Informed consent is a fundamental ethical requirement for research involving human participants, human data, or human biological material. Consent must be obtained in accordance with internationally recognized ethical principles and applicable national and institutional regulations, and documented appropriately.
Authors are responsible for ensuring that informed consent procedures are reviewed and approved by an appropriate ethics committee or institutional review board as part of the ethical approval process, where required.
Informed consent requirements apply not only to direct participation in research, but also to the use of identifiable human data or biological materials, including secondary use where applicable.
Information regarding informed consent and ethical approval must be clearly reported in the manuscript and may be subject to editorial assessment during the review process.
Informed Consent
Authors must ensure that informed consent has been obtained from all human participants prior to their inclusion in the research, unless a justified and ethically approved waiver applies.
Informed consent must be:
- freely given and voluntary;
- based on adequate and comprehensible information about the purpose, procedures, potential risks, and anticipated benefits of the research;
- obtained without coercion, undue influence, or pressure.
Where applicable, participants must be informed of their right to withdraw from the study at any time without penalty or loss of benefits to which they are otherwise entitled.
Informed consent is normally obtained in written form. Alternative forms of consent (such as verbal or electronic consent) may be acceptable only where approved by an appropriate ethics committee and must be clearly justified and documented.
When participants lack the legal capacity to provide informed consent, consent must be obtained from a legally authorized representative, and assent from the participant should be obtained where appropriate.
Authors must ensure that informed consent procedures, including the form of consent and any waivers, have been reviewed and approved by an appropriate ethics committee or institutional review board.
Information regarding informed consent must be clearly reported in the manuscript, including the form of consent obtained and any approved exceptions.
Form of Consent
Informed consent is normally obtained in written form. Where written consent is not feasible, alternative forms of consent—such as verbal, electronic, or implied consent—may be acceptable only if explicitly approved by an appropriate ethics committee and clearly justified.
The consent form used must be appropriate to the study design and participant population, consistent with applicable ethical standards and regulations, and approved as part of the ethical review process.
Consent information must be provided in a language and manner understandable to participants, enabling them to make an informed and voluntary decision about participation.
Authors must ensure that appropriate records of informed consent are maintained and can be verified if requested during editorial assessment or peer review.
Where research involves the publication of identifiable personal data, images, audio, or video materials, explicit consent for publication must be obtained in addition to consent for participation, and this must be clearly stated in the manuscript.
The form of consent used, including any approved alternative or waiver, must be clearly described in the manuscript.
Waivers of Consent
In certain limited circumstances, informed consent may be waived or modified, provided that such a waiver is ethically justified and explicitly approved by an appropriate ethics committee or institutional review board.
Examples of situations where a waiver of informed consent may be considered include:
- retrospective studies involving existing data or materials;
- research using anonymized or publicly available data, where individuals cannot be reasonably identified;
- minimal-risk research where obtaining informed consent is impracticable and where the research could not be carried out otherwise.
Waivers of informed consent are permitted only when the rights, safety, and welfare of participants are not adversely affected and when appropriate measures are in place to protect privacy and confidentiality.
Waivers of consent are not applicable to interventional research involving direct interaction with participants, except in exceptional circumstances explicitly approved by an ethics committee.
Any waiver or modification of informed consent must be clearly documented, explicitly stated in the ethical approval, and fully justified in the manuscript. Authors are responsible for providing a transparent explanation of the rationale for the waiver and for demonstrating compliance with applicable ethical standards.
Vulnerable Populations
Special care must be taken when research involves vulnerable populations, including but not limited to minors, individuals with impaired decision-making capacity, or socially or economically disadvantaged groups. Vulnerability may arise from personal characteristics, health status, legal status, or situational factors that limit an individual’s ability to provide informed consent freely.
In such cases, authors must ensure that:
- additional safeguards are implemented to protect the rights, dignity, safety, and well-being of participants;
- the level of risk is minimized and is strictly justified in relation to the potential benefits of the research;
- vulnerable individuals are not exploited or unduly influenced to participate in research;
- informed consent is obtained from legally authorized representatives where required, and assent is obtained from participants when appropriate;
- enhanced measures are in place to protect privacy, confidentiality, and sensitive information.
Research involving vulnerable populations must receive specific ethical review and approval, and the inclusion of such populations must be clearly justified in the study design and ethical approval documentation.
Authors are responsible for clearly describing in the manuscript the safeguards implemented and the consent and assent procedures applied when involving vulnerable populations.
Use of Identifiable Data and Images
Explicit informed consent is required for the publication of identifiable personal data, images, audio, video, or other materials that could reasonably lead to the identification of a research participant. Identifiability may arise not only from direct identifiers (such as names or facial features), but also from indirect identifiers or combinations of information that could allow identification.
Authors must ensure that identifying information is removed or fully anonymized unless explicit consent for publication has been obtained and documented. Pseudonymization alone may not be sufficient to prevent identification and does not replace the requirement for informed consent for publication.
Consent for publication of identifiable materials must be separate from and in addition to consent for participation in the research, and must explicitly cover the intended use and dissemination of the materials.
Authors should be aware that masking, blurring, or editing images does not necessarily eliminate the risk of identification. When there is any reasonable possibility that a participant could be identified, explicit consent for publication is required.
Authors are responsible for assessing the potential risk of identification and for ensuring compliance with applicable ethical standards and data protection requirements. Documentation of consent for publication must be retained and made available upon request during editorial assessment or peer review.
Relationship with Ethical Approval
Informed consent procedures must be reviewed and approved by an appropriate ethics committee, institutional review board, or equivalent body as part of the ethical approval process. Where applicable, informed consent must be obtained prior to the participation of individuals in the research.
Authors are responsible for ensuring that informed consent procedures are consistent with the approved ethical protocol and applicable regulations.
Authors must clearly state in the manuscript:
- that informed consent was obtained prior to participation, or that an ethically approved waiver or modification applies;
- the form of consent used (e.g., written, verbal, electronic), as approved by the ethics committee;
- any approved waivers, modifications, or exceptions to standard informed consent procedures;
- the name of the approving ethics committee or review board and the relevant approval or reference number, where applicable.
Information related to informed consent and ethical approval may be subject to editorial assessment to verify consistency and compliance with ethical standards. Authors must be prepared to provide supporting documentation upon request.
Editorial Assessment
Manuscripts may be subject to editorial review at any stage of the editorial process to assess compliance with informed consent and ethical approval requirements.
Editors may request additional information, supporting documentation, or clarification where informed consent procedures or ethical approval details are unclear, incomplete, or insufficiently reported. Such requests are intended to ensure transparency and compliance before further editorial consideration.
Where necessary, editors may consult reviewers, members of the editorial board, ethics committees, or external experts when evaluating informed consent and ethical approval issues.
Failure to adequately address informed consent requirements or to demonstrate ethical approval may result in editorial actions, including requests for revision, rejection of the manuscript, or other measures, in accordance with the journal’s Research Ethics Policy and Publication Ethics & Malpractice Statement.