Research Ethics

The International Journal of Medical Students (IJMS) requires research involving human participants, identifiable human material or data, or animals to meet applicable ethical, legal, institutional, and professional standards.

Authors are responsible for obtaining the appropriate review, approval, exemption, waiver, consent, and registration before conducting the research. Publication by the IJMS does not replace the responsibilities of investigators, institutions, sponsors, or ethics committees.

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Contents

  1. Ethical Principles
  2. Research Involving Human Participants
  3. Ethics Review, Approval, and Exemption
  4. Informed Consent for Research Participation
  5. Privacy and Confidentiality of Participants
  6. Case Reports and Consent for Publication
  7. Vulnerable Populations and Additional Protections
  8. Clinical-Trial and Research Registration
  9. Secondary Data, Records, and Publicly Available Information
  10. Biobanks, Registries, and Human Biological Material
  11. Animal Research
  12. Reporting Ethics Information
  13. Editorial Verification and Documentation
  14. Ethical Concerns Identified During Review
  15. Related Policies and Resources

Ethical Principles

Research submitted to the IJMS must respect the rights, dignity, safety, privacy, and welfare of participants and communities.

Ethical research requires:

  • a scientifically and socially valuable research question;
  • methods capable of answering the research question;
  • a favorable balance between anticipated benefits, risks, and burdens;
  • fair participant selection;
  • appropriate independent ethical review;
  • meaningful informed consent unless an authorized waiver applies;
  • protection of privacy and confidential information;
  • additional safeguards for participants at increased risk of harm or exploitation;
  • transparent registration and reporting when applicable; and
  • accurate reporting of favorable, unfavorable, negative, and inconclusive findings.

Research involving human participants should comply with the current Declaration of Helsinki and the requirements of the responsible institution, ethics committee, jurisdiction, and regulatory authority.

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Research Involving Human Participants

Research involving human participants includes research that:

  • recruits or interacts directly with individuals;
  • assigns participants to an intervention;
  • collects information through examinations, surveys, interviews, observations, or procedures;
  • uses identifiable or potentially identifiable health information;
  • uses medical records, administrative records, images, recordings, or biological specimens;
  • links multiple datasets in a manner that may permit identification; or
  • uses identifiable human material or data obtained through a registry, repository, database, or biobank.

Authors must not assume that a project is exempt from ethical review solely because it is retrospective, observational, educational, anonymous, minimal risk, conducted online, based on records, or described as quality improvement.

The appropriate ethics committee or institutional authority must determine whether review, approval, exemption, or a waiver is required.

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Ethics Review, Approval, and Exemption

Before research begins, investigators must obtain the review and determination required by the appropriate ethics committee, institutional review board, research ethics board, or equivalent independent authority.

Determination Reporting requirement
Approved Identify the reviewing body and provide the approval number when one was issued.
Exempt Identify the authority that made the exemption determination and provide the reference number when available.
Consent waived Identify the approving authority and explain the authorized waiver in the manuscript.
Review not required Identify the institutional or regulatory basis and the authority that made or confirmed the determination when available.

Authors must not make an exemption or waiver determination on behalf of an ethics committee unless the applicable institutional or legal framework expressly permits investigator self-determination.

Approval obtained after the research was conducted does not ordinarily correct the absence of required prospective ethical review.

When research was conducted at multiple institutions or in multiple countries, authors should identify the ethics review arrangements applicable to each participating site or explain the authorized reliance or centralized-review process.

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Participation in research must ordinarily be voluntary and based on an informed-consent process appropriate to the study, population, risks, and local requirements.

The manuscript should state:

  • whether consent was written, verbal, electronic, or otherwise documented;
  • who provided consent;
  • whether parental or guardian permission was obtained;
  • whether participant assent was obtained when applicable;
  • whether consent was waived and by which authority;
  • whether participants received compensation or reimbursement when relevant; and
  • whether circumstances existed that could affect voluntariness.

Consent for participation in research is distinct from consent to publish identifiable information. Obtaining one does not automatically establish the other.

When consent could not be obtained or was waived, the manuscript must identify the authorized basis for proceeding without consent.

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Privacy and Confidentiality of Participants

Authors must protect participant privacy and limit the collection, use, and publication of identifiable information to what is ethically and scientifically justified.

Manuscripts, figures, tables, supplementary files, screenshots, photographs, imaging studies, pedigrees, and source documents must not contain unnecessary direct or indirect identifiers.

