying of another person’s data/findings, or resubmission of an entire publication under another author’s name (either in the original language or in translation), or verbatim copying of >100 words of original material in the absence of any citation to the source material, or unattributed use of original, published academic work, such as the structure, argument or hypothesis/idea of another person or group where this is a major part of the new publication and there is evidence that it was not developed independently.” As per COPE, minor plagiarism constitutes, “verbatim copying of <100 words without indicating that these are a direct quotation from an original work (whether or not the source is cited), unless the text is accepted as widely used or standardized (e.g., the description of a standard technique) or close copying (not quite verbatim, but changed only slightly from the original) of significant sections (e.g., >100 words) from another work (whether or not that work is cited)”. Based on these broad guidelines, the editorial team of the journal decides which category the article falls in. In case of minor plagiarism in a submitted article, the author is asked to make necessary corrections. In case of minor plagiarism in a published article, author needs to be contacted and a correction needs to be published in the next issue. In case of major plagiarism, the journal editor must contact all authors and seek explanation. The head of the institution must also be informed. If the article has already been published, then it must be retracted. If images have been published without permission, the author should be asked to seek permission from copyright holder. If permission is not granted, the image has to be withdrawn and an apology has to be issued.

CONFLICT OF INTEREST

What is conflict of interest?

“Interest” may be defined as an objective, commitment, or value held by an individual, group of people, or institution and has an impact on them. Examples include desires to conduct a meaningful study, obtain a promotion, garner fame, or increase income. COI is a situation where two or more contradictory interests exist and compromises have to be made as a consequence. When, as a clinician, you want a patient you treat to improve, and on the same patient, you want to study the effectiveness of a new medication, we have an example of a COI. In research, COI exists when a researcher, author, reviewer, or editor has some other interest that could hamper their impartiality or maliciously influence their decisions or actions.

Types of conflict of interest

COI can take different forms:

Financial (e.g., sponsorship or funding obtained for the study, receiving payments for travel or speaking engagements, having financial interests in the outcome of the research as in researching the effectiveness of a molecule when you have stocks in the company that produces it.)

Personal (e.g., a peer reviewer assessing a manuscript or grant application from someone who had defeated him in an election.)

Professional (e.g., a researcher yearns to get statistically significant and exciting results so that the paper can be published in a journal that meets the Medical Council of India criteria for promotion.)

Emotional (e.g., a senior researcher asking her students to be participants in her study and they reluctantly oblige, fearing repercussions)

Ideological (e.g., an ardent atheist researching the effectiveness of prayer).

Consequences of conflict of interest

Researchers with COI have been found to be more likely to choose control interventions that have higher chances of yielding favorable results, selectively publish favorable outcomes only, publish study conclusions that are not consistent with the results, decide not to publish studies with unfavorable results, or favor certain interventions in systematic reviews or clinical practice guidelines they author.[24]

How researchers can identify their conflict of interest

The existence of a COI per se is not a bad thing. However, the researcher has to make appropriate revelations about the same and take possible precautions. The below points should be kept in mind when judging whether a certain matter is to be considered a COI or not:

Do not conclude yourself that the money involved is too small to be mentioned as a COI. An amount you feel is unimportant may be regarded as very important by someone else

If the relationship is revealed later, will that make a reasonable reader feel deceived or misled?

As the U. S office of research integrity says, “if in doubt, disclose.”

Researchers conducting clinical trials can use “The Financial Conflicts of Interest Checklist 2010” to identify and record their COIs in the various stages of the research.[25]

How should researchers handle their conflict of interest

Researchers should disclose COIs as and when they arise, even if they feel that the COI will not affect the integrity of the study. Disclosure should be done to sponsors, co-researchers, Institutional Ethics Committee (IEC), study participants, and journal editors. When the study is in progress, the researcher may decide not to take part in discussions or decisions on matters that may be potentially influenced by the COI and excuse themselves from such activities related to that research.

