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Ethics policy

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Research & publication ethics
  • Enacted on Jun 22, 2012
  • First revision Jul 1, 2017
  • Second revision Jan 1, 2022
  • Recently revised Sept 1, 2023

Table of Contents

Kosin Medical Journal (KMJ) requires ethically appropriate practices in research. The research ethics guidelines for KMJ were created according to the policy that this journal accomplished through good research practice by referring to the ethics guidelines of several reference organizations [Council of Science Editors, (http://www.councilscienceeditors.org), International Committee of Medical Journal Editors (ICMJE, http://www.icmje.org), World Association of Medical Editors (WAME, http://www.wame.org), and the Korean Association of Medical Journal Editors (KAMJE, http://www.kamje.or.kr)].
Research must be performed in an ethical manner and adhere to research standards and regulations, domestic and international laws, and guidelines outlined in publications such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) guidelines, Law on Life Ethics and Safety, Medical Law, Pharmacy Law, Medical Device Law, In Vitro Diagnostic Medical Device Law, Law on Advanced Regenerative Medicine and Advanced Bio-pharmaceuticals Safety and Support, Personal Information Protection Law, and the Regulations of Institution or Orgnaization’s Clinical Trial and Medical Research Ethics Committee, among others.
If research deals with data obtained by experiments using human subjects or any human data that has already been obtained in routine working processes or previous studies, a qualified Institutional Review Board (IRB) must be involved in the review of the study. And research must be subsequently approved by this review board. Fundamentally, we referred to the regulations declared by the World Medical Association as outlined in the principles of the Declaration of Helsinki, https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects.
In the case of research involving animals, the responsible Institutional Animal Care and Use Committee (IACUC) must review and approve the study. Any research that presents severe biosafety issues must be reviewed and approved by an Institutional Biosafety Committee (IBC).
Ethical statements should be described in the methods section wherein the approval of the study components by the appropriate review boards must be declared. Furthermore, the manuscript authors must clearly state whether informed consent was required or waived.
Authors must submit proof of IRB approval for their studies and clarify the statements of informed consent in clinical studies using human subjects. To address any misconduct found in submitted manuscripts, KMJ will refer to the guidelines outlined by the Committee on Publication Ethics (COPE, http://publicationethics.org).
Before initiating the research, the principal investigator must obtain approval from the Institutional Review Board (IRB) for the consent form template, participant information sheet, and other documented data provided to research participants, unless the study falls under the exempt category designated by the IRB, in which case consent from research participants or documentation thereof may not be required.
A consent form should include a clear and concise description of the research to which the participant will consent. It should include the following information in the participant information sheet and informed consent document:
  1. The fact that the study is being conducted for research purposes.
  2. The purpose of the study.
  3. Information about the investigational medicinal product/medical device for the research and the probability of being randomly assigned to the test group or control group.
  4. Various tests or procedures that the participants will undergo during the research, including invasive procedures.
  5. Instructions that the participants must follow.
  6. The fact that it is an unproven study.
  7. The anticipated risks or discomfort that may affect the participants (including fetuses in trials involving pregnant women and infants in trials involving lactating women).
  8. Whether there are expected benefits or no expected benefits for subjects’ participation in the study.
  9. Other treatment options or types available to the subjects, along with potential risks and benefits of those treatments.
  10. Compensation or treatment that will be provided to the subjects in case of any trial-related injuries.
  11. For any financial compensation for participating in the research, the estimated amount and the indication that this compensation may be adjusted based on the degree or duration of participation in the trial.
  12. The expected costs for the subjects resulting from their participation in the research.
  13. The decision to participate in the clinical trial must be voluntary, and the participants have the right to refuse or withdraw from the trial at any time without losing any benefits stipulated in the consent form.
  14. The fact that monitoring personnel, inspectors, the review board, and the head of the Ministry of Food and Drug Safety have the authority, within the adherence of guidelines designed to protect the participants' confidentiality, to access the participants' medical records to verify the conduct and quality of data for the research, and that such access is permitted by the informed consent document signed by the participants or their representatives.
  15. Records that can identify the subjects will be kept confidential, and the fact that the subjects' identities will remain confidential when the results of the study are published.
