It is good practice for journals to adopt publication policies to ensure that ethical and responsible research is published, and that all necessary consents and approvals have been obtained from authors to publish their work. These publication policies might include the items presented in the sections below.
1. Human rights, privacy, and confidentiality
For manuscripts reporting medical studies involving human participants, it is suggested that journals require authors to provide a statement identifying the ethics committee that approved the study, and that the study conforms to recognized standards, for example:
- Declaration of Helsinki
- US Federal Policy for the Protection of Human Subjects
- European Medicines Agency Guidelines for Good Clinical Practice
These standards encourage authors to conduct studies in a way that ensures adequate steps have been taken to minimize harm to participants, to avoid coercion or exploitation, to protect confidentiality, and to minimize the risk of physical and psychological harm.
Across the scholarly disciplines there are variations in practice around privacy and confidentiality, relative to the risks of participation and the reasonable expectations of participants.
In the biomedical sciences, editors should consider only publishing information and images from individual participants where the authors have obtained the individual’s free prior informed consent. The International Committee of Medical Journal Editors guidance says:
“Non-essential identifying details should be omitted. Informed consent should be obtained if there is any doubt that anonymity can be maintained. For example, masking the eye region in photographs of patients is inadequate protection of anonymity.”
The best policy is for journals to require that authors confirm whether explicit written consent to publish has been received from any people described (for example, in case reports), shown in still or moving images, or whose voices are recorded. In the case of technical images (for example, radiographs or micrographs), editors should also ensure that all information that could identify the subject has been removed from the image. For voices or images of any human subject, permission according to applicable national laws must be sought from research participants before recording. In many jurisdictions it is a requirement that formal copyright clearance is obtained to publish any video or audio recordings. When publishing genetic sequences or family genograms editors may need consent from more than just the index case. The CARE guidelines are useful for editors who publish case reports.
In the social sciences and humanities, there are numerous ethical guidelines for researchers working with human participants. Social science and humanities researchers regularly work with audio and video materials gathered in public places where there is no reasonable expectation of privacy. They also use materials derived from broadcast sources, as in some political science or cultural studies work, where copyright must be addressed but where consent issues do not arise. However, wherever appropriate, social scientists are also responsible for protecting the confidentiality of human participants, and obtaining informed consent from all participants by openly communicating any and all information that is likely to influence their willingness to participate (for example, sponsorship, purpose and anticipated outcomes, and possible consequences that publication of the research may have for participants). Guidelines include those from the American Sociological Association, International Society of Ethnobiology, and American Anthropological Association.
For social research data the Association of Social Anthropologists of the UK and the Commonwealth suggests in its “Ethical Guidelines for Good Research Practice” that it is not always possible or necessary to gain written consent to publish, particularly when researchers are working with people with limited literacy or in cultures where formal bureaucratic procedures are problematic. However, it remains prudent for journals to ask authors to provide evidence that they have obtained informed consent. The American Anthropological Association’s statement recommends that:
“Informed consent does not necessarily imply or require a particular written or signed form. It is the quality of the consent, not its format, which is relevant.”
Exceptional cases might arise where gaining an individual’s free prior informed consent is not possible but where publishing an individual’s information or image can be demonstrated to have a genuine public health interest or to serve an important public need. In cases like this, before taking any action editors should seek and follow counsel from the journal owner, the publisher, and/or legal professionals.
2. Cultures and heritage
US Office for Human Research Protection has a searchable database of independent community institutional review boards that approve research and publication of culturally sensitive materials. More information is provided in “Principles and Procedures: Conducting Research in a Maori Context” from Waikato Institute of Technology and “Community IRBs and Research Review Boards: Shaping the Future of Community-Engaged Research” from Albert Einstein College of Medicine.
There is recognition of increasing innovation in the management of joint copyright in relation to intercultural research, to enable appropriate legal acknowledgment of intellectual property in attribution and acknowledgment. This is presented in the section on authorship which follows.
Editors should consider any sensitivities when publishing images of objects that might have cultural significance or cause offence (for example, religious texts or historical events). In addition:
- Editors should be conscious of the ethics surrounding publication of images of human remains, and should recognize that human remains are perceived differently in different cultures. Images of human remains should not be published without consideration of the views of any demonstrated genealogical descendants or affiliated cultural communities, if feasible. In cases where descendants or affiliated cultural communities cannot be contacted, images of human remains should not be published without consultation with and permission from the curating institution or relevant stakeholder. For more information refer to the British Association of Biological Anthropology and Osteoarchaeology Code of Ethics.
- Cultural restrictions do exist in some cultures that prevent publication of the names of deceased people. In Aboriginal Australian culture, this often extends to publication of photographs or film footage of deceased persons. Editors are encouraged to consider any sensitivities and, if necessary, confer with the author about appropriate representation of subjects in published work.
3. Registering clinical trials
The World Health Organization and Declaration of Helsinki both suggest that clinical trials should be registered prospectively, before participants are enrolled. The International Federation of Pharmaceutical Manufacturers and Associations also requires its members to register trials. Legislation varies. For example, the US Food and Drug Administration Amendments Act of 2007 does not require registration for Phase 1 studies.
Medical journals that publish clinical trials should make prospective registration a requirement for publication of such trials. Clinical trial registration numbers should be included in all papers that report their results. A suitable statement about this in journal instructions for authors might read: “We require that clinical trials are prospectively registered in a publicly accessible database. Please include the name of the trial register and your clinical trial registration number at the end of your abstract. If your trial is not registered, or was registered retrospectively, please explain the reasons for this.”
