Food Systems, Safety & Sustainability (FSSS) requires all research to be planned, conducted, reviewed, and reported in accordance with applicable ethical, legal, professional, institutional, environmental, and public-safety standards.

Ethical oversight extends beyond obtaining an approval number. Authors must demonstrate that the rights, dignity, safety, welfare, privacy, cultural interests, and legitimate expectations of research participants, communities, animals, researchers, and affected third parties were considered throughout the research process.

Research involving human participants, identifiable personal information, human biological materials, animals, potentially hazardous agents, sensitive ecosystems, protected knowledge, or significant public-safety risks must receive appropriate independent review and authorisation before the relevant research activity begins.

1. Scope

This policy applies to research involving or affecting:

• human participants;
• patients, volunteers, consumers, workers, students, employees, farmers, producers, or community members;
• surveys, interviews, focus groups, observations, experiments, interventions, or behavioural research;
• identifiable or potentially identifiable personal information;
• human biological materials, genetic information, or biospecimens;
• administrative, health, educational, commercial, employment, or social-media records;
• animals used in research, teaching, testing, field studies, or product evaluation;
• agricultural, veterinary, fisheries, wildlife, ecological, or environmental research;
• Indigenous, traditional, local, or community-held knowledge and data;
• pathogens, toxins, allergens, hazardous chemicals, genetically modified organisms, or antimicrobial-resistant organisms;
• food-safety systems, critical infrastructure, supply-chain security, or dual-use information;
• artificial-intelligence systems processing protected or sensitive information;
• commercially or legally restricted research materials;
• research involving significant environmental, occupational, social, cultural, or public-health risks; and
• other activities requiring ethical, regulatory, institutional, community, or governmental oversight.

2. General Ethical Principles

Research submitted to FSSS should be consistent with the following principles:

• Respect for persons: Individuals must be treated as autonomous participants and protected where autonomy is limited.
• Scientific and social value: Risks and burdens must be justified by a meaningful research purpose.
• Favourable risk–benefit balance: Foreseeable risks should be minimised and proportionate to anticipated benefits or knowledge gained.
• Fair participant selection: Individuals and communities should not be included or excluded unfairly.
• Independent review: Relevant research should be assessed by a competent and sufficiently independent review body.
• Informed consent: Participation should ordinarily be voluntary and based on adequate information.
• Privacy and confidentiality: Personal information must be collected, used, stored, shared, and published responsibly.
• Protection of vulnerable groups: Additional safeguards are required where individuals or communities face increased risk of coercion, exploitation, stigma, or harm.
• Transparency: Ethical procedures, approvals, limitations, amendments, and relevant adverse events must be reported honestly.
• Accountability: Researchers remain responsible for ethical conduct even where approval has been granted.
• Community and cultural respect: Research must consider collective rights, local governance, cultural values, and community interests where applicable.
• Environmental responsibility: Research should avoid unnecessary environmental harm and comply with relevant conservation and biosafety requirements.
• Justice and equity: The benefits and burdens of research should be distributed fairly.
• Public protection: Publication should not create an unjustifiable risk to food safety, health, agriculture, infrastructure, animals, communities, or the environment.

3. Independent Ethical Review

Research requiring ethical review must be approved by a competent independent body before the relevant activities begin.

Depending on the jurisdiction and research design, the review body may be described as:

• an institutional review board;
• a research ethics committee;
• a human research ethics committee;
• an animal ethics or animal care and use committee;
• a biosafety committee;
• a data-access or privacy committee;
• an Indigenous or community governance body;
• a regulatory authority;
• a governmental or environmental review body; or
• another institution authorised to conduct the relevant review.

The review body should be sufficiently independent of the researchers, sponsor, and commercial interests involved in the study.

4. Information Required in the Manuscript

Where ethical or regulatory approval was required, the manuscript must state:

• the full name of the approving body;
• the institution and jurisdiction of the approving body;
• the approval, reference, or protocol number where available;
• the date of approval where relevant;
• the ethical principles, regulation, or legal framework followed;
• whether informed consent was obtained;
• whether consent for publication was obtained where applicable;
• whether a waiver, exemption, or expedited procedure was granted;
• the authority that granted the waiver or exemption;
• trial or study registration information where applicable;
• material protocol amendments affecting ethical approval;
• relevant adverse events or safety concerns; and
• other approvals, permits, or authorisations required for the research.

The information should appear in the Methods section and, where required by the journal template, in a separate Ethics Approval statement.

5. Recommended Ethics Approval Statement

Ethics Approval: This study was reviewed and approved by the [full name of ethics committee or institutional review board], [institution and country] (approval number: [number]; approval date: [date]). The research was conducted in accordance with applicable institutional and national ethical requirements and the principles relevant to the study design.

