Ethical Non-Compliance and Editorial Action

The journal takes concerns about non-compliance with research ethics seriously and will respond in a fair, proportionate, evidence-based, and transparent manner while protecting participants, the integrity of the scientific record, and the legitimate rights of all parties involved.

Ethical non-compliance may concern research involving human participants, children or vulnerable participants, informed consent, parental permission or child assent, privacy and confidentiality, biological materials, genetic data, secondary use of data, clinical trial registration, participant safety, or other requirements established in the journal’s Research Ethics Policy.

The World Medical Association Declaration of Helsinki (2024) states that reports of research not conducted in accordance with its principles should not be accepted for publication.

Scope of Ethical Non-Compliance

Potential ethical non-compliance may include, but is not limited to:

  • absence of required ethics committee or IRB approval;
  • research initiated before required prospective ethical approval;
  • false, altered, fabricated, or misleading ethics documentation;
  • conducting research materially outside the scope of an approved protocol;
  • failure to obtain required informed consent;
  • inappropriate or undocumented waiver of consent;
  • failure to obtain required parental or legally authorized representative permission;
  • failure to seek appropriate child assent;
  • disregard of a participant’s ethically relevant dissent;
  • unjustified inclusion or exploitation of vulnerable participants;
  • inadequate assessment or management of participant risks;
  • serious failures in safety monitoring;
  • unauthorized access to medical records;
  • inappropriate use of human biological materials;
  • unauthorized secondary use of identifiable data or specimens;
  • serious breaches of privacy or confidentiality;
  • publication of identifiable patient information without required permission;
  • misuse or misrepresentation of genetic or genomic data;
  • failure to meet applicable clinical trial registration requirements;
  • material inconsistency between ethics approval, protocol, registry information, and the research actually conducted;
  • deliberate concealment of ethically relevant information from editors, reviewers, participants, or ethics committees.

Ethical non-compliance does not necessarily imply deliberate misconduct. Each case must be assessed individually.

Honest Error, Non-Compliance and Misconduct

The journal distinguishes between:

  • honest error;
  • misunderstanding or administrative non-compliance;
  • negligent or reckless failure to meet ethical requirements;
  • deliberate research or publication misconduct.

The nature, seriousness, consequences, intent, and effect on participant protection and the reliability of the scientific record will be considered when determining an appropriate response.

ICMJE similarly notes that different forms of research-integrity problems are not equivalent and that each situation requires individual assessment.

An honest error may require correction without implying misconduct, whereas fabrication of ethics approval, concealment of missing consent, or deliberate misrepresentation may require formal investigation and stronger editorial action.

Initial Editorial Assessment

When a credible ethical concern is raised, the journal may conduct an initial assessment to determine:

  • the nature and seriousness of the concern;
  • whether participants may have been placed at risk;
  • whether the concern affects the reliability or ethical legitimacy of the research;
  • whether further documentation is required;
  • whether an institution, ethics committee, sponsor, or other competent body should be involved.

The journal may request from the authors:

  • ethics approval or exemption documentation;
  • relevant protocol sections;
  • consent or assent procedures;
  • trial registration information;
  • documentation concerning biological materials or data access;
  • safety-monitoring information;
  • explanations of protocol deviations;
  • other evidence reasonably necessary to assess the concern.

Authors are expected to respond accurately and within a reasonable timeframe.

Editorial Action Before Publication

If an ethical concern arises while a manuscript is under consideration, the journal may:

  • request clarification or additional documentation;
  • temporarily suspend peer review or the editorial decision;
  • obtain independent ethical or methodological advice;
  • ask authors to correct incomplete or inaccurate ethical disclosures;
  • request confirmation from the responsible ethics committee or institution;
  • refer serious concerns to an appropriate institution or competent authority;
  • reject the manuscript where compliance with fundamental ethical requirements cannot be established.

The journal will not accept a manuscript merely because formal ethics approval exists if the available evidence raises serious concerns about participant protection or the ethical conduct of the research.

ICMJE recognizes that approval by an ethics review body does not prevent editors from independently judging whether research was conducted appropriately.

Contact with Institutions and Ethics Bodies

Some concerns cannot be adequately investigated by a journal alone.

Where appropriate, the journal may communicate with:

  • the responsible research ethics committee or IRB;
  • the authors’ institution;
  • research-integrity or compliance offices;
  • the study sponsor or funder;
  • clinical trial authorities;
  • other competent regulatory or professional bodies.

The journal may provide information reasonably necessary for a legitimate investigation while respecting confidentiality, privacy, and applicable legal requirements.

ICMJE recommends that editors initiate appropriate procedures when research misconduct or integrity concerns arise and consider informing relevant institutions and funders.

