Publication Ethics

RESEARCH ETHICS

Research Involving Human Subjects

Institutional Review Board Statement

In reporting research involving human subjects, human materials, human tissues, or human data, authors are required to declare adherence to the Declaration of Helsinki of 1975, as revised in 2013. According to Article 23 of this declaration, prior approval from the local Institutional Review Board (IRB) or an equivalent ethics committee is mandatory to ensure compliance with national and international guidelines. At a minimum, the 'Institutional Review Board Statement' section of the article must include the project identification code, date of approval, and the name of the ethics committee or IRB.

An example of such a statement is: “The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the Ethics Committee of XXX (Project identification code) on [date of approval].”

For non-interventional studies (e.g., surveys, questionnaires, social media research), it is imperative that all participants are fully informed regarding the assurance of their anonymity, the purpose of the research, the intended use of their data, and any potential risks associated with participation.

As with all research involving human subjects, ethical approval from a relevant ethics committee must be secured prior to the commencement of the study. If ethical approval is deemed unnecessary, authors must either provide an exemption from the ethics committee or reference the local or national legislation that exempts the study from requiring ethical approval.

In cases where an exemption is granted, the name of the ethics committee providing the exemption should be included in the 'Institutional Review Board Statement' section, along with a comprehensive explanation for the exemption from ethical approval.

Informed Consent Statement

When submitting manuscripts that involve human subjects, data, or tissue, it is essential to include a statement confirming informed consent for research participation. In certain cases, such as ethnographic studies, verbal informed consent may be permissible. Authors are required to justify the use of verbal consent in the "Informed Consent Statement" section. Additionally, a copy of the script used for obtaining verbal consent must be submitted during the submission process.

For manuscripts containing identifiable patient or participant information, such as personal details, images, or videos, written informed consent for publication must be secured from the individuals involved or their relatives/guardians before submission to JFIKI. A blank version of the consent form, excluding names or signatures, should be provided upon submission.

For publication in JFIKI, the consent, permission, or release form should grant unlimited permission for publication in all formats, including print, electronic, and online, as well as sublicensed and reprinted versions, translations, and derivative works, under an open access license. To protect the privacy of patients, participants, and others, signed forms should not be submitted. Identifiable information about participants should only be included if it is relevant to the research, such as photographs showing specific symptoms. Personal identifiers like initials should not appear in images, and details should be anonymized as much as possible, avoiding specific age, ethnicity, or occupation unless pertinent to the conclusions. Privacy protection measures may include de-identifying data, adding noise, or obscuring parts of the database. Editors have the authority to reject submissions that fail to comply with these requirements.

The Editorial Office retains the authority to ask for additional documentation if deemed necessary. The manuscript submitted will undergo a thorough review by the Editorial Office, and if requested, supporting documents such as signed consent forms and any relevant discussions from the ethics board must be supplied. Example of an Informed Consent Statement: “Informed consent for participation was obtained from all subjects involved in the study.” OR “Informed consent for participation is not required as per local legislation [provide local legislation].” OR “Verbal informed consent was obtained from the participants. Verbal consent was obtained rather than written because [state the reason],” OR “Informed consent for publication was obtained from all identifiable human participants.”

Requirements for Studies on Vulnerable Groups and Organ Transplants

When a study includes vulnerable populations, the editorial office will conduct an extra review of the manuscript. Authors may be asked to supply documentary proof, such as blank consent forms and any relevant discussion documents from the ethics board or other pertinent organizations. Furthermore, if studies categorize groups by race, ethnicity, gender, disability, disease, etc., the article must clearly justify the necessity of such categorization.

Articles on human organ transplantation studies must adhere to all policies concerning research involving human subjects. Authors are also required to identify the institution(s), clinic(s), or department(s) from which the organs or tissues were obtained. JFIKI does not accept manuscripts that present data on organs and/or other materials acquired through illegal commercial activities, executed prisoners, or other unethical organ donation practices. Manuscripts discussing this issue, such as editorials or reports on its secondary effects, may be considered at the Editor-in-Chief's discretion but require a written appeal to the editorial office before submission. For additional resources on organ transplantation, JFIKI refers to the glossary maintained by the Organ Procurement and Transplantation Network (https://optn.transplant.hrsa.gov/patients/ /).