  16. The commitment to inform the participants or their representatives promptly if any new information arises during the research that may influence their continued participation.
  17. Contact information for individuals who can be reached in case additional information regarding the research and the participants' rights is needed or if trial-related injuries occur.
  18. Conditions and reasons for discontinuing the individual's participation in the study if such situations arise during the trial.
  19. The expected duration of the individual's participation in the research.
  20. An approximate number of participants actively involved in the research.
To ensure ethical practices, it is essential that research participants receive proper instructions and provide their consent to participate in the study by completing the relevant informed consent documents. Authors may be requested to submit a sample consent form with all personal information removed. In cases where written consent is not obtained and verbal consent is given, or when consent cannot be obtained, authors must provide an explanation in the manuscript. It is important to note that the use of verbal consent or the absence of consent should be approved by the appropriate IRB or ethics committee. For further guidance on patient privacy, anonymity, and informed consent, authors can refer to the privacy and confidentiality guidelines of the International Committee of Medical Journal Editors (ICMJE).
"Conflict of Interest" refers to situations in which the professional judgment of researchers and IRB members, IRB administrators, etc. (hereinafter referred to as IRB stakeholders) regarding primary interests may be unduly influenced or potentially influenced by secondary interests.
"Significant Financial Conflict" means cases in which researchers and IRB stakeholders have significant financial interests related to the research, which may fall under any of the following circumstances:
  1. Cases where researchers stand to gain financial benefits such as patents or intellectual property rights if the research results are commercialized.
  2. Cases where the researchers or their immediate family members serve as directors, executives, or officers of pharmaceutical or bio-related companies.
  3. Cases where the researchers or their immediate family members have received remuneration exceeding 5 million KRW from publicly traded entities or hold equity interests valued at more than 5 million KRW as of the reporting date within the past year.
  4. Cases where the researchers or their immediate family members have received remuneration exceeding 5 million KRW from non-publicly traded entities or the researchers hold shares (e.g., stocks, stock options or other equity interests) in such entities.
"Immediate family members" refers to parents, spouses, children, and cohabitants in a de facto marriage relationship.
"Conflict of Interest Review Board (COIRB)" is a committee established to review reports related to conflicts of interest involving individuals and organizations. The COIRB examines whether significant conflicts of interest exist and manages such conflicts when verified.
The corresponding author of each article is responsible for informing the editor about any potential conflicts of interest that could impact the research or interpretation of data. It is important to disclose potential conflicts of interest in the cover letter, even if the authors are confident that their judgment has not been influenced during the preparation of the manuscript. Examples of such conflicts may include financial support or personal affiliations with pharmaceutical companies, political pressure from interest groups, or academic disputes. The disclosure forms should follow the format of the ICMJE Uniform Disclosure Form for Potential Conflicts of Interest. The editor will decide whether to include details of the potential conflict in the published paper. Additionally, all sources of funding for the study must be explicitly stated. KMJ requests authors to inform its editor about any conflicts of interest before reviewing a specific manuscript.
KMJ adheres to the authorship recommendations provided by the ICMJE (2019) (http://www.icmje.org/icmje-recommendations.pdf), and the Good Publication Practice Guidelines for Medical Journals, 3rd Edition (KAMJE, 2019, https://www.kamje.or.kr/board/view?b_name=bo_publication&bo_id=13&per_page=).
The aim of the criteria for authorship is to recognize individuals who have made substantial contributions to the work and to assume their corresponding responsibility. Authorship credit should be based on the following criteria:
  1. Substantial contributions to the conception or design of the work, or the acquisition, analysis, or interpretation of data for the work.
  2. Participation in drafting the work or critically reviewing it for important intellectual content.
  3. Giving final approval of the version to be published.
  4. Agreement to be accountable for all aspects of the work to ensure that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
All individuals designated as authors must meet all four criteria, and those who meet the criteria should be identified as authors. If an individual does not meet all four criteria but has made some contributions, he or she should be acknowledged in the manuscript.
It is the responsibility of the individuals conducting the work to identify those who meet the authorship criteria. Collaboration and co-authorship with colleagues from the research locations are encouraged. The order in which authors are listed on the byline may vary and should be collectively decided upon by the authorship group and not by the journal editors.
