RESEARCH ETHICS AND POLICIES
Conflict of Interest:
Financial contributions and any potential conflict of interest must be clearly acknowledged under the heading ‘Conflict of Interest’. Authors must list the source(s) of funding for the study. This should be done for each author.
All individuals listed as authors must have contributed substantially to the design, performance, analysis, or reporting of the work and are required to indicate their specific contribution. Anyone (individual/company/institution) who has substantially contributed to the study for important intellectual content, or was involved in the in drafting or revising the manuscript must also be acknowledged.
Guest or honorary authorship based solely on position (e.g. research supervisor, departmental head) is discouraged
The specific requirements for authorship have been defined by the International Committee of Medical Journal Editors (www.icmje.org). Examples of authors' contributions are: 'designed research/study', 'performed research/study', 'contributed important reagents', 'collected data', 'analyzed data', 'wrote paper' etc. This information must be included in the submitted manuscript as a separate paragraph under the heading ‘Acknowledgements’. The corresponding author is responsible for obtaining permission from all co-authors for the submission of any version of the manuscript and for any changes in the authorship.
HUMAN AND ANIMAL RIGHTS:
Research Involving Humans
All clinical investigations should be conducted according to the Declaration of Helsinki principles. For all manuscripts reporting data from studies involving human participants, formal review and approval by an appropriate institutional review board or ethics committee are required.
Compliance with the guidelines of the International Committee of Medical Journal Editors www.icmje.org) is recommended, in accordance with the patient’s consent for research or participation in a study as per the applicable laws and regulations regarding the privacy and/or security of personal information, including, but not limited to, the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and other U.S. federal and state laws relating to confidentiality and security of personally distinguishable evidence, the General Data Protection Regulation (GDPR) (EU) 2016/679 and member state implementing legislation, Canada's Personal Information Protection and Electronic Documents Act, India's Information Technology Act and related Privacy Rules, (together "Data Protection and Privacy Laws").
It is the responsibility of the author to ensure that:
- Patients' names, initials, or hospital numbers are not mentioned anywhere in the manuscript (including figures).
- Authors are responsible for obtaining the patient consent-to-disclose forms for all recognizable patients in photographs, videos, or other information that may be published in the Journal, in derivative works, or on the journal’s web site and for providing the manuscript to the recognizable patient for review before submission.
- The consent-to-disclose form should indicate specific use (publication in the medical literature in print and online, with the understanding that patients and the public will have access) of the patient's information and any images in figures or videos, and must contain the patient's signature or that of a legal guardian along with a statement that the patient or legal guardian has been offered the opportunity to review the identifying materials and the accompanying manuscript.
- If the manuscript has an individuals’ data, such as personal details, audio-video material, etc., consent should be obtained from that individual. In case of children, consent should be obtained from the parent or the legal guardian.
- A specific declaration of such approval and consent-to-disclose form must be made in the copyright letter and in a stand-alone paragraph at the end of the article especially in the case of human studies where inclusion of a statement regarding obtaining the written informed consent from each subject or subject's guardian is a must. The original should be retained by the guarantor or the corresponding author. Editors may request to provide the original forms by fax or email.
- All such case reports require by a proper consent being obtained prior to publishing.
Editors may request that authors provide documentation of the formal review and recommendation from the institutional review board or ethics committee responsible for oversight of the study. The editors reserve the right to reject manuscripts that do not comply with the above-mentioned requirements. The author will be held responsible for false statements or failure to fulfill the above-mentioned requirements.
Anonymous images, that do not identify the individual directly or indirectly, such as through any identifying marks or text, do not require formal consent, for example, X-rays, ultrasound images, pathology slides or laparoscopic images.
In case consent is not obtained, concealing the identity through eye bars or blurring the face would not be acceptable.
Research Involving Animals:
For research involving animals, the authors should indicate whether the procedures followed were in accordance with the standards set forth in the eighth edition of “Guide for the Care and Use of Laboratory Animals” (grants.nih.gov/grants/olaw/guide-for-the-care-and-use-of-laboratory-animals_prepub.pdf published by the National Academy of Sciences, The National Academies Press, Washington, D.C.).
