Methoden vergelijken

	Gegevensbescherming en privacy in onderzoek	Onderzoek met Kwetsbare Populaties
Vakgebied	Onderzoeksethiek	Onderzoeksethiek
Familie	Process / pipeline	Process / pipeline
Jaar van ontstaan	1996	1979
Grondlegger	European Union; U.S. Department of Health and Human Services; International research ethics community	U.S. Department of Health and Human Services; World Health Organization; International research ethics community
Type	Regulation	Guideline
Oorspronkelijke bron	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, Subparts B, C, D.
Aliassen	research privacy, GDPR research, data security, confidentiality	vulnerable subjects, special populations, vulnerable groups, additional protections
Verwant	5	5
Samenvatting	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.	Vulnerable populations are groups with limited capacity to protect themselves due to age, cognitive ability, institutional dependency, or social circumstances. Regulatory frameworks in the U.S. (45 CFR 46 Subparts B, C, D) and internationally identify specific vulnerable populations—children, prisoners, pregnant women, cognitively impaired individuals—and mandate additional ethical protections beyond standard informed consent. These protections include obtaining informed consent from surrogate decision-makers (parents, guardians), additional assurances of minimal risk, and enhanced monitoring for safety. Research ethics committees apply heightened scrutiny to studies involving vulnerable populations and may deny approval if special protections are inadequate.