Last updated: August 12, 2024

Academic rules and norms

For research studies using human or animal subjects, the trial’s design, conduct and reporting of results must conform to Good Clinical Practice guidelines [such as the Good Clinical Practice and Clinical Trials in Food and Drug Administration (USA) or the Medical Research Council Guidelines for Good Clinical Practice (UK)] and/or to the World Medical Association Declaration of Helsinki. Generally, we suggest that the national standard of the lead investigator be followed. If authors have any doubt as to whether the research was conducted in accordance with the above standards, the rationale for the chosen experimental approach must be clearly presented, along with a statement and proof of explicit approval given by the appropriate Institutional Review Board (IRB, for human subjects) and/or the Institutional Animal Care and Use Committee (IACUC, for animal subjects) for conducting the doubtful aspects of the study. Authors must provide the following statements/documents related to academic rules and norms before the final acceptance of their original article for publication. The following statements/documents will be published online together with the manuscript.

1 Institutional Review Board (IRB) statement. Any article describing a study involving human and/or animal subjects should provide the information of its approval by the related institution/organization’s Institutional Review Board and, if available, corresponding approval ID, stated explicitly in the Footnotes section. In addition, authors are required to provide the primary version (PDF) of the Institutional Review Board’s official approval, prepared in the official language of the authors’ country to the Editorial Office; for example, authors from China should provide the Chinese version of the document, authors from Italy should provide the Italian version of the document, etc.

Sample wording: The study was reviewed and approved by the [Name of Institution or Organization] Institutional Review Board.

2 Informed consent statement. Any research article describing a study involving humans should contain a statement clearly in the footnotes section stating that all involved persons (subjects or legally authorized representative) gave their informed consent (written or verbal, as appropriate) prior to study inclusion. In addition, authors are required to provide the primary version (PDF) of the Informed Consent Form that has been signed by all subjects and investigators of the study, prepared in the official language of the authors’ country to the Editorial Office; for example, authors from China should provide the Chinese version of the document, authors from Italy should provide the Italian version of the document, etc.

Sample wording: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.

3 Clinical trial registration statement. Any research study (clinical trial) that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes must be registered. Authors must provide the registration identification number and the URL for the trial's registry, stated explicitly in the Footnotes section. In addition, authors are required to provide the PDF version of the document providing the registration identification number and the URL for the trial's registry.

Sample wording: This study is registered at [URL]. The registration identification number is [registration identification number].

4 Institutional Animal Care and Use Committee (IACUC) statement. Any article describing a study involving animal subjects should be approved by the Institutional Animal Care and Use Committee and the protocol number should be stated explicitly in the Footnotes section. In addition, authors are required to provide the primary version (PDF) of the Institutional Animal Care and Use Committee’s official approval in the official language of the authors’ country to the Editorial Office; for example, authors from China should provide the Chinese version of the document, authors from Italy should provide the Italian version of the document, etc.

Sample wording: All procedures involving animals were reviewed and approved by the Institutional Animal Care and Use Committee of the [Name of Institution] (IACUC protocol number: [Protocol No. ###]).

5 Animal care and use statement. Any manuscript describing a study that used animal subjects must include a statement in the Materials and Methods section affirming that all appropriate measures were taken to minimize pain or discomfort, and details of the animals’ care should be provided.

Example wording: The animal protocol was designed to minimize pain or discomfort to the animals. The animals were acclimatized to laboratory conditions (23°C, 12h/12h light/dark, 50% humidity, ad libitum access to food and water) for two weeks prior to experimentation. Intragastric gavage administration was carried out with conscious animals, using straight gavage needles appropriate for the animal size (15-17 g body weight: 22 gauge, 1 inch length, 1.25 mm ball diameter). All animals were euthanized by barbiturate overdose (intravenous injection, 150 mg/kg pentobarbital sodium) for tissue collection.

6 Biostatistics Review Certificate. Any manuscript describing a study that used biostatistics must provide the PDF version of a statement affirming that the statistical review of the study was performed by a biomedical statistician to the Editorial Office.

Sample wording: The statistical methods of this study were reviewed by [name(s) of individual(s)] from [name(s) of organization(s)]…

7 Conflict-of-interest statement. A conflict-of-interest statement is required for all article and study types. In the interests of transparency and helping reviewers to assess any potential bias in a study’s design, interpretation of its results or presentation of its scientific/medical content, we require all authors of each paper to declare any conflicting interests (including but not limited to commercial, personal, political, intellectual or religious interests) that are related to the work submitted for consideration of publication in the Footnotes section. In addition, authors are required to click and download the fillable ICMJE Form for Disclosure of Potential Conflicts of Interest (PDF), and fill it in. The Corresponding Author is responsible for filling out and providing this form to the Editorial Office.

Sample wording: [Name of individual] has received fees for serving as a speaker, a [position; such as consultant and/or an advisory board member] for [name(s) of organization(s)]. [Name of individual] has received research funding from [name(s) of organization(s)]. [Name of individual] is an employee of [name(s) of organization(s)]. [Name of individual] owns stocks and/or shares in [name(s) of organization(s)]. [Name of individual] owns patent [patent identifier information (including patent number, two-letter country code, and kind code) and a brief description].

8 Data sharing statement. Clinical research and basic research studies require a data sharing statement. The data sharing statement will be provided in the Footnotes section, and will be presented in the form as shown in the sample below.

Sample wording: Technical appendix, statistical code, and dataset available from the corresponding author at [email address or URL]. Participants gave informed consent for data sharing [or ...consent was not obtained but the presented data are anonymized and risk of identification is low... or consent was not obtained but the potential benefits of sharing these data outweigh the potential harms because...]". If no other data, please state: No additional data are available.