Update on requirements for ethics and welfare reporting in <i>The Journal of Physiology</i>
Ken D. O’Halloran
Abstract
This editorial is intended to highlight key reporting obligations pertaining to ethics and animal welfare matters for papers published in The Journal of Physiology. On occasion, research articles under consideration at The Journal are referred to me for review of ethics and welfare issues. I also have sight of many more articles in the context of my contribution as a Reviewing Editor. Many referrals are routine, whilst others relate to specific queries or concerns raised during the review process. Several unintended gaps in reporting requirements emerge as a recurring theme, motivating this editorial, which seeks to highlight key information that should be included in research articles. I hope this article will serve as a useful resource for prospective authors, reviewers and editors. A checklist is provided; however, it is not exhaustive (Table 1). Readers are referred to The Journal guidelines, principles and standards for the reporting of animal experiments (Grundy, 2015), and the ARRIVE 2.0 guidelines, and are reminded to continue to consult The Journal website for complete and detailed information on established and evolving policies (Table 2). Ethical approval Human studies Animal studies Anaesthetic agents Analgesia and post-operative care Surgical and experimental procedures Fate of animals Humane killing of experimental animals It is a requirement to start the Methods section of a manuscript with the sub-heading Ethical approval. Explicit details are required including the institutional body that reviewed and approved the study (including ethics approval number/code, where available) and details of the regulatory body providing authorisation or licence for the study, where applicable. On occasion, historical data sets are used for contemporary analyses. Such manuscripts are considered with reference to the regulatory standards applicable at the time of the original study. Authors should provide details confirming compliance with same. Prospective authors are encouraged to consult with The Journal prior to submission. For studies in human participants, a statement confirming that participants provided written informed consent is required. It is a requirement that the study conformed to the principles of the Declaration of Helsinki. This must be stated. If the study was a registered trial, details should be provided. If the research study was not a trial, then it is a requirement to state that the study conformed to the principles of the Declaration of Helsinki, except for registration in a database. For studies in animals, the source, strain, sex and age of the animals used must be clearly stated. Explicit clarity on the number of animals used must be provided. A clear statement on pertinent details of animal husbandry and the feeding regimen employed in the study must be provided. The fate of the animals at the end of the study must be clearly stated. Explicit detail is required on the dose and route of administration of anaesthetic agents used in studies, including supplemental doses where applicable. The Journal strongly advocates for the use of the most refined approaches for recovery surgery, non-recovery procedures and euthanasia. For animal studies, it is essential that clarity is provided on the steps taken throughout procedures performed under anaesthesia that ensured adequacy of depth of anaesthesia. Whereas it may appear redundant, authors are required to re-state dose and route of anaesthetic agents and provide details on how assurance of an adequate depth of anaesthesia was determined before commencing surgical procedures, and throughout the duration of procedures. Details should be provided at each relevant juncture in the Methods for explicit clarity on adherence to and compliance with this essential welfare requirement for each cohort of animals used in the study. There is an expectation in recovery studies that animals will receive post-operative analgesia and a requirement to report on post-operative monitoring. If researchers forego the use of an analgesic, then strong justification is required, including confirmation that the issue was carefully considered and explicitly approved by the ethics committee/regulatory body, and this should be clearly stated in the manuscript. Such cases are considered on a case-by-case basis by The Journal. Whereas reference to previously published work is helpful, it does not waive the requirement for full description of all procedures performed on human participants and/or experimental animals. Prospective authors are reminded that there are no word restrictions to the Methods section of The Journal. Less is not more! The fate of all animals used in the study should be fully evident. The Methods should be constructed in a manner that provides clarity in respect of each cohort of animals used from start to finish of the study. In complex studies, such detail is often inadvertently masked in the reporting of the study. An important detail, where applicable, is full disclosure of the successive surgical and/or experimental procedures applied to cohorts of animals, so that the cumulative exposure, and hence complete experimental fate, of the animals is fully evident. Inherent in this requirement is the expectation that this was also clear to the ethics committee and/or approval body such that regard for welfare was undertaken in full appreciation of the cumulative burden of procedures. Animals must be killed using methods approved for that species, stage of development and size. The Journal of Physiology follows strict standards, based on those set out in the Animals (Scientific Procedures) Act Schedule 1 in the UK, and in Annex IV in the European Directive 2010/63/EU (Table 2). Information on the method of humane killing must be provided for each cohort of animals used in the study. Authors should state that animals were killed, not sacrificed. The Journal of Physiology seeks to uphold the highest standards of ethics and welfare. It is essential that adherence to these standards is fully and transparently reported in article submissions to The Journal where they form a crucial element of the peer-review process, and when published, provide a permanent record of studies exacting the highest standards in the conduct of research. None. K.D.O'H.: Conception or design of the work; Drafting the work or revising it critically for important intellectual content; Final approval of the version to be published; Agreement to be accountable for all aspects of the work. None. Ken D. O'Halloran is Senior Ethics Editor, The Journal of Physiology. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.