Human and Animal Research Ethics

1. Purpose and Scope

AMG Transcend Association requires research involving human participants, human data, human biological material, or animals to be conducted and reported in accordance with recognized ethical principles and applicable legal, regulatory, institutional, and professional requirements.

This policy establishes publisher-level requirements for human and animal research across the journals published by AMG Transcend Association.

Authors are responsible for ensuring that all required ethical approvals, permissions, safeguards, authorizations, and declarations applicable to their research have been obtained and accurately reported.

Individual journals may establish additional requirements appropriate to their aims and scope, disciplines, study designs, research populations, and types of published content.

2. Research Involving Human Participants

Research involving human participants must respect their rights, dignity, safety, welfare, privacy, and autonomy.

Research involving humans, including research using identifiable human data or human biological material, must be conducted in accordance with applicable ethical standards, institutional requirements, and laws and regulations and, where relevant, internationally recognized principles for research involving human participants, including the Declaration of Helsinki.

Authors must ensure that:

• the research has a scientifically and ethically justified design;
• foreseeable risks and burdens are appropriately assessed and minimized;
• risks are reasonable in relation to the anticipated benefits and scientific value of the research;
• participation is voluntary;
• appropriate informed consent is obtained unless a justified and ethically approved waiver, modification, or alternative applies;
• privacy, confidentiality, and data-protection requirements are respected;
• vulnerable individuals and populations receive appropriate additional protections;
• the research is conducted in accordance with the protocol and conditions approved by the responsible ethics body.

3. Ethical Review and Approval for Human Research

Where ethical review is required, research must receive approval from an appropriately constituted ethics committee, institutional review board, or equivalent authorized body before the relevant research activities begin.

Authors must accurately report, where applicable:

• the name of the approving ethics committee, institutional review board, or equivalent body;
• the approval, protocol, or reference number, where available;
• confirmation that approval was obtained prospectively where prior approval was required;
• relevant information concerning waivers, exemptions, amendments, or other ethical determinations.

Where formal ethical approval was not required, authors must be able to explain the basis for that determination in accordance with applicable institutional, legal, regulatory, and disciplinary requirements.

Approval obtained retrospectively does not ordinarily remedy the absence of prior approval where prospective ethical review was required.

Material changes to an approved research protocol must receive additional review or approval where required.

4. Informed Consent and Participant Autonomy

Human participation must be based on appropriate informed consent unless an ethically justified and formally approved waiver, modification, or alternative is applicable.

Consent procedures must be appropriate to the study design, participant population, applicable regulations, and level of risk.

Participants must not be subjected to coercion, inappropriate pressure, exploitation, or undue influence.

Where individuals have limited or absent capacity to provide legally valid consent, appropriate procedures involving legally authorized representatives and, where applicable, participant assent must be followed.

Consent to participate in research does not automatically constitute consent for publication of identifiable information, images, recordings, or case details.

Detailed requirements concerning informed consent, consent waivers, identifiable information, consent for publication, and clinical research are addressed in the Informed Consent and Clinical Trials policy.

5. Vulnerable Participants and Populations

Research involving individuals or populations whose circumstances may limit their ability to protect their own interests requires particular ethical attention.

Vulnerability may arise from factors including age, impaired decision-making capacity, health status, dependency relationships, social or economic disadvantage, institutionalization, or other circumstances relevant to the research context.

Where vulnerable participants are included:

• their inclusion must be scientifically and ethically justified;
• risks and burdens must be appropriately minimized;
• additional safeguards must be implemented where necessary;
• consent and assent procedures must reflect the participants’ circumstances and legal capacity;
• inappropriate inducement, exploitation, coercion, or undue influence must be avoided;
• applicable ethical approval must cover the relevant participant population and procedures.

Vulnerability must be assessed according to the actual circumstances and context of the research rather than assumed solely from membership in a particular demographic or social group.

6. Privacy, Confidentiality, and Human Data

Research involving personal, medical, genetic, genomic, biometric, behavioral, or other sensitive information must comply with applicable privacy, confidentiality, ethical, institutional, legal, and data-protection requirements.

Authors must use appropriate safeguards to limit unauthorized identification, access, disclosure, transfer, or reuse of participant information.

Anonymization, pseudonymization, restricted access, controlled data sharing, or other protective measures should be used where appropriate to the nature of the data and research.

