Expression of Concern Policy
Expression of Concern Policy
Policy for Issuing Expressions of Concern Regarding Published Articles
The Journal of Pharmacovigilance and Drug Research (JPADR) is committed to preserving the integrity, transparency, and reliability of the scholarly record. When serious questions arise regarding the reliability, ethical compliance, validity, or integrity of published research, but sufficient evidence is not yet available to warrant correction or retraction, the journal may issue an Expression of Concern.
This policy establishes a transparent, fair, and consistent framework for issuing Expressions of Concern while ensuring procedural fairness to authors and protecting readers and the scholarly community.
This policy has been developed in accordance with recommendations and best practices of:
- Committee on Publication Ethics (COPE)
- International Committee of Medical Journal Editors (ICMJE)
- Council of Science Editors (CSE)
- World Association of Medical Editors (WAME)
- Directory of Open Access Journals (DOAJ)
1. Purpose
The purpose of this policy is to establish a transparent, fair, and evidence-based process for issuing Expressions of Concern regarding articles published in JPADR when credible concerns arise about the reliability, integrity, ethical compliance, or validity of published research but available evidence remains insufficient to support immediate correction or retraction.
This policy aims to:
- Protect the integrity of the scholarly record.
- Promote transparency in scholarly publishing.
- Ensure procedural fairness for authors.
- Inform readers of significant unresolved concerns.
- Support responsible editorial decision-making.
- Maintain confidence in published research.
JPADR recognizes that Expressions of Concern are precautionary editorial notices intended to inform readers while investigations remain ongoing or unresolved.
2. Scope
This policy applies to concerns involving published articles appearing in the Journal of Pharmacovigilance and Drug Research.
The policy applies to:
- All articles published in JPADR.
- Authors and co-authors.
- Editors and Editorial Board members.
- Peer reviewers.
- Readers and whistleblowers.
- Research institutions.
- Funding agencies.
- Regulatory authorities.
- Third-party complainants.
The policy applies regardless of whether concerns are identified before or after publication, provided the article has entered the scholarly record.
3. Policy Statement
JPADR may publish an Expression of Concern when credible evidence raises substantial doubts regarding a published article but available information remains insufficient to justify immediate correction or retraction.
An Expression of Concern serves to:
- Alert readers to potential issues affecting the publication.
- Preserve transparency during investigations.
- Protect the integrity of the scholarly record.
- Inform the scientific community while inquiries remain ongoing.
- Avoid premature editorial conclusions before all evidence has been evaluated.
An Expression of Concern is not a finding of research misconduct and should not be interpreted as proof of wrongdoing. It represents an interim editorial measure pending further investigation or clarification.
4. Definition
An Expression of Concern is a formal editorial notice issued by the journal to inform readers that serious concerns have been raised regarding a published article and that further investigation is underway or unresolved.
The notice is intended to:
- Promote transparency.
- Maintain fairness and due process.
- Protect readers.
- Preserve the scholarly record.
- Provide timely editorial communication while investigations continue.
5. Circumstances Warranting an Expression of Concern
JPADR may consider issuing an Expression of Concern when one or more of the following situations arise.
5.1 Suspected Research Misconduct
Concerns involving:
- Data fabrication.
- Data falsification.
- Image manipulation.
- Selective reporting.
- Misrepresentation of findings.
where investigations remain ongoing or evidence is inconclusive.
5.2 Questions Regarding Data Reliability
Substantial doubts concerning:
- Accuracy of data.
- Validity of analyses.
- Authenticity of results.
- Reproducibility of findings.
when sufficient evidence is not yet available to determine appropriate corrective action.
5.3 Unresolved Ethical Concerns
Concerns relating to:
- Human subject protections.
- Informed consent.
- Institutional ethics approval.
- Animal welfare compliance.
- Patient confidentiality.
where verification remains pending.
5.4 Authorship or Contributorship Disputes
Significant disputes involving:
- Authorship ownership.
- Undisclosed contributors.
- Ghost authorship.
- Honorary authorship.
that may affect the integrity of the publication.
5.5 Institutional Investigations
When:
- An institution initiates an investigation.
- Regulatory authorities commence inquiries.
- Funding agencies undertake misconduct reviews.
and the outcome remains pending.
5.6 Inconclusive Evidence
When available evidence raises substantial concerns but remains insufficient to justify:
- Retraction.
- Correction.
- Editorial dismissal of allegations.
5.7 Delayed Investigations
When institutional or regulatory investigations are significantly delayed and readers should be informed that important concerns remain unresolved.
6. Sources of Concerns
Concerns leading to an Expression of Concern may originate from a variety of credible sources.
These may include:
- Authors.
- Readers.
- Peer reviewers.
- Editors.
- Research institutions.
- Regulatory agencies.
- Funding bodies.
- Whistleblowers.
- Independent researchers.
- Post-publication review platforms.
Anonymous allegations may also be considered where they are accompanied by credible evidence capable of supporting further editorial assessment.