6. Documentation Requested by the Journal

Authors must retain and, when reasonably requested, provide documentation supporting their ethical declarations.

The journal may request:

• the original approval letter;
• the approved research protocol;
• participant-information sheets;
• blank consent or assent forms;
• consent-for-publication forms;
• approval of protocol amendments;
• trial or study registration records;
• data-protection impact assessments;
• data-use or data-transfer agreements;
• animal ethics approvals;
• biosafety and laboratory approvals;
• fieldwork, collection, import, export, or environmental permits;
• community or Indigenous governance approvals;
• adverse-event or safety reports;
• independent monitoring documentation;
• evidence supporting an exemption or waiver; and
• other records necessary to assess ethical compliance.

Sensitive documents should be transmitted through a secure mechanism approved by the Editorial Office.

7. Verification of Ethical Approval

The journal may verify ethical approval where:

• the approval information is incomplete or inconsistent;
• the committee or institution cannot be identified;
• the approval appears to post-date the research;
• the study procedures differ materially from the approved protocol;
• the approval number appears invalid or duplicated;
• the named review body does not appear competent to review the research;
• participant protections are unclear;
• a reviewer or reader raises a credible concern;
• the research involves an unusually high level of risk; or
• there is another reason to question the accuracy of the declaration.

Verification may involve contacting the approving committee, institution, regulator, sponsor, or another authorised body.

8. Approval Must Precede Research

Required ethical approval must normally be obtained before:

• participant recruitment;
• informed-consent procedures;
• collection of personal or biological data;
• delivery of an intervention;
• experimental procedures;
• animal acquisition or use;
• access to protected records;
• collection of protected specimens;
• processing of community-governed knowledge;
• commencement of regulated fieldwork; or
• another activity for which prior review is required.

Authors should not begin research while an ethics application is pending unless the review body has explicitly authorised the relevant preparatory activity.

9. Retrospective Ethical Approval

Retrospective approval obtained after research has begun or ended does not ordinarily correct the absence of required prior ethical review.

A manuscript involving retrospective approval must explain:

• why approval was not obtained before the research;
• which activities occurred before approval;
• what authority reviewed the matter retrospectively;
• whether participants or animals were exposed to risk;
• whether consent was obtained;
• whether the institution conducted an investigation;
• what remedial measures were adopted; and
• why publication would remain ethically justified.

FSSS may reject the manuscript even where retrospective approval has been issued.

10. Exemptions and Waivers of Ethical Review

Some research may be exempt from formal ethical review under applicable institutional or national rules. Authors should not normally make this determination solely by themselves.

Where an exemption applies, the manuscript should identify:

• the body or authority that determined the exemption;
• the date or reference number where available;
• the category or legal basis of the exemption;
• the type of data or research involved;
• whether identifiable information was used;
• whether consent was required; and
• the privacy and confidentiality protections applied.

Recommended statement:

Ethics Review Exemption: The [name of authorised body] determined that this study was exempt from formal ethics review because [brief basis]. The exemption was issued under [applicable institutional or legal provision] (reference number: [number], where available).

11. Human-Participant Research

Human-participant research includes more than clinical experimentation. It may include:

• clinical and nutritional interventions;
• surveys and questionnaires;
• interviews and focus groups;
• behavioural experiments;
• consumer research;
• workplace and occupational studies;
• research involving farmers, producers, workers, students, or households;
• observation of identifiable individuals;
• research involving identifiable records;
• social-media and online-community research;
• research using biological samples;
• research involving photographs, audio, or video;
• secondary analysis of protected data; and
• other activities involving interaction with individuals or use of their identifiable information.

Authors must comply with applicable ethical and legal requirements for all such research.

12. Informed Consent

Participation in research must ordinarily be voluntary and based on valid informed consent.

The consent process should provide information concerning:

• the identity and affiliation of the researchers;
• the purpose of the research;
• the procedures involved;
• the expected duration of participation;
• reasonably foreseeable risks and discomforts;
• potential benefits;
• alternatives to participation where relevant;
• compensation, reimbursement, or incentives;
• privacy and confidentiality;
• collection and future use of data or samples;
• data sharing and repository deposit;
• commercial use or intellectual-property implications where applicable;
• the voluntary nature of participation;
• the right to withdraw and any limits on withdrawal;
• contact information for questions or complaints; and
• the identity of the responsible ethics body where appropriate.

13. Documentation of Consent

Consent may be documented in writing, electronically, orally, or through another method approved by the relevant ethics body.

The manuscript should explain:

• how consent was obtained;
• when consent was obtained;
• who obtained consent;
• what information participants received;
• whether participants received a copy of the consent information;
• how capacity and comprehension were assessed where necessary;
• how consent records were stored; and
• why a non-written method was used where applicable.

