Editorial Ethical Issues in Biomedical and Publication

(BIRDEM Med J 2018; 8(1): 1-8)

“Ethics” in simple terms is defined as “norms for obligation to ethics and ethical issues are prerequisite conduct” that distinguishes between acceptable and to be generated among scientific community,teachers, unacceptable behavior. Though ethical norms are learnt postgraduate and graduate students and professionals since childhood at home, school, religious places, etc., engaged in sponsored or selfsponsored research about it is influenced throughout the life, impacted by various what constitutes “research misconduct” and life experiences which explain the large variations in “deviations,” so that one can guard against these and interpretation of ethical norms among individuals. follow the ethical norms while perusing research/ Ethical norms related to biomedical research and publication as well as while reviewing articles submitted publication are laid down by various national and for editorial review. international agencies. The Nuremberg Code and In relation to biomedical research and publication, it by World Medial Association has several perspectives for which a researcher needs is the landmark in ethical standards followed all over to be knowledgeable and sensitive. These are:(i) the world for biomedical research and uniform Research design: Careful approach to research design, requirements for manuscripts submitted to biomedical data collection and interpretation.(ii) Confidentiality: journals (formulated by International Committee of Maintaining confidentiality of research subjects and Medical Journal Editors) for publication. personnel records.(iii) Acknowledgement: Always acknowledging the source; using scientific materials The best evidence shows that misconduct is a very rare without acknowledging the source amounts to occurrence in research and there is no evidence that plagiarism.(iv) Knowledge advancement: Aim to science has become ethically corrupt. The rate of advance knowledge and research and not one’s career. misconduct has been estimated to be as low as 0.01% Avoid temptation for duplicate publication of the same to as high as 1% of researchers per year. According to research in different journals or in different languages, the “bad apple” theory, most scientists are highly ethical. without proper declaration to the effect.(v) Risk/benefit: Only those who are morally corrupt, economically Protect the subjects/patients included in the research desperate (in cases of grant application), or study, minimizing risks and maximizing benefits, psychologically disturbed will commit misconduct. specially the vulnerable population. Informed consent of the patient/guardian (in the case of minors) in the Research and publication play a very vital role in presence of witness is absolutely essential to protect progress of sciences in any field. As publication of the interests of the human subjects enrolled in the scientific papers is now linked to professional career study.(vi) Animal design: Design animal experiments up gradation, the pressure for publication of papers is only if absolutely necessary and meaningful. Show tremendous. Postgraduate teachers lack adequate proper care and compassion and minimize pain and experience themselves and time to guide the students suffering during the experiments. into research design, its execution, analysis, and more importantly, into research norms and ethics. In current PRINCIPLES OF WRITING A SCIENTIFIC scenario, there is a real danger of compromising the PAPER scientific quality of research papers. We need to focuse Scientific research demands precision. on four general ethical issues: authorship, , should respect this precision in the form of clarity. The duplicate or repetitive publication, and conflict of scientific way of thinking and application of scientific interest. There is increased temptation to deviate from methods require honesty, criticality, trust, creativity and the ethical norms for research and publication. Hence, openness. Acceptance of these principles are desirable Birdem Medical Journal Vol. 8, No. 1, January 2018 prerequisites for successful engagement in science by characteristics of the sample (experimental group, students and young researchers.These help qualifying controls, and their properties). It is necessary to explain research institution that produces competent promoters what is researched, asked, tested as follows: Sampling (initiators) for the future technological cultural and (random, consecutive, and representative), the sample political development of society. Defining principles of size (patient gender, age), the control group, and the good scientific and good laboratory practice should criteria for exclusion from the study, the control group encourage the development of standardized principles if any.It should be described how the research was done: and guidelines for accurate and quality data in scientific Type of study (prospective, retrospective or combined), research. data collection (surveys, inventory or checkup), the The text of observational and experimental articles: technique of measuring results (operative treatment, is usually divided into sections in accordance with so laboratory tests). It is necessary to specify where the called “IMRAD” structure: Introduction, Methods, research was conducted. . Results, and Discussion. Papers related to Result: Results are an important part of writing an programs and practice might have different than IMRAD article. The research results are usually most carefully structure (drug). There is a key question for each section read and should be a detailed plan, welldocumented of the IMRAD structure of the paper, which an author Discussion: Discussion is a critical review of the data needs to keep in mind, while writing the manuscript. described in the results. The results should be compared Title of the scientific paper: contains a brief description with other findings and discuss the theoretical and of the content. The title should accurately describe the practical research outcome. It should point out gaps with content of the article. There are two types of titles: explanation. Indicative title talks about the work that covers and Conclusion: Conclusion should be short, clear and informative titleconvey the message of the article and precise. It is necessary to make the final statement of recommended for beginners. A good title should be: (a) what logically follows from the results of the work, list Short, (b) correct, (c) clear, (d) complete, (e) informing, only the most important and give the message. Good (d) attractive. It should also include: Characteristics of conclusions should not surprise attentive reader. The the article, showing what is most important in the work. reader should get the impression that he himself had It is necessary to specify the names of the authors and written it. their affiliations. References: References should be in accordance with /summary and title can be written in two the instructions provided by the journal, and otherwise forms: Reference and Information. It can be written in used Vancouver or Harvard citation style. author’s native language and English. ETHICAL PRINCIPLES FOR MEDICAL The structure of the summary should look like this: RESEARCH INVOLVING HUMAN SUBJECTS Introduction, goal, materials and methods, the location The World Medical Association (WMA) has developed of the study, measuring the outcomes of the study, the the Declaration of Helsinki {http://www. results and conclusions. hopitalmontfort.com/en/neweditiondeclaration Summary: Summary is the distillate of which will be helsinki1] as a statement of ethical principles for medical presented and should show: What has been done, what research involving human subjects, including research are the results, what the results means. on identifiable human material and data. Consistent with Introduction: Writing an introduction has its own rules: the mandate of the WMA, the declaration is addressed A clear definition of a the problem, why exactly this primarily to physicians. issue was explored, there is no need to explain what General principles can be found in the textbooks, do not need to explain The Declaration of Geneva of the WMA binds the the terms of the title. physician with the words, “The health of my patient will Materials and Methods: Materials and Methods be my first consideration”, and the International Code describe how the study was conducted and the of Medical Ethics declares that, “A physician shall act

2 Editorial in the patient’s best interest when providing medical Transparency care”. Sources of funding for research or publication should Medical progress is based on research that ultimately always be disclosed. Editors should state this directly must include studies involving human subjects. Medical in their editorial policy. Authors should routinely include research is subject to ethical standards that promote and information about research funding in all papers they ensure respect for all human subjects and protect their prepare for publication. Where a health and rights. It is the duty of physicians who are registration number is available, this should be included. involved in to protect the life, health, dignity, integrity, right to selfdetermination, privacy, Authorship acknowledgment and confidentiality of personal information of research The International Committee of Medical Journal Editors subjects.. (ICMJE) provides a definition of authorship that is applicable beyond the medical sector. The ICMJE Physicians must consider the ethical, legal and authorship criteria state ‘Authorship: regulatory norms and standards for research involving human subjects in their own countries as well as National institute of health (NIH) in its “Guidelines for applicable international norms and standards. Medical Conduct of Research” have recommended that1. research involving human subjects must be conducted (Authorship): What is authorship? only by individuals with the appropriate ethics and In the literary world, an author is someone who creates scientific education, training and qualifications. a written work. In the academic research world, however, Research registration and publication and dissemination an author is much more of results According to the Uniform Requirements for Every research study involving human subjects must Manuscripts Submitted to Biomedical Journals, . be registered in a publicly accessible database before (promoted by the International Committee of Medical recruitment of the first subject. Researchers, authors, Journal Editors (ICMJE). sponsors, editors and publishers all have ethical Designation as an author must satisfy four conditions. obligations with regard to the publication and Author: The author must have: dissemination of the results of research. Sources of funding, institutional affiliations and conflicts of interest 1. Contributed substantially to the conception and design must be declared in the publication. Reports of research of the study, the acquisition of data, or the analysis and interpretation not in accordance with the principles of this declaration should not be accepted for publication. 2. Drafted or provided critical revision of the article 3. Provided final approval of the version to publish PUBLICATION ETHICS depends, to a great extent, on trust. 4. Agreed to be accountable for all aspects of the work Editors trust peer reviewers to provide fair assessments, in ensuring that questions related to the accuracy or authors trust editors to select appropriate peer reviewers, integrity of any part of the work are appropriately and readers put their trust in the peerreview process. investigated and resolved Academic publishing also occurs in an environment of Authors of research papers should state whether they powerful intellectual, financial, and sometimes political had complete access to the study data that support the interests that may collide or compete. Good decisions publication. Contributors who do not qualify as authors and strong editorial processes designed to manage these should also be listed and their particular contribution described. This information should appear as an interests will foster a sustainable and efficient publishing acknowledgment. Sample authorship description/ system, which will benefit academic societies, journal acknowledgment. Collecting authorship information for editors, authors, research funders, readers, and research papers, authorship should be decided at the publishers.Good publication practices do not develop study launch. Policing authorship is beyond the by chance, and will become established only if they are responsibilities of an editor. Editors should demand actively promoted. The general principles of publication transparent and complete descriptions of who has ethics are: contributed to a paper.

