guide / Submission statement template

Ethics Approval and Informed Consent Statement for Medical Papers

Templates and guidance for ethics approval, informed consent, waiver, animal ethics, and patient consent statements in medical manuscripts.

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What should an ethics approval and informed consent statement include in a medical paper?

An ethics approval and informed consent statement should identify the review body, approval number or protocol ID when available, consent process, waiver if applicable, patient publication consent for identifiable case material, and animal care standards when relevant. The wording should match the study design and journal policy.

Short answer

An ethics approval and informed consent statement should identify the review body, approval number when available, consent process, waiver when applicable, and special patient consent details for identifiable case material. The statement must match the study design and journal policy.

What to include

  • Name of the ethics committee, institutional review board, or relevant review body.
  • Approval number, protocol ID, or date when available.
  • Whether written informed consent was obtained.
  • Whether consent was waived and why, when approved by the review body.
  • For case reports or identifiable images, whether the patient or authorized representative reviewed and consented to publication.
  • For animal research, the institutional or national animal care standards followed.
  • For retrospective studies, registry studies, or public datasets, the applicable exemption or waiver language.

Template examples

This study was approved by [review body] (approval number: [ID]). Written informed consent was obtained from all participants.

The requirement for informed consent was waived by [review body] because [brief approved reason].

Written informed consent for publication of this case report and accompanying images was obtained from the patient.

How SciPaperX helps

SciPaperX can check whether the ethics and consent statement matches the article type, patient identifiability, human or animal research status, and journal instructions.