השוואת שיטות

	הגנה על נתונים ופרטיות במחקר	תהליך הגשת בקשה לוועדת אתיקה
תחום	אתיקה במחקר	אתיקה במחקר
משפחה	Process / pipeline	Process / pipeline
שנת המקור	1996	1991
הוגה השיטה	European Union; U.S. Department of Health and Human Services; International research ethics community	U.S. Department of Health and Human Services; International research oversight organizations
סוג	Regulation	Guideline
מקור מכונן	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.	U.S. Department of Health and Human Services. (2018). Protection of Human Subjects. Code of Federal Regulations Title 45, Part 46, Section 46.109.
כינויים	research privacy, GDPR research, data security, confidentiality	IRB application, REC application, ethics approval, protocol submission
קשורות	5	5
תקציר	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.	Submitting a research protocol to an ethics committee (IRB, REC, or equivalent) is a mandatory procedural gateway in human subjects research. The application process requires researchers to document their study design, justify scientific rationale, disclose risks and benefits, provide participant protections (informed consent forms), and address ethical considerations. The submission includes a completed ethics application form, protocol document, consent forms, researcher CVs, and evidence of institutional support. This standardized process enables ethics committees to conduct rigorous, timely, and consistent review before research commences.