Studies in Human and Animals

Authors must follow ethical guidelines for studies carried out in humans and animals.

Studies in humans

Work which involves the use of human subjects should be carried out in accordance with the World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects.

Manuscripts should follow the International Committee of Medical Journal Editors (ICMJE) recommendations for the conduct, reporting, editing and publication of scholarly work in medical journals and aim to be representative of human populations in terms of sex, age and ethnicity. Sex and gender terms should be used correctly, as outlined by WHO (World Health Organization).

Manuscripts must include a statement that all procedures were performed in compliance with relevant laws and institutional guidelines and have been approved by the appropriate institutional committee(s). The statement should contain the date and reference number of the ethical approval(s) obtained.

Manuscripts must also include a statement that the privacy rights of human subjects have been observed and that informed consent was obtained for experimentation with human subjects.

This journal will not accept manuscripts that contain data derived from unethically sourced organs or tissue, including from executed prisoners or prisoners of conscience, consistent with recommendations by Global Rights Compliance on Mitigating Human Rights Risks in Transplantation Medicine. For all studies that use human organs or tissues, sufficient evidence must be provided that these were procured in line with WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation. The source of the organs or tissues used in clinical research must be transparent and traceable. If your manuscript describes organ transplantation you must additionally declare within the manuscript that:

• autonomous consent free from coercion was obtained from the donor(s) or their next of kin.

• organs and/or tissues were not sourced from executed prisoners or prisoners of conscience.

Studies in animals

All animal experiments should comply with ARRIVE (Animal Research: Reporting of In Vivo Experiments) guidelines.

Studies should be carried out in accordance with Guidance on the operation of the Animals (Scientific Procedures) Act 1986 and associated guidelines, EU Directive 2010/63 for the protection of animals used for scientific purposes or the NIH (National Research Council) Guide for the Care and Use of Laboratory Animals (PDF) or those of an equivalent internationally recognized body.

The sex of animals, and where appropriate, the influence (or association) of sex on the results of the study must be indicated and a statement included in your manuscript that such guidelines as listed above have been followed.

Clinical trials must be registered in a public trials registry in accordance with International Committee of Medical Journal Editors (ICMJE) clinical trials guidelines and as a condition of publication in this journal.Purely observational studies, in which the assignment of the medical intervention is not at the discretion of the investigator, do not require registration.

Some key excerpts from the guidelines include:

• Trials must be registered at or before the onset of patient enrolment.

• The clinical trial registration number should be included at the end of the article abstract.

• A clinical trial is defined as any research study that prospectively assigns human participants, or groups of humans, to one or more health-related interventions to evaluate the effects of health outcomes.

• Health-related interventions include any intervention used to modify a biomedical or health-related outcome such as drugs, surgical procedures, devices, behavioural treatments, dietary interventions, and process-of-care changes.

• Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.

We recommend that authors follow CONSORT guidelines when presenting randomized controlled trials.

Authors must provide the CONSORT checklist at manuscript submission with an accompanying flow diagram illustrating the progress of patients through the trial, including recruitment, enrolment, randomization, withdrawal, completion and a description of the randomization procedure.

The equator network has guidelines covering CONSORT:

• Read the CONSORT guidelines.

• Follow the CONSORT checklist.

Authors must disclose all posting in registries of results of the same or closely related work.

We follow the International Committee of Medical Journal Editors (ICMJE) clinical trials guidelines. Editors will not consider results to be a prior publication if they have already been posted in the same clinical trials registry in which primary registration resides, as long as the results are presented in the form of a brief structured abstract (fewer than 500 words) or table.

Disclosing results in other circumstances, such as in an investors’ meeting, for example, is discouraged and may jeopardise consideration of your manuscript by this journal.