Research work on animals should be carried out in accordance with the NC3Rs ARRIVE Guidelines. For In Vivo Experiments, please visit https://www.nc3rs.org.uk/arrive-guidelines
Authors should clearly state the name of the approval committee, highlighting that legal and ethical approvals were obtained prior to initiation of the research work carried out on animals, and that the experiments were performed in accordance with the relevant guidelines and regulations stated below.
- US authors should cite compliance with the US National Research Council's "Guide for the Care and Use of Laboratory Animals"
- The US Public Health Service's "Policy on Humane Care and Use of Laboratory Animals" and "Guide for the Care and Use of Laboratory Animals"
- UK authors should conform to UK legislation under the Animals (Scientific Procedures) Act 1986 Amendment Regulations (SI 2012/3039).
- European authors outside the UK should conform to Directive 2010/63/EU.
- Research on animals should adhere to ethical guidelines of The Basel Declaration and the International Council for Laboratory Animal Science (ICLAS) ethical guidelines.
- The manuscript should clearly include a declaration of compliance with the relevant guidelines (e.g. the revised Animals (Scientific Procedures) Act 1986 in the UK and Directive 2010/63/EU in Europe) and/or relevant permissions or licenses obtained by the IUCN Policy Statement on Research Involving Species at Risk of Extinction and the Convention on the Trade in Endangered Species of Wild Fauna and Flora.
Research Involving Plants
All experimental research on plants (either cultivated or wild), should comply with international guidelines. The manuscript should include a declaration of compliance of field studies with relevant guidelines and/or relevant permissions or licenses obtained by the IUCN Policy Statement on Research Involving Species at Risk of Extinction and the Convention on the Trade in Endangered Species of Wild Fauna and Flora.
Unethical behavior and misconduct may be pointed out by anyone to the Editor and Publisher with sufficient evidences. The Editor, in consultation with the Publisher, will initiate investigation against this Unethical misconduct, complete the procedure till an unbiased decision is reached, and maintain confidentiality throughout the process of the investigation. The Author should be given the opportunity to reply to all minor or major accusations.
In case of serious breaches, the employer may be informed where appropriate, by the Editor/Publisher, after reviewing all available information and evidences or after seeking help from experts in that field.
- Author(s) and Reviewers must be informed in case of misinterpretation or mishandling of International Acceptable Standards.
- A strict notice should be sent to the author and reviewer to avoid future unethical misconduct.
- An Editorial on the reported misconduct should be published or official notice of unethical behavior should be posted on the website.
- Official letter about this misconduct should be issued to the Head of Departments, Funding Agencies of the accused author and the reviewer, as well as Abstracting & Indexing Agencies.
- Where required, retraction and withdrawal of publication may be undertaken from the Publisher’s journal in discussion with the Head of the Department of the author or reviewer, and other higher authorities should be informed.
- The Publisher may impose restrictions for some period on future publications from the accused author in the journals.
Registration of Systematic Reviews:
Bentham OPEN Publishers supports retrospective registration of systematic reviews, in a suitable registry (such as PROSPERO). The registered systematic review must include the registration number as the last line of the manuscript abstract.
Consent for Publication:
If the manuscript has an individuals’ data, such as personal detail, audio-video material etc., consent should be obtained from that individual. In case of children, consent should be obtained from the parent or the legal guardian.
All such case reports should be followed by a proper consent prior to publishing.
A specific declaration of such approval and consent-to-disclose form must be made in the copyright letter and in a stand-alone paragraph at the end of the article especially in the case of human studies where inclusion of a statement regarding obtaining the written informed consent from each subject or subject's guardian is a must. The original should be retained by the guarantor or corresponding author. Editors may request to provide the original forms by fax or email.
