EMHJ Guidelines on Ethical Conduct and Publication of Health Research
These guidelines present key issues related to research and publication ethics and EMHJ’s expectations of papers submitted for publication. They are intended as a reference for authors and reviewers.
Background
Adherence to ethical standards for the conduct and reporting of research is not only a moral imperative, it also results in better and more meaningful research. As with all peer-reviewed journals, EMHJ has encountered cases of suspected breach of ethical research conduct and publication, including lack of ethical clearance and/or informed consent of participants when needed, and instances of plagiarism or duplicate publication. Our experience in addressing such incidents suggest that in some cases the authors were genuinely unaware of, or unfamiliar with, key ethical aspects of research conduct and publication, for example, what constitutes plagiarism or why duplicate publication is unacceptable.
EMHJ endeavours to maintain the highest ethical standards for the articles it publishes. To do so, the journal follows established international standards and guidelines on the conduct and publication of health research, including the World Medical Association’s Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS), the Committee on Publication Ethics (COPE), the International Committee of Medical Journal Editors (ICMJE), and the World Association of Medical Editors (WAME).
EMHJ considers these guidelines as necessary to make its position known and to provide authors with clear and easily accessible information on the important ethical issues to ensure that their papers are ethically compliant. Therefore, the review and endorsement of draft guidelines on ethical conduct and publication of health research was included in the agenda of the Expanded EMHJ Editorial Meeting in June 2015.
Based on key resources and documents by leading institutions and associations for research and publication ethics, the guidelines were drafted and revised in 2015 and shared with the Editorial Board for comments. A review of the guidelines was then made based on comments of board members.
The guidelines explain EMHJ’s position on specific ethical aspects of the conduct and reporting of research. They provide authors with guidance on the ethical standards they are expected to conform to while preparing papers for submission and outline EMHJ’s procedures if the standards are breached.
Authors’ responsibilities
Papers submitted for consideration for publication to the EMHJ should comply with the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals of the ICMJE.
Ethical approval
EMHJ expects authors to adhere to the Ethical Principles for Medical Research Involving Human Subjects outlined in the World Medical Association’s Declaration of Helsinki and CIOMS. For research involving humans, every research article submitted to EMHJ must include a declaration that before carrying out its field work, the study had obtained ethical clearance from a recognized body in the country, for example, the institutional review boards or research ethics committees. Ethical clearance from non-national bodies may be acceptable if there is a valid justification (e.g. lack of a national or local ethics committee). EMHJ may request relevant documentation of such ethical approval. Research involving animals are expected to follow the relevant standards of ethical research. If ethical clearance was not considered to be required, a statement indicating the reasons it was not required must be provided. In any case, authors are expected to follow all requirements of ethical conduct of research, reporting of the findings, and preparation of manuscripts.
Informed consent
EMHJ requires, where appropriate, a statement from authors that all persons who participated in their research had given their voluntary, informed, written consent. Verbal consent may be acceptable, however, if there is a reasonable justification or where authorised by the body providing ethical approval. Where participants are unable to give such consent, surrogate consent may be acceptable (e.g. from a parent), however, surrogate consent always requires ethical approval. Authors may be requested to provide copies of informed consent form with all details, including explanatory information provided to participants.
Participant confidentiality and respect
Manuscripts should be prepared in such a way that they preserve participants’ confidentiality. Authors are expected to obtain an individual’s explicit consent for the use of any personal or medical information that may make the participant identifiable and must ensure the dignity and respect of the participants and their communities in their manuscript.
Competing interests
EMHJ requires authors to provide details of any competing interests. A competing interest may occur when an author’s personal, family, or institutional interests (e.g. sources of funds, earnings, relationships, etc.) may affect the research, its findings, or publication of the manuscript. EMHJ will not reject a paper solely on the basis of a declared competing interest but will take this into consideration, when assessing a paper and, if considered relevant, including such information in the published paper.
Funding
EMHJ requires authors to state all sources of funding for their study.
Clinical trials registration
EMHJ requires registration of clinical trials in a public trials registry before undertaking the trial, as a condition of consideration for publication. More information about registration of clinical trials can be obtained at http://www.who.int/ictrp/trial_reg/en/.
Authorship
EMHJ follows the ICMJE recommendations on authorship credits, which aim to ensure that all and only those who have made material contribution to the research are named as authors. These require that all four of the following criteria be met to be considered an author:
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.
Every person who meets all four criteria should be identified as an author. Those who meet some, but not all, of these criteria should be included in an acknowledgement. It should be noted that data collection, laboratory testing, data management, acquisition of funds, provision of support for the study, etc. do not qualify (on their own) an individual for being included as an author.
