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Ethical Principles for Medical and Human Research
The Iranian Rehabilitation Journal (IRJ) is committed to protecting the rights, dignity, safety, privacy, and well-being of individuals participating in research. All research involving human participants, identifiable human material, or identifiable human data must be conducted in accordance with applicable institutional and national ethical requirements and internationally recognized principles of research ethics.
IRJ follows the ethical principles of the current version of the World Medical Association (WMA) Declaration of Helsinki and the applicable recommendations of the International Committee of Medical Journal Editors (ICMJE). The Journal also applies relevant guidance from the Committee on Publication Ethics (COPE) when concerns arise regarding the ethical conduct or reporting of research.
Authors are responsible for ensuring that their research has been conducted ethically and that all necessary approvals and permissions were obtained before the research began. Publication in IRJ does not replace or supersede the ethical responsibilities of investigators, institutions, research ethics committees, or research sponsors.
Research involving human participants, identifiable human biological material, or identifiable human data must receive approval from an appropriate institutional review board, research ethics committee, or equivalent independent ethics body before the study begins, whenever such approval is required.
Authors should state the name of the approving institution or ethics committee and provide the ethics approval number or code in the manuscript. This information should normally be reported in the Methods and/or Ethical Considerations section, as appropriate to the study design and the Journal’s article structure.
When a study is exempt from formal ethics review under applicable regulations, authors should clearly state the basis for the exemption and, where appropriate, identify the authority that determined the exemption. Authors should not independently declare a study exempt from ethical review when formal determination by an appropriate body is required.
IRJ may request documentation of ethics approval, exemption, or other relevant ethical authorization at any stage of the editorial process or after publication when legitimate questions regarding research ethics arise.
Research involving human participants must be conducted in accordance with the ethical principles of the current version of the World Medical Association Declaration of Helsinki and applicable national and institutional requirements.
Authors should ensure that the welfare, rights, dignity, and interests of research participants take precedence over the interests of science and society. Research involving human participants should have an appropriate scientific basis, a favorable balance of anticipated benefits and potential risks or burdens, and adequate measures for protecting participants.
IRJ refers authors, reviewers, and editors to the current official version of the Declaration of Helsinki published by the World Medical Association rather than reproducing an older version of the Declaration on the Journal website. Where the Declaration is revised, the Journal applies the current internationally recognized version as appropriate.
Informed Consent to Participate
Participation in research should be voluntary. Prospective participants must receive appropriate information about the purpose, methods, anticipated benefits, potential risks and burdens, relevant sources of funding, possible conflicts of interest, and other information necessary for an informed decision, as applicable to the research.
Informed consent should be obtained from participants before enrollment whenever required. The consent process should be appropriate to the participants and research context and should comply with the requirements of the approving ethics committee and applicable regulations.
Authors should report in the manuscript whether informed consent was obtained. When written informed consent was waived by an appropriate ethics committee, the manuscript should state that the requirement for consent was waived and provide the relevant ethical justification or approval information where appropriate.
A participant’s refusal to participate or decision to withdraw from a study should not result in inappropriate disadvantage or affect the individual’s entitlement to appropriate clinical care.
Participants Unable to Provide Informed Consent
Research involving individuals who are incapable of providing informed consent requires additional ethical safeguards. Such individuals should be included in research only when their inclusion is scientifically and ethically justified and when the research complies with applicable ethical and legal requirements.
Where required, informed consent should be obtained from a legally authorized representative. When a participant is capable of providing assent, the participant’s wishes should also be respected in accordance with applicable ethical standards.
Researchers should take particular care to ensure that individuals who cannot provide consent are not included merely because they are readily accessible or less able to refuse participation.
Vulnerable Individuals and Groups
Additional protections should be provided when research involves individuals or groups who may be particularly vulnerable to coercion, undue influence, exploitation, harm, or inequitable treatment.
Vulnerability may arise from medical condition, disability, impaired decision-making capacity, age, dependency, institutionalization, socioeconomic circumstances, or other contextual factors. The existence of vulnerability does not by itself justify excluding individuals from research, particularly when research is needed to address their health or rehabilitation needs.