14. Waiver of Informed Consent

A waiver or alteration of informed consent must be authorised by a competent ethics body or other legally authorised institution.

The manuscript must report:

• the approving body;
• the reason for the waiver;
• the applicable ethical or legal basis;
• whether the research involved no more than minimal risk;
• whether obtaining consent was impracticable;
• how participant rights and welfare were protected;
• whether debriefing was provided; and
• what privacy safeguards were implemented.

Recommended statement:

Waiver of Informed Consent: The requirement for informed consent was waived by the [name of ethics body] because [brief reason and ethical basis]. The study used [describe data or procedures], and safeguards were implemented to protect participant privacy and welfare.

15. Consent for Publication

Consent to participate in research does not automatically constitute consent to publish identifiable information.

Separate consent for publication is required where an individual may be identifiable through:

• their name or initials;
• photographs or video;
• audio recordings;
• direct quotations;
• detailed personal histories;
• rare occupations, diagnoses, characteristics, or events;
• specific workplaces, farms, institutions, or locations;
• family or community relationships;
• genetic or biometric information; or
• a combination of indirect identifiers.

Consent for publication must be obtained before publication and should be documented in a form appropriate to the applicable legal and ethical requirements.

16. Recommended Consent-for-Publication Statement

Consent for Publication: Written informed consent was obtained from the participant or authorised representative for publication of the information and materials contained in this article.

Where no identifiable information is included:

Consent for Publication: The manuscript contains no information that identifies individual participants. Separate consent for publication was therefore not required.

17. Privacy and Confidentiality

Researchers must collect and use only the personal information necessary for the legitimate research purpose.

Authors should describe, where relevant:

• data minimisation;
• pseudonymisation or anonymisation;
• encryption and access controls;
• secure data storage;
• retention and destruction periods;
• data transfer and cross-border processing;
• third-party processors;
• data-sharing arrangements;
• limits on secondary use;
• procedures for reporting data breaches;
• restrictions on publication; and
• measures taken to reduce re-identification risk.

Removal of names alone may not provide adequate anonymity.

18. Online and Social-Media Research

Public accessibility of online content does not automatically eliminate ethical responsibilities.

Authors conducting research involving websites, forums, social-media platforms, online groups, digital communities, or user-generated content should consider:

• users’ reasonable expectations of privacy;
• platform terms and conditions;
• whether the community is open, closed, or restricted;
• whether quotations can be traced through search engines;
• whether usernames or profile information are identifiable;
• whether vulnerable individuals are involved;
• whether consent or community permission is required;
• risks created by automated data collection;
• data-protection requirements;
• whether paraphrasing is needed to reduce identification;
• ethical requirements for screenshots or images; and
• the effect of publication on individuals and communities.

19. Research Involving Children and Adolescents

Research involving children or adolescents requires safeguards appropriate to age, maturity, legal capacity, and research risk.

Authors should report:

• permission from a parent, guardian, or legally authorised representative where required;
• assent from the child or adolescent where appropriate;
• the information provided in age-appropriate language;
• procedures for respecting dissent;
• protection against coercion;
• privacy safeguards;
• procedures for responding to disclosures of harm or risk;
• the justification for including minors;
• age-specific risks and benefits; and
• the approving ethics body.

20. Adults with Limited Decision-Making Capacity

Where participants may have limited capacity to provide informed consent, authors must explain:

• how capacity was assessed;
• why inclusion was necessary;
• whether an authorised representative provided permission;
• whether participant assent was sought;
• how dissent was respected;
• what additional safeguards were used;
• how participation served the participant group or relevant knowledge need; and
• how the risk–benefit balance was assessed.

21. Participants in Dependent Relationships

Additional care is required where participants are students, employees, patients, prisoners, military personnel, recipients of services, junior researchers, migrant workers, or others in a dependent relationship with the research team or institution.

Authors should explain how they prevented:

• actual or perceived coercion;
• undue influence;
• academic or employment consequences;
• loss of services or benefits;
• retaliation for refusal or withdrawal;
• inappropriate access to confidential responses; and
• participation decisions being known to supervisors or assessors.

22. Payments, Incentives, and Reimbursement

Participant payment should compensate time, inconvenience, and reasonable expenses without creating inappropriate pressure to participate or remain in a study.

Authors should disclose:

• the amount and form of payment;
• reimbursement of expenses;
• non-financial incentives;
• how payment was determined;
• whether payment was prorated for partial participation;
• whether treatment or services depended on participation; and
• the ethics body’s approval of the arrangement.

23. Deception and Incomplete Disclosure

Research involving deception, concealment, or incomplete disclosure requires specific ethical justification and prior approval.

