Ethical Principles and Malpractice Statement

Ethical Principles and Malpractice Statement

The ethics statements of the Journal of Clinical Trials and Experimental Investigations (JCTEI) are based on the Code of Conduct guidelines of the Committee on Publication Ethics (COPE), available at www.publicationethics.org.  JCTEI follows the COPE Code of Conduct and Best Practice Guidelines for Journal Editors, and Core Practices, and aims to adhere to its Best Practice Guidelines. As a strong JCTEI scientific community (i.e., the publisher, editors, authors, and reviewers) we all are obliged to comply with these ethical practices.

Publisher's Responsibilities

Publisher has to prepare policies and design the journal’s website according to COPE’s Principles of Transparency and Best Practice in Scholarly Publishing.

Publisher agrees that all accepted papers have been published as open-access under the CC-BY license without requiring any article submission, processing, and/or publishing charges.

Publisher agrees to work with editors, editorial board members, and editors' assistants to determine the journal policies in line with COPE periodically and follows these policies.

Publisher guarantees editorial independence, respect the peer review process and disclaims being involved in editorial decisions.

Publisher guarantees to publish the volume and issues on a timely basis.

Publisher declares to remain neutral concerning jurisdictional claims in published maps and institutional affiliation.

Publisher conducts rules and policies for research ethics, consent, including confidentiality, and the legal requirements for human and animal research.

Publisher conducts the relationship rules between publisher, editors and third-parties in any contract, protects intellectual property and copyright, respects privacy and supports editorial independence.

Publisher guarantees not to allow any sponsors to be involved in decisions about the journal's publishing policies even if they support the publisher financially.

Publisher guarantees to comply with the journal's publishing policies, particularly in the context of transparency and integrity (e.g., research funding, conflicts of interest, and reporting standards).

The publisher guarantees to comply with the journal's publishing policies, particularly in the context of appeals and complaints.

The publisher guarantees to maintain the integrity of the scientific work.

The publisher guarantees to assist-third parties (grant funders, institutions, etc.) responsible for the investigation of suspected research and publication misconduct and to facilitate the resolution of these cases whenever possible.

Publisher guarantees to publish clarifications, corrections, and retractions based on editorial board decisions.

Editors' Responsibilities

JCTEI editors are independent, decisions about the editorial review process are not determined by any third-party agencies or governments' policies.

JCTEI editors are responsible for the peer-review process of the manuscripts and make the last decision on which manuscripts will be published based on the reviewers’ and editorial board members’ comments.

JCTEI editors carry out the editorial review of the submitted manuscript entirely based on its scientific merit regardless of the author's gender, age, sexual orientation, race, citizenship, ethnic background, religion, political view, and institutional affiliation.

JCTEI editors are responsible for implementing and carrying out the publication policies of the journal.

JCTEI editors govern the process by forming a committee from the editorial board members in cases such as copyright violation, plagiarism, and libel.

JCTEI editors, editorial board members, and editors' assistants may not expose any information publicly about the submitted manuscript to anyone except the corresponding author and the publisher.

JCTEI editor-in-chief has full authority to publish the journal's content timely regarding accepted manuscripts.

JCTEI editors are responsible for assigning the manuscripts to reviewers who have expertise in the related research fields.

JCTEI editors ensure that all submitted manuscripts should undergo peer-review by at least two reviewers whose research is related to the submitted manuscripts. If the decision is inconclusive, JCTEI editors assign a third reviewer to reach out for a conclusive decision.

JCTEI editors, editorial board members and editors' assistants cannot use unpublished materials and information in submitted manuscripts for their own research purpose without the authors' written consent.

JCTEI editors cannot use the privileged information or ideas obtained from handling manuscripts for their personal advantage and are responsible for keeping them confidential.

JCTEI editors refrain from carrying out the editorial processes of the manuscripts that have conflicts of interest arising from competition, collaboration or other relationships with any of the authors, companies or institutions affiliated with them; instead of this, they have to ask another editorial board member to carry out to the editorial process of the manuscripts.

JCTEI editors require all contributors of the published manuscripts to disclose related competing interests and publish corrections if competing interests are revealed after publication. If needed, other suitable actions will be taken, such as the retraction or declaration of concern.

