Purpose and Scope
This policy applies to research involving human participants, identifiable human data or biological material, clinical information, interventions, surveys, interviews, observations, records, images, and other activities for which human-research ethical obligations may arise.
Treata journals expect authors to comply with applicable law, institutional requirements, ethical standards, and relevant journal instructions. Publication review does not replace the responsibilities of researchers, institutions, ethics committees, sponsors, or regulators.
Ethical Review and Approval
Research requiring prospective review by an institutional review board, research ethics committee, or equivalent body should receive appropriate approval before the research is conducted. Manuscripts should identify the approving body and relevant approval information where required.
If authors state that formal review was not required or was waived, they should be prepared to explain the basis for that determination. Editors may request supporting documentation when the ethical status of the work is unclear.
Participant Welfare and Scientific Justification
Research involving humans should be scientifically and ethically justified, with risks and burdens considered in relation to anticipated benefits and the value of the knowledge sought. Vulnerability, dependency, unequal power relationships, and barriers to voluntary participation require particular care.
Editorial assessment may consider whether the reported methods and ethical safeguards are compatible with responsible human research even when formal approval is documented.
Informed Consent for Research Participation
When informed consent is required, it should be obtained through a process appropriate to the research context and participant population. Information should be understandable and participation should be voluntary, subject to lawful and ethically justified exceptions.
Waivers or alterations of consent should be authorized by the appropriate ethics body where required and should be reported sufficiently for editorial assessment.
Consent for Publication
Consent to participate in research is not necessarily the same as consent to publish identifiable information. When an individual could reasonably be identified from text, photographs, pedigrees, case details, multimedia, or combinations of information, appropriate publication consent should be obtained unless a justified and lawful alternative applies.
Removing a name may not be sufficient to prevent identification. Authors and editors should consider the totality of information presented.
Privacy, Confidentiality and Identifiability
Manuscripts should avoid unnecessary disclosure of personal information. Direct identifiers and indirectly identifying details should be minimized where they are not scientifically necessary, while avoiding data alteration that would make the research record misleading.
Data-sharing and transparency expectations do not override privacy, consent, ethical, or legal restrictions. Restrictions on access should be explained transparently where relevant.
Prospective Registration and Clinical Research
Clinical trials and other studies subject to prospective registration requirements should be registered in an appropriate public registry within the timeframe required by the journal, applicable standards, law, or regulation. Registration information should be reported accurately in the manuscript.
Journal-specific clinical-trial requirements are governed by the Treata Clinical Trials policy and the journal’s author instructions.
Secondary Data, Biobanks and Previously Collected Material
Research using existing records, registries, biobanks, repositories, administrative datasets, or previously collected samples may still require ethical review, consent, authorization, governance approval, or safeguards appropriate to the source and intended use.
Authors should not assume that prior collection or de-identification automatically removes all ethical obligations.
Vulnerable Populations and Sensitive Contexts
Research involving children, people with impaired decision-making capacity, displaced populations, prisoners, dependent relationships, stigmatized conditions, emergencies, or other sensitive contexts may require additional protections and careful explanation of consent and oversight.
Editors may seek specialist ethical advice when the balance of scientific value, participant protection, and reporting is uncertain.
Ethics Statements and Supporting Documentation
Manuscripts should include the ethics information required by the journal, which may include committee name, approval identifier, consent process, registration, data-protection measures, and relevant waivers. Statements should be specific enough to permit meaningful understanding rather than relying only on generic assertions of compliance.
Editors may request approval letters, consent forms, protocols, registry records, or other documentation when necessary, while handling sensitive records with appropriate confidentiality.
Concerns and Non-Compliance
If credible concerns arise about approval, consent, participant welfare, privacy, registration, or the accuracy of ethics statements, editors may pause processing, request clarification, obtain expert advice, or contact the relevant institution or ethics body where appropriate.
Evidence of ethical approval does not prevent further assessment if the reported research appears inconsistent with the approval or with fundamental participant protections. Allegations should nevertheless be evaluated fairly and on evidence.
Post-Publication Action
Ethical problems discovered after publication should be assessed for their effect on participant protection, legality, and the reliability or legitimacy of the published work. Depending on the circumstances, a correction, restriction of sensitive material, expression of concern, retraction, or other action may be necessary.
Actions should protect participants while preserving as much of the scholarly record as is ethically and legally appropriate.
Journal Implementation and Version Control
This policy is publisher mandatory. Journals may impose stronger discipline-specific requirements for ethics statements, consent, trial registration, reporting guidelines, privacy, or documentation. Such requirements should be stated clearly in journal instructions.
Material changes should be versioned and preserved. Human-research requirements should be interpreted together with Treata policies on consent and privacy, clinical trials, research data, publication ethics, and corrections.
Version Control
Version 1.0. This page is the canonical publisher-level text for the current version. Material revisions should be versioned and dated, while superseded versions remain identifiable so that historical applicability can be determined.