10. Ethical Approval of Research

Purpose

The Pakistan Journal of Gastroenterology (PJG) is committed to publishing research conducted in accordance with the highest ethical standards. All studies involving human participants, human biological materials, identifiable personal data, or animals must comply with internationally accepted ethical principles and applicable national regulations.

The Journal follows the ethical principles outlined by the Declaration of Helsinki, the International Committee of Medical Journal Editors (ICMJE), the Committee on Publication Ethics (COPE), the Council for International Organizations of Medical Sciences (CIOMS), and relevant national regulatory authorities.

10.1 Human Research Ethics Approval

Research involving human participants, human tissues, biological specimens, or identifiable personal information must receive prior approval from a recognized Institutional Review Board (IRB), Research Ethics Committee (REC), or an equivalent ethics committee before the study begins.

Authors must state in the manuscript:

  • Name of the approving Ethics Committee or IRB.
  • Approval number/reference number.
  • Date of approval (where applicable).

10.2 Ethical Compliance Statement

Every manuscript reporting human research must include an Ethics Statement confirming that:

  • Ethical approval was obtained before commencement of the study.
  • The research complied with the Declaration of Helsinki and applicable institutional or national ethical guidelines.
  • Participants' rights, safety, dignity, and confidentiality were protected throughout the study.

10.3 Informed Consent

For research involving human participants, authors must confirm that informed consent was obtained from all participants before enrollment.

Where participants are minors or unable to provide informed consent, consent must be obtained from a parent, legal guardian, or other legally authorized representative in accordance with applicable laws and institutional policies.

Where required, authors should also confirm that consent was obtained for the publication of identifiable information or clinical images.

10.4 Studies Exempt from Ethical Approval

Certain types of research may not require formal ethical approval under applicable institutional or national regulations, including:

  • Systematic reviews and meta-analyses.
  • Narrative reviews.
  • Editorials.
  • Letters to the Editor.
  • Publicly available anonymized datasets.
  • Bioinformatics or computational studies using publicly accessible databases, where no new human participants are recruited and no identifiable personal information is used.

Where ethical approval is not required, authors should clearly explain the reason within the manuscript.

10.5 Retrospective Studies

For retrospective studies, authors must state whether ethical approval or an ethics committee waiver was obtained in accordance with institutional requirements.

Where informed consent was waived by the Ethics Committee, this should also be clearly stated.

10.6 Clinical Trials

Clinical trials must:

  • Obtain prior ethical approval.
  • Be prospectively registered in a recognized public clinical trial registry.
  • Include the trial registration number in the manuscript.

Authors should also comply with the Journal's Clinical Trial Registration Policy.

10.7 Documentation

The Editorial Office may request:

  • Ethics approval letter.
  • IRB approval certificate.
  • Participant consent documentation (where applicable).
  • Additional ethical documentation during editorial assessment.

Failure to provide requested documentation may delay review or result in rejection.

10.8 Editorial Assessment

Editors may request clarification whenever:

  • Ethical approval information is incomplete.
  • Ethical approval appears inconsistent with the study design.
  • Research raises ethical concerns.
  • Ethical documentation cannot be verified.

Where serious ethical concerns exist, the Journal may contact the authors' institution or Ethics Committee for clarification.

10.9 Non-Compliance

Failure to comply with ethical requirements may result in:

  • Requests for clarification or additional documentation.
  • Suspension of editorial processing.
  • Manuscript rejection.
  • Retraction of published articles.
  • Notification of the relevant institution(s).
  • Other editorial actions consistent with COPE guidance.

10.10 Author Responsibility

The Corresponding Author is responsible for ensuring that:

  • Appropriate ethical approval was obtained before commencing the research.
  • The manuscript accurately reports ethical approval details.
  • All applicable informed consent requirements have been met.
  • Supporting ethical documentation can be provided upon request.

References

This policy has been developed in accordance with:

  • Declaration of Helsinki (World Medical Association).
  • International Committee of Medical Journal Editors (ICMJE) Recommendations.
  • Committee on Publication Ethics (COPE) Core Practices.
  • Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines.
  • Applicable national laws and institutional ethical regulations.