Policies on Conflict of Interest, Human and Animal Rights, and Informed Consent

Conflict of Interest

A Declaration of Conflicting Interests policy refers to a formal policy a journal may have to require a conflict-of-interest statement or disclosure from a submitting or publishing author(s)—guideline based on COPE. Conflicts of interest arise when author(s), reviewers, or editors have interests that are not fully apparent and that may influence their judgments on what is published. They have been described as those which, when revealed later, would make a reasonable reader feel misled or deceived.

• Reviewers: To ensure that the review process is free of conflicts of Interest: 1) Editors should select a guest or section editor when there is a conflict of interest concerning an author(s). Editors should ensure that reviewers are free of conflict of interest concerning an author(s). 2) Reviewers should contact the editorial office to declare any potential conflicts of interest in advance of reviewing an article.3) Minor conflicts do not disqualify a reviewer from reporting on an article but will be taken into account when considering the reviewer’s recommendations.
• Author(s): All author(s) and co-author(s) are required to disclose any potential conflict of interest when submitting their article (e.g., employment, consulting fees, research contracts, stock ownership, patent licenses, advisory affiliations, etc.). If the article is subsequently accepted for publication, this information should be included in the end section.
• Editors: Editors should not make any editorial decisions or get involved in the editorial process if they have any conflicts of Interest (financial or otherwise) for a submitted manuscript. An editor may have conflicts of Interest if a manuscript is submitted from their academic department or institution in such situations; The JANH has a policy that is When an editor submits their work to their journal, a colleague in the editorial office must manage the manuscript, and the editor/author(s) must withdraw from the discussion and decision about it.

Human Participants

Our policy is to ensure that all articles published by the JANH report on work that is morally acceptable and expects the author(s) to follow the World Medical Association’s Declaration of Helsinki. To achieve this, we aim to appraise the ethical aspects of any submitted work that involves human participants, whatever descriptive label is given to that work, including research, audit, and sometimes debate.

All research must have been carried out within an appropriate ethical framework. If there is suspicion that work has not occurred within an appropriate ethical framework, Editors may reject the manuscript and/or contact the author(s)’ ethics committee. On rare occasions, the Editor has serious concerns about the ethics of a study, the manuscript may be rejected on ethical grounds, even if approval from an ethics committee has been obtained.

Statement of Ethics Approval

We require every research article submitted to include a statement that the study obtained ethics approval (or a statement that it was not required and why), including the name of the ethics committee or institutional review board, the number/ID of the approval, and a statement that participants gave informed consent before taking part.

In addition, we welcome detailed explanations of how investigators and author(s) have considered and justified their work's ethical and moral basis. If such detail does not easily fit into the manuscript, please provide it in the cover letter or upload it as a supplemental file when submitting the article. We will also be pleased to see copies of explanatory information given to participants. Even if we do not include such detailed information in a final published version, we may make it available to peer reviewers and editorial committees. We have already asked peer reviewers to consider and comment on the ethics of the submitted work.

Appraisal of Ethical Issues

Editorial appraisal of ethical issues goes beyond simply deciding whether participants in a study gave informed consent, although this is one very important issue to consider. Editors should judge whether the overall design and conduct of each piece of work are morally justifiable, as summed up by the following questions:

• How much does this deviate from current normal (accepted, local) clinical practice?
• What is the (additional) burden imposed on the patients (or others)?
• What are (additional) risks posed to the patients (or others)?
• What benefit might accrue to the patients (or others)?
• What are the potential benefits to society (future patients)?

Even when a study has been approved by a research ethics committee or institutional review board, editors may be worried about the ethics of the work. Editors may then ask the author(s) for more detailed information, such as:

• How they justified the ethical and moral basis of the work
• to provide the contact details of the research ethics committee that reviewed the work so that the journal can request further information and justification from that committee
• to explain what ethical issues they considered and how they justified their work for studies that have not been reviewed by research ethics committees or institutional review boards

Editors may ask other editorial colleagues to evaluate the ethical aspects of an article, the author(s) comments, and the response of the relevant research ethics committee to the journal’s queries about ethics approval. This consultation may be informal, between the journal’s editors, or more formal, through seeking the advice of the Committee on Publication Ethics (COPE). Problems referred to COPE will be considered anonymous summaries of the relevant articles written by the editors concerned.

What happens when the journal considers a study to be unethical?

We believe that editors must take on issues of unethical audit or research, not to seek punishment for the author(s), but to prevent unethical practices and to protect patients.

Suppose the Editor, with or without the advice of its ethics committee and/or COPE, considers the work in a submitted article ethically unsound. In that case, the editor may seek further advice or recommend an investigation or action. The fact that the article would have been rejected anyway for other scientific or editorial reasons would not prevent the editor from taking such further action on serious ethics problems.

In the first instance, the editor would usually contact the head of the department where the work was done to explain their concerns and recommend a local investigation. Secondly, the editor might write to the professional registration body of the paper’s guarantor or principal investigator.

Exceptional circumstances

In rare instances, the journal might publish an article despite ethical problems in its reported work. The usual reason would be that work done in one setting might not reach the ethical standard of work done in another because of differing local resources and standards for health care and research. In deciding to publish such an article, we would consider the study's context carefully and aim to balance the overall benefit to society against the possible harm to the research participants.

Animal Participants

All material published in JANH that reports experiments performed using animals must adhere to high ethical standards concerning animal welfare. Manuscripts will be considered for publication only if the work described: 1) follows international, national, and institutional guidelines for the humane treatment of animals and complies with relevant legislation; 2) has been approved by the ethics review committee at the institution or practice at which the studies were conducted (where such a committee exists); 3) for studies involving non-human primates, demonstrates that the standards meet those of the NC3Rs primates guidelines; 4) for studies using client-owned animals, demonstrates a high standard (best practice) of veterinary care, and involves informed client consent.

Before a manuscript can be accepted, the author(s) must:

• Confirm that legal and ethical requirements have been met regarding the humane treatment of animals described in the study;
• Specify the ethical review committee approval process in the Materials or Methods section and the international, national, and/or institutional guidelines followed.

Editors can reject manuscripts based on ethical or animal welfare concerns. Papers may be rejected on ethical grounds if the study involves unnecessary pain, distress, suffering, or lasting harm to animals or if the severity of the experimental procedure does not appear to be justified by the value of the work presented.

What happens when the journal considers a study unethical?

Manuscripts describing animal research must include a justification for the use of animals and the particular species used. They should also provide details of animal welfare, including information about housing, feeding, and environmental enrichment, a description of steps taken to minimize suffering, humane endpoints, and the method of euthanasia. If the study has any implication for the 3Rs (replacement, reduction, and refinement), these should be discussed in enough detail so that readers can implement the 3Rs in similar experiments.

Informed consent

In the JANH, 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. Author(s) should disclose to these patients whether any potentially identifiable material might be available online or in print after publication. As local regulations or laws dictate, patient consent should be written and archived with the journal, author(s), or both. Nonessential identifying details should be omitted. Informed consent should be obtained if there is 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 altered to protect anonymity, such as in genetic pedigrees, author(s) should provide assurance, and editors should note that such alterations do not distort scientific meaning. When informed consent has been obtained, it should be indicated in the published article.