Standard-of-care evaluation

Research that adds no constraint, or minimal constraints, to the usual care pathway: evaluating practices, care strategies or products already used in routine. Care is delivered as usual — what makes it research is the data collection and the methodology.

Regulatory frameworks

• WorldwideDeclaration of Helsinki · ICH E6(R3) good clinical practice · public trial registration (WHO principle) · local ethics committees (IRB in the United States, REB in Canada, HREC in Australia)
• European UnionNo dedicated EU regulation: Regulation 536/2014 only applies where a medicinal product is studied outside its marketing authorisation · GDPR — Regulation (EU) 2016/679 for data · otherwise, each country's national research law
• FranceLoi Jardé — RIPH 2 (minimal risks and constraints, list set by decree) or RIPH 3 (non-interventional: information and non-objection) · opinion of an ethics committee (CPP), ANSM informed · CNIL reference methodologies
• BelgiumLaw of 7 May 2004 on experiments on the human person, covering both interventional and non-interventional studies · opinion of an accredited ethics committee · lighter procedure and opt-out possible for non-interventional studies