7. Assessment of Concerns
Upon receiving an allegation or report, the journal shall conduct a preliminary assessment to determine the nature, credibility, and potential significance of the concerns before deciding whether further investigation is warranted.
The assessment may consider:
- The seriousness of the concern.
- The credibility of available evidence.
- The potential impact on the scientific record.
- Whether immediate editorial action is necessary.
Where appropriate, the journal may consult:
- Subject matter experts.
- Statistical reviewers.
- Ethics advisors.
- Editorial Board members.
- Institutional representatives.
The outcome of this preliminary assessment will guide subsequent editorial actions, including whether additional investigation, author consultation, or issuance of an Expression of Concern should be considered.
8. Investigation Process
JPADR follows a structured, fair, and evidence-based process when evaluating concerns regarding published articles. The investigation process seeks to balance transparency, procedural fairness, and protection of the scholarly record.
Step 1: Preliminary Review
The Editor-in-Chief or a designated editor shall:
- Assess the available evidence.
- Review relevant documentation.
- Evaluate the seriousness of the allegations.
- Determine whether further inquiry is warranted.
Step 2: Author Notification
Where appropriate, authors shall normally be:
- Informed of the concerns raised.
- Given an opportunity to respond.
- Invited to provide supporting evidence or clarification.
- Allowed reasonable time to submit explanations.
Step 3: External Consultation
Where necessary, the journal may seek assistance from:
- Independent subject experts.
- Statistical reviewers.
- Research institutions.
- Regulatory authorities.
- Research ethics committees.
Step 4: Editorial Evaluation
Following review of all available information, the editorial team shall determine whether:
- No editorial action is required.
- A correction is appropriate.
- An Expression of Concern should be issued.
- Retraction should be considered.
Editorial decisions shall be based upon available evidence, applicable ethical guidance, and the need to protect readers and maintain the integrity of the scholarly record.
9. Decision to Issue an Expression of Concern
The decision to publish an Expression of Concern shall be made after careful editorial evaluation and consideration of the available evidence.
The decision may be made by:
- The Editor-in-Chief.
- A designated Editorial Ethics Committee.
- The Editorial Board, where appropriate.
In reaching a decision, the journal may consider:
- The credibility of available evidence.
- The seriousness of the concerns.
- The potential impact on readers.
- The progress of institutional investigations.
- The need to preserve transparency while investigations remain unresolved.
The decision to issue an Expression of Concern does not imply research misconduct or establish wrongdoing. It is intended solely to inform readers that important concerns remain under evaluation.
10. Content of an Expression of Concern Notice
An Expression of Concern notice should provide sufficient information to inform readers while maintaining fairness, objectivity, and confidentiality where appropriate.
The notice should:
- Clearly identify the affected article.
- Describe the nature of the concerns.
- Summarize the status of any investigation.
- Avoid defamatory or speculative language.
- Present factual and objective information.
- State where conclusions have not yet been reached.
Confidential information shall not be disclosed unless necessary to protect the scholarly record or required by applicable legal or ethical obligations.
11. Publication and Indexing of Notices
Expressions of Concern are considered permanent components of the scholarly record and shall remain accessible to readers unless subsequently superseded by another editorial action.
Where applicable, an Expression of Concern shall:
- Be assigned a separate publication record.
- Receive a Digital Object Identifier (DOI).
- Be permanently linked to the original article.
- Be freely accessible to readers.
- Be clearly labelled as an "Expression of Concern."
Unless legal or ethical circumstances require otherwise, the original article shall remain available while prominently indicating the existence of the associated Expression of Concern.
12. Updating an Expression of Concern
Following completion of an investigation, JPADR shall determine the most appropriate editorial action based on the available evidence.
Remove the Expression of Concern
The notice may be removed if allegations are found to be unsupported and no concerns remain regarding the integrity of the publication.
Issue a Correction
Where errors are identified but the scientific findings remain reliable, the journal may publish an appropriate correction.
Retract the Article
If investigations conclude that the findings are unreliable or serious misconduct has occurred, the journal may retract the article in accordance with its Retraction Policy.
Maintain the Expression of Concern
Where significant concerns remain unresolved despite reasonable investigative efforts, the journal may continue to display the Expression of Concern to inform readers.
Any subsequent editorial action shall be electronically linked to both the original article and the Expression of Concern notice to preserve transparency and continuity of the scholarly record.
13. Rights of Authors
Authors whose publications become the subject of an Expression of Concern shall be treated fairly throughout the editorial process.
Authors have the right to:
- Receive timely notice of the allegations.
- Provide explanations and supporting evidence.
- Respond to editorial inquiries.
- Submit corrections where appropriate.
- Appeal editorial decisions in accordance with the journal's Appeals and Complaints Policy.
JPADR is committed to ensuring procedural fairness while maintaining the integrity of editorial investigations.
14. Responsibilities of Editors
Editors play a central role in maintaining the integrity of the scholarly record during investigations involving Expressions of Concern.
