RESEARCH ETHICS AND POLICIES
CONFLICT OF INTEREST
All potential conflicts of interest (competing interests) that could have a direct or indirect influence on the work must be disclosed by the authors. Even if an author does not have a conflict, disclosing affiliations and interests allows for a more comprehensive and open approach, which leads to a more accurate and objective evaluation of the work. Conflicts of interest, whether genuine or imagined, are a perspective to which the readers are entitled.
The publication of a conflict statement in the article itself, as well as the submission of the conflict disclosure form, is required for all types of papers. It is not necessarily the case that a monetary relationship with examination support or funding for counseling work is inappropriate. Even if the authors do not have any conflict of interest, they still need to provide a confirmation statement in their manuscripts, i.e., “The author(s) confirm(s) that there is no conflict of interest related to the manuscript.”
The following are some examples of potential conflicts of interest that are directly or indirectly related to the research:
Financial competing interests include (but are not limited to):
- Type of support/grant number
- Institutional Conflicts of Interest
- Funds received by the author
- Funds received by the institution
- Travel allowances for the research
- Funds received for article preparation and reviewing
- Funds for conducting review activities
- Support provided for article writing assistance, for drugs, equipment, etc
- Paid lectures
- Pending fund or grant
Financial conflicts of interest can be personal as well as institutional. Personal conflict of interest occurs when a contributor involved in the publication process either receives an amount of money or expects to receive some financial help (including any other financial benefits such as patents or stocks, gifts or services) that may impact the work related to a specific publication. More importantly, in academic research, such financial relationships can lead to institutional conflicts of interest (COIs) because the economic interests of the institution or institutional representatives may unsuitably affect the decision-making process.
An institutional conflict of interest arises in a situation when financial interests of an institution or any institutional official (e.g., investments held by the university in a company) have the potential to unduly influence the research conducted by its employees or students, or pose an unacceptable risk to human subjects. Such conflicts usually arise in a state of affairs where a research project directly offers assistance or a benefit to an external entity via evaluation, validation, trial or test of an invention, product, drug, service or technology, and the institution holds a financial interest with the external entity. Such financial interests incorporate, but are not limited to, receipt of licensing payments or royalties from the external entity, or ownership interest with the external entity. When human subjects are involved in any research project, and the institution supports such a financial interest, the conflict of interest is speculated to be unreasonable.
Non-financial competing interests include (but are not limited to):
In addition, interests other than monetary and any funding (non-financial interests) should be declared if they are relevant to readers. Personal relationships or conflicting interests directly or indirectly related to research, as well as professional interests or personal opinions that may impact your research, are examples of these.
Intellectual property, in basic terms, refers to any intangible property that is the result of creativity, such as patents, copyrights, etc. Similarly, this section seeks to know about copyright and patent (licensed patent, pending or issued) and any payment received for intellectual property, such as:
- Licensed Patent
- Issued Patent
- Pending Patent
All conflict of interest disclosure forms are collected by the corresponding author. It is sufficient for the corresponding author to sign the disclosure form on behalf of all authors in author collaborations when legal agreements for representation allow it. The templates of the form can be found here.
Before the reference list, the corresponding author will include a summary statement in the text of the article that reflects what is reported in the potential conflict of interest disclosure form (s). Author(s) may declare(s) names of reviewers who they think might have a potential conflict of interest; therefore, Editorial Office could avoid inviting such reviewers for an unbiased opinion.
UNDISCLOSED CONFLICT OF INTEREST
Undisclosed conflict of interest cases before or after the publication of an article are dealt with as per the guidelines of COPE.
- Undisclosed conflict of interest in a submitted article (View COPE guidelines)
- Undisclosed conflict of interest in a published article (View COPE guidelines)
For more information on COIs, see the guidance from the ICMJE.
Bentham OPEN tries to conduct a transparent peer-review process with the help of the reviewers who do not have any conflict of interest with the authors. In this connection, reviewers who belong to the same institute or countries as authors are not invited to review manuscripts. However, it is not possible for the Editorial Office to be aware of all competing interests; therefore, it is expected from authors to submit:
- List of reviewers who they think have a conflict of interest to ensure a transparent and unbiased review process.
The Editorial Office expects reviewers:
- Not to accept manuscript review requests if they have any potential conflict of interest and inform the Editorial Office accordingly.
- To decline review requests if they have recently published or submitted an article with any of the authors listed in the manuscript.
- To inform the Editorial Office if they have any personal relationship with the authors or work in the same institutes as of authors, which could affect the review transparency.
- To abstain from reviewing and informing the Editorial Office/Editor-in-Chief/Handling Editors about any scientific misconduct or fraud, plagiarism, conflict of interest, or any other unethical behavior related to the manuscript, which they found while reviewing it.
During the submission of review comments, reviewers are asked to reconfirm that they do not have any conflict of interest related to the article. After confirming the below statement, they can submit their comments.
“I hereby confirm that I don’t have any conflict of interest related to the manuscript.”
If, however, there are still any remaining interests, then reviewers must mention those in the ‘Confidential’ section of the review form.
Reviewers are not encouraged to contact authors directly regarding any of their conflicts of interest. Peer reviewers should follow journals’ policies in situations they consider to represent a conflict to reviewing.
UNDISCLOSED CONFLICT OF INTEREST
If reviewers intentionally undisclosed any conflict of interest, then they will be blacklisted for any future peer reviewing activity of the journal.
The Editorial Office always ensures that an author, if added after peer review activity of a manuscript, is not part of the reviewers’ list who have conducted a peer review of the same manuscript.
Editors must not review submitted manuscripts if they have any personal, professional or financial involvement/conflict of interest with the authors of the manuscript. Every participant involved in the peer review process, including editorial board members, reviewers, and editors, must declare any potential conflicts of interest to ensure a transparent and unbiased review activity.
Editors-in-Chief or Editors who are responsible for the initial and final decision should recuse themselves to review or take decisions on any manuscript that is written by authors affiliated to the same institute as of editor, or if they have been a family member, competitor, collaborator, or have published any manuscript in last 3 years with the authors associated with the manuscript. They can however nominate someone else on the Board who could provide a neutral opinion on the manuscript.
Manuscripts submission by an Editor/Editor-in-Chief
The initial and final decision on the manuscripts submitted by an Editor/Editor-in-Chief will be taken by any other member of the Board. The Editorial Office will identify members who do not have any potential conflict of interest with the Editor or Editor-in-Chief.
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. Please refer COPE guidelines available at https://publicationethics.org/resources/guidelines/journals'-best-practices-ensuring-consent-publishing-medical-case-reports.
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.
RESEARCH CONDUCTED IN SPECIAL OR CRITICAL SITUATIONS
Bentham OPEN expects all contributors to respect values of justice, benevolence, and autonomy when conducting research. We understand that certain situations such as medical emergencies or humanitarian crises may differ from non-emergency scenarios. Bentham OPEN recommends that research efforts should not hurt human subjects/respondents or the researchers, and should be conducted with sufficient scientific rigor as permissible in these situations, respectively. Care should be taken to address potential problems faced by persons who may be victims of disasters or involved in a medical emergency. These are vulnerable individuals and their privacy and dignity should be respected. Researchers should make note of this in their research and identify potential issues in their work that may arise because of such situations. Research directed in emergency circumstances should be to the greatest advantage of survivors involved in the research and with the goal of minimizing any future casualties. For guidance, the essential requirements of research in emergency situation are the preservation of human life, wellbeing and security, along with the rights to protection, privacy and confidentiality of subjects.
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 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 must 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. For further details, please visit complete guidelines at:http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html
- 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: (https://www.ismpp.org/gpp2)
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.