Identifiers may include:

  • names or initials;
  • medical-record, identification, or account numbers;
  • complete dates of birth;
  • addresses or precise locations;
  • facial features or distinctive physical characteristics;
  • institution-specific identifiers;
  • rare combinations of demographic or clinical information; and
  • dates, circumstances, or narratives that permit recognition.

Removing names alone may not be sufficient when the remaining information could identify an individual. Altering factual details solely to prevent identification is not acceptable when the alteration could distort the scientific record.

The Journal’s handling of personal information submitted through its website and editorial system is addressed separately in the Privacy and Data Protection policy.

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Case Reports and Consent for Publication

Authors of Case Reports must obtain consent for publication from the patient or an authorized legal representative when the individual may be identifiable from the text, images, clinical circumstances, or their combination.

Consent for publication should cover:

  • the clinical information included in the manuscript;
  • photographs, imaging, recordings, pedigrees, or other visual material;
  • the possibility that the article will be freely accessible online;
  • the possibility that complete anonymity cannot be guaranteed; and
  • any supplementary material intended for publication.

The manuscript should state that consent for publication was obtained. Authors should retain the original consent documentation securely and provide confirmation or documentation if requested by the Journal.

When the patient lacks decision-making capacity, is deceased, or is a minor, authors must follow the applicable legal and ethical requirements for authorization.

Masking part of a face or removing direct identifiers does not eliminate the need for consent when the individual may still be recognized.

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Vulnerable Populations and Additional Protections

Research involving individuals or communities at increased risk of coercion, exploitation, discrimination, stigma, reidentification, or other harm requires safeguards proportionate to those risks.

Additional protections may be necessary for:

  • children and adolescents;
  • individuals with impaired decision-making capacity;
  • people in dependent or hierarchical relationships;
  • patients receiving emergency or intensive care;
  • people who are incarcerated or otherwise deprived of liberty;
  • refugees, displaced populations, or people affected by conflict;
  • economically or educationally disadvantaged populations;
  • Indigenous peoples and culturally distinct communities;
  • people with stigmatized conditions or identities; and
  • small communities in which individuals may be readily recognized.

Authors should explain relevant protections, community engagement, culturally appropriate consent procedures, translation or interpretation, and the management of risks associated with identification or group-level harm.

Community permission or institutional authorization does not replace the individual consent of participants when individual consent is required.

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Clinical-Trial and Research Registration

A clinical trial must be registered in a publicly accessible registry at or before the time of first participant consent or enrollment.

For this policy, a clinical trial is research that prospectively assigns individuals or groups to a health-related intervention to evaluate its effect on a health outcome.

Health-related interventions may include:

  • medications or biological products;
  • surgical or procedural interventions;
  • medical devices;
  • behavioral or educational interventions;
  • dietary interventions;
  • quality-improvement interventions;
  • process-of-care changes; and
  • other interventions intended to modify a health-related outcome.

The manuscript should provide the registry name, registration number, registration date, and accessible registry record. The registered outcomes and analysis plan should remain consistent with the submitted report, and material discrepancies must be explained.

Ethics approval does not replace prospective trial registration.

Retrospective registration may be considered only in exceptional circumstances. Authors must explain why prospective registration did not occur. Delayed registration may affect whether the manuscript is eligible for consideration.

Prospective registration of systematic-review protocols, observational studies, analysis plans, and other research is encouraged when an appropriate registry is available.

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Secondary Data, Records, and Publicly Available Information

Research using previously collected data, records, online information, or publicly accessible datasets must comply with the conditions under which the information was collected and made available.

Authors should report:

  • the source of the data;
  • whether the data were identifiable, coded, deidentified, or anonymous;
  • the authorization or legal basis for access;
  • the applicable ethics determination;
  • whether participant consent covered the secondary use;
  • the measures used to protect confidentiality;
  • any restrictions imposed by the data provider; and
  • whether linkage or analysis created a meaningful risk of reidentification.

Information being publicly accessible does not automatically make every form of collection, analysis, quotation, linkage, or publication ethically acceptable.

Authors must consider the expectations of the individuals or communities represented, the sensitivity of the information, the possibility of reidentification, and the potential for individual or group harm.

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Biobanks, Registries, and Human Biological Material

Research using human biological specimens, health registries, biobanks, repositories, or linked health databases must have appropriate ethical and institutional authorization.

