Research involving human participants, tissue or data should be approved by relevant institutional ethics committee(s) and should conform to international ethical and legal standards for research.
The name of the ethics committee that approved the research, the ethics committee approval number and the types of consent obtained should be included in the manuscript. In cases where the need for formal ethics committee approval was waived, the name of the ethics committee that granted the waiver should be included in the manuscript.
Authors should obtain consent (including from parents/legal guardians where applicable) to publish from individual participants if their manuscript includes any data that might identify them. For example, this includes photographs, videos, individual clinical data, quotes, demographic details and any other details that might identify the participant.
In the conduct of their research, authors should prospectively obtain consent from the individuals involved to participate in their research and/or for their tissues (for example, biopsy material), or data to be used. The need for consent and method of obtaining consent may be determined by the authors’ institutional ethics committee or other equivalent and relevant guidance or body. Details of consent to participate should be described in the manuscript, and evidence of consent or consent procedures may be requested by the editor.
Where consent for participation was not obtained (for example, in cases where the participants were not capable of providing consent), the editor may ask to see evidence that the need for consent was waived by an ethics committee.
Research reporting animal research should follow the ARRIVE reporting guidelines . Research involving vertebrates and regulated invertebrates should comply with relevant national and international animal welfare guidelines and where possible, be approved by an ethics committee. The name of the ethics committee and the ethics committee approval number should be provided at submission along with details of the national and international guidelines that were followed.
Animal euthanasia methods should comply with the American Veterinary Medical Association Guidelines for the Euthanasia of Animals or relevant and appropriate equivalent.
As a condition of consideration for publication, registration of clinical trials in a public trials registry is required. A clinical trial is defined by the International Committee of Medical Journal Editors (in accordance with the definition of the World Health Organization) as any research project that prospectively assigns human participants or groups of humans to one or more health- related interventions to evaluate the effects on health outcomes [1]. Trials must be registered before the start of patient enrolment. The registry must be accessible to the public at no charge. It must be open to all prospective registrants and managed by a not-for-profit organization. There must be a mechanism to ensure the validity of the registration data, and the registry should be electronically searchable. An acceptable registry must include at minimum a unique trial number, trial registration date, secondary identification information if assigned by sponsors or others, funding source(s), primary and secondary sponsor(s), responsible contact person, research contact person, official scientific title of the study, research ethics review, the medical condition being studied, intervention(s), key inclusion and exclusion criteria, study type, anticipated trial start date, target sample size, recruitment status, primary outcome, and key secondary outcomes. Trial registry name, registration identification number, and the URL for the registry should be included in the manuscript.
[1] Outlined by the International Committee of Medical Journal Editors, available at: https://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html
Authors should follow the Enhancing QUAlity and Transparency Of health Research (EQUATOR) guidelines when reporting health-related research, and provide any specific additional information (e.g. CONSORT flowcharts) accordingly.
The same duty of care and respect for human dignity apply to research involving archaeological human remains as for research on contemporary human data. Researchers are expected to have obtained appropriate permissions and consent, and complied with relevant national and international legal requirements and regulations in the conduct of their research.
In accordance with the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity , we expect authors publishing research involving the collection of biological specimens, samples or fossils to ensure legal permits from the country of origin have been obtained and are available for review. All such samples must be collected in an ethical and equitable way, and in accordance with relevant applicable laws.