“Ethics Committee Approval and Participant Consent Were Not Required”: Challenging a Persistent Misconception in Biomedical Research

Abstract

Biomedical journal editors often encounter manuscripts claiming that ethics review or participant consent was unnecessary because the studies were low risk or did not involve patients. Such claims may reflect misunderstandings of contemporary research ethics. Ethical responsibilities extend to research involving human participants, identifiable data, biological materials, and digital or online settings. Exemption from ethics review and waiver or modification of informed consent are distinct decisions that should be made in accordance with applicable regulations and, where required, determined by an ethics committee rather than the investigator alone. This article examines four common misconceptions and provides practical guidance for clear ethics statements in biomedical manuscripts.