The manuscript should describe, as applicable:

  • how the specimens or data were originally obtained;
  • the consent provided for storage and future use;
  • the governance of the repository or registry;
  • the authorization for the reported secondary use;
  • whether materials or data were identifiable, coded, or deidentified;
  • the procedures for protecting privacy and confidentiality;
  • the process governing access and transfer;
  • community or participant restrictions on use;
  • whether results may have implications for relatives or identifiable groups; and
  • the ethics review applicable to the reported analysis.

Authors must not use biological material or data beyond the scope permitted by the applicable consent, governance framework, ethics determination, law, or agreement.

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Animal Research

Research involving animals must receive the review and approval required by the responsible institutional or national authority and must comply with applicable animal-welfare standards.

The manuscript should identify:

  • the approving body;
  • the approval or protocol number when one was issued;
  • the species and relevant animal characteristics;
  • housing and husbandry when relevant;
  • anesthesia, analgesia, monitoring, and humane endpoints;
  • procedures used to minimize pain, distress, and unnecessary use;
  • the method of euthanasia when applicable; and
  • the reporting guideline followed.

Authors should apply the principles of replacement, reduction, and refinement and justify the selected model and number of animals.

Approval by an animal-care body does not prevent the Journal from declining research when the reported treatment of animals appears ethically unacceptable or inadequately justified.

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Reporting Ethics Information

Applicable ethics information should appear in the Methods section or another clearly identified location appropriate to the article type.

Topic Information to report
Ethics review Name of the reviewing body and approval, exemption, or waiver number when available.
Informed consent How consent was obtained or the authority that approved a waiver.
Consent for publication A statement confirming consent when identifiable information is published.
Clinical-trial registration Registry name, registration number, registration date, and accessible record.
Animal research Approving body, protocol number when available, and applicable welfare standards.
Secondary data or specimens Data or specimen source, authorization, consent basis, and ethics determination.
Privacy protections Relevant procedures used to protect confidentiality and reduce reidentification risk.

Statements such as “ethical standards were followed” are not sufficient when more specific information is applicable and available.

Do not include confidential participant information in ethics documentation uploaded to the submission system unless specifically requested and transmitted through an appropriate confidential process.

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Editorial Verification and Documentation

The Journal may request information or documentation necessary to verify ethical compliance, including:

  • an ethics approval, exemption, or waiver letter;
  • the approved protocol or relevant protocol sections;
  • the participant information and consent materials;
  • confirmation of consent for publication;
  • clinical-trial or protocol-registration records;
  • data-use or material-transfer authorization;
  • institutional confirmation;
  • animal-care approval;
  • permission to use protected materials; or
  • clarification from the responsible ethics committee.

Documents should be submitted through the manuscript record or another secure method identified by the Journal. Authors should remove unnecessary personal information before submission.

Providing documentation does not guarantee that the Journal will consider the research ethically acceptable. Editors retain responsibility for determining whether the work is suitable for publication.

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Ethical Concerns Identified During Review

Editorial processing may be paused when questions arise regarding ethics approval, consent, registration, participant protection, privacy, use of specimens or data, animal welfare, or another ethical matter.

The Journal may:

  • request an explanation from the authors;
  • request supporting documentation;
  • seek advice from the IJMS Ethics Committee or another qualified adviser;
  • contact the responsible ethics committee or institution when appropriate;
  • request revision or removal of identifiable material;
  • decline the manuscript;
  • withdraw acceptance before publication; or
  • refer a possible integrity concern for evaluation under the Research Integrity policy.

The IJMS Ethics Committee advises editors on ethics questions arising during editorial work. It does not approve research protocols and does not replace the ethics committee responsible for reviewing the study.

Learn About the IJMS Ethics Committee
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Editorial Policies

Editorial independence, decision-making, confidentiality, peer review, and conflicts involving editors or reviewers.

Authorship and Disclosures

Authorship criteria, CRediT contributions, acknowledgments, funding, and competing interests.

Research Integrity

Originality, data and image integrity, plagiarism, duplicate publication, and investigation of possible misconduct.

Corrections, Retractions, and Appeals

Correction of published articles, expressions of concern, retractions, appeals, and complaints.

Privacy and Data Protection

How the Journal collects, uses, protects, retains, and discloses personal information.

Manuscript Preparation

Where and how authors should report ethics, consent, registration, and participant-protection information.
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