Last updated October 13, 2017
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 in Food and Drug Administration-Regulated Clinical Trials (USA) or the Medical Research Council Guidelines for Good Clinical Practice in Clinical Trials (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 IRB (for human subjects) and/or the IACUC (for animal subjects) for conducting the doubtful aspects of the study. Authors must provide the following 8 files related to academic rules and norms before the final acceptance of their original article for publication. The following 8 files will be published online together with the manuscript.
1 Institutional Review Board (IRB) statement. The ethics approval document(s)/letter(s) must be provided in a PDF format, and each statement must also be mentioned as a footnote in the manuscript text.
Sample wording: The study was reviewed and approved by the [Name of Institution or Organization] Institutional Review Board.
2 Informed consent statement. This file must be provided in a PDF format, and the statement must also be mentioned as a footnote in the manuscript text.
Sample wording: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
3 Clinical trial registration. 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 months 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. The approval document(s)/letter(s) must be provided in a PDF format, and each statement must also be mentioned as a footnote in the manuscript text.
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. The statement must also be mentioned in the text.
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 statement. This statement must be mentioned in the text, and a certificate of statistical review signed by a biostatistician must be provided in PDF format.
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. This file must be signed by the corresponding author and provided in a PDF format, and the statement must also be mentioned as a footnote in the manuscript text.
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. The statement must be mentioned as a footnote in the manuscript text.
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.