- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
3.1 Declaration of Helsinki
The current revision of the Declaration of Helsinki (Appendix 1) is the accepted basis for clinical trial ethics, and must be fully followed and respected by all parties involved in the conduct of such trials. Any departures from the Declaration must be justified and stated in the protocol. Independent assurance that subjects are protected can only be provided by an ethics committee and freely obtained informed consent.