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Guidelines for Manuscript Type and Related Ethics Documents
Browse: 3112  |   Download: 53  |   Issue Date: 2017-06-27

Last updated October 20, 2017

 

 

Guidelines for Manuscript Type and Related Ethics Documents

 

First, for all manuscripts involving human studies and/or animal experiments, author(s) must submit the related formal ethics documents that were reviewed and approved by their local ethical review committee. This is mandatory and is one of the determining factors for whether or not the manuscript will be sent for peer review or finally accepted. If human and animal studies received waiver of the approval requirement from the ethics committee, the author(s) must provide an official statement to this effect by the ethics committee. The guidelines for manuscript type and related ethics documents/statements are described as follows:

 

1 ETHICS DOCUMENT(S) REQUIRED FOR DIFFERENT MANUSCRIPT TYPES

Manuscript Type

Name(s) of ethics documents required

Sample

Editorial, Review, Frontier, Diagnostic advances, Therapeutic advances, Field of Vision, Minireview, Letter to the Editor, Evidence-Based Medicine, Systematic review, Meta-Analysis, Scientometrics

Conflict-of-Interest Disclosure Form

Please download the fillable ICMJE Form for Disclosure of Potential Conflicts of Interest (PDF), fill in it, and then upload the completed PDF version to the system.

 

Note: The Corresponding Author is responsible for filling out a Conflict-of-Interest Disclosure Form.

Download

Basic study

(1) Institutional Review Board Approval Form or Document

Please upload the PDF version of the Institutional Review Board’s official approval to the system.

Download

(2) Institutional Animal Care and Use Committee Approval Form or Document

Please upload the PDF version of the Institutional Animal Care and Use Committee’s official approval to the system.

Download

(3) Conflict-of-Interest Disclosure Form

Please download the fillable ICMJE Form for Disclosure of Potential Conflicts of Interest (PDF), fill in it, and then upload the completed PDF version to the system.

 

Note: The Corresponding Author is responsible for filling out a Conflict-of-Interest Disclosure Form.

Download

(4) Biostatistics Review Certificate

Please upload the PDF version of a statement affirming that the statistical review of the study was performed by a biomedical statistician to the system.

Download

Case Control study, Observational study, Retrospective Cohort study, Retrospective study, Clinical Practice study

(1) Institutional Review Board Approval Form or Document

Please upload the PDF version of the Institutional Review Board’s official approval to the system.

Download

(2) Signed Informed Consent Form(s) or Document(s)

Please upload the PDF version of the Informed Consent form signed by all subjects and investigators of the study.

Download

(3) Conflict-of-Interest Disclosure Form

Please download the fillable ICMJE Form for Disclosure of Potential Conflicts of Interest (PDF), fill in it, and then upload the completed PDF version to the system.


Note: The Corresponding Author is responsible for filling out a Conflict-of-Interest Disclosure Form.

Download

(4) Biostatistics Review Certificate

Please upload the PDF version of a statement affirming that the statistical review of the study was performed by a biomedical statistician to the system.

Download

Clinical Trials study, Prospective study, Randomized Controlled trial, Randomized Clinical trial

(1) Institutional Review Board Approval Form or Document

Please upload the PDF version of the Institutional Review Board’s official approval to the system.

Download

(2) Clinical Trial Registration Statement

Please upload the PDF version of the document providing the registration identification number and the URL for the trial's registry.

Download

(3) Signed Informed Consent Form(s) or Document(s)

Please upload the PDF version of the Informed Consent form signed by all subjects and investigators of the study.

Download

(4) Conflict-of-Interest Disclosure Form

Please download the fillable ICMJE Form for Disclosure of Potential Conflicts of Interest (PDF), fill in it, and then upload the completed PDF version to the system.


Note: The Corresponding Author is responsible for filling out a Conflict-of-Interest Disclosure Form.

Download

(5) Biostatistics Review Certificate

Please upload the PDF version of a statement affirming that the statistical review of the study was performed by a biomedical statistician to the system.

Download

Case report

(1) Signed Informed Consent Form(s) or Document(s)

Please upload the PDF version of the Informed Consent form signed by all subjects and investigators of the study.

Download

(2) Conflict-of-Interest Disclosure Form

Please download the fillable ICMJE Form for Disclosure of Potential Conflicts of Interest (PDF), fill in it, and then upload the completed PDF version to the system.


Note: The Corresponding Author is responsible for filling out a Conflict-of-Interest Disclosure Form.

Download

 

2 ETHICS POLICIES/STATEMENTS

2.1 Institutional review board. Any article describing a study (basic research, clinical research, and case report) involving human and/or animal subjects is required to have the institutional review board (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 on the title page.

 

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

 

2.2 Institutional animal care and use committee. 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 title page section.

 

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]).

 

2.3 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.

 

2.4 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 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].

 

2.5 Informed consent. 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.

 

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.

 

2.6 Conflict-of-interest. 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 title page 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.

 

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].

 

 2.7 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 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.

 

2.8 Biostatistics. 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) Statistical techniques are suitable or correct; and compliance with the following BPG directives; (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). Statistical data should be expressed as mean ± SD or mean ± SE. Common statistical expressions contains t-test are identified as: t-test as t; F-test as F; chi-square test as c2; relative coefficient as r; degree of freedom as df; number of samples as n; and probability as P.

 

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

 

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 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 E-mail or phone number, must be submitted to the editorial 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 (E-mail and phone number), and the manuscript title.

 

About BPG

The BPG, founded on January 15, 1993, is a professional publisher of medical journals that is dedicated to discovering and disseminating knowledge under the precondition of complying with the publishing ethics.

 

BPG is committed to supporting CrossRef, the Association of Learned and Professional Society Publishers (ALPSP), and the International Association of Scientific, Technical & Medical Publishers (STM), and is a member of all these associations.

 

BPG currently publishes 43 clinical medical journals, covering a wide range of topics, including internal medicine, pediatrics, neurology, psychiatry, dermatology, medical imaging, clinical laboratory diagnostics, surgery, obstetrics and gynecology, ophthalmology, otorhinolaryngology, oncology, sports medicine, anesthesiology, and emergency medicine.

 

BPG follows the Code of Conduct and Best Practice Guidelines for Journal Editors and Publishers developed by the Committee on Publication Ethics (COPE), implements the policy of single-blind peer review and online open access publishing for all journals, and releases the manuscript-related documents of peer-review report, authors’ answering reviewers, institutional ethics approval document(s), and CrossCheck detection report along with the manuscript upon publication.

 

Many journals published by the BPG are indexed in Science Citation Index Expanded (Web of Science), Current Contents/Clinical Medicine, Journal Citation Reports, Index Medicus, MEDLINE, PubMed, PubMed Central, and Scopus.

 

All BPG journals process manuscripts using the self-developed F6Publishing system, which is a modern publishing system that integrates the functions of online peer review, manuscript production, manuscript release, and management of highly influential experts, editorial board members, invited manuscripts, publishing fee, and production fee.