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Editors should employ appropriate systems to inform A possible measure against honorary authorships has contributors about authorship criteria (if used) and/or been implemented by some scientific journals, in to obtain accurate information about individuals’ particular by the Nature journals. They demand that each contributions. new manuscript must include a statement of Editors should ask authors to submit, as part of their responsibility that specifies the contribution of every initial submission package, a statement that all author. individuals listed as authors meet the appropriate Ghost authorship occurs when an individual makes a authorship criteria, that nobody who qualifies for substantial contribution to the research or the writing authorship has been omitted from the list, and that of the report, but is not listed as an author. Twothirds contributors and their funding sources have been of industryinitiated randomized trials may have properly acknowledged, and that authors and evidence of ghost authorship. contributors have approved the acknowledgment of their Anonymous/unclaimed authorship:Authors occasionally contribution. forgo claiming authorship, for a number of reasons. Manuscripts authored by a large group would need to Historically some authors have published anonymously list not only the name of involved organizations but also to shield themselves when presenting controversial the members who satisfy the four authorship criteria claims listed above. Authorship order: Rules for the order of multiple authors in a list have historically varied significantly 2. Acknowledgement: Those who do not meet these between fields of research. Some fields list authors in criteria but have still helped in some way to the study order of their degree of involvement in the work, with like providing technical help, writing assistance, or the most active contributors listed first; other fields, such Department/Institutional head for providing access to as mathematics or engineering (e.g., control theory), the institutional infrastructure for the conduct of the sometimes list them alphabetically.Historically research study, etc. should be relegated to the biologists tended to place a principal investigator acknowledgement section. (supervisor or lab head) last in an author list The following are some notable implications regarding If someone does not meet all four criteria to be named author order. as an author, the ICMJE recommends acknowledgment The “first author” is a coveted position because of credit instead of authorship the increased visibility., readers may falsely 3.Authors/Contributor: An approach suggested to associate the first author with someone having more resolve the conflict between credit and responsibility importance. for any research study is to designate “authors” as Traditionally, the last author position is reserved “contributors,” each required to list their specific role for the supervisor or principal investigator. As such, in the study . this person receives much of the credit when the research goes well and the flak when things go **4.Guarantor:one of the contributor/author may take wrong. The last author may also be the up “Guarantorship,” i.e., accountability for veracity of corresponding author, the person who is the data and ethical conduct of all aspects of the study. primary contact for journal editors. (Many reputed international journals like JAMA, Given that there is no uniform rule about author Nature, BMJ, etc. have adopted this approach.) order, readers may find it difficult to assess the Honorary authorship is sometimes granted to those nature of an author’s contribution to a research who played no significant role in the work, for a variety project. of reasons. The United States National Academy of To address this issue, some journals, particularly Sciences, however, warns that such practices “dilute the medical ones, insist on detailed author contribution credit due the people who actually did the work, inflates notes. Nevertheless, even this tactic does little to the credentials of those so ‘honored,’ and make the counter how strongly citation rules have enhanced proper attribution of credit more difficult the attention firstnamed authors receive.

