- Purpose and Scope
AMG Transcend Association requires research involving human participants to respect participant autonomy, dignity, safety, privacy, and the right to make an informed and voluntary decision about participation.
This policy establishes publisher-level requirements concerning informed consent, consent waivers, individuals with limited capacity to consent, consent for publication of identifiable information, and the registration and reporting of clinical trials across the journals published by AMG Transcend Association.
These requirements apply together with applicable ethical, legal, regulatory, and institutional requirements and with the relevant journal-specific policies.
- Informed Consent to Participate
Informed consent must be obtained from human participants before their participation in research unless an ethically justified and appropriately approved waiver or modification applies.
Consent must be:
- freely and voluntarily given;
- obtained without coercion, inappropriate pressure, or undue influence;
- based on information that is understandable and appropriate to the participant;
- obtained from an individual with the capacity and authority to provide consent; and
- documented in accordance with the approved research protocol and applicable requirements.
Participants should receive sufficient information to make an informed decision concerning participation, including, where relevant:
- the purpose and nature of the research;
- the procedures or interventions involved;
- reasonably foreseeable risks, burdens, and potential benefits;
- relevant alternatives where applicable;
- confidentiality and data-use arrangements;
- voluntary participation and the applicable right to withdraw;
- relevant compensation, reimbursement, or treatment arrangements where applicable; and
- other information required by the approved protocol, ethics body, or applicable law.
Consent to participate in research does not by itself constitute consent for every subsequent use or publication of identifiable information.
- Form and Documentation of Consent
Written informed consent should normally be obtained where appropriate to the nature of the research.
Alternative forms of consent, including electronic or verbal consent, may be acceptable where they are ethically appropriate, permitted under applicable requirements, and approved by the responsible ethics committee or equivalent body where such approval is required.
The form of consent must be appropriate to the study design and participant population.
Information provided to participants must be communicated in a language and manner they can reasonably understand.
Authors are responsible for maintaining appropriate records demonstrating that required consent procedures were followed. Journals may request confirmation or supporting documentation when necessary to assess a specific ethical concern.
Authors should not routinely submit completed participant consent forms containing confidential personal information unless specifically requested and an appropriate secure procedure has been established.
- Waivers or Modifications of Informed Consent
A waiver or modification of informed consent may be accepted only where it is ethically and legally permissible and, where required, has been explicitly approved by an appropriate ethics committee, institutional review board, or equivalent body.
Authors must not determine solely for themselves that informed consent can be omitted where independent ethical approval of a waiver is required.
A waiver may be relevant, for example, to certain retrospective, minimal-risk, secondary-data, or other research where obtaining individual consent is impracticable and participant rights and welfare remain appropriately protected.
The existence and basis of any waiver or modification must be reported transparently in the manuscript where relevant.
A waiver of consent must not be used merely for convenience or to avoid appropriate participant protections.
- Participants with Limited Capacity and Vulnerable Circumstances
Where prospective participants cannot provide legally or ethically valid informed consent, appropriate consent must be obtained from a legally authorized representative or through another procedure permitted by applicable requirements.
Where participants are capable of understanding the research to an appropriate degree but do not have full legal capacity to consent, their assent should be sought where appropriate in addition to the required permission or consent from an authorized representative.
Additional safeguards must be used where participants may be particularly susceptible to coercion, undue influence, exploitation, or limitations on autonomous decision-making.
The inclusion of such participants must be scientifically and ethically justified and covered by appropriate ethical review where required.
- Consent for Publication of Identifiable Information
Consent to participate in research and consent to publish identifiable information are distinct.
Where a manuscript contains personal data, images, audio, video, clinical details, case information, or combinations of information through which an individual could reasonably be identified, explicit consent for publication must be obtained where required.
Removing names or direct identifiers may not be sufficient if an individual remains reasonably identifiable from other information.
Masking, cropping, blurring, or otherwise modifying an image does not automatically eliminate the possibility of identification.