Authors must report:

• why the research could not be conducted without deception;
• why the deception did not expose participants to unreasonable risk;
• what information was withheld;
• when and how participants were debriefed;
• whether participants could withdraw their data after debriefing;
• how distress or harm was managed; and
• the ethics body that authorised the procedure.

24. Interviews, Focus Groups, and Qualitative Research

Qualitative research requires attention to relational, contextual, and interpretive ethical issues.

Authors should consider:

• the researcher–participant relationship;
• power differences;
• recording and transcription consent;
• use of direct quotations;
• translation and interpreter confidentiality;
• disclosure of illegal, harmful, or sensitive activity;
• group confidentiality in focus groups;
• risks of deductive identification;
• participant review of quotations where applicable;
• data-sharing limitations;
• researcher safety and emotional welfare; and
• ethical management of unexpected findings.

25. Secondary Use of Existing Data

Secondary analysis of existing data may require ethical review, data-owner permission, or another form of authorisation.

Authors must report:

• the original data source;
• how access was obtained;
• whether the data were public, restricted, or identifiable;
• the legal and ethical basis for secondary use;
• whether original consent permitted the analysis;
• whether ethics approval or exemption was obtained;
• whether data linkage occurred;
• how privacy was protected; and
• any restrictions affecting publication or data sharing.

The fact that data already exist does not automatically make their secondary use ethically exempt.

26. Human Biological Materials and Genetic Data

Research involving human tissue, blood, cells, microbiome samples, genetic information, or other biological materials must comply with applicable consent, governance, storage, transfer, and privacy requirements.

Authors should report:

• the source of the materials;
• whether materials were collected prospectively or obtained from a repository;
• the consent obtained;
• the scope of permitted future use;
• ethics or biobank approval;
• material-transfer agreements;
• identifiability and re-identification risks;
• genomic data-sharing arrangements;
• return of individual findings where applicable;
• commercialisation or intellectual-property implications;
• international transfer arrangements; and
• destruction, return, or long-term storage procedures.

27. Incidental and Individual Findings

Studies may reveal information relevant to a participant’s health, safety, livelihood, legal position, or family members.

Where such findings are foreseeable, authors should explain:

• whether findings will be returned;
• which findings qualify for return;
• who will evaluate their validity and significance;
• whether confirmatory testing is required;
• how participant preferences are respected;
• whether counselling or referral is available;
• how family implications are managed; and
• what the ethics-approved protocol requires.

28. Clinical Trials and Interventional Studies

Prospective interventional studies involving human participants must comply with applicable ethical-review and registration requirements.

Authors must provide:

• ethics approval;
• prospective registration in an appropriate public registry where required;
• the registration number;
• the registration date;
• the protocol version;
• the prespecified primary and secondary outcomes;
• information concerning monitoring and safety oversight;
• serious adverse-event reporting procedures;
• material protocol amendments;
• reasons for early termination where applicable;
• consent procedures; and
• the data-sharing plan where required.

Retrospective registration does not replace prospective registration where prospective registration was required.

29. Food, Nutrition, and Community Interventions

Food, dietary, nutritional, agricultural, behavioural, educational, or community interventions may create physical, psychological, cultural, economic, or social risks.

Authors should consider:

• allergies and intolerances;
• nutritional adequacy;
• medication–food interactions;
• foodborne illness;
• weight stigma and eating-disorder risk;
• culturally or religiously sensitive dietary practices;
• household food security;
• community-level effects;
• financial or livelihood consequences;
• fairness in access to intervention benefits;
• monitoring and stopping procedures; and
• referral or care for participants experiencing harm.

30. Case Reports and Case-Based Research

Case reports involving identifiable individuals normally require consent for publication even where formal research ethics approval is not required.

Authors should:

• remove unnecessary identifying details;
• obtain consent from the individual or authorised representative;
• avoid altering factual details solely to create anonymity;
• explain any legally authorised exception;
• consider the privacy of relatives and third parties;
• avoid including images or documents without permission; and
• retain evidence of consent.

31. Indigenous, Traditional, and Community Research

Research involving Indigenous peoples, traditional knowledge, local ecological knowledge, customary food systems, community-held data, biological resources, or culturally sensitive information must respect applicable collective rights and governance.

Authors should address:

• community engagement before the research;
• individual and collective consent where applicable;
• community governance or ethics approval;
• ownership and control of data and knowledge;
• access, reuse, and publication conditions;
• culturally restricted or sacred knowledge;
• appropriate attribution and authorship;
• benefit sharing;
• return and communication of findings;
• risks of stigma, exploitation, or commercial appropriation;
• community review of sensitive representations where appropriate; and
• ongoing responsibilities after publication.