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Common methods for listing authors others or by a commercial sponsor. Additionally, authors The following are some common methods for are expected to keep all study data for later examination establishing author order lists. even after publication.

1. Relative contribution. As mentioned above, the Attributing authorship to a group most common way authors are listed is by relative The ICMJE provides guidance for instances where a contribution. The author who most substantially number of authors report on behalf of a larger group of worked on the draft article and the underlying investigators.This guidance is applicable outside the research becomes the first author. The others are medical sector. ranked in descending order of contribution. International Committee of Medical Journal Editors However, in many disciplines, such as the life guidance states: “When a large, multicenter group has sciences, the last author in a group is the principle conducted the work, the group should identify the investigator—the person who supervised the work. individuals who accept direct responsibility for the 2. Alphabetical list. Certain fields, particularly those manuscript. These individuals should fully meet the involving large group projects, employ other criteria for authorship defined above… When submitting methods. For example, highenergy particle physics a group author manuscript, the corresponding author teams list authors alphabetically. should clearly indicate the preferred citation and should 3. Multiple “first” authors. Additional “first” authors clearly identify all individual authors as well as the group can be noted by an asterisk or other symbol name”. The individual authors who accept direct accompanied by an explanatory note. This practice responsibility for the manuscript should list the members is common in interdisciplinary studies; however, , of the larger authorship group in an appendix to their the first name listed on a paper will still enjoy more acknowledgment. visibility than any other “first” author. A REVIEWER 4. Multiple “last” authors. Similar to recognizing It is the professional obligation and essential duty toward several first authors, multiple last authors can be science to accept and to review the manuscript recognized via typographical symbols and pertaining to one’s discipline. It is an honor and a footnotes. This practice arose as some journals privilege to be asked to review a manuscript and should wanted to increase accountability by requiring not be taken as a burden. senior lab members to review all data and Reviewing involves evaluating the (i) scientific content interpretations produced in their labs. and quality of research, (ii) clarity and logic of 5. Negotiated order.. While there are clearer practices presentation, and (iii) ethical validity of the study. for designating first and last authors, there’s no It is not only the researcher but also the reviewer who overriding convention for the middle authors. The should adhere to high ethical standards. The reviewer list can be decided by negotiation, so sharpen those should provide accurate, courteous, unbiased, and persuasive argument skills! justifiable report on the submitted manuscript in a timely As it is evident that choosing the author order can be manner. It is unbecoming of a reviewer to make quite complicated; therefore, researchers should derogatory comments and personal attacks in review of consider these factors early in the research process. author’s submission and rejecting a manuscript for Don’t wait until the manuscript is drafted before you publication even without reading it. Still worse, some decide on the author order. unethical, unscrupulous reviewer can even try to block Responsibilities of Author: All authors, including co the publication and steal the idea and then take credit authors, are usually expected to have made reasonable by publishing it themselves. attempts to check findings submitted for publication. To guard against these possibilities, most journals send In some cases, coauthors of faked research have been the manuscript to 2 or 3 reviewers. It is also expected accused of inappropriate behavior or research that the manuscript copy is not retained and the data or misconduct for failing to verify reports authored by its interpretation is not used before the publication of

5 Birdem Medical Journal Vol. 8, No. 1, January 2018 manuscript, without prior permission of the authors. 3. The review process is conducted anonymously; However, the most important fact is that the reviewer Science never reveals the identity of reviewers to has highest standard of integrity and ethical principles. authors. The submitted manuscript is a privileged Peer review.: is the evaluation of work by one or more communication and must be treated as a people of similar competence to the producers of the confidential document. Please destroy all copies work (peers). It constitutes a form of self-regulation of the manuscript after review. Please do not share by qualified members of a profession within the the manuscript with any colleagues without the relevant field explicit permission of the editor. Reviewers should Professional peer review focuses on the performance not make personal or professional use of the data of professionals, with a view to improving quality, or interpretations before publication without the upholding standards, or providing certification. authors’ specific permission (unless you are writing Professional peer review is common in the field of health an editorial or commentary to accompany the care, where it is usually called clinical peer review article). Scholarly peer review (also known as