The publication of information, images, audio, video, case details, or combinations of information from which an individual may reasonably be identified may require specific consent for publication in addition to consent for participation in the research.

Removal of obvious identifiers does not necessarily eliminate the possibility of identification where combinations of information could reasonably identify an individual.

Detailed requirements concerning identifiable information and consent for publication are addressed in the Informed Consent and Clinical Trials policy.

7. Research Involving Human Biological Material

Research involving human tissues, cells, specimens, biological samples, or other human-derived material must comply with applicable ethical, consent, privacy, institutional, legal, and regulatory requirements.

Authors must ensure that the collection, storage, access, transfer, secondary use, and analysis of such material are appropriately authorized where required.

Where material was obtained from repositories, biobanks, previous studies, clinical sources, collaborators, or other third parties, authors must ensure that its use for the reported research is consistent with applicable permissions, consent arrangements, ethical approvals, governance requirements, and legal requirements.

Where relevant, manuscripts should provide sufficient information concerning the source and ethical status of human-derived materials to permit appropriate editorial and scholarly assessment.

8. Research Involving Animals

Research involving animals must be scientifically justified and conducted with appropriate regard for animal welfare.

Animal studies must comply with applicable national, institutional, and regulatory requirements and with recognized principles for the ethical use of animals in research.

Where ethical review is required, the study must receive approval from an appropriately authorized animal ethics, animal care and use, or equivalent committee before the relevant experimental work begins.

Authors must ensure that animal research:

• has a scientifically justified purpose;
• uses an appropriate species and experimental model;
• applies the principles of Replacement, Reduction, and Refinement (the 3Rs);
• uses no more animals than are reasonably required to achieve scientifically valid objectives;
• minimizes avoidable pain, suffering, distress, and lasting harm;
• uses appropriate anesthesia, analgesia, sedation, monitoring, and supportive care where required;
• establishes appropriate humane endpoints;
• provides suitable housing, husbandry, environmental conditions, and veterinary or welfare oversight where applicable;
• is conducted by personnel with appropriate training, competence, and supervision.

9. Replacement, Reduction, and Refinement

The ethical design and conduct of animal research must take appropriate account of the principles of Replacement, Reduction, and Refinement.

Replacement

Where scientifically appropriate methods can achieve the research objective without the use of animals, suitable alternatives should be considered.

Replacement approaches may include non-animal experimental systems, computational approaches, in vitro models, or other scientifically appropriate methods depending on the research question.

Reduction

The number of animals used should be sufficient to achieve scientifically valid objectives while avoiding unnecessary animal use.

Reduction must not be pursued in a manner that makes the research inadequately designed, underpowered, or incapable of producing meaningful results, because poorly designed studies may themselves constitute an unnecessary use of animals.

Refinement

Experimental procedures, animal care, handling, housing, monitoring, and endpoints should be designed to minimize pain, suffering, distress, and adverse effects while supporting appropriate scientific outcomes.

The application of the 3Rs must be considered in relation to the nature, scientific objectives, and circumstances of the research rather than treated as a purely numerical or administrative requirement.

10. Animal Welfare, Pain, and Humane Endpoints

Potential animal pain, suffering, distress, and adverse effects must be anticipated and appropriately managed.

Where applicable, study protocols must include suitable measures concerning:

• anesthesia and analgesia;
• peri-procedural monitoring;
• postoperative or supportive care;
• recognition of clinical, physiological, or behavioral signs of distress;
• intervention criteria;
• humane endpoints;
• appropriate methods of euthanasia.

Any withholding of analgesia, anesthesia, or other welfare measures where they would ordinarily be indicated must be scientifically and ethically justified and must be consistent with the approved protocol and applicable animal-welfare requirements.

Unexpected serious welfare concerns arising during a study must be addressed promptly in accordance with applicable ethical, veterinary, institutional, and regulatory requirements.

11. Ethical Approval and Reporting for Animal Research

Authors must accurately and transparently report applicable ethical information concerning animal research.

Where ethical approval is required, the manuscript must identify:

• the approving animal ethics, animal care and use, or equivalent committee;
• the approval or protocol reference number, where available;
• other information necessary to establish the ethical oversight applicable to the study.