Individual consent does not automatically replace valid collective or community governance requirements.

32. Community Engagement

Where research materially affects a defined community, researchers should consider meaningful engagement throughout the study.

Engagement may include:

• consultation during research design;
• discussion of priorities and risks;
• participation in governance;
• development of culturally appropriate consent materials;
• community involvement in interpretation;
• agreement concerning data access and publication;
• communication of findings in an accessible form;
• benefit-sharing arrangements; and
• procedures for complaints or withdrawal of community support.

33. Research Involving Animals

Research involving live animals must receive approval from an appropriate animal ethics or animal care and use committee before the research begins.

Authors must report:

• the name of the approving committee;
• the approval number;
• the applicable legislation or institutional standard;
• species, strain, sex, age, and relevant animal characteristics;
• housing and husbandry conditions;
• experimental procedures;
• anaesthesia and analgesia;
• humane endpoints;
• euthanasia methods;
• adverse events;
• sample-size justification;
• randomisation and blinding;
• measures taken to reduce suffering; and
• compliance with the applicable reporting guideline.

34. Replacement, Reduction, and Refinement

Animal research should apply the principles of replacement, reduction, and refinement:

• Replacement: use non-animal alternatives wherever scientifically appropriate.
• Reduction: use no more animals than necessary to answer the research question reliably.
• Refinement: modify procedures to minimise pain, distress, and lasting harm and to improve welfare.

Scientific convenience alone does not justify unnecessary animal use or suffering.

35. Reporting Animal Research

In vivo animal studies must be reported in accordance with ARRIVE 2.0 and should satisfy the Essential 10 as a minimum.

Submission of an ARRIVE checklist does not replace:

• prior animal ethics approval;
• compliance with animal-welfare legislation;
• appropriate veterinary oversight;
• scientific justification for animal use;
• humane experimental conduct; or
• complete reporting of adverse events and exclusions.

36. Veterinary, Livestock, and Farm Research

Research involving livestock, companion animals, farmed fish, wildlife, or veterinary patients must consider both scientific objectives and animal welfare.

Authors should report:

• owner or custodian permission where applicable;
• veterinary oversight;
• effects on ordinary husbandry;
• treatment of control animals;
• procedures for illness, injury, or distress;
• whether animals were privately or commercially owned;
• financial or production consequences for owners;
• biosecurity measures;
• withdrawal periods relevant to food production; and
• plans for animals after the study.

37. Wildlife and Field Research

Wildlife, fisheries, ecological, agricultural, and field research must comply with applicable permits and minimise harm to organisms, habitats, and communities.

Authors should report:

• collection, capture, handling, tagging, or sampling permits;
• landowner or site permission;
• protected-species authorisations;
• import and export permits;
• biosafety and quarantine requirements;
• methods used to minimise disturbance;
• release or rehabilitation procedures;
• mortality and adverse events;
• impacts on non-target species;
• habitat restoration where applicable;
• local or community consultation; and
• precautions concerning sensitive location information.

38. Environmental Ethics

Ethical oversight should consider foreseeable environmental harms caused by research activities.

Relevant issues may include:

• release of organisms or genetically modified materials;
• soil, water, or air contamination;
• chemical and biological waste;
• effects on biodiversity;
• damage to protected habitats;
• introduction of invasive species;
• overharvesting or destructive sampling;
• greenhouse-gas emissions from unusually resource-intensive research;
• effects on local food or water resources;
• risks to workers and nearby communities; and
• long-term environmental monitoring requirements.

39. Laboratory Safety and Biosafety

Research involving biological, chemical, radiological, or physical hazards must comply with applicable safety requirements.

Authors should report, where relevant:

• institutional biosafety or safety approval;
• the containment level;
• risk-assessment procedures;
• personnel training;
• personal protective equipment;
• sample handling and storage;
• transport requirements;
• decontamination and waste disposal;
• exposure and incident-response procedures;
• occupational-health monitoring;
• regulatory licences; and
• measures protecting the public and environment.

40. Food-Safety and Biosecurity Risks

Research involving pathogens, toxins, allergens, contamination, antimicrobial resistance, food-processing vulnerabilities, or supply-chain security may require enhanced oversight.

The journal may request evidence of:

• biosafety review;
• biosecurity review;
• food-safety risk assessment;
• regulatory authorisation;
• secure data and material handling;
• controlled access to sensitive methods;
• appropriate containment;
• incident-response procedures;
• dual-use risk assessment; and
• responsible communication planning.

41. Dual-Use Research

Dual-use research has legitimate scholarly value but may also provide information, materials, or methods that could be misused.