refereeing) is 4. You should be aware of Science’s policies for the process of subjecting an author’s scholarly work, authors regarding conflict of interest, data research, or ideas to the scrutiny of others who are availability, and materials sharing. experts in the same field, before a paper describing this Protecting research subjects work is published in a journal or as a book. The peer Journals should ask authors to state that the study they review helps the publisher (that is, the editorinchief are submitting was approved by the relevant Research or the editorial board) decide whether the work should be accepted, considered acceptable with revisions, or Ethics Committee or Institutional Review Board. If rejected. human participants were involved, manuscripts must be accompanied by a statement that the experiments were Medical peer review may be distinguished in 4 undertaken with the understanding and appropriate classifications: 1) clinical peer review; 2) peer informed consent of each. evaluation of clinical teaching skills for both physicians and nurses;[17][18] 3) scientific peer review of journal Editors should reserve the right to reject papers if there articles; 4) a secondary round of peer review for the is doubt whether appropriate procedures have been clinical value of articles concurrently published in followed. If a paper has been submitted from a country medical journals.[19] where there is no Ethics Committee, Institutional Review Board, or similar review and approval, editors should Ethical Guidelines for Reviewers use their own experience to judge whether the paper 1. Reviews should be objective evaluations of the should be published. If the decision is made to publish research. If you cannot judge a paper impartially, a paper under these circumstances a short statement you should not accept it for review or you should should be included to explain the situation. notify the editor as soon as you appreciate the Research misconduct: Not following the above ethical .Reviews should be constructive and courteous and norms and scholarly conduct with an intent to deceive the reviewer should respect the intellectual is termed “research misconduct.” independence of the author. The reviewer should avoid personal comments; Science reserves the right THE MAIN FORMS OF SCIENTIFIC AND to edit out comments that will hinder constructive PUBLISHING MISCONDUCT discussion of manuscripts. The Oxford English Dictionary describes fraud as “wrongful or criminal deception intended to result in 2. Just as you wish prompt evaluations of your own financial or personal gain” and deceit as “the action or research, please return your reviews within the time practice of deceiving someone by concealing or period specified when you were asked to review misrepresenting the truth”. the paper. If events will prevent a timely review, it is your responsibility to inform the editor at the Research organizations and the literature have defined time of the request. these behavioral patterns within the umbrella title of

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“Research Misconduct”. Researchers rely on the published data, and have to be There are three major and most severe forms of scientific skilled to selectively process these data, to incorporate fraud, scientific and publishing dishonesty or previous knowledge into a new paper, and to distinguish misconduct, in proposing, conducting or evaluation of original ideas and research results from already research and presentation of the research results: publicized ones. Inventing data and results (fabrication); One more category in this is “Redundant (multiple) publication”- in which already published work is Alteration or changing the results (falsification); and republished with new additional data Plagiarism (plagiarism), including selfplagiarism Journal instructions should clearly explain what is, and (selfplagiarism), fragmented, repetitive and double what is not, considered to be prior publication. Journals publication (duplicate publication). may choose to accept (i.e. consider “not redundant”) In the process of publishing scientific papers, it is the republication of materials that have been accurately important to know how a completed research should be translated from an original publication in a different described in a scientific paper language. Journals that translate and publish material Fabrication: Fabrication is the practice of inventing data that has been published elsewhere should ensure that or results and recording and/or reporting them in the they have appropriate permission (s), should indicate research record. clearly that the material has been translated and re published, and should indicate clearly the original source Falsification : Falsification is the practice of omitting of the material. Editors may request copies of related or altering research materials, equipment, data, or publications if they are concerned about overlap and processes in such a way that the results of the research possible redundancy. Republishing in the same are no longer accurately reflected in the research record language as primary publication with the aim of serving Both of these schemes are probably among the most different audiences is more difficult to justify when serious offenses in scientific research as they challenge primary publication is electronic and therefore easily the credibility of everyone and everything involved in a accessible, but if editors feel that this is appropriate they research effort. should follow the same steps as for translation. Editors Plagiarism: The term plagiarism stems from the Latin should ensure that subgroup analyses, metaand word plagium, meaning kidnapping a man. It literary