Consent and ethical approval. Studies on human subjects must comply with the Helsinki Declaration of 1975, revised October 2013 (see https://www.dhmjournal.com/index.php/author-instructions for a copy).

Studies using animals must comply with National Health and Medical Research Council Guidelines or their equivalent in the country in which the work was conducted. It is insufficient to refer to previous publications for details of animal welfare and procedural care. The Physiological Society provides detailed advice regarding animal experimentation and its reporting in research publications and this link is provided with their kind permission: https://physoc.onlinelibrary.wiley.com/doi/full/10.1113/jphysiol.2010.192278

A statement affirming Ethics Committee (Institutional Review Board) approval (and the approval number) should be included in the text at the beginning of the methods section. A copy of that approval should be uploaded with the submission. Similarly, a statement affirming the securing of written informed consent from subjects should be included in the methods where this was part of the methodology.

Clinical trials commenced after 2011 must have been registered at a recognised trial registry site such as the Australia and New Zealand Clinical Trials Registry http://www.anzctr.org.au/ or EudraCT in Europe https://eudract.ema.europa.eu/. Details of the registration must be provided in the accompanying MSF, and should also be mentioned in the methods section.

For individual case reports, evidence of informed patient consent to anonymous publication of their clinical details and/or images, etc. must be provided. Case series, where only limited anonymous summary data are reported do not require patient consent, but must have been assessed by an ethics committee and, if indicated, have ethics approval. Consult your local ethics committee if you are unsure.