Research Ethics and Informed Consent Policy
Research Ethics and Informed Consent Policy
JSOMER requires ethically justified research, appropriate prior review, meaningful consent, proportionate risk management, and protection of privacy, dignity, safety, and community interests.
Purpose and Coverage
This policy governs human participant research, ethics review, informed consent, publication consent, vulnerable populations, health research, online and social media studies, AI and computational research, secondary use, biological materials, animal and field research, privacy, security, documentation, and suspected violations.
Research Ethics at a Glance
- Prior ethics approval, exemption, or formal determination should normally precede research activity.
- Consent must be voluntary, understandable, appropriately documented, and free from coercion.
- Consent to participate is distinct from consent to publish identifiable information.
- Public accessibility does not make online or social media data ethically unrestricted.
- Secondary use requires assessment of consent, identifiability, linkage, governance, and law.
- JSOMER may verify approvals, consent, protocols, registrations, and data-use records.
Approval, Consent, Privacy, Online Research, and Ethical Verification
01General Ethical Principles and ScopeView details +
JSOMER protects the rights, dignity, safety, privacy, autonomy, and well-being of individuals, communities, and other living subjects. The policy applies to all manuscripts regardless of discipline, method, country, data source, funding, or article type.
Ethical responsibility applies throughout design, review, recruitment, consent, collection, storage, analysis, sharing, interpretation, manuscript preparation, publication, and post-publication oversight.
- Research must be ethically justified, methodologically appropriate, proportionate in risk and benefit, and fair in participant selection.
- Privacy, confidentiality, data security, transparency, and responsible reporting must be maintained.
02Human Participant Research and Prior Ethics ReviewView details +
Interaction, intervention, biological material, identifiable records, private information, linked data, health information, online communities, and identifiable social media data normally require prior review by an independent authorized ethics body.
Researchers must not assume exemption merely because research is low risk, anonymous, online, educational, based on existing data, or conducted through a commercial platform.
03Ethics Approval, Reporting, and VerificationView details +
Manuscripts should report the reviewing body and institution, approval or reference number, date, protocol where relevant, and material conditions, exemptions, waivers, or limitations. Approval should normally precede recruitment, data collection, intervention, or access to protected information.
JSOMER may request approval, exemption, consent, protocol, registration, data-use, institutional, and translated records before or after publication. A documentation request does not itself indicate misconduct.
04Independent Editorial Ethical AssessmentView details +
Formal ethics approval does not require JSOMER to conclude that research is ethically acceptable for publication. Editors may independently assess risk, participant protection, consent, privacy, vulnerability, social media use, protocol compliance, and publication harm.
Multi-institutional or multinational work must satisfy applicable local, institutional, national, community, and data-controller requirements; one approval does not automatically replace required local authorization.
05Informed Consent, Forms of Consent, and WaiversView details +
Voluntary informed consent must be obtained before participation unless an authorized body approves a waiver or modification. Information should be understandable and address purpose, procedures, duration, risks, benefits, privacy, recordings, future use, sharing, compensation, contacts, voluntariness, and withdrawal.
Consent may be written, electronic, orally recorded, obtained through an approved online process, or provided by a legally authorized representative. Waivers require an identified authority, reason, safeguards, and conditions.
06Withdrawal, Compensation, Deception, and Online ParticipationView details +
Participants should receive accurate information about whether and until when data or materials may be withdrawn. Researchers must not promise removal when anonymization, completed analysis, law, or technical conditions make it impossible.
Compensation must be proportionate and must not create undue influence. Deception requires prior ethical justification, safeguards, and debriefing where applicable. Online studies must address eligibility, age, electronic consent, bots, metadata, cookies, platform collection, secure transmission, withdrawal, and safeguarding.
07Children, Decision-Making Capacity, and Additional ProtectionView details +
Research involving children should use age-appropriate information, authorized permission where required, meaningful assent, and safeguards for dissent, privacy, distress, and online risks.
Adults with impaired or fluctuating capacity require capacity assessment, appropriate authorization, respect for assent and dissent, justified inclusion, minimized risk, and continuing consent where relevant. Other vulnerable or dependent groups may require additional protection.
08Health Research, Clinical Trials, and Consent for PublicationView details +
Health research should report approval, consent, applicable trial registration, protocol information, risk management, adverse events, confidentiality, monitoring, sponsor involvement, and access to complete data. Trials requiring prospective registration should be registered before first enrollment.
Consent to participate is distinct from consent to publish. Specific permission is required when personal, clinical, visual, audio, username, searchable quotation, location, or contextual information may reasonably identify an individual.
09Identifiable Images, Recordings, and Case MaterialView details +
Partial blurring, masking eyes, renaming, or removing one identifier may not ensure anonymity. Authors must assess facial and bodily features, backgrounds, metadata, voice, location, timing, clinical combinations, quotations, and context.
When identification remains reasonably possible, written publication consent is required. Case reports should obtain consent covering clinical details, images, recordings, context, and open-access publication.
10Privacy, Confidentiality, and Data SecurityView details +
Safeguards may include minimization, separation of identifiers, access controls, encryption, secure transfer, pseudonymization, robust anonymization, aggregation, small-cell suppression, quotation paraphrasing, metadata removal, logging, retention limits, and secure deletion.
Coded, pseudonymized, or deidentified data are not anonymous when identity can be restored or inferred. Relevant breaches must be disclosed when participant welfare, consent, legality, or reliability may be affected.
11Social Media and Internet-Mediated ResearchView details +
Public accessibility does not automatically eliminate privacy expectations, consent, ethics review, identifiability, contextual integrity, or potential harm. Closed, invitation-only, support, patient, survivor, activist, and other sensitive communities require heightened protection.