Because IRJ publishes research involving disability and rehabilitation populations, authors should pay particular attention to accessibility of the consent process, communication needs, supported decision-making where appropriate, and the avoidance of assumptions that disability alone implies inability to provide informed consent.
The inclusion of vulnerable participants should be scientifically justified, ethically approved, and accompanied by safeguards appropriate to the nature and degree of vulnerability.
Medical and rehabilitation research involving human participants should be conducted only when the importance of the research objective is proportionate to the foreseeable risks and burdens to participants.
Before the study begins, researchers should assess reasonably foreseeable risks and burdens and compare them with anticipated benefits to participants and the potential value of the knowledge to be gained.
Researchers should implement appropriate measures to minimize risks and monitor participant safety throughout the study. When emerging information indicates that risks have become unacceptable or that the study can no longer be ethically justified, appropriate action should be taken, including modification or discontinuation of the research when necessary.
Researchers must protect the privacy of participants and the confidentiality of personal and research information. Collection, storage, analysis, sharing, and publication of identifiable information should comply with ethical approval, applicable laws and regulations, and appropriate data-protection requirements.
Manuscripts should not contain unnecessary identifying information. Names, initials, hospital identification numbers, exact personal details, recognizable photographs, or other information that may permit identification should not be published unless scientifically necessary and appropriate consent for publication has been obtained.
Authors should consider whether combinations of apparently non-identifying information could nevertheless permit identification of an individual, particularly in Case Reports, rare conditions, small populations, or highly specific rehabilitation settings.
Consent to participate in research and consent to publish identifiable information are distinct ethical requirements. When a manuscript contains identifiable information about an individual, appropriate consent for publication must be obtained when required.
This requirement is particularly important for Case Reports, clinical photographs, videos, pedigrees, detailed case histories, and other materials from which a patient or participant could reasonably be identified.
Authors are responsible for obtaining and retaining appropriate documentation of consent for publication. IRJ may request confirmation or documentation of such consent when necessary. The Journal will treat consent documentation confidentially.
Removing names or obscuring the eye region of a photograph does not necessarily guarantee anonymity. When there is a reasonable possibility that an individual could be identified, authors should obtain appropriate consent for publication.
Research Using Human Biological Materials or Identifiable Data
Research involving identifiable human biological materials, medical records, clinical databases, registries, or other identifiable human data must comply with applicable ethical, legal, and institutional requirements.
Where ethics approval and/or informed consent is required for the collection, use, secondary use, or sharing of such materials or data, authors should obtain the necessary authorization before conducting the research.
For secondary analyses of previously collected data or biological materials, authors should clearly describe the source of the data or materials and provide relevant information concerning ethical approval, consent, waiver of consent, or exemption where applicable.
IRJ follows the current ICMJE recommendations concerning clinical trial registration. Clinical trials should be registered in a publicly accessible and recognized clinical trial registry in accordance with applicable ICMJE requirements.
The trial registration number and registry should be reported in the manuscript. Prospective registration is expected where required by applicable standards. When registration occurred retrospectively, authors should disclose this and provide an appropriate explanation.
Clinical trial registration does not replace approval by a research ethics committee or the requirement for informed consent. Registration information should accurately reflect the study protocol, including prespecified primary and secondary outcomes where applicable.
Editors may compare the submitted or published report with the trial registry or protocol when evaluating consistency between planned and reported methods and outcomes.
Research Protocols and Changes to Approved Research
Research should be conducted in accordance with the protocol approved by the relevant research ethics committee. Substantial changes to an approved protocol should receive appropriate ethical review or approval before implementation when required.
Authors should transparently report important changes to study methods, outcomes, eligibility criteria, sample size, or analyses when such changes affect interpretation of the research.
For clinical trials and other prospectively registered studies, unexplained discrepancies between the registered protocol and the submitted manuscript may require clarification during editorial assessment.
