Last updated: November 20, 2025

Academic rules and norms

Human research: For research studies using humans, the study’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), the Medical Research Council Guidelines for Good Clinical Practice (UK)] and/or to the World Medical Association Declaration of Helsinki.

Organ transplantation research: All procedures and studies involving organ transplantation are required to have been carried out according to WHO Guiding Principles On Human Cell, Tissue And Organ Transplantation outlined by the World Health Organization, abided by the Declaration of Istanbul, and involved no illegal commercial transactions, the use of organs or other material from executed prisoners, or other unethical practices in obtaining donor organs.

Animal research: For research studies using animal subjects, the study’s design, conduct and reporting of results must conform to code practice guidelines [such as the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training or Code of Practice for the Housing and Care of Animals Used in Scientific Procedures or EU Regulations On Animal Research].

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 (basic research, clinical research) involving human and organ transplantation is required to have the IRB name, whether institutional (part of the author(s)’ academic/medical institution, such as the Oak Grove Children’s Hospital Institutional Review Board) or commercial/independent/private (contracted for-profit organizations, such as the ClinicCare Coalition for Human Rights Institutional Review Board), 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 (Approval ID. [####, if available]).

2 Informed consent statement. Any research article describing a study (clinical research and case report) involving humans and organ transplantations should contain a statement in the Footnotes section clearly stating that all involved persons (subjects or legally authorized representative) gave their informed consent (written or verbal, as appropriate) prior to study inclusion. In general, the BPG requires that any and all details that might disclose the identity of the subjects under study should be omitted or anonymized. In the rare situation that a study participant’s identifiable information is crucial to the case presentation, the statement of informed consent is absolutely necessary, unless the participant is deceased. 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.

Note: Waiver of informed consent for human study subjects may be justifiable under certain rare and specific conditions, such as for a trial with demonstrated minimal risk or cases of emergency care. Authors may petition the BPG for waiver of informed consent, but there is no guarantee that the petition will be granted. In general, the BPG favors the requirement of informed consent for all reports of information (anonymized or identifiable) and reserves the right to refuse publication of such if informed consent was not obtained.

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 have 6 mo from the first patient enrollment to register the trial, but BPG recommends registration prior to enrollment. This registration policy applies to prospective/randomized/controlled trials only. Authors must provide 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 (basic research) involving animal subjects is required to have the Institutional Animal Care and Use Committee (IACUC)’s institution name (such as the Genovese Institute) and protocol number (such as 14-9347-39G or EN-21549) 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 number]).

5 Animal care and use statement. Any manuscript describing a study (basic research) 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, 12 h/12 h light/dark, 50% humidity, ad libitum access to food and water) for 2 wk 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 Organ transplantation: Any manuscript describing a study involving organ transplantations must include a statement in the Materials and Methods section affirming that their study involved no illegal commercial transactions, the use of organs or other material from executed prisoners, or other unethical practices in obtaining donor organs, and the name of the institution(s)/clinic(s)/department(s) from which the organs/tissues were obtained should be provided.

Example wording: The donor organs/tissues were obtained from [Name of Institution(s)/Clinic(s)/Department(s)]. The study involved no illegal commercial transactions, the use of organs or other material from executed prisoners, or other unethical practices in obtaining donor organs.

7 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)]…

8 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, the BPG requires all authors of each paper to declare in the Footnotes section 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 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].

9 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.