Ethics Committee Approval Process

Last Updated: January 4, 2025

The Advanced Journal of Biomedicine & Medicine (AJBM) is committed to ensuring that all published research adheres to the highest ethical standards in line with COPE, ICMJE, WAME, and WHO guidelines.

SECTION 1: GENERAL PRINCIPLES

1.1 Purpose and Scope

This policy applies to:

  • All research involving human participants (including clinical trials, observational studies, surveys, and qualitative research).

  • Animal research studies.

  • Secondary data analyses involving identifiable or sensitive information.

  • Clinical trials and post-marketing studies.

1.2 Core Principles

AJBM requires that all studies demonstrate:

  • Protection of participants’ rights, dignity, and welfare.

  • Compliance with relevant national, institutional, and international ethical standards (e.g., Declaration of Helsinki, ARRIVE, CIOMS).

  • Scientific validity and methodological rigor.

  • Transparency, integrity, and accountability in all aspects of research conduct and reporting.

SECTION 2: SUBMISSION REQUIREMENTS

2.1 Required Documentation

Authors must provide the following at submission:

  • Ethics committee or Institutional Review Board (IRB/IACUC) approval letter.

  • Protocol number and approval date.

  • Details of study registration (if applicable).

  • Copies of any approved protocol amendments.

  • Evidence of continuing or renewed ethical approval (for long-term studies).

2.2 Study Registration

Mandatory registration applies to:

  • Clinical trials: must be registered in an ICMJE/WHO-approved registry (e.g., ClinicalTrials.gov, WHO ICTRP, EUCTR).

  • Systematic reviews/meta-analyses: PROSPERO registration strongly encouraged.

  • Observational studies: registration required where mandated by funders or ethics committees.

SECTION 3: REVIEW PROCESS

3.1 Initial Screening

The Editorial Office will:

  • Verify submission of required ethics approvals.

  • Confirm trial/study registration details.

  • Ensure completeness and consistency of documentation.

3.2 Verification of Approvals

  • Approval letters must be valid, dated, and match the study protocol.

  • Compliance with local/national laws and international standards will be checked.

3.3 Additional Review

Additional ethical scrutiny will be applied to studies involving:

  • Vulnerable populations (children, prisoners, persons with impaired decision-making capacity).

  • High-risk procedures.

  • International/multi-site research requiring multiple ethics approvals.

  • Studies with ethical controversies or heightened sensitivity.

SECTION 4: POST-APPROVAL REQUIREMENTS

4.1 Protocol Amendments and Updates

Authors must:

  • Submit any protocol amendments for editorial review.

  • Provide updated ethics approvals when relevant.

  • Notify the Editorial Office of major changes in study design or conduct.

4.2 Adverse Event Reporting

  • Serious Adverse Events (SAEs) must be reported promptly to both the ethics committee and the journal if they impact participant safety or study integrity.

  • Authors must provide safety monitoring reports and corrective actions, where applicable.

SECTION 5: PUBLICATION REQUIREMENTS

5.1 Ethical Statements in Manuscripts

All manuscripts must include:

  • Name of the approving ethics committee or IRB.

  • Protocol number and approval date.

  • Study registration details (if applicable).

  • A statement of compliance with recognized ethical guidelines (e.g., Declaration of Helsinki for human studies, ARRIVE guidelines for animal research).

5.2 Transparency

Authors must:

  • Disclose any ethical challenges or exceptions.

  • Provide justification where informed consent or registration was not possible.

  • Respond to reviewer or editorial queries on ethics transparently.

SECTION 6: NON-COMPLIANCE

6.1 Identification of Issues

The Editorial Office will flag manuscripts with:

  • Missing or invalid ethics approvals.

  • Inconsistencies between protocol and approvals.

  • Lack of registration where required.

6.2 Resolution Process

Steps may include:

  • Requesting clarification or additional documentation from authors.

  • Consulting external ethics experts.

  • Rejecting submissions or issuing post-publication corrections, expressions of concern, or retractions, following COPE flowcharts.