Potential concerns include research that could facilitate:

• intentional contamination of food or water;
• enhancement or dissemination of harmful biological agents;
• circumvention of food-safety testing;
• evasion of monitoring or regulatory controls;
• identification of critical supply-chain vulnerabilities;
• unsafe replication of hazardous procedures;
• misuse of toxins or allergens;
• attacks on agricultural or food infrastructure;
• harmful automated decision-making; or
• another credible threat to public, animal, agricultural, or environmental safety.

FSSS may obtain specialist advice, require modification of methodological details, restrict supplementary information, delay publication, or reject work where risks cannot be managed responsibly.

42. Researcher and Fieldworker Safety

Ethical oversight should also protect researchers, laboratory personnel, interpreters, fieldworkers, and community partners.

Relevant safeguards may include:

• occupational-health assessment;
• laboratory and field safety training;
• lone-working procedures;
• security planning;
• procedures for violence, harassment, or political instability;
• psychological support for distressing research;
• appropriate insurance;
• safe transport and accommodation;
• infection-prevention measures;
• incident reporting; and
• emergency communication procedures.

43. Artificial Intelligence and Automated Processing

Use of artificial intelligence to process participant, community, animal, environmental, or sensitive food-system information must be consistent with the approved protocol, consent process, privacy obligations, and the journal’s AI and Research Integrity Policy.

Authors should report:

• the data supplied to the system;
• the provider and model used;
• whether the system retains or reuses input data;
• where data were processed;
• whether cross-border transfer occurred;
• the legal and ethical basis for processing;
• human oversight;
• bias and fairness assessment;
• security and confidentiality safeguards;
• procedures for correcting automated errors; and
• whether the use was approved by the relevant ethics body.

44. Research Conducted in Multiple Jurisdictions

Multinational or multi-institutional research may require approval from more than one ethics or regulatory body.

Authors should explain:

• which institutions and countries participated;
• which body provided primary review;
• whether local approval or reliance agreements were obtained;
• how differences in legal and ethical requirements were addressed;
• how cross-border data and sample transfers were governed;
• how local communities were engaged;
• how benefits and authorship were distributed;
• whether local researchers participated meaningfully; and
• how exploitation or ethical double standards were avoided.

Approval in one jurisdiction does not automatically eliminate requirements in another.

45. Research in Low-Resource or Emergency Settings

Research conducted during disasters, outbreaks, conflict, displacement, food emergencies, or severe resource constraints must not lower essential ethical protections.

Authors should address:

• urgency and scientific necessity;
• feasibility of valid consent;
• protection from exploitation;
• fair participant selection;
• effects on humanitarian or essential services;
• coordination with local authorities and communities;
• data and sample governance;
• safety of researchers and participants;
• return of results;
• access to benefits arising from the research; and
• adaptations approved by the ethics body.

46. Ethical Amendments and Protocol Deviations

Material changes to an approved study should receive ethics approval before implementation unless an immediate change is necessary to remove an urgent hazard.

Authors must disclose material changes involving:

• eligibility criteria;
• participant recruitment;
• consent procedures;
• interventions or exposures;
• sample size;
• outcomes;
• data collection;
• data sharing;
• use of biological samples;
• AI or automated processing;
• safety monitoring;
• community agreements; or
• another element affecting participant, animal, community, or environmental welfare.

Unapproved deviations must be explained and may require institutional investigation.

47. Adverse Events and Unanticipated Problems

Authors must report material adverse events and unanticipated problems honestly.

The manuscript should state, where applicable:

• the type and number of adverse events;
• severity and expectedness;
• relationship to the research;
• reporting to the ethics body or regulator;
• changes made to reduce risk;
• whether recruitment or research was suspended;
• whether participants were informed;
• whether the study was terminated; and
• the outcome of any safety investigation.

Negative safety information must not be omitted because it is commercially, reputationally, or academically inconvenient.

48. Ethical Approval Does Not Guarantee Publication

Approval by an ethics committee, institutional review board, animal committee, or regulator does not oblige FSSS to accept the manuscript.

The journal may determine that research remains unsuitable where:

• the risk–benefit balance appears unacceptable;
• participants or communities were exploited;
• consent was materially inadequate;
• privacy protections were insufficient;
• animal suffering was not justified;
• environmental harm was excessive;
• the approving body lacked appropriate authority or independence;
• the approved protocol was not followed;
• important ethical information was concealed;
• publication would create an unjustifiable safety risk; or
• the research conflicts with the journal’s ethical standards.

49. Studies Not Requiring Formal Ethics Approval

Certain scholarly activities may not require formal ethics approval, depending on jurisdiction and institutional policy.