Authentication of Cell Lines:
The NIH acknowledges the misidentification and/or cross-contamination of cell cultures e.g. HeLa cells being used in a research study as a serious problem. In order to ensure the validation of the work and proper utilization of resources, it is a prerequisite that correct reagents be used in studies dealing with established human (tumor) cell lines that have been cultured for more than 4 years up to the date of submission of the manuscript. Cell lines such as short-term cultures of human tumors, murine cell lines (as a catalog of DNA profiles is not yet available) and tumor cell lines established in the course of the study that is being submitted, are presently exempt from this rule. To minimize the risk of working with misidentified and/or contaminated cell lines, tests such as isoenzyme analysis, karyotyping/cytogenetic analysis and, more recently, molecular techniques of DNA profiling may be carried out to authenticate cell cultures. These tests may help confirm or establish the identify profile for a cell line. Bentham OPEN recommends that all cell lines be authenticated prior to submitting a paper for review. Authors are therefore required to provide authentication of the origin and identity of the cells by performing cell profiling either in their own laboratory or by outsourcing an approved laboratory or cell bank. Authentication is required when a new line is established or acquired, before freezing a cell line, if the performance of the line is not consistent or results are unexpected, if using more than one cell line, and before publication of the study.
The cell lines profile should be cross-checked with the profile of the donor tissue of other continuous cell lines such as provided by the authentic data bank such as www.dsmz.de/fp/cgi-bin/str.html, ATCC@ etc.
Randomized Drug Clinical Trial Studies:
Randomized drug clinical trial studies are biomedical or health-related interventional and/or observational research studies conducted in phases in human beings who are randomly allocated to receive or not receive a preventive, therapeutic, or diagnostic intervention that follows a pre-defined protocol. The study is intended to determine the safety and efficacy of approaches to disease prevention, diagnosis and treatment.
Authors of randomized controlled trials are encouraged to submit trial protocols along with their manuscripts. All clinical trials must be registered (before recruitment of the first participant) at an appropriate online public trial registry that must be independent of for-profit interest (e.g.,www.clinicaltrials.gov). If you wish the editor(s) to consider an unregistered trial, please explain briefly why the trial has not been registered.
- All randomized clinical trials should include a flow diagram and authors should provide a completed randomized trial checklist (see CONSORT Flow Diagram and Checklist; www.consort-statement.org) and a trial protocol.
- Studies of diagnostic accuracy must be reported according to STARD guidelines; (www.stard-statement.org)
- Observational studies (cohort, case-control, or cross-sectional designs) must be reported according to the STROBE statement, and should be submitted with their protocols; (www.strobe-statement.org).
- Genetic association studies must be reported according to STREGA guidelines; (www.equator-network.org/reporting-guidelines/strobe-strega/)
- Systematic reviews and meta-analyses must be reported according to PRISMA guidelines; (www.prisma-statement.org)
- To find the reporting guidelines see (www.equator-network.org)
Important points to remember while submitting clinical trials:
- Each manuscript should clearly state an objective or hypothesis; the design and methods (including the study setting and dates, patients or participants with inclusion and exclusion criteria, or data sources, and how these were selected for the study); the essential features of any interventions; the main outcome measures; the main results of the study; a comment section placing the results in context with the published literature and addressing study limitations; and the conclusions. Data included in research reports must be original.
- Trial registry name, registration identification number, and the URL for the registry should be included at the end of the abstract and also in the space provided on the online manuscript submission form. If your research article reports the results of a controlled health care intervention, list the trial registry, along with the unique identifying number (Please note that there should be no space between the letters and numbers of your trial registration number). Studies designed for other purposes, such as to study pharmacokinetics or major toxicity (e.g., phase 1 trials), are exempted.
- All reports of randomized trials should include a section entitled “Randomization and Masking”, within the Methods section.
- The manuscript must include a statement identifying the institutional and/or licensing committee that has approved the experiments, including any relevant details.
- The SI system of units and the recommended international non-proprietary name (rINN) for drug names must be used. Kindly ensure that the dose, route, and frequency of administration of any drug you mention are correct.
- Please ensure that the clinical trials sponsored by pharmaceutical companies follow the guidelines on good publication practice: (www.gpp-guidelines.org)
The editors reserve the right to reject manuscripts that do not comply with the above-mentioned requirements. The author will be held responsible for false statements or failure to fulfill the above-mentioned requirements.
A small paragraph summarizing the contents of the article, presenting the final outcome of the research or proposing further study on the subject, may be given at the end of the article under the Conclusion section.