Ethical rules - Links of interest, human and animal rights, informed patient consent

Links of interest - Declaration of financial and non-financial relationships and activities, and links of interest

Public trust in the scientific process and the credibility of published articles depends in part on the transparency of an author's management of relationships and activities directly related to the work involved in planning, conducting, writing, peer-reviewing, editorializing, and publishing a scientific study.

A conflict of interest is defined as a situation in which professional judgment regarding a primary interest (such as the well-being of patients or the validity of research) is likely to be influenced by a secondary interest (such as financial gain). The perception of conflicts of interest is just as important as the conflicts of interest themselves.

Individuals may disagree about whether an author's relationships and activities constitute ties of interest. While the presence of relationships and activities does not always indicate a problematic influence on the content of an article, perceptions of connections can undermine confidence in science as much as real connections. Readers should be able to assess an author's relationships and activities and to estimate the consequences for the content of the article. These principles justify the obligation of transparent declarations. Complete declarations by an author show his or her commitment to transparency, and help maintain confidence in scientific methods.

Financial relationships [e.g., salary, consulting, financial interests (stock or stock options), honoraria, patents, paid forensics] are the most easily identifiable ties of interest, the ones most often judged as potential ties of interest, and the ones most likely to undermine the credibility of the journal, the authors, and the science itself. Other interests may also represent or be perceived as ties, such as personal relationships or rivalries, academic competition, and intellectual beliefs.

Authors should avoid signing agreements with study sponsors, whether for-profit or not, that interfere with the authors' access to all study data or ability to analyze and interpret the data, and to prepare and publish manuscripts independently when and where they choose. Policies that dictate where authors must publish their work violate this principle of academic freedom. Authors may be required to provide the journal with agreements binding them to study sponsors.

Deliberate failure to disclose these relationships and activities on journal forms is a form of scientific misconduct.

Stakeholders

All parties involved in the peer review and publication processes-not only authors but also reviewers, editors, and journal board members-must reflect on and declare their relationships and activities as they carry out their respective roles in the review and publication process.

Authors

When submitting a manuscript of any type or format, authors are required to declare any relationships and activities that may influence their work or be perceived as doing so.

Proofreaders

Editors should ask the reviewers to whom they wish to entrust the evaluation of a manuscript if any relationships and activities exist that might influence their task. These peers should disclose to the editors any relationships and activities that might influence their opinion of the manuscript and refrain from reviewing specific manuscripts if their impartiality might be compromised. They should not exploit knowledge gained from the manuscript prior to publication for their own purposes.

Editors and Editorial Boards

Editors who make final decisions about publication of articles must recuse themselves from participating in editorial decisions if there are relationships or activities that might affect their impartiality with respect to manuscripts submitted to them. If they are involved in editorial decisions, other editorial staff members must provide the editors with a description of their relationships and activities (which could affect their editorial judgment) and recuse themselves from any decision in which there is an interest that may create a potential connection. Members of the editorial staff should not use information gained from their work on manuscripts for personal gain. Editors and other members of the editorial staff must regularly publish their own declarations of interest in accordance with the legislation applicable to them, and for France on the website www.transparence.sante.gouv.fr.

Declaration of interest

The published articles include the authors' declarations of interest revealing:

–  authors' relationships and activities;

–  sources of support for the study, including names of sponsors, and explanations of the role of these sources, if any, in the design of the study plan, collection, analysis, and interpretation of data, writing of the report, and restrictions on submission of the report for publication. If the supporting source had no role in these steps or did not impose restrictions on publication, the authors should state;

–  whether the authors had access to the study data, explaining the nature and extent of that access and whether or not they continue to have access to the data.

In addition to the above requirements, editors may ask authors of a study funded by an organization with a proprietary or financial interest in the outcome to sign a statement, such as "I have been given full access to the data set for this study and take full responsibility for the integrity of the data and the accuracy of the data analysis."

Predatory Journals or Pseudo-Reviews

A growing number of entities are advertising themselves as "scholarly medical journals" but do not function as "scholarly medical journals." These journals (predatory or pseudo-journals) accept and publish almost all submissions and charge publication fees for articles, often informing authors after their manuscript has been accepted for publication. They often claim to peer-review, but do not, and may deliberately use names similar to those of well-established journals. They may claim to be members of ICMJE without being members (see www.icmje.org for current ICMJE members), and that they follow the recommendations of organizations such as ICMJE, COPE, and WAME without following them. Researchers should be aware of the existence of such entities and avoid submitting research to them for publication. Authors are responsible for evaluating the integrity, history, practices, and reputation of the journals to which they submit manuscripts. Recommendations from various organizations are available to help identify the characteristics of prestigious peer-reviewed journals (www.wame.org/identifying-predatory-or-pseudo-journals and www.wame.org/about/principlesof-transparency-and-best-practice). Asking for help from scientific mentors, senior colleagues, and/or those with many years of academic publishing experience can also be helpful.

Authors should avoid citing articles published in predatory journals or pseudo-reviews.

