Methods to obtain informed consent in medical and biological research involving human subject: application to studies on digestive endoscopy

The Declaration of Helsinki states that participation by individuals in medical research as subjects is voluntary, and consent must be obtained after adequate provision of information about the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study [1]. Moreover, the potential subject must be informed of the right to refuse study participation or to withdraw consent at any time without reprisal. For medical research using identifiable human material or data, physicians must seek informed consent for its collection and/or reuse. However, in exceptional situations in which consent would be impossible or impractical to obtain, such as retrospective studies using old existing materials, the research may be done only after approval by a research ethics committee.

Publication History

Article published online:
10 June 2022

• References

• 1 WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. Available at https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
• 2 Ikeda T, Yoshizaki T, Eguchi T. et al. Efficacy of specimen pasting after cold snare polypectomy for pathological evaluation of horizontal margins. Endosc Int Open 2022; 10: E7120-E718
• 3 倫理指針（本文）（平成29年2月28日一部改正. available at https://www.mhlw.go.jp/content/10600000/000757206.pdf