JCTEI editors protect the integrity of the published manuscripts by corrections and retractions when ethical concerns are raised with regard to a submitted manuscript or published paper.

JCTEI editors are responsible for tracking reviewers' and editorial misconduct. When ethical complaints have been presented concerning the submitted or published manuscripts, JCTEI editors should take measures in line with the journal's policies.

JCTEI editors will investigate every reported act of unethical publishing, even if it is exposed years after publishing. If the unethical violation is well-founded, retraction or correction rules will be applied and published in the journal.

JCTEI editors follow the COPE Flowcharts when dealing with cases of suspected misconduct.

JCTEI editors, editorial board members, and editors' assistants are welcome to submit their original manuscripts to the JCTEI, but they have to know that they cannot be involved in the peer-review and editorial decision-making process for their own manuscripts. In this case, the publisher chooses a guest editor for the JCTEI editors, editorial board members, and editors’ assistants' manuscripts to handle independently the peer-review and editorial decision-making process. The publisher clearly states the case to the readers (e.g., via a footnote, endnote on the article or on the journal website) on how to carry out the JCTEI staff's manuscripts. When JCTEI encounters disagreements, JCTEI follows COPE Guidelines.

Reviewers’ Responsibilities

Peer-review is the process used to evaluate the quality of the manuscripts before they are published. Therefore, independent researchers whose field of research are related to the submitted manuscript must evaluate the manuscripts for validity, originality, and significance to assist editors to conclude whether the manuscript should be published in JCTEI.

JCTEI reviewers must acknowledge that all manuscripts are reviewed with impartiality based on the scientific content of the manuscripts regardless of the author's gender, age, sexual orientation, race, citizenship, ethnic background, religion, political view, and institutional affiliation.

JCTEI reviewers are expected to inform the editor in charge if any conflict of interest arises to decline the request of review for the assigned manuscript.

JCTEI reviewers must acknowledge being constructive and objective in their reviews, avoiding being unfriendly or inflammatory and making libellous or degrading personal comments.

JCTEI reviewers must acknowledge reviewing the manuscripts falling within their expertise of research on time.

JCTEI reviewers cannot use the privileged information or ideas obtained from reviewed manuscripts for their personal advantage/disadvantage or to discredit others.

JCTEI reviewers must acknowledge that all information concerning the manuscripts is held confidential.

JCTEI reviewers must confirm that the detailed reviewing report must be shared with the JCTEI editors confidentially through the journal management system.

JCTEI reviewers can state the following four decisions for the submitted manuscripts:

• Accept for Publication
• Revisions Required (Accept with minor revisions: Revisions are checked by the editors)
• Resubmit for Review (Major revisions: It will be reviewed for the second round) 
• Reject (It is not recommended for publishing)

Based on the reviewers' decisions third or fourth reviewer can be assigned. In such a case, the same process of review will be performed. See also reviewer guideline.

Authors’ Responsibilities

Everyone who meets the JCTEI criteria for authorship must be listed as an author. JCTEI expects that all authors will take public responsibility for the content of the manuscripts submitted to the JCTEI. The contributions of all authors must be described in the "Declarations" section of the manuscript. All authors should be contacted by email during the submission to ensure that they are aware of and approve the submission of the manuscript, its content, and its authorship. 

Authors should confirm that the submitted manuscripts are not plagiarised, unpublished, original, and not submitted elsewhere at the same time.

Authors must confirm that they take full accountability against issues of plagiarism, copyright infringement, or other violations. Therefore, if there are third-party copyright materials, copyrighted tables, illustrations, figures, or quotations published elsewhere or other works in their manuscripts, they must hold permission or acknowledgment and declare it clearly to the editorial board with a cover letter during the submission.

Authors must have obtained consent, and ethical approval and followed ethical legislation if their research includes human and animal subjects and they have to declare how they perform the ethical principles as an endnote or in the method section.

Authors should declare clearly any potential conflict of interest clearly for each author.

Authors should submit their manuscripts which are completed/written honestly, clearly, and without falsification, fabrication, or improper data manipulation. Authors should present their research methods clearly so that researchers can confirm the results and not false or wittingly mistaken statements that create unethical behavior.

