Ethical approval of human research
All planning conduct and reporting of human research must be in accordance with the Declaration of Helsinki. This includes any study involving human subjects, medical records and human tissues. Authors should also seek the approval to conduct research from an independent local, regional or national review board (e.g. Institutional Review Board (IRB) or ethics committee). Any considerations or approvals made by this committee must not reduce or eliminate the protections for research subjects set out by the Declaration of Helsinki. If doubt remains whether the research was conducted in accordance with the Declaration of Helsinki, the author must demonstrate the rationale for the independent local, regional or national review boards decision. A statement declaring review board approval must be included in the manuscript.
Ethical approval for use of human cell lines and tissues
Human cell lines and tissues are considered forms of human biospecimens. For this reason, we please ask authors to include a statement in their manuscripts detailing the relevant ethical approval and patient consent for the use of human cell lines or tissues in their studies. This is an essential requirement especially where the human material used is potentially identifiable, such as material contained in biobanks or similar repositories. If the cell lines or tissues were purchased through an accredited commercial provider, please provide details of this. If ethical approval or patient consent was not sought or provided, please provide an explanation for this.
Clinical Trial Registration
To be considered for publication, all submissions of clinical trials involving human subjects must have registered the trial in a public trials registry. This is in accordance with the Declaration of Helsinki. Ideally, the clinical trial should be prospectively registered in an acceptable registry that is accessible to the public at no charge, open to prospective registrants, allows for the validity of the registration data to be checked and is electronically searchable. Authors must include the Clinical Trial Registration number in the manuscript.
Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc.
Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.
Full details of clinical trial registration and the necessary requirements can be found on the ICJME website.
Please note: The Clinical Trial Registration guidelines were adapted from information provided by the International Committee of Medical Journal Editors (ICMJE) and the World Health Organization (WHO).
Case reports/Case series/Clinical datasets
In some instances, a case report or case series containing information on less than three patients may not require IRB approval. This is because a case series of less than three subjects may not be considered generalized knowledge or research. However, this requirement is dependant on the institution, country or region implementing it and authors must ensure they have followed the correct regulatory requirements of their respective institution or country. Outside this requirement, all case reports, case series or clinical datasets must have IRB approval and authors must be aware that IRB approval cannot be given retroactively. A statement declaring IRB approval must be included in the manuscript. Details of Journals’ Best Practices for Ensuring Consent for Publishing Medical Case Reports can be found on COPEs website.
Ethical approval of animal research
All manuscripts involving animal research must show the work followed international, national and institutional guidelines for the ethical and legal treatment of animals. Authors must show the study was approved by an ethics review committee from the same institution at which the study was conducted. For non-human primate studies and veterinary studies using client-owned animals, it must be demonstrated the work meets the standards set out in NC3Rs primates guidelines and follows veterinary care best practices guidelines. For veterinary studies informed client consent must also be provided. IJSM advises all authors conducting animal research to read and follow NC3Rs ARRIVE guidelines. The guidelines set out the currently accepted procedures for the reporting of research using animals and are available in various translations including Chinese Mandarin. A statement declaring the ethical review committee’s approval must be included in the manuscript.