or research studies using human or animal subjects, the trial’s design, conduct, and reporting of results must conform to Good Clinical Practice guidelines (such as the Good Clinical Practice in Food and Drug Administration (FDA)-Regulated Clinical Trials (USA) or the Medical Research Council Guidelines for Good Clinical Practice in Clinical Trials (UK)) and/or to the World Medical Association (WMA) Declaration of Helsinki.
Any work describing a study that used human subjects must include a statement that affirms the experiments were performed with prior informed consent (written or verbal, as appropriate) from each participant.
Humans: When reporting experiments on human subjects, authors should indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008 (5). If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the author(s) must explain the rationale for their approach and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study.
Animals: When reporting experiments on animals, authors should indicate whether the institutional and national guide for the care and use of laboratory animals was followed. Experimental research on vertebrates or any regulated invertebrates must comply with institutional, national, or international guidelines, and where available should have been approved by an appropriate ethics committee. A statement detailing compliance with guidelines and/or ethical approval must be included in the work. For studies involving client-owned animals, author(s) must document informed client consent and adherence to a high standard (best practice) of veterinary care.
Statement on Informed Consent
Consent: For all research involving human subjects, informed consent to participate in the study should be obtained from participants (or their parent or guardian in the case of children under 18 and a statement to this effect should appear in the work.
Consent for publication of individual patient data: For all works that include details, images, or videos relating to individual participants, written informed consent for the publication of these must be obtained from the participants (or their parent or legal guardian in the case of children under 18) and a statement to this effect should appear in the work. A consent form must be made available to the Editor(s) on request and will be treated confidentially. In cases where images are entirely unidentifiable and there are no details on individuals reported within the manuscript, consent for publication of images may not be required. The final decision on whether consent to publish is required lies with the Editor(s).
Patients have a right to privacy that should not be infringed without informed consent. Identifying information, including patients’ 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 a patient who is identifiable be shown the manuscript to be published. Authors should identify individuals who provide writing assistance and disclose the funding source for this assistance. Identifying details should be omitted if they are not essential. Complete anonymity is difficult to achieve, however, an informed consent should be obtained if there is any doubt. 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 that alterations do not distort scientific meaning and the author(s) are responsible to notify the editor(s) in such instances and editor(s) should so note accordingly. The requirement for informed consent should be included in the journal’s instructions for authors. When informed consent has been obtained it should be indicated in the published work.