Scientific Validity as an Ethical Requirement
Research involving human participants should be scientifically sound. Poorly designed research may expose participants to inconvenience, burden, or risk without a reasonable prospect of producing meaningful knowledge.
IRJ therefore considers methodological quality, appropriate study design, adequate description of sampling and sample-size determination, appropriate outcome measures, valid measurement instruments, suitable statistical analysis, and transparent reporting to be relevant not only to scientific quality but also to responsible research conduct.
Ethics committee approval does not by itself establish the scientific validity of a study. Manuscripts remain subject to independent scientific and methodological assessment through the Journal’s editorial and peer-review processes.
Authors should report research involving human participants accurately, completely, and transparently. Positive, negative, inconclusive, or unexpected results should be reported honestly and should not be selectively omitted or distorted.
As described in the IRJ Instructions for Authors, manuscripts should follow internationally recognized reporting guidelines appropriate to the study design when an established guideline is available. These include CONSORT, STROBE, PRISMA, PRISMA-ScR, STARD, CARE, COREQ or SRQR, TRIPOD, CHEERS, and other relevant standards.
The Journal may request applicable reporting checklists, flow diagrams, protocols, registration records, ethics documentation, or other information necessary to evaluate the completeness and integrity of the research report.
Authors are responsible for the accuracy and integrity of the data presented in their manuscripts. Fabrication, falsification, inappropriate data manipulation, selective alteration of results, and misleading presentation of research findings are inconsistent with the ethical standards of IRJ.
Research records should be maintained for an appropriate period in accordance with institutional, ethical, legal, and funder requirements. When substantial questions arise concerning the integrity or reliability of a study, IRJ may request relevant research records, statistical outputs, protocols, original images, or other supporting documentation.
Authors should cooperate with legitimate requests made as part of an editorial or research-integrity assessment.
IRJ supports responsible research transparency and data sharing while recognizing the ethical and legal obligations associated with health information and participant confidentiality.
Research data should not be made publicly available when doing so would violate informed consent, participant privacy, confidentiality agreements, applicable law, or requirements established by an ethics committee.
When data can be responsibly shared, authors are encouraged to describe the availability of supporting data in accordance with the Journal’s Instructions for Authors and Data Availability requirements where applicable.
Any de-identification or anonymization procedures should be appropriate to the nature of the dataset and the risk that individuals could be re-identified.
Research Involving Rehabilitation Populations
Because IRJ publishes research involving rehabilitation, disability, and special-needs populations, particular attention should be paid to ethical issues that may arise in these research settings.
Disability should not automatically be equated with impaired decision-making capacity. Researchers should assess capacity appropriately and provide accessible information and reasonable communication support where necessary to enable meaningful participation in the consent process.
Research interventions should not unnecessarily interfere with participants’ established rehabilitation or clinical care. Recruitment through therapeutic relationships should be managed carefully to minimize the possibility that patients feel obligated to participate because their clinician or rehabilitation provider is involved in the research.
Researchers should also consider accessibility, burden of participation, transportation, fatigue, communication difficulties, and other circumstances that may disproportionately affect people with disabilities when designing and conducting research.
Compensation and Undue Influence
Payments, reimbursements, services, or other incentives offered to research participants should not be of a nature or magnitude that could constitute inappropriate pressure or undue influence.
Reimbursement for reasonable expenses or compensation for time and inconvenience may be ethically acceptable when approved by the appropriate ethics committee.
Financial arrangements should be described transparently to the ethics committee and, where relevant, to participants. Participation in research should remain voluntary regardless of compensation.
Post-Trial and Post-Study Considerations
Where applicable to the nature of the research, investigators and sponsors should consider appropriate arrangements for participants after completion of a study, particularly when the research involves interventions that may provide important clinical benefit.
Such arrangements should be considered during study planning and reviewed by the appropriate ethics committee when required.
Authors should report relevant post-study arrangements when they are an important component of the ethical conduct or interpretation of the research.