The corresponding author is the one who takes primary responsibility for communication with the journal during the manuscript submission, peer-review, and publication process. He or she ensures all administrative requirements, ethical considerations, and disclosures are properly completed and reported. The corresponding author should be available to respond to editorial queries and post-publication critiques. The editors of KMJ will send copies of all correspondence to all listed authors.
In cases where a large multi-author group has conducted the study, authorship should be decided upon before starting the work, and all members of the group named as authors should meet the authorship criteria. Some large multi-author groups may designate authorship by a group name, and the corresponding author should specify the group name and clearly identify the individual group members who are authors or collaborators. The corresponding author should clearly indicate the preferred citation and include the names of all individual authors as well as the group name. Other group members are typically acknowledged in the Acknowledgments section. It is important to note that contributing to funding acquisition, data collection, or general supervision of the research group alone does not meet the criteria for authorship. The corresponding author is responsible for communicating with the editor of KMJ and representing the opinions of all authors. If the byline includes a group name, individual group members' names will be listed separately with their specific roles identified in the paper.
When co-authoring papers with researchers in the same group who have a special relationship, such as minors under the age of 19 or family members (including a spouse and children), plans involving them must be disclosed to affiliated institutions and co-researchers before the study begins. Affiliated institutions and relevant academic organizations should be informed prior to manuscript submission. If it is determined that the affiliation of co-authors' authorship is invalid, the KMJ Editorial Board will notify the associated institutions (e.g., school and affiliation) from which the author(s) received any benefits.
Redundant publication and plagiarism are unethical practices within academia and the publishing industry, involving the improper use of previously published work.
Redundant publication, also known as duplicate publication or self-plagiarism, occurs when an author republishes substantially the same work or its parts without proper citation or acknowledgment of the original source(s). This includes submitting the same paper to multiple journals or presenting identical research findings in different publications. Such practices create a false impression of new research and lead to unnecessary repetition in the scientific literature. Additionally, they can raise copyright concerns and unfairly inflate an author's publication record. Journals have strict policies against redundant publication and expect authors to disclose any potential overlaps with their previous work when submitting new manuscripts.
Comparatively, plagiarism involves using someone else's ideas, words, data, or intellectual property without giving appropriate credit or obtaining permission from the original author or source. This can take various forms, such as directly copying text without citation, paraphrasing someone else's work without proper acknowledgment, or presenting others' research findings as one's own. Plagiarism represents serious scholarly misconduct that undermines the principles of academic integrity, fairness and credibility.
Redundant publication and plagiarism both damage the credibility and reputation of authors while eroding the trust within the scientific community and the academic publishing process. To maintain the quality and ethics of academic research, it is crucial for authors to adhere to proper citation practices and respect the intellectual property rights of others.
Within the KMJ, redundant publication is considered when the same work is reported multiple times without proper acknowledgment of the original source(s). Such reports with significant similarities possess the following characteristics:
  • (a) All reports should share at least one common author. The absence of common authors may suggest plagiarism rather than redundant publication.
  • (b) The subjects or study populations in the reports are either the same or they overlap.
  • (c) The methodology employed in the reports tends to be identical or approaching identical.
  • (d) The results and their interpretation generally display minimal variation.
When authors submit a manuscript to the KMJ, they are required to enclose a letter to the editor, highlighting any potential overlap with previously published material or manuscripts under consideration elsewhere. Moreover, authors must explicitly state how the manuscript submitted to the KMJ differs significantly from other materials. In the Methods section, any previous reporting of the patient population should be disclosed, along with the appropriate references cited.
To maintain the originality and integrity of published manuscripts, the KMJ editorial committee employs Ithenticate (https://www.ithenticate.com) to screen all submitted manuscripts for plagiarism before publication.
For a clinical trial to be eligible for publication, it must involve the prospective assignment of human subjects to intervention and comparison groups, aiming to investigate the cause-and-effect relationship between a medical intervention and a health outcome. To meet this requirement, the trial must be inputted into the primary registry.
The KMJ accepts registrations from any of the primary registries affiliated with the WHO International Clinical Trials Portal (http://www.who.int/ictrp/en), NIH ClinicalTrials.gov (http://www.clinicaltrials.gov), ISRCTN Registry (www.ISRCTN.org), Clinical Research Information Service (CRIS, https://cris.nih.go.kr/) and the Korea CDC (http://www.cdc.go.kr/CDC/eng/main.jsp).