secondary analyses are clearly identified as analyses of means theft, taking material authored by others and data that have already been published, that they refer presenting as someone else’ Plagiarism is basically directly to the primary source, and that (if available) intended to deceive the reader’s.Is appropriation of they include the clinical trial registration number from another person’s idea, processes, results, text, or the primary publication. illustration/clinical photographs, etc. without its So it may overemphasize the importance of the findings acknowledgement. Referring to the United States’ Office by its appearance more than once and can interfere with of Research Integrity (ORI) definition of plagiarism, the process of metaanalysis, besides infringe on the which is “unattributed textual copying. International Copyright Law. Plagiarism can be divided into 1.direct (plagiarism of the text); 2.mosaic (the borrowing ideas and opinions Research misconduct” are given as follows: (a)I from original source and a few verbatim words of ntentional or gross negligence leading to fabrication of phrases without crediting the author) and 3..self- scientific message or a false credit or emphasis given to plagiarism (which refers to reusing one’s own work a scientist. (b)Intentional distortion of the research process by fabrication of the text, hypothesis, or methods without citations).Plagiarism could also be termed as from another researcher’s manuscript or publication or 4. “salami-slicing”the selective use of researchproject results to maximize the number of presentations distortion of the research process in other ways. possible i.e., identical slices as described by Medial Other deviation.research misconduct is unacceptable Journal Editors (MJE)(some does not recognize it a issue, other deviations” are activities that are considered category). unethical like.

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Giving authorship to a colleague or relation who provides significant funds in the areas of health, has not contributed substantially to the research research, and development, and oversees bodies such study. as The National Institute of Health and The Office of Suppression” of unfavorable data which are in Public Health and Science. conflict with the researcher’s or sponsor’s (of the The Committee on Publication Ethics (COPE) was study) interest or an adverse event in a clinical established in 1997 by a small group of medical journal research. editors in the UK, but now has over 7000 members Deliberate omission of contributions by other worldwide from all academic fields. Membership is researchers to increase the importance of their own open to editors of academic journals and others research study. interested in publication ethics. Several major publishers (including Elsevier, WileyBlackwell, Springer, Taylor Applying inappropriate statistical techniques to and Francis, Palgrave Macmillan and Wolters Kluwer) enhance the significance of one’s own research. have signed up some, if not all, of their journals as COPE Deviating from the research approved by members. COPE provides advice to editors and the Institutional Ethical Committee. publishers ‘. COPE does not investigate individual cases, Not reporting an adverse event in a human research but encourages editors to ensure that cases are experiment. investigated by the appropriate authorities (usually a research institution or employer). It is important to understand why researchers indulge into scientific misconduct/ deviations. According to the The UK Research Integrity Office is another body “stressful” or “imperfect” environment theory, various representing the interests of over 50 universities and institutional pressures, incentives, career ambitions, organizations dedicated to scientific research set up in pursuit of fame, etc. can be the causes for misconduct. 2006. Poor supervision of junior researchers by teachers and CONCLUSIONS guides is one of the contributing factors in scientific If one wants to create a scientific work, must have on misconduct. his mind that creating a scientific work requires Conflict of interest:More generally conflict of interest creativity and openness, honesty, trust, and obeying the can be defined as any situation in which an individual ethical principles for writing a scientific paper. or corporation is in a position to exploit a professional As well an author in medical sciences should always or official capacity in some way for their personal or follow the words; “The health of my patient will be my corporate benefit. first consideration”, (Declaration of Geneva, Adopted The board of ethics define “conflict of interest as a by the 2nd General Assembly of the WMA, Geneva, situation “in which personal and/or financial Switzerland, September 1948). consideratios have potential to influence or compromise While working on a an biomedical research involving professional judgement in clinical human subjects medical workers should have on mind service,research,consultation,instruction,administration that it is the duty of the physician to remain the protector or any other professional activity. of the life and health of that person on whom biomedical INTERNATIONAL BODIES research is being carried out. A researcher should know One of the oldest organizations dealing with research how to create a paper to publish a research work. He / misconduct is the ORI in the United States. Set up in she must know parts and pattern of a scientific paper. 1992, it oversees and directs Public Health Service Follow the responsibilities of an author and obligation research integrity activities. With a huge budget, it to ethics.

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