Authors may be demanded to ensure the raw data regarding submission for editorial review, and should, in any event, be ready to keep such data for a reasonable amount of time after publication.

Authors should submit manuscripts only that have been conducted in an ethical and responsible manner and that comply with the journal's publishing policies and scope.

Authors should acknowledge that resources such as data/support/financial have been used in improving the manuscript. These resources can be defined as Grant Maker, Foundation, or institutions, that provided ideas and expertise that greatly supported the research.

Authors should acknowledge that if they find any mistakes or inaccuracies after publishing manuscripts, they must inform the JCTEI editors.

Authors should submit their manuscripts only to one journal at a time. Authors should be aware that submitting the same article to more than one journal at the same time creates unethical publishing behaviour and it is unacceptable.

Authors must confirm that the Publisher retains all the copyrights unconditionally and indefinitely to distribute the published manuscripts.

Authorship & Contributorship

All authors’ roles must be described in the "Declarations" section on manuscripts and should be contacted during submission to ensure that they are aware of and approve the submission, its content, and its authorship. 

The authors’ order should be based on the contributions of the manuscript. The authorship should not be ordered according to academic position or other indicators of power. All contributing authors should be credited in the order of their contribution to the authoring process.

All those who have contributed to the production of an intellectual output are entitled to be listed as authors. "Ghost" authoring should not be allowed and it is not acceptable to list as authors people who have not directly contributed to the research or its written outputs as authors.

All authors' status and institutional location should be made visible in research and its outputs.

Authors have a fundamental obligation to acknowledge and attribute to all external sources, financial or in-kind, such as organizations or sponsors that contribute directly or indirectly to the research.

Authors should explain the publication history of the articles or books they submit for publication. If an existing article or book is substantially similar in content and format to a previously published article, this should be noted and the place of previous publication indicated.

Deceased authors
If a manuscript is submitted with a deceased author listed, or an author passes away while the manuscript is being peer reviewed, then a footnote or similar should be added to the published article to indicate this. Often journals use a dagger symbol (†) with a footnote explaining the situation. A co-author should vouch for the contribution made by the deceased author and their potential conflicts of interest. If the deceased author was a corresponding author then another co-author should be nominated. Note that copyright is considered personal property under the law. If the author had not yet signed a copyright transfer agreement or license, or granted a co-author the right to do so on his/her behalf in writing, permission would need to be obtained from the author’s inheritor.

Changes to authorship

Editors and journal staff as authors

Editors or board members should not be involved in editorial decisions about their own scholarly work. Journals should establish and publish mechanisms and clearly defined policies for handling submissions from editors, members of their editorial boards, and employees. We recommend that:

• Editors and editorial team members are excluded from publication decisions when they are authors or have contributed to a manuscript.
• A short statement may be useful for any published article that lists editors or board members as authors to explain the process used to make the editorial decision.

While some journals will not consider original research papers from editors or employees of the journal, others have procedures in place for ensuring fair peer review in these instances.

Citations

Citation and reference to appropriate and relevant literature is an essential part of scholarly publishing and is a shared responsibility among all involved (authors, editors, peer reviewers). Authors should not engage in excessive self-citation of their own work. Editors and peer reviewers should not ask authors to add citations to their papers when there is no strong scholarly rationale for doing so. The issue of inappropriate citation (including citation stacking and citation cartels) has been discussed by COPE, and COPE have produced a discussion document on citation manipulation with recommendations for best practice.

Ethnicity and race

When detailing demographic information about a study population, it is advisable to use terms to designate ethnicity (e.g. African American and South Asian) rather than race. The British Sociological Association (BSA) have devised some language guidelines for when referring to ethnicity and race.

Human studies and subjects

For manuscripts reporting studies involving human participants, including but extending beyond medical research, journals should require a statement from authors to confirm that the appropriate ethical approval has been received, along with details of the approving ethics committee, and that the study conforms to recognized standards, see for example, Declaration of Helsinki; US Federal Policy for the Protection of Human Subjects; European Medicines Agency Guidelines for Good Clinical Practice or the Ethical Review Methods for Biomedical Research involving Humans adopted by the National Health and Family Planning Commission of the People’s Republic of China.