Authors must minimize unnecessary identifying information and must ensure that publication of identifiable material is consistent with the consent provided and with applicable ethical, privacy, and data-protection requirements.
Where consent for publication is required, authors must retain appropriate documentation and confirm in the manuscript that such consent was obtained.
- Clinical Trials
For the purposes of this policy, a clinical trial is a research study in which human participants or groups of participants are prospectively assigned to one or more health-related interventions in order to evaluate effects on health outcomes.
Health-related interventions may include, as applicable:
- medicines or biological products;
- medical devices;
- surgical or procedural interventions;
- diagnostic or radiological procedures;
- behavioral interventions;
- nutritional interventions;
- preventive interventions;
- rehabilitation interventions;
- process-of-care interventions; or
- other interventions intended to evaluate effects on health outcomes.
The terminology used by authors or investigators does not determine whether a study is subject to clinical-trial registration requirements. Editors may assess the actual study design and intervention when determining whether registration is required.
Observational research in which investigators do not prospectively assign participants to a health-related intervention is not considered a clinical trial solely because health outcomes are studied.
- Prospective Clinical-Trial Registration
Clinical trials submitted to AMG Transcend Association journals must be registered in an appropriate publicly accessible clinical-trial registry prospectively, before recruitment or enrollment of the first participant begins.
For clinical trials beginning participant enrollment after adoption of this policy, prospective registration is a condition of consideration for publication.
Registration should make the existence and essential design of the trial publicly accessible before participant enrollment and must not be delayed until completion of the study, preparation of the manuscript, or submission for publication.
Registration with an ethics committee, institution, sponsor, or internal study database does not by itself satisfy the requirement for public clinical-trial registration.
- Acceptable Clinical-Trial Registries
Clinical trials should be registered in a registry that provides an appropriate publicly accessible trial record and meets recognized standards for clinical-trial registration.
Acceptable registration includes registration in:
- a Primary Registry participating in the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) Registry Network; or
- ClinicalTrials.gov.
Where applicable laws or regulations require registration in another registry or system, authors must comply with those requirements in addition to satisfying the journal’s applicable publication requirements.
The registry record must be publicly accessible and sufficiently complete to identify the trial and its principal prespecified characteristics.
- Registration Information in the Manuscript
Manuscripts reporting clinical trials must identify the trial registration.
Authors must provide, as applicable:
- the name of the registry;
- the trial registration number or identifier; and
- sufficient information to allow the registry record to be located and compared with the submitted report.
The registration number should be included in the manuscript and in other article metadata where required by the journal.
Authors are responsible for ensuring that registration information is accurate.
Editors may compare the manuscript with the registered trial record when assessing the study.
- Consistency Between Registration, Protocol, and Publication
Authors must report clinical trials transparently and must not conceal material differences between the registered trial, approved protocol, and published report.
Where relevant, editors may examine:
- prespecified primary and secondary outcomes;
- study interventions and comparator groups;
- eligibility criteria;
- planned sample size;
- recruitment dates;
- trial status; and
- other material aspects of the registered study design.
Legitimate protocol amendments may occur during a trial. Material changes must be appropriately documented, ethically or regulatorily approved where required, and reflected in the trial registry where applicable.
Changes to outcomes, analyses, eligibility criteria, interventions, or other important trial characteristics must not be concealed in a manner that could mislead readers regarding what was prospectively planned.
Authors must provide an appropriate explanation for material discrepancies when requested by the journal.
- Late or Retrospective Registration
Registration performed after recruitment or enrollment of the first participant has begun is retrospective registration and does not satisfy the principle of prospective clinical-trial registration.
For trials beginning enrollment after adoption of this policy, retrospective registration will not ordinarily satisfy the journal’s requirements for consideration as a prospectively registered clinical trial.
For trials initiated before adoption of this requirement, or where exceptional circumstances require editorial assessment, authors must disclose:
- the date on which participant enrollment began;
- the date on which the trial was registered;
- the reason registration was not completed prospectively; and
- any other information requested by the journal to evaluate the circumstances.
