Informed Consent and Clinical Trials

Policy effective date: 1 June 2026

Last updated:  1 August 2026

1. Purpose and Scope

AMG Transcend Association requires research involving human participants to respect participant autonomy, dignity, safety, welfare, privacy, and the right to make an informed and voluntary decision concerning participation.

This policy establishes publisher-level requirements concerning informed consent, consent waivers or modifications, 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.

Individual journals may establish additional requirements appropriate to their aims and scope, study designs, clinical disciplines, and types of human research considered for publication.

2. 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, modification, or alternative applies.

Consent must be:

• freely and voluntarily given;
• obtained without coercion, inappropriate pressure, exploitation, 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, or through another legally and ethically appropriate mechanism;
• 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, treatment, or injury-related arrangements where applicable;
• other information required by the approved protocol, ethics body, institutional requirements, or applicable law.

Consent to participate in research does not by itself constitute consent for every subsequent use or publication of identifiable information.

3. Form and Documentation of Consent

Written informed consent should normally be obtained where appropriate to the nature of the research and applicable ethical or regulatory requirements.

Alternative forms of consent, including appropriately documented 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 and process of consent must be appropriate to the study design, participant population, level of risk, and applicable requirements.

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 where necessary to assess a specific ethical concern.

Authors should not routinely submit completed participant consent forms containing confidential or identifiable personal information unless specifically requested and an appropriate secure procedure has been established.

4. 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 authorized body.

Authors must not determine solely for themselves that informed consent can be omitted where independent ethical approval of a waiver or modification 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, privacy, 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.

5. 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 ethical, legal, and institutional 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, dependency, 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.

6. 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 where 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, legal, 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.

7. 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;
• educational interventions intended to affect health outcomes;
• nutritional or dietary interventions;
• preventive interventions;
• rehabilitation interventions;
• quality-improvement or process-of-care interventions;
• other interventions intended to modify or evaluate health-related 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, assignment procedure, intervention, and outcomes when determining whether registration requirements apply.

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.

Where there is genuine uncertainty concerning whether a study constitutes a clinical trial, authors are encouraged to consider registration prospectively and to consult the applicable journal requirements before enrollment begins.

8. 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 enrollment of the first participant.

For clinical trials beginning participant enrollment on or after the effective date of this requirement, prospective registration is a condition of consideration for publication.

Registration must make the existence and essential prespecified design of the trial publicly accessible before participant enrollment and must not be intentionally delayed until completion of the study, analysis of results, preparation of the manuscript, or submission for publication.

Registration with an ethics committee, institution, sponsor, funder, regulatory file, or internal study database does not by itself satisfy the requirement for public clinical-trial registration.

Authors remain responsible for satisfying any additional legal, regulatory, institutional, sponsor, or funder registration requirements applicable to the trial.

9. Acceptable Clinical-Trial Registries

Clinical trials must be registered in an appropriate publicly accessible registry meeting recognized standards for clinical-trial registration.

Acceptable registration includes:

• a Primary Registry in the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) Registry Network; or
• ClinicalTrials.gov.

Where applicable laws, regulations, funders, sponsors, or institutions require registration in another registry or system, authors must also comply with those requirements.

The registry record must be publicly accessible and sufficiently complete to identify the trial and its essential prespecified characteristics.

Authors are responsible for ensuring that the selected registry is appropriate for the applicable journal, regulatory, ethical, and publication requirements.

10. Registration Information in the Manuscript

Manuscripts reporting clinical trials must identify the trial registration.

Authors must provide:

• the name of the registry;
• the trial registration number or unique identifier;
• sufficient information to allow the public registry record to be located and compared with the submitted report.

The trial registration number must be included in the manuscript and, where required by the relevant journal, in the abstract and article metadata.

Authors are responsible for ensuring that trial-registration information is accurate and corresponds to the study being reported.

Editors may compare the submitted manuscript with the publicly available trial-registration record when assessing the study.

11. Consistency Between Registration, Protocol, and Publication

Authors must report clinical trials transparently and must not conceal material differences between the registered trial, approved protocol, statistical or analytical plan where applicable, and submitted or published report.

Where relevant, editors may examine:

• prespecified primary and secondary outcomes;
• interventions and comparator groups;
• eligibility criteria;
• planned sample size;
• recruitment or enrollment dates;
• trial status;
• prespecified analyses;
• other material aspects of the registered study design.

