Ethics

Clinical Trials

Clinical trials should be prospectively registered with the appropriate governing agency (for example, ClinicalTrials.gov). To ensure that the research methodology is transparent, usable, and reproducible, the authors should consult the EQUATOR Network early in the research project. The EQUATOR site has tools and FAQs for selecting the appropriate reporting method, thus providing editors and reviewers with a roadmap to evaluate the quality of the study and its application to clinical research.

All studies involving human participants should be planned and performed in compliance with the Helsinki–Ethical Principles for Medical Research Involving Human Subjects (2013) or other appropriate protocols. This information, as well as the names of local institutional review boards (IRB) and regional and national agencies (such as the FDA) that approved the study, should be named in the Methods section. If the study was exempted from approval, details of the exemption should be included.

Privacy & Informed Consent

Informed, written consent must have been obtained from study participants (or a legal guardian) to report their biomedical, clinical, and biometric data. All identifying information must be removed from text, tables, and figures. Examples include participants’ names or initials, hospital identification numbers, and identifying physical features in photographs.

Individuals (or their legal guardian) whose full details are included in a Case Report must consent to publication of the article under a Creative Commons License 4.0, with the understanding that the information in the report and any accompanying photographs will be freely available to see on the internet and to reuse. A statement confirming that informed consent was obtained should be included in the manuscript.

The Journal recommends submitting photographs and motion images of persons only when necessary. Crop photographs and edit motion images to focus solely on the notable aspects being described. Facial and other physical features may be obscured.

Animal Studies

All animal studies should be conducted according to the National Institutes of Health (NIH) Guide for the Care and Use of Laboratory Animals or the equivalent. The manuscript must include which guidelines were followed and a statement indicating the name of the institutional animal care and use committee that approved the experimental protocol. If the study was exempted from approval, details of the exemption should be included.