Last updated July 25, 2016
Guidelines for manuscript preparation, submission, and manuscript format: Original articles
Original article contains basic study, case control study, clinical trials study, observational study, prospective study, randomized clinical trial, randomized controlled trial, retrospective cohort study, and retrospective study.
For full original articles guidelines for manuscript preparation, submission, and manuscript format, please click on the links below:
2 Format for Case Control Study
3 Format for Clinical Trials Study
4 Format for Observational Study
5 Format for Prospective Study
6 Format for Randomized Clinical Trial
7 Format for Randomized Controlled Trial
8 Format for Retrospective Cohort Study
9 Format for Retrospective Study
ACADEMIC RULES AND NORMS
1 Human and Animal Rights Statement
2 Institutional Review Board Statement
3 Informed Consent Statement
4 Clinical Trial Registration Statement
5 Institutional Animal Care and Use Committee Statement
6 Animal Care and Use Statement
7 Biostatistics Statement
8 Conflict-of-Interest Statement
9 Data Sharing Statement
INTRODUCTION
In general, Baishideng Publishing Group (BPG) recommends that all authors considering submission to any BPG journal first read the “Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication” published by the International Committee of Medical Journal Editors (ICMJE), which is available at: http://www.icmje.org/recommendations/archives/2008_urm.pdf. All journals published by the BPG comply with the ICMJE’s uniform requirements for manuscripts to the full extent.
The various ethics statements related to scientific conduct (i.e. study design, including methods and subjects) for all studies published in BPG journals are detailed below.
The authors are required to make the following statements in the manuscript’s title page or the Materials and Methods section. A copy of any approval document(s)/letter(s) or waiver of confirmation must also be provided in PDF format. BPG will include all the confirmations along with the manuscript as a permanent part of the online publication.
1 HUMAN AND ANIMAL RIGHTS STATEMENT
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 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.
All research reports that are submitted for consideration of publication in a BPG journal must include statement(s) of proof that the appropriate approvals were obtained from the relevant IRB or research ethics committee. Any manuscript describing a study that used human subjects must include a statement that affirms the experiments were performed with prior informed consent (written or verbal, as appropriate) from each participant. All personal information must be anonymized prior to publication, unless a record of explicit consent from the involved patient(s) has been provided. Any manuscript describing a study that used animal subjects must include a statement in the Materials and Methods section (or text describing the experimental procedures) that affirms all appropriate measures were taken to minimize pain or discomfort, and details of the animals’ care should be provided.
2 INSTITUTIONAL REVIEW BOARD STATEMENT
Any article describing a study (basic research, clinical research, and case report) involving human and/or animal subjects 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 Clinic Care Coalition for Human Rights Institutional Review Board), stated explicitly in the title page. In addition, a copy of any ethics approval document(s)/letter(s) or waiver should be provided to the BPG in PDF format.
Sample wording: The study was reviewed and approved by the [Name of Institution or Organization] Institutional Review Board.
3 INFORMED CONSENT STATEMENT
Any research article describing a study (clinical research and case report) involving humans should contain a statement in the title page 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, a copy of any approval document(s)/letter(s) or waiver should be provided to the BPG in PDF format.
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 BPG for waiver of informed consent, but there is no guarantee that the petition will be granted. In general, 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.
Sample wording: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
4 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 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].
Some registries are listed below:
Australian New Zealand Clinical Trials Registry
Brazilian Clinical Trials Registry (ReBec)
Clinical Research Information Service (CRiS), Republic of Korea
Clinical Trials Registry - India (CTRI)
Cuban Public Registry of Clinical Trials (RPCEC)
EU Clinical Trials Register (EU-CTR)
German Clinical Trials Register (DRKS)
Iranian Registry of Clinical Trials (IRCT)
Japan Primary Registries Network (JPRN)
Pan African Clinical Trial Registry (PACTR)
Sri Lanka Clinical Trials Registry (SLCTR)
5 INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE STATEMENT
Any article describing a study (basic research) involving animal subjects is required to have the IACUC’s institution name (such as the Genovese Institute) and protocol number (such as 14-9347-39G or EN-21549) stated explicitly in the title page section. In addition, a copy of any approval document(s)/letter(s) or waiver should be provided to the BPG in PDF format.
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]).
6 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. In addition, a copy of the signed statement should be provided to the BPG in PDF format.
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.
7 BIOSTATISTICS STATEMENT
Any manuscript describing a study (basic research and clinical research) that used biostatistics must include a statement in the Materials and Methods section affirming that the statistical review of the study was performed by a biomedical statistician. Statistical review is performed before the submission or after peer-review. The author invites an expert in Biomedical Statistics to evaluate the statistical method(s) used in the study, including but not limited to the t-test (group or paired comparisons), chi-square test, ridit, probit, logit and regression (linear, curvilinear, or stepwise) modeling, correlation, analysis of variance, and analysis of covariance. The review by the biomedical statistician is conducted with respect to the following points: (1) Statistical methods are adequately and appropriately described when they are used to verify the results; (2) Whether the statistical techniques are suitable or correct; (3) Only homogeneous data can be averaged. Standard deviations are preferred to standard errors. The number of observations and subjects (n) is given. Losses in observations, such as drop-outs from the study, are reported; (4) Values, such as ED50, LD50 and IC50, have the 95% confidence limits calculated and have been compared by weighted probit modeling (using the functions described by Bliss and Finney); and (5) The word “significantly” is replaced by its synonyms (if it indicates extent) or the P value (if it indicates statistical significance). In addition, a copy of any approval document(s)/letter(s) or waiver should be provided to the BPG in PDF format.
For example, if a biostatistics editor is employed by the authors, the person’s name (first name and family (sur)name), qualifications, and contact information must be submitted to the WJG editorial office in the form of a letter of confirmation of service. If the biostatistics editing was performed by a commercial service provider, the company’s name and contact information, including URL and email or phone number, must be submitted to the WJGeditorial office in the form of a letter of confirmation of service. The letters of confirmation of service must include the corresponding author’s name (first name and family (sur)name) and contact information (email and phone number), and the manuscript title.
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 it results or presentation of its scientific/medical content, the BPG requires all authors of each paper to declare any conflicting interests (including but not limited to commercial, personal, political, intellectual, or religious interests) in the title page that are related to the work submitted for consideration of publication. In addition, reviewers are required to indicate any potential conflicting interests they might have related to any particular paper they are asked to review, and a copy of signed statement should be provided to the BPG in PDF format.
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
Basic research and clinical research studies require a data sharing statement. The data sharing statement will be provided in the title page, and will be presented in the following form: Technical appendix, statistical code, and dataset available from the corresponding author at Dryad repository, who will provide a permanent, citable and open-access home for the dataset. In addition, a copy of the signed statement should be provided to the BPG in PDF format.
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.