Legitimate protocol amendments may occur during a clinical 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, sample size, or other important trial characteristics must not be concealed or presented in a manner that could mislead readers regarding what was prospectively planned.

Authors must provide an appropriate explanation for material discrepancies where requested by the journal.

12. Late or Retrospective Registration

Registration performed after enrollment of the first participant has begun constitutes retrospective or late registration and does not satisfy the principle of prospective clinical-trial registration.

For trials beginning participant enrollment on or after the effective date of this policy requirement, retrospective registration will not ordinarily satisfy the journal’s prospective-registration requirement.

Late registration is an exception requiring specific editorial assessment and must not be treated as an alternative to prospective registration.

For trials initiated before the effective date 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;
• any other information requested by the journal to evaluate the circumstances.

Late or retrospective registration must not be concealed or described as prospective registration.

Where an exception is considered, the responsible editor must evaluate the circumstances, including the timing and reason for delayed registration and whether the absence of prospective registration creates concerns about selective reporting, outcome modification, transparency, or research integrity.

Editorial consideration of an exceptionally late-registered or historically unregistered trial does not establish a general exception to the prospective-registration requirement.

13. 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 ethical 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 received appropriate ethical approval or that participants provided valid informed consent.

Authors are responsible for satisfying each requirement applicable to their research.

14. Reporting of Clinical Trials

Clinical trials must be reported accurately, completely, transparently, and consistently with the applicable protocol, registry information, ethical approvals, and recognized reporting standards.

Authors should follow reporting guidelines appropriate to the study design, including the CONSORT reporting guideline for randomized controlled trials, where applicable, or other relevant discipline-specific reporting standards.

The existence of a registered protocol or trial record does not justify selective reporting, omission of relevant outcomes, suppression of unfavorable results, or presentation of exploratory or post hoc analyses as though they had been prespecified.

Relevant changes from the registered or approved study plan must be identified and explained where necessary for accurate interpretation of the findings.

Funding, sponsor involvement, author access to data, and relevant competing interests must be disclosed in accordance with applicable publisher and journal policies.

15. Responsibilities of Authors

Authors reporting research involving human participants or clinical trials are responsible for ensuring that:

• applicable informed-consent requirements were satisfied or an appropriate waiver or modification was obtained;
• required ethical review and approval were obtained prospectively;
• consent for publication of identifiable information was obtained where required;
• clinical trials were appropriately and prospectively registered where applicable;
• trial-registration information reported in the manuscript is accurate;
• relevant differences between registration, protocol, and published reporting are transparently identified and explained;
• required funding, sponsorship, and competing-interest information is disclosed;
• supporting information can be provided where legitimately requested during editorial assessment or assessment of a subsequent ethical or integrity concern.

False, fabricated, materially misleading, or deliberately incomplete statements concerning consent, ethical approval, participant enrollment, or trial registration may constitute a publication-ethics or research-integrity concern.

16. Editorial Assessment

Editors may request clarification or supporting information where informed consent, ethical approval, trial registration, or reporting is unclear, incomplete, or potentially inconsistent.

Editorial assessment may include examination of:

• ethical approval information;
• informed-consent statements;
• approved waivers or modifications;
• trial-registry records;
• relevant protocol information;
• participant-enrollment and registration dates;
• reported and registered outcomes;
• explanations for material discrepancies.

Where necessary, editors may seek independent ethical, clinical, statistical, methodological, regulatory, or other appropriately qualified expert advice.

A manuscript may be rejected where required consent, ethical approval, or prospective clinical-trial registration was not obtained, or where significant unresolved discrepancies prevent reasonable confidence in the ethical, transparent, or reliable conduct and reporting of the research.

Editorial action must reflect the nature, timing, seriousness, and implications of the problem and must be fair and proportionate.

17. 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, documentation, trial records, protocol information, or other relevant supporting material.

Where the published record is incomplete or inaccurate but the underlying work remains reliable, clarification or correction may be appropriate.

Where concerns materially affect the ethical acceptability, reliability, transparency, or integrity of the publication, further action may include:

• an expression of concern;
• retraction;
• institutional or regulatory referral;
• another proportionate measure necessary to protect participants, readers, or the scholarly record.

Post-publication actions must be taken in accordance with the applicable Publication Ethics and Research Integrity and Corrections, Retractions and Expressions of Concern policies.

18. 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
• Complaints and Appeals

Individual journals may establish additional requirements appropriate to the types of human research and clinical studies they consider for publication.