Informed Consent
Free and informed consent is a fundamental requirement for respecting the autonomy, dignity, rights, and welfare of research participants.
Participation in research must be voluntary. Individuals capable of providing informed consent must not be enrolled unless they have freely agreed to participate after receiving and understanding sufficient information about the research.
The journal requires informed-consent procedures to comply with the World Medical Association Declaration of Helsinki (2024), applicable ethical and legal requirements, the approved research protocol, and the requirements of the responsible ethics committee. The Declaration of Helsinki identifies free and informed consent as an essential component of respect for individual autonomy.
Information Provided to Participants
Before consent is obtained, potential participants must receive information in plain, understandable, and appropriate language.
As applicable to the study, information should include:
- the purpose and aims of the research;
- the nature and methods of the study;
- the procedures the participant will undergo;
- which procedures are experimental or research-related rather than routine clinical care;
- the expected duration of participation;
- reasonably foreseeable risks, discomforts, and burdens;
- anticipated benefits, including when no direct personal benefit is expected;
- appropriate alternatives where relevant;
- provisions for protecting privacy and confidentiality;
- collection, use, storage, and sharing of personal information or biological materials;
- sources of research funding and relevant conflicts of interest;
- incentives, reimbursement, or compensation, where applicable;
- arrangements for treatment or compensation for research-related harm where applicable;
- whom participants may contact for information about the study or their rights;
- the voluntary nature of participation;
- the right to refuse or withdraw without inappropriate penalty or reprisal;
- any other information material to an informed decision.
The 2024 Declaration of Helsinki specifically requires potential participants to be informed in plain language about the aims, methods, anticipated benefits, risks and burdens, researcher qualifications, funding, conflicts of interest, privacy protections, incentives, and provisions relating to research-related harm.
Understanding and Opportunity to Ask Questions
Obtaining a signature alone does not establish ethically valid informed consent.
Researchers must make reasonable efforts to ensure that the participant has understood the relevant information before consent is obtained.
Participants should have sufficient opportunity to:
- ask questions;
- request clarification;
- consider participation without inappropriate pressure;
- discuss participation with family members or trusted persons where desired and appropriate.
The amount, format, and method of communication should take account of the participant’s language, literacy, health condition, cognitive ability, communication needs, and other relevant circumstances.
Voluntariness
Consent must be given freely.
Researchers must avoid:
- coercion;
- threats or intimidation;
- deception about material aspects of the study;
- excessive or inappropriate inducement;
- exploitation of dependency;
- creating the impression that medical care or other legitimate benefits depend on participation.
The decision not to participate must not adversely affect a person’s appropriate clinical care or legitimate relationship with healthcare professionals.
The Helsinki Declaration requires particular caution when a potential participant is in a dependent relationship with the researcher or may consent under duress. In such circumstances, consent should be sought by an appropriately qualified person independent of that relationship.
Documentation of Consent
Informed consent should be appropriately documented in accordance with the approved protocol, ethics committee requirements, and applicable law.
Under the 2024 Declaration of Helsinki, freely given informed consent should normally be formally documented on paper or electronically. Where consent cannot be expressed in either form, non-written consent should be formally witnessed and documented.
The journal does not require authors to submit participants’ signed consent forms routinely with a manuscript unless specifically requested. Authors are responsible for retaining appropriate documentation in accordance with applicable institutional, ethical, and legal requirements.
Documents containing personally identifiable information must be handled securely.
Right to Refuse or Withdraw
Participants must be informed that they may refuse participation or withdraw consent in accordance with applicable ethical requirements without reprisal.
A decision not to participate, or to discontinue participation, must not inappropriately affect the participant’s access to standard medical care or the patient–healthcare professional relationship.
When a participant withdraws, the handling of information or biological materials already collected should follow the consent terms, approved protocol, applicable law, and ethics committee requirements.
Researchers should explain relevant limits on withdrawal where, for example, data have already been irreversibly anonymized or incorporated into completed analyses.
Ongoing Consent
Consent should be regarded as an ongoing ethical process, particularly in longitudinal research or studies in which material circumstances change over time.
Participants should receive relevant new information that could reasonably affect their willingness to continue participation.
Re-consent may be necessary when there are significant protocol changes, new material risks, major changes in the participant’s circumstances, or changes in decision-making capacity, as required by the responsible ethics committee or applicable regulations.
Participants Unable to Provide Independent Consent
When a potential participant lacks the capacity to provide free and informed consent, additional safeguards are required.
Consent must be obtained from a legally authorized representative where required, while taking account of the participant’s own expressed preferences and values.
Where the participant can provide assent, that assent should also be sought, and dissent should be respected in accordance with applicable ethical requirements. The 2024 Declaration of Helsinki sets out these additional protections and limits inclusion of persons unable to consent to circumstances involving potential personal benefit or minimal risk and minimal burden, together with appropriate safeguards.
For pediatric participants, detailed requirements are provided in Parental Permission and Child Assent.
Emergency Research
Research involving persons temporarily incapable of providing consent, including certain emergency situations, requires particular safeguards.
Such research may proceed without prior consent only where:
- the participant’s condition preventing consent is a necessary characteristic of the research population;
- the research cannot reasonably be delayed;
- the conditions for inclusion without prior consent are specified in the approved protocol;
- the responsible ethics committee has approved the arrangement;
- all other applicable ethical and legal requirements are satisfied.
Consent for continued participation must be obtained as soon as reasonably possible from the legally authorized representative or from the participant if decision-making capacity is regained.
Biological Materials and Identifiable Data
Consent requirements also apply, where relevant, to the collection, processing, storage, and foreseeable secondary use of human biological materials and identifiable or re-identifiable data.
The 2024 Declaration of Helsinki requires free and informed consent for these activities. Where consent for secondary research on stored data or biological materials is impossible or impracticable to obtain, such research should proceed only after appropriate ethics committee consideration and approval.
Detailed requirements are provided in Human Biological Materials and Genetic Data and Secondary Data and Retrospective Research.
Research Consent and Consent for Publication
Consent to participate in research must be distinguished from consent for publication.
Research consent does not automatically authorize publication of identifiable photographs, case descriptions, pedigrees, genetic information, videos, or other material from which an individual may be identified.
ICMJE states that identifiable patient information should not be published without written informed consent for publication from the patient or, where applicable, the parent or guardian.
Detailed requirements are provided in Consent for Publication.
Reporting in the Manuscript
For research requiring informed consent, authors should include an appropriate statement in the manuscript indicating, as applicable:
- that informed consent was obtained;
- from whom consent was obtained;
- whether consent was written, electronic, or otherwise appropriately documented;
- whether parental or legally authorized representative permission was required;
- whether child assent was obtained;
- whether an ethics committee approved a waiver or modification of consent.
Authors must not state that informed consent was obtained unless this accurately reflects the procedures followed.
Where consent was legitimately waived, authors should identify the responsible ethics committee or competent body and clearly state the waiver where appropriate.
Journal Verification
The journal may request information or documentation concerning the consent process when necessary to assess ethical compliance.
This may include participant-information materials, blank consent forms, assent documents, waiver decisions, protocol provisions, or confirmation from the responsible ethics committee.
The journal generally does not require identifiable signed consent forms unless there is a specific reason to verify them, and any such information must be handled with appropriate confidentiality and data protection.
Failure to obtain required informed consent, fabrication or alteration of consent documentation, or material misrepresentation of the consent process may result in rejection or action under the journal’s Research Misconduct, Editorial Actions, and Corrections and Retractions policies.