Examples may include:

• analysis of wholly public, non-identifiable aggregate data;
• systematic reviews of published literature;
• theoretical or conceptual articles;
• analysis of publicly available policy documents;
• laboratory research not involving humans, animals, or regulated hazards;
• quality-improvement activities formally classified as non-research; and
• other activities formally determined to be outside ethics-review requirements.

Authors must still comply with privacy, copyright, confidentiality, safety, community-governance, and other applicable requirements.

Where there is uncertainty, authors should obtain a formal determination from the relevant institutional authority.

50. Quality Improvement, Audit, and Programme Evaluation

Projects described as quality improvement, service evaluation, audit, surveillance, or programme evaluation may still require ethical or regulatory review.

The manuscript should explain:

• the purpose of the activity;
• whether it was designed to produce generalisable knowledge;
• the responsible institutional authority;
• whether a formal determination was obtained;
• whether participants were exposed to additional procedures or risks;
• whether identifiable information was used;
• whether findings were intended for publication; and
• the ethical and privacy safeguards applied.

Labelling a project as an audit or evaluation does not automatically exempt it from ethical review.

51. Funding and Sponsor Responsibilities

Funders and sponsors must not interfere with ethical review or pressure researchers to disregard participant, animal, community, environmental, or public-safety protections.

Authors must disclose:

• the identity of the funder or sponsor;
• the sponsor’s role in research design and conduct;
• who was responsible for safety monitoring;
• whether the sponsor had access to identifiable data;
• whether publication was contractually restricted;
• whether adverse events were reported independently;
• who provided compensation for research-related injury where applicable; and
• any conflict of interest affecting ethical oversight.

52. Editorial Assessment of Ethical Compliance

Editors and reviewers may assess:

• whether appropriate review occurred;
• whether approval preceded the research;
• whether the consent process was appropriate;
• whether vulnerable participants were protected;
• whether risks were justified and minimised;
• whether data sharing is consistent with consent;
• whether animal welfare standards were followed;
• whether environmental, biosafety, or dual-use risks were addressed;
• whether community permissions were respected;
• whether ethical information is complete and internally consistent; and
• whether additional documentation or specialist review is required.

Peer reviewers provide advice but do not replace the competent ethics or regulatory body.

53. Concerns Identified before Publication

Where an ethical concern is identified before publication, FSSS may:

• request clarification;
• request ethics documentation;
• request consent or permit information;
• contact the approving body or institution;
• obtain independent ethical, legal, clinical, veterinary, biosafety, or community advice;
• pause peer review or production;
• require additional safeguards or reporting;
• request removal of identifiable or sensitive information;
• reject the manuscript;
• refer the matter to an institution or regulator; or
• take another proportionate action under the Publication Ethics Policy.

54. Concerns Identified after Publication

Where an ethical concern is identified after publication, the journal may:

• request an explanation and supporting documentation;
• contact the relevant ethics body or institution;
• seek independent expert advice;
• publish a clarification or correction;
• remove identifiable information where legally and technically possible;
• publish an expression of concern;
• retract the article where the research or publication is seriously unethical or unreliable;
• notify a funder, regulator, repository, or other journal; or
• take another action necessary to protect affected parties and the scholarly record.

55. Potential Ethical Misconduct

Potential ethical misconduct includes:

• conducting research without required prior approval;
• fabricating or altering an approval document;
• providing a false approval number;
• misrepresenting an exemption or waiver;
• conducting procedures beyond the approved protocol;
• failing to obtain required informed consent;
• publishing identifiable information without valid permission;
• concealing serious adverse events;
• using protected data or samples without authority;
• violating community or Indigenous governance requirements;
• causing unjustified animal suffering;
• conducting unsafe or unlawful laboratory procedures;
• concealing significant environmental or public-safety risks;
• misrepresenting retrospective approval as prior approval;
• uploading protected participant information to an unauthorised AI system; and
• deliberately providing false or incomplete ethical declarations.

56. Honest Errors and Administrative Irregularities

Not every documentation error establishes misconduct. The journal will distinguish between:

• a minor reporting omission;
• an incorrect committee name or reference number;
• a correctable administrative error;
• a misunderstanding of local classification requirements;
• a material protocol deviation;
• conduct without required approval; and
• deliberate falsification or concealment.

Editorial action will be proportionate to the evidence, seriousness of the problem, risk to affected parties, reliability of the research, and need to maintain an accurate scholarly record.

57. Confidentiality and Fairness

Ethical concerns will be handled as confidentially, impartially, and promptly as reasonably possible.

The journal will seek to:

• distinguish allegations from established findings;
• preserve relevant evidence;
• avoid premature public accusations;
• manage conflicts of interest;
• give affected individuals a reasonable opportunity to respond;
• limit disclosure to those with a legitimate need to know;
• protect participants, communities, animals, and whistleblowers where possible; and
• document significant decisions.