Where relevant to understanding the ethical and scientific conduct of the research, manuscripts should also report:

• the applicable institutional or regulatory framework;
• the species and experimental model used;
• relevant anesthesia, analgesia, welfare, monitoring, and humane-endpoint measures;
• applicable permits, licenses, or other authorizations.

Authors must be prepared to provide supporting documentation where legitimately requested during editorial assessment or assessment of a subsequent ethical concern.

Where permits, licenses, or other authorizations are required for the acquisition, capture, transport, handling, housing, use, or study of animals, authors are responsible for ensuring that these requirements have been satisfied.

12. Reporting of Animal Research

Animal research must be reported transparently and in sufficient detail to permit appropriate scientific and ethical assessment.

Where applicable to the study type, authors should follow recognized reporting guidance for animal research, including the ARRIVE Guidelines, or other relevant discipline-specific reporting standards.

Reporting should provide sufficient information concerning the animals, experimental design, procedures, interventions, allocation methods, welfare measures, statistical analysis, and other relevant aspects of the study to allow readers and reviewers to evaluate the methods and findings appropriately.

Compliance with a reporting guideline does not substitute for ethical approval, scientific justification, or appropriate animal-welfare practices.

13. Documentation and Editorial Assessment

Authors are responsible for the accuracy and completeness of all statements concerning human and animal research ethics.

Editors may request, where relevant:

• evidence of ethical approval;
• approval or protocol documentation;
• explanations concerning exemptions or waivers;
• consent-related documentation;
• information concerning protocol amendments or deviations;
• animal-welfare information;
• applicable permits, licenses, or regulatory authorizations;
• other documentation necessary to assess a specific ethical concern.

Editors may seek independent ethical, scientific, clinical, veterinary, legal, or other appropriately qualified expert advice where necessary.

The existence of an ethical approval document does not prevent an editor from raising legitimate concerns about whether the research was conducted or reported in an ethically acceptable manner.

Documentation requests must be proportionate to the issue under assessment and handled subject to applicable confidentiality, privacy, legal, ethical, and data-protection requirements.

14. Missing or Inadequate Ethical Compliance

Failure to include an ethics statement in a manuscript does not necessarily mean that required ethical approval was absent.

Where approval was appropriately obtained but incompletely reported, the journal may request clarification or correction.

Where required ethical approval, informed consent, permission, or authorization was not obtained, or where substantial concerns remain concerning participant protection or animal welfare, the matter may constitute a substantive ethical problem rather than a reporting deficiency.

Depending on the circumstances, the journal may:

• request clarification or supporting documentation;
• suspend or pause editorial consideration while the concern is assessed;
• obtain independent expert advice;
• request correction or additional reporting;
• reject the manuscript;
• refer serious concerns to an institution, ethics committee, regulatory authority, funder, or other appropriate body;
• take appropriate post-publication action where the work has already been published.

Actions must be evidence-based, fair, and proportionate to the nature and seriousness of the concern.

An allegation or incomplete record must not automatically be treated as established misconduct.

15. Post-Publication Ethical Concerns

Credible concerns relating to human or animal research ethics that arise after publication must be assessed regardless of whether ethical approval was reported at the time of publication or the article successfully completed peer review.

Authors may be required to provide relevant documentation, approvals, explanations, or other supporting evidence.

Where appropriate, the journal may seek information or advice from relevant institutions, ethics bodies, regulatory authorities, or independent experts.

Where an ethical issue affects the reliability, ethical acceptability, legality, or transparency of the published research, appropriate action may include:

• clarification;
• correction;
• expression of concern;
• retraction;
• another measure necessary to protect participants, animal welfare, readers, or the integrity of the scholarly record.

Detailed procedures are addressed in the Publication Ethics and Research Integrity and Corrections, Retractions and Expressions of Concern policies.

16. Relationship with Other Policies

This policy should be read together with applicable AMG Transcend Association and journal policies concerning:

• Research Ethics
• Informed Consent and Clinical Trials
• Publication Ethics and Research Integrity
• Data Integrity and Reproducibility
• Authorship and Contributor Responsibilities
• Conflict of Interest and Competing Interests
• Corrections, Retractions and Expressions of Concern
• Complaints and Appeals

Individual journals may establish additional requirements appropriate to the research disciplines, methodologies, study designs, participant populations, animal models, and types of content they publish.