1. Human Subject Research
Manuscripts containing information related to human participants should clearly state that the research has been approved by the authors’ Institutional Review Board (IRB) or by equivalent ethics committee(s), and has complied with all relevant international guidelines expressed in the Declaration of Helsinki. Copies of these guidelines and policy statements must be available for review by the editor if necessary.
All efforts should be made to protect patient privacy and anonymity. Identifying information, including photos, should not be included in the manuscript unless the information is crucial and the individual has provided written consent by completing the Consent Form for Publication. More information about patient privacy, anonymity, and informed consent can be found in the International Committee of Medical Journal Editors (ICMJE) Privacy and Confidentiality guidelines.
2. Clinical Trials
Clinical trials must be registered according to the following guidelines, as supported by the International Committee of Medical Journal Editors (ICMJE) Obligation to Register Clinical Trials.
Trials must be registered in one of the registries approved by the ICMJE or WHO.
Submissions of all clinical trials must also include the study protocol, which will be published with the manuscript if accepted.
Authors of manuscripts describing the results of clinical trials must adhere to the CONSORT reporting guidelines appropriate to their trial design. Before the paper can enter peer review, authors must:
- Provide the registry name and number in the methods section of the manuscript
- Provide a copy of the trial protocol as approved by the ethics committee and a completed CONSORT checklist as Supporting Information (which will be published alongside the paper, if accepted)
- Include the CONSORT flow diagram as the manuscript’s “Figure 1”
The methods section must include the name of the registry, the registry number, and the URL of your trial in the registry database for each location in which the trial is registered.
3. Animal Research
All animal research must have approval from the authors’ Institutional Animal Care and Use Committee (IACUC) or equivalent ethics committee(s), and must have been conducted according to applicable national and international guidelines. Approval must be received prior to beginning research.
We ask authors to follow the Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines for all submissions describing laboratory-based animal research ARRIVE Guidelines Checklist to be published as supporting information.
Manuscripts describing studies that use death as an endpoint will be subject to additional ethical considerations, and may be rejected if they lack appropriate justification for the study or consideration of humane endpoints.
The methods sections of manuscripts reporting results of animal research must include ethics statements that specify:
- The full name of the relevant ethics committee that approved the work, and the associated permit number(s) (where ethical approval is not required, the manuscript should include a clear statement of this and the reason why)
- Relevant details for efforts taken to ameliorate animal suffering
For example:
“This study was carried out in strict accordance with the recommendations in the Guide for the Care and Use of Laboratory Animals of the National Institutes of Health. The protocol was approved by the Committee on the Ethics of Animal Experiments of the University of xxx (Permit Number: 12-3456). All surgery was performed under sodium pentobarbital anesthesia, and all efforts were made to minimize suffering”.