Administrator permission does not necessarily constitute member consent. Direct interaction, private messages, entry into closed spaces, sensitive disclosures, traceable quotations, vulnerable participants, interventions, and online manipulation normally require explicit consent or a documented authorized waiver.
12Social Media Quotations, Identities, Scraping, and Platform DataView details +
Verbatim posts may be searchable and identifying. Authors should consider ethically defensible paraphrasing, removal of handles and images, modification of nonessential details, controlled access, or explicit permission without distorting analytical meaning.
Scraping, APIs, archives, brokers, and third-party datasets require disclosure of source, dates, method, access conditions, platform rules, identifiers, deleted content, filtering, bots, anonymization, security, approval, and sharing limits. Technical access or platform permission does not itself establish ethical permission.
13Computational and Artificial Intelligence ResearchView details +
Large-scale collection, linkage, profiling, automated classification, sensitive inference, facial recognition, geolocation, private-network analysis, retained deleted content, and released models or datasets require proportionate risk assessment.
AI studies should address lawful acquisition, provenance, consent, training-data documentation, protected attributes, bias, fairness, validation, explainability, privacy, security, reidentification, human oversight, misuse, automated decisions, community effects, and release risks.
14Secondary Use of Human Participant DataView details +
Secondary use is not automatically exempt from ethics review, even when undertaken by the original collector. Assessment depends on identifiability, keys, linkage, original consent and purpose, sensitivity, privacy expectations, law, institutional rules, access agreements, and formal ethics determinations.
- Anonymous data were never identifiable and cannot reasonably be linked to individuals.
- Anonymized data were previously identifiable but identifiers and reidentification mechanisms were irreversibly removed.
- Coded or pseudonymized data retain a key or mechanism and are not anonymous.
- Deidentified data may remain identifiable through indirect variables, linkage, or context.
15Secondary Data Authorization, Consent Compatibility, and ReportingView details +
Broad consent does not authorize every future use. New analysis must remain compatible with original consent, approval, participant expectations, law, governance, and controller conditions; otherwise renewed consent, a waiver, approval, or another authorization may be needed.
Manuscripts should report the source, original purpose, collector and controller, access route, identifiability, linkage, consent, waiver, ethics decision, safeguards, sharing limitations, and governance conditions. JSOMER may request supporting documentation.
16Biological, Genetic, Genomic, and Biometric MaterialsView details +
Research using human tissues, specimens, genetic material, or biological material should report source, approval, collection and future-use consent, identifiability, storage, repository, linkage, privacy, incidental findings, and sharing limits.
Genetic, genomic, facial, voice, behavioral, location, and biometric information require attention to continuing identifiability, family and group implications, discrimination, security, consent scope, external access, and anonymization limits.
17Community, Researcher, Environmental, and Animal ProtectionView details +
Community-based and culturally sensitive research should address collective interests, appropriate consent, data sovereignty, benefit sharing, attribution, restricted knowledge, local partnerships, and stigmatization. Researcher and staff safety should also be considered.
Animal research requires prior authorized approval, welfare reporting, and Replacement, Reduction, and Refinement. Environmental, field, and citizen-science work should meet permit, conservation, community, heritage, data-governance, and safety requirements.
18Exemptions, Retrospective Approval, and Protocol ComplianceView details +
Studies that may not require formal approval still need a specific justification, and exemption does not remove duties concerning consent, privacy, confidentiality, data protection, harm minimization, and law.
JSOMER does not ordinarily accept retrospective approval as a substitute for required prospective approval. Research should follow the approved protocol; material deviations must be documented, disclosed, and assessed. Ethics records and exemptions must not be fabricated, altered, misapplied, or concealed.
19Editorial Review and Suspected Ethics ViolationsView details +
Reviewers and editors should report concerns confidentially to the handling editor and must not contact participants or ethics bodies directly, disclose allegations publicly, attempt reidentification, or conduct unauthorized investigations.
Before publication, JSOMER may suspend evaluation, request records, seek expert advice, contact institutions, require safeguards, reject, or withdraw a manuscript. After publication, JSOMER may correct, issue an Expression of Concern, restrict sensitive material, remove identifying information, retract, or take another protective action.
20Standard Ethics and Consent DeclarationsView details +
Ethics Approval: The study was approved by the [full name of the ethics committee or institutional review board] on [date] under Approval No. [number].
Ethics Approval: The [full name of the authorized body] determined that the study was exempt on [date] under Exemption No. [number] because [specific reason].
Informed Consent: Informed [written/electronic/oral] consent was obtained from all participants using the approved procedure.
Informed Consent: Permission was obtained from parents or legally authorized representatives, and age-appropriate assent was obtained.
Informed Consent: The requirement was waived by the [full name of the ethics body] under Approval No. [number] because [specific reason].
Consent for Publication: Written informed consent for publication of identifiable information was obtained from the individual or legally authorized representative.
Ethics Approval: This secondary analysis was approved or formally exempted by the [authorized body] on [date] under [Approval/Exemption] No. [number].
Animal Ethics Approval: The protocol was approved by the [animal ethics committee] on [date] under Approval No. [number].
21Author Declaration and Policy ReviewView details +
The authors confirm compliance with applicable ethical, institutional, and legal requirements and accurate disclosure of approvals, exemptions, permissions, registrations, data-use authorizations, and consent procedures. Supporting documentation will be provided upon request.
This policy is reviewed periodically. Material revisions will be disclosed on the journal website.
Contact
Questions may be sent to editor@jsomer.org.
Last updated: July 20, 2026