Clinical Trials Registration

Registration

Clinical trials must adhere to all regulations concerning Research Involving Human Subjects. Additionally, JFIKI complies with the guidelines set by the International Committee of Medical Journal Editors (ICMJE), which mandate that clinical trials be registered in a public trial registry at or before the initial patient enrollment to be considered for publication. According to the ICMJE, a clinical trial is any research endeavor that prospectively assigns individuals or groups to an intervention, with or without concurrent comparison or control groups, to explore the link between a health-related intervention and a health outcome. Consequently, the term 'clinical trial' encompasses not only studies conducted in hospitals or involving pharmaceuticals but also any research involving participant randomization and group classification in relation to the intervention being evaluated. Authors are required to preregister clinical trials with an international clinical trial registry.

Appropriate databases include clinicaltrials.gov, the EU Clinical Trials Register, and those listed on the World Health Organisation’s International Clinical Trials Registry . The registry name, trial registration number, and registration date should be included in the Institutional Reviewer Board statement or the Materials and Methods section. Purely observational studies, such as cohort studies, cross-sectional studies, and case–control studies, do not need registration. Editors may allow exceptions to pre-trial registration requirements in certain situations. If an exception is granted, authors must register the trial retroactively and clearly state the date and reasons for the retroactive registration in the Materials and Methods section of the publication. Approval from an independent local, regional, or national review body to conduct a study is not equivalent to prospective clinical trial registration. JFIKI reserves the right to reject any paper lacking trial registration from further peer review. Randomized Clinical Trial Reporting Guidelines In addition to clinical trial registration, JFIKI requires a completed CONSORT 2025 checklist and flow diagram as a submission condition when reporting the results of a randomized clinical trial. Checklist templates are available on the CONSORT website, which also details several CONSORT checklist extensions for various designs and data types beyond two-group parallel trials. At a minimum, clinical trial articles should address the content specified by each checklist item.

Ethical Guidelines for the Use of Animals in Research

The editors will mandate that the potential benefits derived from any research involving harm to animals must be substantial in comparison to the costs incurred by the animals. Furthermore, the procedures employed should not be likely to offend the majority of readers. Authors are particularly encouraged to ensure that their research adheres to the widely recognized '3R' principles [NSW Department of Primary Industries and Animal Research Review Panel. Three Rs. Available online: https://www.dpi.nsw.gov.au/dpi/animals/animal-ethics-infolink/three-rs

• Replacement of animals by alternatives wherever possible,
• Reduction in number of animals used, and
• Refinement of experimental conditions and procedures to minimize the harm to animals.

Authors are required to detail housing, husbandry, and pain management in their manuscripts. If national laws mandate it, research involving vertebrates or higher invertebrates must receive approval from the relevant ethics committee before proceeding. At a minimum, the project identification code, approval date, and the name of the ethics committee or institutional review board should be included in the 'Institutional Review Board Statement' section. Research activities must adhere to both national and institutional guidelines. Animal welfare statements should verify compliance with all applicable laws. Clinical studies involving animals and interventions beyond standard care need ethics committee oversight, as per the American Veterinary Medical Association guidelines. For studies involving client-owned animals, informed consent from the client must be obtained and documented in the research manuscript. Owners should be fully informed of any potential risks associated with the procedures and the intention to publish the research. If possible, a high level of veterinary care should be provided. Authors are accountable for the accuracy of the statements in the manuscript.

If ethical approval is not required by national regulations, authors must provide an exemption from the ethics committee, if available. When a study is exempted, the name of the ethics committee granting the exemption should be mentioned in the 'Institutional Review Board Statement' section, along with a detailed explanation of why ethical approval was unnecessary. If no animal ethics committee is available to review applications, authors should be aware that reviewers and editors will assess the ethics of their research. Authors should provide a justification for their work from an ethical standpoint, using the same utilitarian framework employed by ethics committees. Authors may be required to provide this justification even if they have obtained ethical approval.

Research Involving Cell Lines

When submitting research involving cell lines, the Methods section should specify the source of these cell lines. For well-known cell lines, their origin must be mentioned, along with references to either a published study or a commercial provider. In cases where new, previously unpublished cell lines are used, including those received as gifts from other labs, it is necessary to provide details of institutional review board or ethics committee approval. Additionally, if the cell line is derived from human sources, confirmation of written informed consent must be included.

An example of Ethical Statements:

Observational research with a cross-sectional design and retrospective collection of medical record data has been carried out and  ethical exemption obtained from the Ethics Commission of the Faculty of Medicine, Udayana University No.1300/UN14.2.2.VII.14/LT/2024 with protocol number 2024/01/1/0602 and a research permit from Prof. Dr. I.G.N.G. Ngoerah Hospital with number DP.04.03/D.XVII.2.2.2/27373/2024. Sample data were collected from medical records of heart failure patients at Prof. Dr. I.G.N.G. Ngoerah Hospital who met the exclusion and inclusion criteria while hospitalized in the period January 2022-December 2023 using a purposive sampling method.