Late registration must not be concealed or described as prospective registration.
Editorial consideration of an exceptionally late-registered or historically unregistered trial does not establish a general exception to the prospective-registration requirement.
- Ethics Approval, Consent, and Trial Registration Are Distinct Requirements
Ethical approval, informed consent, and clinical-trial registration serve different purposes and must not be treated as interchangeable.
Approval by an ethics committee does not replace informed consent where consent is required.
Informed consent does not replace ethics approval where independent ethical review is required.
Ethics approval and participant consent do not replace prospective public trial registration where clinical-trial registration is required.
Similarly, registration of a trial does not demonstrate that the study has received appropriate ethical approval or that participants provided valid informed consent.
Authors are responsible for satisfying all requirements applicable to their research.
- Reporting of Clinical Trials
Clinical trials must be reported accurately, completely, and consistently with the applicable protocol, registry information, ethical approvals, and recognized reporting standards.
Authors should use reporting guidelines appropriate to the study design where applicable.
The existence of a registered protocol or trial record does not justify selective reporting, omission of relevant outcomes, or presentation of exploratory analyses as though they had been prespecified.
Relevant changes from the registered or approved study plan should be identified and explained where necessary for an accurate interpretation of the findings.
Funding, sponsor involvement, and relevant competing interests must also be disclosed in accordance with the applicable publisher and journal policies.
- Responsibilities of Authors
Authors reporting research involving human participants or clinical trials are responsible for ensuring that:
- informed-consent requirements were satisfied or an appropriate waiver was obtained;
- required ethical review and approval were obtained prospectively;
- consent for publication of identifiable information was obtained where required;
- clinical trials were appropriately registered where applicable;
- trial registration information reported in the manuscript is accurate;
- relevant differences between registration, protocol, and published reporting are transparently explained;
- required funding, sponsorship, and competing-interest information is disclosed; and
- supporting information can be provided when legitimately requested during editorial assessment.
False, fabricated, misleading, or deliberately incomplete statements concerning consent, ethics approval, or trial registration may constitute a publication-ethics concern.
- Editorial Assessment
Editors may request clarification or supporting information where consent, ethical approval, trial registration, or reporting is unclear or potentially inconsistent.
Editorial assessment may include examination of:
- ethical approval information;
- consent statements;
- approved waivers;
- trial registry records;
- relevant protocol information;
- recruitment and registration dates;
- reported and registered outcomes; and
- explanations for material discrepancies.
Where necessary, editors may seek independent ethical, clinical, statistical, methodological, or other appropriate expert advice.
A manuscript may be rejected where required consent, ethical approval, or prospective trial registration was not obtained, or where significant unresolved discrepancies prevent confidence in the ethical or transparent conduct and reporting of the research.
Editorial action must reflect the nature, timing, seriousness, and implications of the problem.
- Post-Publication Concerns
Credible concerns relating to informed consent, ethical approval, clinical-trial registration, selective outcome reporting, or material discrepancies between a publication and the registered study must be assessed even after publication.
Authors may be required to provide explanations or relevant supporting documentation.
Where the published record is incomplete or inaccurate but the underlying work remains reliable, correction or clarification may be appropriate.
Where concerns materially affect the ethical acceptability, reliability, or integrity of the publication, further action may include an expression of concern, retraction, institutional referral, or another proportionate measure.
Post-publication actions must be taken in accordance with the applicable Publication Ethics and Research Integrity and Corrections, Retractions and Expressions of Concern policies.
- Relationship with Other Policies
This policy should be read together with applicable AMG Transcend Association and journal policies concerning:
- Research Ethics;
- Human and Animal Research Ethics;
- Publication Ethics and Research Integrity;
- Conflict of Interest and Competing Interests;
- Data Integrity and Reproducibility;
- Authorship and Contributor Responsibilities;
- Corrections, Retractions and Expressions of Concern; and
- Complaints and Appeals.
Individual journals may establish additional requirements appropriate to the types of human research and clinical studies they consider for publication.