Research Study Ethics Policy

Participant Protection in Research Studies

JLE requires that each research article submitted include a statement that the study received ethics approval (or a statement that it was not required and why), including the name of the ethics committee(s) or institutional review board(s).

Authors must ensure that the conduct and publication of research involving human data is in accordance with the Declaration of Helsinki as revised in 2013 (www.wma.net/fr/policies-post/declaration-dhelsinki-de-lamm-principes-ethiques-applicables-a-la-recherche-medicale-impliquant-d es-etres-humans/).

All authors must have approval to conduct research from an independent local, regional, or national human rights committee (e.g., ethics committees, institutional review boards). If there is any doubt as to whether the research was conducted in accordance with the Declaration of Helsinki, the authors must explain the rationale for their approach and demonstrate that the local, regional, or national review board has explicitly approved the questionable aspects of the study. Approval by a responsible review board does not preclude the writers from having their own judgment about whether the conduct of the research was appropriate.

In the case of animal experiments, the authors should indicate whether national and institutional guidelines for the care and use of laboratory animals have been followed.

Additional recommendations on ethics in animal research are available in the International Association of Veterinary Editors' Consensus Author Guidelines on Animal Ethics and Welfare (http://www.veteditors.org/consensus-author-guidelines-on-anima l-ethics-and-welfare-for-editors).

Evaluation of ethical issues

Editorial assessment of ethical issues goes beyond simply deciding whether participants in a study have given informed consent. Editors can judge whether the overall design and conduct of each work is morally justifiable, even when a study has been approved by a research ethics board or institutional review board.

Informed consent policy

Patient consent and confidentiality

JLE's policy is based on the values of SPEPS member publishers, European Union data protection legislation, French law, and guidelines issued by the General Medical Council and the Committee on Publication Ethics (COPE).

Any manuscript containing personal patient data must be AVR compliant and ensure anonymization, consent, and patient confidentiality. JLE reserves the right to refuse to publish any manuscript that does not comply with the requirements set forth in this policy.

Patients' right to privacy requires that they have given informed consent to any identifying information. No patient-identifying information (including names, initials, or hospital numbers) should be published in written descriptions, photographs, or genealogy unless the information is essential for scientific purposes and the patient (or the patient's parents or guardian) has given written informed consent for publication. Informed consent, in this case, requires that the identifiable patient has viewed the manuscript to be published. Authors must disclose to such patients any potentially identifying information that may be available on the Internet as well as in the print version after publication.

Patient consent should be written and archived by the journal and/or authors, as required by local regulations or laws. Because a journal that archives consent will know the identity of the patients involved, some journals may decide that patient confidentiality is best protected if the authors archive the consent and provide the journal with a written statement that they have received and archived the written patient consent.

If not essential, identifying information should be omitted. If there is any doubt about whether anonymity can be maintained, informed consent should be obtained. For example, masking the eye area in patients' photographs does not sufficiently protect their anonymity. If identifying features of patients are altered to protect their anonymity, authors should provide assurance that such alterations do not distort scientific meaning and editors should verify this.

The requirement for informed consent is specified in the instructions to journal authors. Where applicable, the fact that informed consent has been obtained should be specified in the published article.

If consent cannot be obtained because the patient cannot be located, then publication will only be possible if the information can be sufficiently anonymized. Anonymization means that neither the patient nor anyone else could identify the patient as detailed in the anonymization standard.

Deceased patients

If the patient is deceased, JLE requests that the author(s) seek permission from the next of kin as a matter of courtesy and medical ethics. If next of kin cannot be reached, JLE will weigh the likelihood of identification against the likelihood of causing offense if identified in making a decision about whether to publish without a relative's consent.

Child

If the patient is under the age of 18, JLE asks the parents or guardians to give consent on behalf of the minor. When the child has a sufficient understanding of the consent process and its implications, he or she should also sign the consent form. For younger children, even if the parents consent, the authors should consider whether the child might regret the release of his or her identifiable information in the future.

The ultimate decision to use material involving children (and those who cannot legally consent for themselves) will rest with the editor of the newspaper who will consider the possibility of future harm to an individual as a result of publishing material about him or her as a minor.

Patients who are legally incompetent

If the patient does not have the mental capacity to make a decision about publication, no one can give consent on the patient's behalf. Even if someone does have this authority, for example, through a health and welfare power of attorney, it must be exercised in the best interests of the patient. It may be beneficial to the patient to have their case described in a publication, but this is usually not obvious or certain. In such cases, the editor will require that all personal information be anonymized or will refuse to publish it.

Patient images

JLE's policy on obtaining consent for the publication of patient photos or videos is a subset of its general policy on patient privacy. If there is any chance that a patient can be identified from a photograph or other static or moving image, or from its caption or accompanying text, the patient's written consent to publication is required.

Images or multimedia files (e.g., video, audio) may be used without consent as long as they are anonymized by removing any identifying marks and are not accompanied by text that could reveal the identity of the patient through clinical or personal details.