The KMJ follows the ICMJE's clinical trial registration policy to prevent selective publication and reporting of research outcomes, avoid duplication of efforts, inform patients about ongoing trials, and provide relevant data to ethics review boards. Inadequate registrations, including missing data fields, uninformative information, or lack of public accessibility, are not accepted.
Retrospective registration, such as registering at the time of manuscript submission, does not fulfill the purposes of trial registration. This policy also applies to research with alternative designs, although non-trial research registration is not mandated. Secondary data analyses of primary trials should reference the registration number of the primary trial.
Authors are responsible for meeting funding and regulatory agencies' requirements regarding clinical trial results reporting in registries. Any discrepancies between registry and journal results must be explained by the authors. Posting brief structured abstracts or tables in compliant registries is not considered prior publication by KMJ.
The trial registration number should be included at the end of the abstract, and trial acronyms should be listed with their registration numbers in the manuscript. Editors may evaluate cases where prospective registration was not feasible, but such exceptions are rare and must be justified. Failure to prospectively register a trial may lead to its inadmissibility to KMJ.
In scientific research, it is crucial to maintain a precise understanding and application of the terms "sex" and "gender." "Sex" refers to biological factors, encompassing anatomical and physiological characteristics, while "gender" pertains to identity, psychosocial, or cultural factors. To ensure accuracy and clarity in reporting, authors must consistently use these terms correctly throughout their studies.
Researchers should provide detailed information about the sex or gender of study participants, as well as the sex of animals or cells used in experiments. The methods employed to determine sex or gender should be transparently outlined to facilitate reproducibility and allow for proper interpretation of the results.
When conducting studies with an exclusive population, limited to one sex, the authors should provide justifications for this approach, except in instances where the rationale is evident, such as in prostate cancer research. These justifications are critical for understanding the appropriateness and relevance of the study design.
Moreover, authors must elucidate how they determined race or ethnicity within their study cohort. This is essential to ensure transparency in research methodologies and to assess the impact of these factors on the study's findings. Authors should also justify the relevance of considering race or ethnicity in their research to address potential biases and inform readers about the implications of their findings.
Overall, adhering to these guidelines fosters accuracy and rigor in scientific research, promoting an in-depth understanding of the influence of sex, gender, race, and ethnicity on study outcomes and conclusions.
When the Journal identifies a potential instance of research or publication misconduct, it may encompass various issues, including redundant (duplicate) publication, plagiarism, fabricated data, alterations in authorship, undisclosed conflicts of interest, ethical concerns with the submitted manuscript, instances where a reviewer has appropriated an author's ideas or data, complaints against editors, and other related matters.
The resolution process for such cases will adhere to the guidelines provided by the Committee on Publication Ethics, ensuring a systematic and fair approach. The Editorial Board of the KMJ will engage in thorough discussions regarding the suspected case, considering all available evidence and relevant factors, to arrive at a well-informed decision.
For any research and publication ethics matters that are not explicitly addressed in the instructions, authors can refer to the Guidelines on Good Publication Practices (http://publicationethics.org) or the Good Publication Practice Guidelines for Medical Journals (http://kamje.or.kr) as authoritative references to obtain information concerning the resolution process.
By employing these comprehensive measures, KMJ will demonstrate its commitment to upholding the highest standards of research integrity and ethical publishing, thereby ensuring the credibility and reliability of the scientific literature.
The KMJ Editorial Board will diligently oversee and uphold publication ethics. This involves following guidelines for article retractions, preserving the academic record, and guarding against compromising intellectual and ethical standards due to business pressures. Additionally, the Board is committed to transparently disclosing corrections, clarifications, retractions, and apologies when necessary, while also ensuring there is no plagiarism or fraudulent data in the journal's content.
The editors have significant responsibilities. They have the authority to accept or reject submissions and carefully manage any potential conflicts of interest, demonstrating fairness and prudence. To maintain scholarly integrity, they strongly support publishing corrections or retractions if errors are found. Furthermore, they strictly maintain the confidentiality and anonymity of the esteemed reviewers who contribute to the journal's rigorous peer-review process.
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