Previous publication
EMHJ expects papers submitted to be original and not already published, accepted for publication, or currently under consideration for publication elsewhere. Authors must affirm this and disclose any papers that overlap with the submitted paper, including paper(s) published in other languages, although translation may occasionally be considered with the agreement of the other journal. Oral presentation of study findings at a conference, or publication of an abstract only in conference proceedings, does not normally prohibit submission of the full paper to EMHJ. Such abstracts should not exceed 500 words.
Scientific misconduct
EMHJ takes any allegation or evidence of scientific misconduct seriously. Examples of scientific misconduct include:
Violation of ethical research standards: failing to adhere to standards for research involving humans and animals.
Fabrication and falsification of data and abuse of accepted research practices such as making up data, deliberately suppressing and/or altering data, and manipulating experiments/analysis to obtain desired results.
Plagiarism: using the published language or ideas of others without appropriate acknowledgment of the source and representing such ideas as one’s own. When referring to the published ideas/opinions of others, full referencing is expected. Brief quoted statements could be acceptable if good justification is provided and such statements are placed within inverted commas.
Duplicate publication: this refers to the publication of a paper by at least one of the authors, that overlaps substantially with another one already published, without clear reference to the previous publication. Duplicate publication is considered unethical particularly for original research because it can lead to double-counting of data and inappropriate weighting of the results of a single study.
Impropriety of authorship: this refers to improperly assigning authorship credit either by inclusion (“guest” authorship) or exclusion (“ghost” authorship).
Any misconduct in the conduct of research and preparation or submission of the manuscript is considered unacceptable by EMHJ.
EMHJ’s response to possible scientific misconduct
EMHJ takes seriously any suspected misconduct in research, publication, or professional behaviour. EMHJ will investigate, in confidence, any cause of concern on a case-by-case basis and seek resolution, applying the guidelines and recommendations of recognized bodies such as COPE, ICMJE, and the World Association of Medical Editors. EMHJ may seek advice from internal or external sources if advice is needed.
Generally, EMHJ will endeavour to resolve issues of scientific misconduct by discussing them with the author(s). However, if concerns remain and the authors cannot provide satisfactory response, the case may be reported to the appropriate authorities, including the authors’ supervisors or employers, and relevant professional bodies.
Submitted papers found to be in breach of publication ethics will be rejected and even if an article is rejected for other scientific reasons, EMHJ may take further action if the research is considered unethical. In the case of an already published paper, unethical behaviour may result in retraction of the paper. Authors found to have infringed ethical standards will be kept on record and may be banned from publishing in EMHJ.
EMHJ responsibilities
EMHJ upholds the authors’ right to fair, objective, and ethical handling of their papers and follows the WAME recommendations on best practices for peer-review selection. EMHJ operates a double-blinded peer-review system and endeavours to ensure that neither the authors nor the reviewers are aware of each other’s identities. Editors and reviewers are required to declare any conflicts of interest and to maintain confidentiality regarding any manuscript under review. Reviewers may not refer a manuscript to a colleague without the permission of the editor and cannot use any part of the paper before publication.
Authors may appeal decisions on their papers if they believe there is good reason or evidence for an appeal. Such appeals will be carefully considered by EMHJ.
Key resources
1. World Medical Association’s Declaration of Helsinki
2. Council for International Organizations of Medical Sciences
a. International Ethical Guidelines for Biomedical Research Involving Human Subjects
b. International Guidelines for Ethical Review of Epidemiological Studies
3. Committee on Publication Ethics
4. International Committee of Medical Journal Editors
Additional publications and resources
WHO
1. Ethical issues in patient safety research: interpreting existing guidance (2013)
3. Quality practices in basic biomedical research (QPBR) training manual (2010)
4. Casebook on ethical issues in international health research (2009)
5. Research ethics committees: basic concepts for capacity-building (2009)
9. Handbook: quality practices in basic biomedical research 2006
10. A practical guide for health researchers (2004)
11. Manual for editors of health science journals (2009)
12. Regulation of privacy and data protection in the use of electronic health information. An international perspective and reference source on regulation and legal issues related to person-identifiable health databases. Pan American Health Organization (2001).
13. Other WHO publications related to the ethics of specific issues can be found at: http://www.who.int/ethics/publications/year/en/
Other
1. Council of Science Editors. White Paper on Publication Ethics
2. The Office of Research Integrity
3. National Institutes of Health. Office of Clinical Research and Bioethics Policy
4. Ethics and Research Guidance. Medical Research Council, UK
7. Danis M, Largent E, Grady C, Wendler D, Chandros Hull S, Shah S, et al. Research ethics consultation: a casebook. OUP; 2012.
