手法を比較

	インフォームド・コンセントの免除	研究におけるデータ保護とプライバシー
分野	研究倫理	研究倫理
系統	Process / pipeline	Process / pipeline
提唱年	1991	1996
提唱者	U.S. Department of Health and Human Services; International research ethics guidelines	European Union; U.S. Department of Health and Human Services; International research ethics community
種類	Guideline	Regulation
原典	U.S. Department of Health and Human Services. (2018). Protection of Human Subjects. Code of Federal Regulations Title 45, Part 46, Section 46.116(c).	European Union. (2018). Regulation (EU) 2016/679 of the European Parliament and of the Council: General Data Protection Regulation (GDPR). Official Journal of the European Union, L 119, 1-88.
別名	consent waiver, waived consent, exempt from consent, research without consent	research privacy, GDPR research, data security, confidentiality
関連	5	5
概要	A waiver of informed consent permits research to proceed without obtaining prospective written or verbal consent from participants. This exception to the standard informed consent requirement applies to specific low-risk research scenarios where obtaining consent is impractical, unnecessary, or would compromise research validity. In the U.S., the regulations (45 CFR 46.116) specify four criteria that must be met for an IRB to approve a waiver; similar criteria apply in the UK (Research Ethics Committee) and EU jurisdictions. Waivers are not automatic; researchers must request them explicitly and justify them to the ethics committee, which determines whether the criteria are met.	Research involving human subjects generates sensitive data: medical records, genetic information, behavioral responses, economic or social information. Regulatory frameworks—HIPAA (Health Insurance Portability and Accountability Act) in the U.S., GDPR (General Data Protection Regulation) in the European Union, and parallel regulations in other countries—establish legal obligations for data protection and privacy. Researchers must implement technical and procedural safeguards to prevent unauthorized access, maintain confidentiality, and comply with participant rights (access, rectification, deletion, data portability). Understanding data protection requirements is not optional compliance; it is foundational to ethical research.