Funding, Sponsorship, and Research Independence
Sources of financial and material support should be disclosed transparently. Authors should identify the funder or sponsor and describe its role in the research when relevant.
Researchers should retain appropriate scientific independence in study design, access to data, data analysis, interpretation of findings, manuscript preparation, and decisions concerning publication.
Agreements with commercial, institutional, governmental, or other sponsors should not prevent investigators from accessing relevant study data or from responsibly publishing scientifically valid findings.
Funding information should be reported in the Funding section of the manuscript in accordance with the IRJ Instructions for Authors.
Authors should disclose financial and non-financial relationships and activities that could influence, or reasonably be perceived to influence, the conduct, interpretation, or reporting of research.
Conflicts of interest do not necessarily make research unethical. Transparency allows editors, reviewers, readers, research participants, and other stakeholders to evaluate potentially relevant interests appropriately.
Authors should provide a Conflict of Interest statement in accordance with the Journal’s dedicated Conflict of Interest Policy and current ICMJE disclosure requirements where applicable.
Artificial Intelligence in Medical Research
The use of artificial intelligence in medical or rehabilitation research does not remove the ethical responsibilities of human investigators. Researchers remain responsible for the scientific validity, accuracy, privacy, confidentiality, transparency, and ethical acceptability of research involving AI-assisted technologies.
When AI systems are used for participant selection, diagnosis, prediction, intervention, data analysis, or other substantive research purposes, authors should describe their use sufficiently to allow scientific and ethical evaluation of the study.
Researchers must take appropriate precautions before entering identifiable or confidential participant information into external AI systems. Use of AI must comply with informed consent, ethics approval, applicable privacy requirements, and the IRJ Artificial Intelligence Policy.
Artificial intelligence systems cannot assume responsibility for research conduct and cannot replace the accountability of investigators, authors, ethics committees, reviewers, or editors.
Ethical Concerns Identified During Editorial Review
IRJ reserves the right to request clarification or supporting documentation when editors or reviewers identify concerns regarding ethics approval, informed consent, participant safety, privacy, trial registration, data integrity, or another aspect of research ethics.
The existence of an ethics approval does not prevent the Journal from investigating an ethical concern. If the Editor considers that a study may have been conducted in a manner inconsistent with accepted ethical standards, additional information may be requested from the authors or the approving institution.
A manuscript may be rejected on ethical grounds when significant concerns cannot be satisfactorily resolved.
Ethical Concerns Identified After Publication
IRJ’s responsibility for research integrity continues after publication. If credible concerns arise regarding the ethical conduct of a published study, the Journal may request information from the authors, institution, research ethics committee, sponsor, or another competent body.
When appropriate, the Journal will follow relevant COPE guidance and its Principles of Publishing Ethics in investigating the matter.
Depending on the findings, post-publication action may include a correction, Expression of Concern, retraction, or another appropriate update to the scholarly record.
Relationship With Other IRJ Policies
This policy should be read together with the IRJ Principles of Publishing Ethics, Instructions for Authors, Peer Review Policy, Conflict of Interest Policy, Artificial Intelligence Policy, CrossMark Policy, and other applicable Journal policies.
Where a specific IRJ policy provides additional requirements for a particular type of research or publication issue, authors should comply with those requirements in addition to the principles described on this page.
Authors are responsible for ensuring compliance with applicable institutional, national, and international requirements even when a particular requirement is not explicitly described in the Journal’s policies.
Reference Standards and Educational Resources
IRJ encourages authors, reviewers, editors, and research personnel to consult the original and current ethical standards relevant to medical and human research rather than relying solely on summaries or outdated versions reproduced elsewhere.
The principal international standards underlying this policy include the current World Medical Association Declaration of Helsinki, the current ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals, and relevant COPE guidance concerning ethical oversight and publication integrity.
Because these standards may be revised over time, IRJ applies their current authoritative versions as appropriate. Authors should consult the official websites of the relevant organizations when detailed or updated guidance is required.
Copyright © The Author(s);
This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 (CC-By-NC 4.0), which permits use, distribution, and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
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