4. Animals in research
Research involving animals should be conducted with the same rigor as research in humans. Journals can encourage authors to implement the 3Rs principles:
“The 3Rs are a widely accepted ethical framework for conducting scientific experiments using animals humanely: Replacement – use of non-animal methods; Reduction – methods which reduce the number of animals used; Refinement – methods which improve animal welfare.”
The International Council for Laboratory Animal Science has published ethical guidelines for editors and reviewers.
Journals should encourage authors to adhere to animal research reporting standards, for example the ARRIVE reporting guidelines, which describe the details journals should require from authors regarding:
- Study design and statistical analysis.
- Experimental procedures.
- Experimental animals.
- Housing and husbandry.
Journals should ask authors to confirm that ethical and legal approval was obtained prior to the start of the study, and state the name of the body giving the approval. Authors should also state whether experiments were performed in accordance with relevant institutional and national guidelines and regulations.
- US authors should cite compliance with the US National Research Council’s “Guide for the Care and Use of Laboratory Animals,” the US Public Health Service’s “Policy on Humane Care and Use of Laboratory Animals,” and “Guide for the Care and Use of Laboratory Animals.”
- >UK authors should conform to UK legislation under the Animals (Scientific Procedures) Act 1986 Amendment Regulations (SI 2012/3039).
- European authors outside the UK should conform to Directive 2010/63/EU.
Editors may ask authors to describe in their articles how discomfort, distress, and pain were avoided and minimized, and to confirm that animals did not suffer unnecessarily at any stage of an experiment.
Editors may request that reviewers comment on the standard of experimental reporting, experimental design, or any other aspects of the study reported that may cause concern. If concerns are raised or clarifications are needed, they may need to request evidence of ethical research approval or question authors.
Journals should ask authors to inform them at the time of manuscript submission if their study has potential for both benevolent and malevolent application. This is often referred to as “dual use research.”
Journals should ask these authors to conform to the National Science Advisory Board for Biosecurity (NSABB) guidelines for Dual Use Life Sciences Research. The June 2007 NSABB report presents a useful description and discussion of “dual use research of concern.”
6. Reporting guidelines
Accurate and complete reporting enables readers to fully appraise research, replicate it, and use it. Editors should encourage authors to follow their discipline’s guidelines for accurate and complete reporting of research. Editors, working with peer reviewers, should ensure that authors provide the information readers need to evaluate the methods and results, so that readers can reach their own conclusions.
- In health research, the EQUATOR Network promotes useful reporting tools.
- In life sciences, useful reporting guidelines are promoted by Future of Research Communications and e-Scholarship (FORCE11). Specific reporting guidance that editors can recommend for animal experiments include the ARRIVE guidelines, the National Research Council’s Institute for Laboratory Animal Research guidelines, and the Gold Standard Publication Checklist from Hooijmans and colleagues.
- Standards for reporting animal studies are discussed in more detail by Landis and colleagues.
- Further guidelines and standards in bioscience are promoted on the Minimum Information for Biological and Biomedical Investigations from MIBBI and by the FAIRsharing website.
- Livestock reporting guidelines are provided by the REFLECT statement.
7. Informed consent policy
Studies on patients or volunteers require ethics committee approval and informed consent, which should be documented in the paper. Patients have a right to privacy that should not be violated without informed consent. Identifying information, including names, initials, or hospital numbers, should not be published in written descriptions, photographs, or pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent for this purpose requires that an identifiable patient be shown the manuscript to be published. Authors should disclose to these patients whether any potential identifiable material might be available via the Internet as well as in print after publication. Patient consent should be written and archived with the journal, the authors, or both, as dictated by local regulations or laws. We decide that patient confidentiality is better guarded by having the author archive the consent and instead providing the journal with a written statement that attests that they have received and archived written patient consent. When informed consent has been obtained, it should be indicated in the published article.
Nonessential identifying details should be omitted. Informed consent should be obtained if there is any doubt that anonymity can be maintained. For example, masking the eye region in photographs of patients is inadequate protection of anonymity. If identifying characteristics are de-identified, authors should provide assurance, and editors should so note, that such changes do not distort scientific meaning.
Patient identifiers will not be published in our journals, unless written informed consent is given and the content is essential for the scientific purpose and merit of the manuscript. Photographs of subjects showing any recognizable features must be accompanied by their signed release authorizing publication, as must case reports that provide enough unique identification of a person (other than name) to make recognition possible. Failure to obtain informed consent of patient prior to submission would result in manuscript rejection.
8. Conflict of Interest Policy
Journal submissions are assigned to editors in an effort to minimize potential conflicts of interest. The following relationships between editors and authors are considered conflicts and are avoided: Current colleagues, recent colleagues, recent co-authors, and doctoral students for which editor served as committee chair. After papers are assigned, individual editors are required to inform the managing editor of any conflicts not included in the list above. In the event that none of the editors satisfy all of the conflict screens, co-editors who are least conflicted will be assigned to the manuscript. In addition, co-editors who are least conflicted are assigned for all paper submissions by sitting editors. Journal submissions are also assigned to referees to minimize conflicts of interest. After papers are assigned, referees are asked to inform the editor of any conflicts that may exist.