Editors shall:
- Act impartially and objectively.
- Maintain confidentiality.
- Evaluate available evidence fairly.
- Avoid actual or perceived conflicts of interest.
- Protect the integrity of the scientific record.
- Follow established publication ethics guidance.
Editorial decisions shall be evidence-based, transparent, and free from inappropriate external influence.
15. Responsibilities of Institutions
Research institutions play an important role in investigating allegations of research misconduct and supporting publication integrity.
JPADR encourages institutions to:
- Investigate allegations promptly.
- Cooperate with journal inquiries.
- Provide relevant findings where permissible.
- Maintain appropriate research oversight mechanisms.
- Support transparent research integrity processes.
Where appropriate, the journal may rely upon institutional findings when determining whether an Expression of Concern should be maintained, updated, replaced by a correction, or followed by retraction.
16. Confidentiality
JPADR shall maintain confidentiality throughout investigations involving Expressions of Concern to the greatest extent possible while ensuring appropriate transparency for the protection of the scholarly record.
Confidential information obtained during investigations shall be handled responsibly and disclosed only when necessary.
Confidential information may be disclosed only when:
- Necessary for a fair and thorough investigation.
- Required by applicable laws or regulations.
- Essential to protect the integrity of the scholarly record.
- Authorized by relevant individuals or institutions.
Editors, reviewers, editorial staff, and external advisors participating in investigations are expected to maintain appropriate confidentiality throughout the review process.
17. Appeals
Authors may appeal the issuance of an Expression of Concern if they believe the editorial decision was based on incomplete information, procedural error, or newly available evidence.
Appeals should:
- Be submitted in writing.
- Clearly identify the grounds for appeal.
- Include relevant supporting documentation.
- Address the specific concerns identified by the journal.
Appeals shall be reviewed independently in accordance with the journal's Appeals and Complaints Policy. Individuals involved in the original decision may be recused where appropriate to ensure an impartial review.
The outcome of the appeal shall be communicated to the authors, and any resulting editorial action shall be documented in the journal's publication record.
18. Relationship with Corrections and Retractions
An Expression of Concern is distinct from a Correction or a Retraction and serves a different editorial purpose within the publication record.
Correction
A Correction is issued when errors are identified that do not invalidate the overall findings or conclusions of the published work.
Retraction
A Retraction is issued when the published findings are determined to be unreliable due to serious error, research misconduct, fabrication, falsification, plagiarism, or other significant ethical concerns.
Expression of Concern
An Expression of Concern is issued when serious concerns have been raised regarding a published article, but the available evidence remains incomplete, investigations are ongoing, or the outcome cannot yet support correction or retraction.
Where appropriate, an Expression of Concern may subsequently be:
- Removed following resolution of concerns.
- Replaced by a Correction.
- Followed by a Retraction.
- Maintained if concerns remain unresolved.
19. Compliance with International Standards
This policy has been developed in accordance with internationally recognized principles of publication ethics and responsible scholarly publishing.
JPADR follows guidance and recommendations issued by:
- Committee on Publication Ethics (COPE).
- International Committee of Medical Journal Editors (ICMJE).
- Council of Science Editors (CSE).
- World Association of Medical Editors (WAME).
- Directory of Open Access Journals (DOAJ).
The journal also supports the ethical standards expected by major scholarly indexing services and research communities, including those associated with Scopus and Web of Science.
20. Policy Review and Amendment
This Expression of Concern Policy shall be reviewed periodically to ensure continued alignment with evolving publication ethics guidance and international scholarly publishing standards.
The policy shall normally be reviewed every three years, or earlier if necessary due to:
- Changes in publication ethics guidance.
- Updates to COPE recommendations.
- Regulatory or legal developments.
- Editorial workflow improvements.
- Advances in scholarly publishing standards.
Any amendments to this policy shall require approval by the Editor-in-Chief and, where appropriate, the Editorial Board.
21. Declaration
The Journal of Pharmacovigilance and Drug Research (JPADR) is committed to preserving the integrity, transparency, and reliability of the scholarly record.
When serious concerns arise regarding published research and available evidence remains incomplete or investigations are ongoing, the journal may issue an Expression of Concern in a fair, transparent, objective, and evidence-based manner.
JPADR is committed to ensuring that all editorial actions concerning Expressions of Concern are conducted in accordance with internationally recognized publication ethics principles, while safeguarding procedural fairness for authors and protecting the interests of readers and the scientific community.
References
- Committee on Publication Ethics (COPE). COPE Retraction Guidelines and Core Practices.
- International Committee of Medical Journal Editors (ICMJE). Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.
- Council of Science Editors (CSE). White Paper on Promoting Integrity in Scientific Journal Publications.
- World Association of Medical Editors (WAME). Recommendations on Publication Ethics Policies.
- Directory of Open Access Journals (DOAJ). Principles of Transparency and Best Practice in Scholarly Publishing.
