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 applicable across the journals published by AMG Transcend Association.
Authors are responsible for ensuring that all required ethical approvals, permissions, safeguards, and declarations applicable to their research have been obtained and accurately reported.
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 biological material, must be conducted in accordance with applicable ethical standards 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 or alternative applies;
- privacy, confidentiality, and data-protection requirements are respected;
- vulnerable individuals and populations receive appropriate additional protections; and
- 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 or review body;
- the approval or reference number, where available;
- confirmation that approval was obtained before commencement of the research; and
- 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 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 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, 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.
Detailed requirements concerning informed consent, consent waivers, identifiable information, 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, or undue influence must be avoided; and
- applicable ethical approval must specifically cover the relevant participant population and procedures.
Vulnerability must be assessed according to the actual circumstances of the research rather than assumed solely from membership in a particular group.
6. Privacy, Confidentiality, and Human Data
Research involving personal, medical, genetic, biometric, behavioral, or other sensitive information must comply with applicable privacy, confidentiality, ethical, and data-protection requirements.
Authors must use appropriate safeguards to limit unauthorized identification, access, disclosure, or reuse of participant information.
Anonymization, pseudonymization, restricted access, 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.
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, or third parties, authors must ensure that its use for the reported research is consistent with applicable permissions, consent arrangements, ethical approvals, and legal requirements.
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; and
- 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 account of the 3Rs.
Replacement
Where scientifically appropriate alternatives can achieve the research objective without the use of animals, such alternatives should be considered.
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 or incapable of producing meaningful results, as 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 and purpose 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 for:
- anesthesia and analgesia;
- peri-procedural monitoring;
- postoperative or supportive care;
- recognition of clinical or behavioral signs of distress;
- intervention criteria;
- humane endpoints; and
- 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.
Unexpected serious welfare concerns arising during a study must be addressed in accordance with applicable ethical and institutional requirements.
11. Ethical Approval and Reporting for Animal Research
Authors must accurately report applicable ethical information concerning animal research.
Where relevant, the manuscript must identify:
- the approving animal ethics or animal care and use committee;
- the approval or protocol reference number, where available;
- the applicable institutional or regulatory framework;
- the species and experimental model used;
- relevant welfare measures; and
- other ethical information necessary to understand how the study was conducted.
Authors must be prepared to provide supporting documentation where legitimately requested during editorial assessment or investigation of an 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, welfare measures, analysis, and other relevant aspects of the study to allow readers to evaluate the methods and findings appropriately.
Compliance with reporting guidelines does not substitute for ethical approval 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 or regulatory authorizations; or
- other documentation necessary to assess a specific ethical concern.
Editors may seek independent ethical, scientific, clinical, veterinary, or other appropriate expert advice where necessary.
Ethical approval does not prevent an editor from raising legitimate concerns about whether research was conducted or reported in an ethically acceptable manner.
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, consent, or authorization was not obtained, or where substantial concerns remain concerning participant protection or animal welfare, the matter may constitute a substantive ethical problem.
Depending on the circumstances, the journal may:
- request clarification or supporting documentation;
- suspend editorial consideration while the concern is assessed;
- obtain independent expert advice;
- reject the manuscript;
- refer serious concerns to an institution, ethics committee, regulatory authority, or other appropriate body; or
- take appropriate post-publication action if the work has already been published.
Actions must be evidence-based and proportionate to the nature and seriousness of the concern.
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.
Authors may be required to provide relevant documentation or explanations.
Where an ethical issue affects the reliability, acceptability, legality, or transparency of the published research, appropriate action may include correction, expression of concern, retraction, or 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; and
- Corrections, Retractions and Expressions of Concern.
Individual journals may establish additional requirements appropriate to the research disciplines, study designs, and types of content they publish.