 

PUBLICATION ETHICS AND MALPRACTICE STATEMENT

In dealing with all aspects of publication ethics, including how to handle cases of research and publication misconduct, Jurnal Farmasi dan Ilmu Kefarmasian Indonesia (JFIKI) adheres to guidelines from the Committee on Publication Ethics (COPE) and the International Committee for Medical Journal Editors (ICMJE).

All studies must be conducted ethically and per local regulations and standards to be scrutinised and approved. The work described in your article must have been carried out in accordance with the Code of Ethics of the World Medical Association Code of Ethics (Declaration of Helsinki) for human experiments and EC Directive 86/609/EEC for animal experiments.

JFIKI adapts COPE to meet a high-quality, ethical standard for publishers, editors, authors, and reviewers. As a critical issue, publication ethics must be clearly explained in order to improve the quality of research worldwide. This section describes the standard for editors, authors, and reviewers. Furthermore, the publisher has no right to interfere with the integrity of the contents and can only provide support for timely publication.

Allegation of Research Misconduct

Fabrication, falsification, citation manipulation, and plagiarism are examples of research misconduct that can occur during the production, performance, review, or reporting of research and the writing of articles. Editors must ensure the accuracy and integrity of the scientific record, especially when previously published papers are involved in such irregularities.

To address misconduct suspicions fairly, editors and editorial boards adhere to COPE best practises, which include an investigation of allegations made by individuals who do not have relevant conflicts of interest. If there is suspicion of misconduct, the corresponding author is contacted for a detailed response, and additional review and participation of experts, such as statistical reviewers, may be sought.

When there is enough evidence of misconduct, submitted manuscripts are rejected, and published articles may be retracted with a link to the original article. Clarifications, additional analyses, or both, published as letters to the editor, often accompanied by a correction notice and correction to the published article, can suffice in cases where misconduct is unlikely.

JFIKI is expected to investigate allegations of scientific misconduct thoroughly. It is the authors', journals', and institutions' critical responsibility to ensure the accuracy of the scientific record. JFIKI will continue to carry out its duties by appropriately responding to concerns about scientific misconduct and taking necessary actions, such as corrections, retractions with replacement, and retractions, to ensure the validity and integrity of the scientific record.

Post-Publication Discussions and Corrections

JFIKI welcomes post-publication discussions and corrections to published articles from readers. If readers want to contribute comments and corrections, they can email the Editor in Chief and explain their thoughts. If the Editor in Chief accepts the discussions and corrections, they will be published as a Letter to the editor in the next issue. The original article's authors may respond to the comments and corrections by sending their response to the Editor in Chief, who may publish it as a Reply to the Letter to the editor.

Article Withdrawal Policy

According to a general principle of scholarly communication, the editor of a learned journal is solely and independently responsible for deciding which articles submitted to the journal will be published. In making this decision, the editor is guided by the editorial board's policies and constrained by current legal requirements regarding libel, copyright infringement, and plagiarism. As a result of this principle, the scholarly archive is important as a permanent, historical record of scholarly transactions. Articles that have been published must be kept as accurate and unaltered as possible. However, very rarely, circumstances may arise when an article is published and then retracted or removed. Such actions should not be taken lightly and should only carried out in exceptional circumstances. In all cases, our official archives at the National Library of the Netherlands will keep all article versions, including those that have been retracted or removed.

This policy was created to address these concerns while also considering current best practices in the scholarly and library communities. We will revisit this issue as standards evolve and change, and we welcome input from the scholarly and library communities. International standards are required for these issues, and we will actively lobby various information bodies to establish international standards and best practices that the publishing and information industries can use. See also the National Library of Medicine's retractions policy and the International Committee of Medical Journal Editors (ICMJE) corrections and retractions recommendations.

Article Withdrawal
Articles in Press are only used for early versions of articles that may contain errors or have been accidentally submitted twice. Occasionally, but infrequently, the articles may violate professional ethical codes, such as multiple submissions, false claims of authorship, plagiarism, fraudulent data use, or the like. Articles in Press (articles accepted for publication but not yet formally published and will not yet have the complete volume/issue/page information) that contain errors or are discovered to be accidental duplicates of previously published articles (s), or are determined by the editors to violate our journal publishing ethics guidelines (such as multiple submission, bogus claims of authorship, plagiarism, fraudulent use of data, or the libel of others). Withdrawn means that the article content (HTML and PDF) is removed and replaced with an HTML page and PDF stating that the article has been withdrawn in accordance with the MEV Policy on Article in Press Withdrawal, along with a link to the most recent policy document.