Journals should only consider publishing research which includes individual participants’ information and images where the authors’ have obtained the prior informed consent from all participants. The International Committee of Medical Journal Editors (ICMJE) guidance states:

“Non-essential identifying details should be omitted. Informed consent should be obtained if there is any doubt that anonymity can be maintained. For example, masking the eye region in photographs of patients is inadequate protection of anonymity.”

In cases where manuscripts may involve potentially vulnerable groups and, therefore, where informed consent may have required particular attention from the study authors and the institution where the work took place, we recommend particular care from journal teams to ensure expected standards have both been met and are described in the articles they publish. The Icelandic Human Rights Center presents a list containing twelve examples of vulnerable groups: “1) women and girls; 2) children; 3) refugees; 4) internally displaced persons; 5) stateless persons; 6) national minorities; 7) indigenous peoples 8) migrant workers; 9) disabled persons; 10) older adults; 11) HIV positive persons and AIDS victims; 12) Roma/Gypsies/Sinti; and 13) lesbian, gay and transgender people.” The Economic and Social Research Council in the UK provides further advice about research with potentially vulnerable people.

To ensure that informed consent has been obtained, journals should require authors to confirm this upon submission, and require that this information be included in a statement to this effect within their manuscript. Note that consent to participate in research is separate from consent to publish. It is necessary to obtain consent to publish if there is any possibility that information shared may identify an individual person, and document that this has been given within the manuscript. Consent forms do not need to be submitted with the manuscript, but researchers should provide necessary details if requested to do so by the journal. Many journals provide their authors with templated consent forms which they can use to seek informed consent from participants. JCTEI has a standard patient consent form available if required.

In the case of technical images (for example, radiographs or micrographs), editors should ensure that all information that could identify the subject has been removed from the image. For voices or images of any human subject, permission according to applicable national laws must be sought from research participants before recording or distributing. In many jurisdictions, it is a requirement that formal copyright clearance is obtained to publish any video or audio recordings. When publishing genetic sequences or family genograms editors may need consent from more than just the index case. The CARE guidelines are useful for editors who publish case reports.

Systematic manipulation of the publication process

Systematic manipulation of the publication process is when an individual or group of individuals aim to publish a manuscript or series of manuscripts by dishonest or fraudulent means. This may involve subverting or unduly influencing the peer review process, engaging in inappropriate practices for authorship or by the publication of fabricated research (see also sections above on Citation manipulation and Fabrication, falsification and image manipulation). COPE’s guidance on systemic manipulation of the publication process explores these issues in detail.

Systematic manipulation may often be associated with paper mill activity i.e. “the process by which manufactured manuscripts are submitted to a journal for a fee on behalf of researchers with the purpose of providing an easy publication for them or to offer authorship for sale” - see this research report on paper mills from COPE and STM for further information. Systematic manipulation is an ongoing concern for all involved in scholarly publishing. JCTEI has discussed findings from a broader investigation involving manipulation at scale in this white paper including the need for vigilance against bad actors and the need for all stakeholders to work together to tackle the root causes. Initiatives such as United2Act and the STM Integrity Hub are bringing stakeholders together to work collaboratively on these challenges. JCTEI will continue to reject manuscripts or retract published articles that have been implicated in systematic manipulation and/or paper mill activity. In such cases, detailed findings of internal investigations will not necessarily be shared with all parties involved in an effort to limit sharing of intelligence with potential bad actors.

Jurisdictional claims

Definitions of sex and/or gender

We ask authors to define how sex and gender have been used in their research and publication. Some guidance:

• Sex generally refers to a set of biological attributes that are associated with physical and physiological features such as chromosomal genotype, hormonal levels, internal and external anatomy. A binary sex categorization (male/female) is usually designated at birth ("sex assigned at birth") and is in most cases based solely on the visible external anatomy of a newborn. In reality, sex categorizations include people who are intersex/have differences of sex development (DSD).

• Gender generally refers to socially constructed roles, behaviors and identities of women, men and gender-diverse people that occur in a historical and cultural context and may vary across societies and over time. Gender influences how people view themselves and each other, how they behave and interact and how power is distributed in society.

Funding sources

When JCTEI encounters disagreements among authors, JCTEI follows the guidance of the Committee on Publication Ethics (COPE)—see here and here.