All human and animal subjects deserve to be treated with dignity and respect in academic research. Researchers should ensure that their work minimizes risk and avoids harm. They also have an ethical obligation to be transparent about their research methods so that editors, peer reviewers, and readers can fairly and adequately assess their work. Annali Italiani di Chirurgia reserves the right to reject any manuscript due to unethical behavior in human or animal research.
For research involving human experiments, the article must include a statement that ethical approval was obtained or a ethical approval is not required (e.g., because of national laws) or where a study has been granted an exemption by an ethics committee, this should be stated within the manuscript with a full explanation, including the name of the ethics committee(s) or institutional review board(s), the number/ID of the approval(s), and a statement that the participants gave informed consent before taking part (or a statement that it was not required and why). Authors should also state that the study conformed to the provisions of the Declaration of Helsinki. Here are some examples for different types of human subjects:
Examples for Clinical Trials: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The trial was conducted in accordance with the Declaration of Helsinki. The study was approved by the local institutional review board (IRB) or other appropriate ethics committee board of XXX (No. the registration number of the ethics board) and informed consent was taken from all individual participants. Additionally, the trial registration number (TRN) and date of registration should be included as the last line of the manuscript abstract. Suitable publicly available registries are those listed on the ICMJE and the WHO International Clinical Trials Registry Platform. For clinical trials that have not been registered prospectively, we encourage retrospective registration to ensure the complete publication of all results. Authors who are unsure whether their trial needs registering should consult the ICMJE FAQs for further information.
Examples for Retrospective Studies: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki. The study was approved by the the local institutional review board (IRB) or other appropriate ethics committee board of XXX (No. the registration number of the ethics board) and informed consent was taken from all individual participants. ( Sometimes individual consent for this retrospective analysis may waived. Authors should check with their institution to make sure they are complying with the specific requirements of their country.）
When reporting experiments on animals, authors should indicate whether institutional and national standards for the care and use of laboratory animals were followed. Animal species/strain, sex, and source (vendor name, location) should be indicated. Please note that we encourage the use of both male and female animals. The use of a single sex should be scientifically justified. This statement is mandatory for acceptance and publication of the manuscript. Authors should ensure that the experimental conditions and procedures of their research minimize any harm to animals. Authors should supply detailed information on the ethical treatment of their animals in their submission. For that purpose they may use the ARRIVE Guidelines which is designed to be used when submitting manuscripts describing animal research. We recommend that authors consult the American Veterinary Medical Association (AVMA) Guidelines for a comprehensive resource for guidance on veterinary best practice for the anesthesia and euthanasia of animals. Manuscripts that submit studies using methods (e.g., chloral hydrate, ether, and chloroform) of anesthesia or euthanasia that are inconsistent with accepted veterinary best practices will not be considered.
Example statement for consideraion: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. Experiments were performed under a project license (No.: the license number) granted by the institutional/regional/national ethics/committee/ethics board of XXX, in compliance with XXX national or institutional guidelines（such as ARRIVE Guidelines） for the care and use of animals.
The contamination or misidentification of cell lines can have a negative impact on the effectiveness of research observations. Therefore, authors need to provide detailed descriptions of the source of the cell line and the methods used for verification in the Materials and Methods section. References should be included for either a published paper or a commercial source. Additional information on cell line contamination is available from the International Cell Line Authentication Committee (ICLAC). We recommend that authors use the NCBI database to check for potential misidentification and contamination issues with human cell lines. It is important to note that, if the cell line is of human origin, written informed consent confirmation must be provided, especially in the case of de novo cell lines. The editors reserve the right to reject any submission that does not meet these requirements.
Example statement for consideraion: Cell line A was isolated from human XXX tissue, while cell line B was purchased from the American Type Culture Collection (ATCC) (No. XXXX). All cell lines were maintained at 37℃ in a XXX atmosphere and were confirmed to be mycoplasma-free using the Mycoplasma XXX test kit. Cell line A procedures were conducted in accordance with the guidelines of the Declaration of Helsinki, approved by the XXX Ethics Committee (protocol number xxxxxxx), and informed consent was obtained. Additionally, all cell lines underwent validation using XXX technology shortly before use.