Article Retraction
Multiple submissions, false claims of authorship, plagiarism, fraudulent use of data, and other violations of professional ethical codes. A retraction is occasionally used to correct errors in submission or publication. The retraction of an article by its authors or the editor on the advice of members of the scholarly community has long been an occurrence in the academic world. Several library and educational bodies have developed standards for dealing with retractions, and MEV has adopted this best practice for article retraction:
- A retraction note titled "Retraction: [article title]" signed by the authors and/or the editor is published and listed in the contents list of a subsequent journal issue.
- The electronic version includes a link to the original article.
- The retraction notice is displayed before the online article. The link resolves to this screen, and the reader can proceed to the article.
- The original article is kept entirely, except for a watermark on each page indicating it has been "retracted."
- The HTML version of the document is no longer available.
- The retraction mechanism adheres to the Committee on Publication Ethics (COPE) Retraction Guidelines, found at https://publicationethics.org/files/retraction-guidelines-cope.pdf.

For Editors

1. An editor should edit every article published on JFIKI.
2. Editors should assist authors to follow the author instructions that we adopt from ICMJE.
3. In making the final decision, the editors may consult with other editors or reviewers.
4. An editor must evaluate each manuscript objectively for publication, judging each on its quality without regard for the authors' nationality, ethnicity, political beliefs, race, religion, gender, seniority, or institutional affiliation of the authors. When there is a potential conflict of interest, he/she should decline his/her assignment.
5. Editors must ensure that the document sent to the reviewer does not contain the author's information and vice versa.
6. Unless they contain offensive or libellous remarks, editors' decisions should be communicated to authors along with reviewers' comments.
7. Editors should respect the author's requests that an individual not review the submission if they are well-reasoned and practical.
8. The confidentiality of the submitted manuscript should be guaranteed by the Editors and all staff.
9. COPE flowcharts will guide editors if there is suspected misconduct or disputed authorship.

 For Reviewers

1. Reviewers must provide feedback on ethical issues and potential research and publication misconduct.
2. Reviewers will complete the work in a timely manner and should notify the editor if they are unable to do so.
3. Reviewers must maintain the manuscript's confidentiality.
4. Reviewers should decline to review manuscripts in which they have a potential conflict of interest with one or more of the authors.

For Authors

1. Author(s) confirm that the material has not been previously published and that they have not transferred any rights to the article to anyone else.
2. Author(s) must ensure that their work is original and that they have properly cited others' work in accordance with the format of the references.
3. Author(s) should avoid plagiarism and self-plagiarism.
4. The publication of 'Salami' is strictly prohibited in JFIKI.
5. Author(s) should ensure they follow the authorship criteria from ICMJE and explained in JFIKI author instructions.
6. The author(s) have not suggested any personal information that could reveal the patient's identity in any description, photograph or pedigree. When pictures of the patient were required for scientific purposes, the author(s) must have written consent.
7. In the case of human experimentation, the authors have certified that the research process adheres to the Helsinki Declaration's ethical standards, as well as domestic and international committees that oversee human experiments. If there are any doubts about whether the research was conducted in accordance with the declaration, the authors should explain why. In the case of animal experiments, the authors have certified that they followed all domestic and foreign guidelines for animal experiments in a laboratory.
8. If there are suspicions of data falsification or fabrication, the author(s) should provide the editor with the data and details of the work.
9. Authors of the journal should clarify everything that may cause a conflict of interest, such as work, research expenses, consultant expenses, and intellectual property on the document of ICMJE form disclosure.

Citation Policy

Authors must ensure that any material sourced from other works, including their own previously published content, is properly cited, and necessary permissions are obtained when required. It is important for authors to avoid excessive self-citation. They should not replicate references from other works unless they have read the cited material. Authors should refrain from preferentially citing their own publications or those of friends, colleagues, or their institution. Additionally, citing advertisements or promotional content is discouraged. In line with COPE guidelines, it is expected that "original wording taken directly from publications by other researchers should appear in quotation marks with the appropriate citations." This rule also applies to an author's own work. COPE has developed a discussion document on citation manipulation, offering recommendations for best practices.