Independence and Fair Process

Ethical concerns will be evaluated without regard to an author’s status, institutional affiliation, nationality, professional position, editorial role, or relationship with the journal.

Authors who are editors, Editorial Board members, institutional colleagues, invited contributors, or otherwise associated with the journal are subject to the same ethical standards.

Where an editor has a conflict of interest, the matter should be handled by another appropriately independent editor or qualified person.

Individuals whose work is questioned should normally be given a reasonable opportunity to respond to the substantive concern unless doing so would compromise participant safety, a legitimate investigation, or a legal obligation.

Confidentiality During Assessment

Allegations, supporting documents, and correspondence concerning ethical concerns should be handled with appropriate confidentiality.

Information should be disclosed only to persons or organizations that have a legitimate need to receive it for editorial assessment, participant protection, or a formal investigation.

Confidentiality must not be used to conceal serious participant-safety concerns or prevent appropriate referral to a competent authority.

Personal and identifiable patient information must receive particular protection throughout any investigation.

Protection of Participants

Where an ethical concern indicates an ongoing or serious risk to participants, participant safety and welfare take priority over normal editorial timelines.

The journal may urgently contact the responsible institution, ethics committee, or another competent authority where necessary.

Editorial assessment does not replace the responsibility of researchers, institutions, sponsors, ethics committees, or regulatory authorities to take appropriate action to protect participants.

Post-Publication Concerns

Publication does not end the journal’s responsibility to respond to credible ethical concerns.

If a serious concern arises after publication, the journal may:

  • request clarification and supporting documentation;
  • initiate an editorial assessment;
  • seek independent expert advice;
  • contact the responsible institution or ethics committee;
  • publish a correction;
  • issue an Expression of Concern while a significant unresolved investigation is ongoing;
  • retract an article where appropriate;
  • take other measures necessary to maintain the integrity of the scholarly record.

ICMJE recommends expressions of concern where significant integrity concerns remain unresolved and retraction where misconduct or errors invalidate the reliability of published work. Retraction notices should be clearly identified and linked to the affected article rather than silently removing the publication.

Corrections, Retractions and the Scientific Record

Editorial action should be determined by the effect of the ethical problem on both participant protection and the reliability of the published record.

Minor or correctable problems may be addressed through an appropriate correction.

Serious problems may require an Expression of Concern or retraction when, for example:

  • the reliability of results or conclusions is fundamentally compromised;
  • the research involved serious ethical violations;
  • essential consent or participant protections were absent;
  • critical ethics documentation was fabricated or materially falsified;
  • published identifiable patient information lacked required permission and cannot be adequately corrected;
  • another serious issue makes continued reliance on the publication unsafe or misleading.

ICMJE distinguishes corrections for factual errors from retractions for problems serious enough to invalidate results or conclusions or involving scientific misconduct. It also recommends transparent version control rather than silent substantive alteration of the record.

No Silent Correction of Serious Ethical Problems

The journal will not resolve a material research-ethics problem by silently deleting, replacing, or changing substantive information in a published article.

Post-publication changes that materially affect the interpretation or ethical status of the work must be accompanied by an appropriate public notice and version-control mechanism.

The original scholarly record should be preserved to the extent appropriate while clearly indicating the current status of the article.

Cooperation with Investigations

Authors are expected to cooperate with legitimate editorial and institutional investigations.

Failure to respond, destruction or concealment of relevant evidence, submission of false documentation, or attempts to interfere with an investigation may itself be considered when determining further editorial action.

The journal may defer a final decision while awaiting the outcome of a competent institutional or ethics investigation when that investigation is necessary to establish facts.

ICMJE recommends that editors seek the outcome of relevant institutional investigations and inform readers of the outcome where appropriate.

Protection of Persons Raising Concerns

Concerns raised in good faith should be considered on their merits.

The journal should not dismiss a concern solely because it is raised by an anonymous or confidential source if sufficient specific information is available to permit reasonable assessment.

At the same time, allegations should not be treated as established facts without appropriate evaluation.

The journal will seek to avoid unnecessary disclosure of the identity of persons raising concerns, subject to applicable law and the requirements of a fair investigation.

Editorial Decisions and Cross-References

Editorial action will be proportionate to the seriousness and consequences of the ethical issue.

Depending on the circumstances, the journal may take no further action, request clarification or correction, suspend consideration, reject a manuscript, refer the matter for investigation, publish a correction or Expression of Concern, retract an article, or take another appropriate measure.

Detailed procedures concerning allegations of misconduct and changes to the published record are provided in the journal’s Publication Ethics sections:

  • Research Misconduct;
  • Editorial Actions;
  • Corrections and Retractions;
  • Complaints and Appeals.

These policies should be read together with the present Research Ethics Policy.

ISSN 2181-3353 (Print)
ISSN 2181-3353 (Online)