Confidentiality cannot be guaranteed where institutional referral, legal compliance, regulatory reporting, public protection, or correction of the scholarly record requires disclosure.

58. Complaints and Appeals

Authors or other affected parties may request reconsideration where they believe that:

• the requirement for ethical review was classified incorrectly;
• a valid approval, exemption, or waiver was overlooked;
• material evidence was not considered;
• the journal’s policy was applied inconsistently;
• the assessing editor or adviser had an undisclosed conflict of interest;
• confidentiality was breached; or
• the editorial action was disproportionate.

The request should identify the manuscript or article, state the specific grounds for reconsideration, and provide supporting documentation.

Further procedures are described in the journal’s Complaints and Appeals Policy.

59. Recommended Declaration Templates

Human Research with Ethics Approval

Ethics Approval: The study involving human participants was approved by the [full committee name], [institution and country] (approval number: [number]). All procedures were conducted in accordance with the approved protocol and applicable ethical requirements.

Informed Consent

Informed Consent: Written informed consent was obtained from all participants before participation.

Electronic Consent

Informed Consent: Participants provided informed electronic consent before accessing the study procedures. The consent process was approved by the [ethics body].

Parental Permission and Assent

Informed Consent: Written permission was obtained from the participants’ parents or legal guardians, and age-appropriate assent was obtained from the participants.

Waiver of Consent

Waiver of Consent: The [ethics body] waived the requirement for informed consent because [reason]. The study involved [brief description], and appropriate privacy and confidentiality safeguards were applied.

Ethics Exemption

Ethics Review Exemption: The [authorised body] determined that the study was exempt from formal ethical review under [applicable category or provision] (reference number: [number], where available).

Public and Non-Identifiable Data

Ethical Oversight: This study analysed publicly available, non-identifiable aggregate data and involved no interaction with human participants. The [authorised institutional body] determined that formal ethics review was not required.

Animal Research

Animal Ethics: All animal procedures were approved by the [full committee name], [institution and country] (approval number: [number]) and were conducted in accordance with applicable animal-welfare requirements.

No Human or Animal Research

Ethical Oversight: This article did not involve human participants, identifiable personal data, human biological material, or live animals. Formal human or animal ethics approval was therefore not applicable.

Community Approval

Community Ethical Approval: The research was reviewed and authorised by [community or governance body]. Individual consent and community-level approval were obtained in accordance with the applicable governance arrangements.

60. Final Ethical Oversight Checklist

Before submission, authors should confirm that:

• all required approvals were obtained before the research began;
• the approving body was competent and sufficiently independent;
• the committee name and approval number are accurate;
• the submitted study corresponds to the approved protocol;
• material amendments and deviations have been disclosed;
• informed consent was obtained or a valid waiver was granted;
• consent for publication was obtained for identifiable material;
• privacy and confidentiality protections are adequate;
• data sharing is consistent with consent and governance requirements;
• children and other vulnerable participants received additional protection;
• payments and incentives were ethically appropriate;
• secondary data were accessed and used lawfully;
• human biological materials were used within the permitted scope;
• clinical or interventional studies were registered where required;
• animal research was approved and reported under ARRIVE 2.0;
• replacement, reduction, and refinement were considered;
• fieldwork and environmental permits were obtained;
• community and Indigenous governance requirements were respected;
• biosafety, food-safety, laboratory, and occupational risks were managed;
• dual-use and public-safety risks were assessed;
• adverse events and unexpected problems were reported honestly;
• AI processing of protected data was authorised and disclosed;
• all ethics documents have been retained;
• the journal can receive supporting documentation securely if requested; and
• all authors have reviewed and approved the ethical declarations.

61. Standards Informing This Policy

This policy is informed by internationally recognised principles concerning ethical oversight and responsible research, including:

• World Medical Association Declaration of Helsinki;
• CIOMS International Ethical Guidelines for Health-Related Research Involving Humans;
• ICMJE: Protection of Research Participants;
• ARRIVE Guidelines 2.0; and
• COPE: Ethical Oversight.

Reference to these organisations means that their guidance informs the journal’s policy. It does not imply membership, certification, endorsement, or formal affiliation unless separately stated and independently verifiable.

62. Contact

Questions concerning ethical approval, review exemptions, informed consent, identifiable information, animal welfare, community governance, biosafety, environmental permits, dual-use risks, or suspected ethical misconduct should be directed to the FSSS Editorial Office through the official contact information provided on the journal website.

Correspondence concerning an existing manuscript or article should include:

• the manuscript title;
• the submission identification number or DOI;
• the type of research involved;
• the name of the approving body;
• the approval or reference number;
• a clear description of the question or concern; and
• relevant supporting documentation.