While submitting the paper to a journal, as per the journal’s instruction to authors, mention the COI in the cover letter, first-page file, or a footnote, or upload the ICMJE (International Council of Medical Journal Editors) COI form as a supplementary file. If there is no COI, write something like, “To the best of our knowledge, the named authors have no financial or other COI.” In the case of funded studies, identify the sponsor and explain the degree of support they provided and the role they had in the research process (i.e., designing the study; collection, analysis, and interpretation of data; writing of the report; the decision to submit the report for publication, etc.,). Also mention, if such is the case, that the IEC has reviewed and approved the financial contributions.

Journals may use the COI as a basis for editorial decisions and publish them along with the article.

CONSEQUENCES OF RESEARCH MISCONDUCT

If concerns of ethical misconduct are raised after the publication of an article, most journal editors follow procedures suggested by the COPE. They may inform the authors’ institutions and funders about the matter and also adopt the following approaches:

Withdrawal

Articles that have been accepted, but not published, will be marked as withdrawn.

Expression of concern

If editors feel concerns about the ethical aspects of an article they published and perceive that the readers should be made aware of potentially misleading information it contains, and if an investigation has been inconclusive but strong indicators remain that the concerns are valid, they may publish an expression of concern. Very rarely, they may issue an expression of concern even while an investigation is underway itself if they anticipate that a decision will take considerable time.

Retraction

If ethical issues like data fabrication, redundant publication, plagiarism, inappropriate authorship, etc., are revealed after the publication of an article, the journal editors may retract the article. Before retraction, the authors will be given an opportunity to provide an explanation. The editor or the publisher may conduct their own investigations into the matter and/or request the authors’ institution to do so. If a decision to retract is finalized, the authors, and sometimes their institutions, will be informed of the same. Retraction notices are then published on the journal website and in the next print issue. Usually, the article will not be removed from the journal website, but a “Retracted” watermark and a link to the retraction notice will be added to it. If the authors of the articles are unwilling or unable to be named as authors of the retraction, the editor may accept retractions by other responsible persons, or the editor may be the sole author of the retraction.

In circumstances in which no misconduct is proven, the journal may publish an exchange of letters to the editor so that matters of debate can be highlighted to the readers.

The term predatory journals refer to those that charge an article processing fee and may, often, invite authors to publish in them, but do not adhere to the standards and best practices adopted by legitimate scholarly journals such as peer reviews and editorial oversight. Currently, there are more than 8000 actively functioning predatory journals and hence, it is important for prospective authors to be aware of the ethical issues involved in publishing[22] and associating oneself with these illegitimate journals [Box 2].

Box 2

Ethical issues in publishing in predatory journals

• Misinformation and misrepresentation: Predatory journals often present distorted information about their goals, roles, and services offered; often they prioritize self-interest at the cost of scientific rigor

• Deviation from global best practices in scholarly publishing: These journals lack mechanisms such as peer review and editing which may result in published work that is lacking in both scientific quality and ethical tenets

• Lack of transparency in journal policies: These journals often do not clearly and transparently display publishing fees, policies and procedures on their websites; this may mislead gullible authors

• Lack of recognition for published work: A published article in a predatory journal does not hold the same prestige as in other legitimate journals; this is a serious ethical issue that involves wastage and lack of due credit for funding and effort expended for the study

• Self-citations to boost impact: Many predatory journals explicitly encourage and often demand papers from their journal to be cited by authors submitting to them, presumably to bolster their impact factor. This undermines the confidence that the reader and the lay public have in the published literature

• Lack of archived content: Predatory journals rarely archive their content in third party sites, thus rendering their content inaccessible for future scrutiny

CONCLUSION

Publication is a complex and responsible job. It has to be objective, impartial, judicious, and comprehensive. It is the responsibility of the publishers to ensure that the published material is valid and true, obtained through methods in keeping with the accepted principles of ethical guidelines. All the authors must be given due credit for the work in proportion to the significance and quantum of their contribution. In this whole process, a large number of areas have to be attended to as has been detailed in the chapter. Possibilities for digression and deviations from the accepted principles are many, against which due precautionary and corrective measures have to be taken. A good publication is a resource and an asset of lasting value.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.