Protection of Research Participants
Helsinki Declaration. All investigators should ensure that the planning conduct and reporting of human research are in accordance with the Helsinki Declaration. All authors should seek approval to conduct research from an independent local, regional, or national review body (e.g., ethics committee, institutional review board). If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach and demonstrate that the local, regional, or national review body explicitly approved the doubtful aspects of the study.
Patient consent and anonymity. Patients have a right to privacy that should not be violated without informed consent. Identifying information, including names, initials, or hospital numbers, should not be published in written descriptions, photographs, or pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives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 an identifiable patient be shown the manuscript to be published. Authors should disclose to these patients whether any potential identifiable material might be available via the Internet as well as in print after publication. Patient consent should be written and archived with the authors. When informed consent has been obtained, it should be indicated in the published article.
Experiments on Animals. When reporting experiments on animals, authors should indicate whether institutional and national standards for the care and use of laboratory animals were followed. Further guidance on animal research ethics is available from the International Association of Veterinary Editors’ Consensus Author Guidelines on Animal Ethics and Welfare.
Clinical trials. Clinical trials must be registered before the start of patient enrollment in public trials registry at or before the time of first patient enrollment as a condition of consideration for publication. The trial registration number must be reported in the paper.
WHEN SUBMITTING A MANUSCRIPT
The corresponding author should indicate the subjects included in the study.
For human studies:
Indicate that "All study participants signed an informed consent form". An exception is for retrospective studies; in this case, state that "Informed consent forms were not obtained due to the retrospective nature of the study".
Indicate that "Ethics Committee approval was obtained" OR "The Ethics Committee determined that approval was not required for this study".
A statement is required that the study described complied with the principles of the Declaration of Helsinki.
When describing a clinical trial, the registration number of the clinical trial should be indicated
In animal studies:
It should be noted whether the maintenance and use of laboratory animals complied with the rules adopted by the institution, recommendations of the national research council, and national laws.
If the study was not performed on animals, it should be noted that "No animals were included in this study"
Example 1: This work was conducted with human subjects. This study was approved by the local bioethics committee. All patients gave informed consent to participate in the study. The study was conducted in accordance with the Declaration of Helsinki. No animals were included in this study
Example 2: A study was conducted with human subjects. The study was approved by the local bioethics committee, which found that no informed consent was required. The study was conducted in accordance with the Declaration of Helsinki. This study did not involve animal experimentation
Example 3: A study was conducted with human subjects. The study was approved by the local bioethics committee. Due to the retrospective nature of the study, no informed consent forms were obtained. The study was conducted in accordance with the Declaration of Helsinki. The animals were not included in this study
Example 4. The study was conducted on animals. The experiment was performed in accordance with the European Convention for the Protection of Vertebrate Animals Used for Experimental or Other Scientific Purposes (Strasbourg, 1986)