The Medicines for Human Use (Clinical Trials) Regulations 2004

Principles based on International Conference on Harmonisation GCP Guideline(1)

3.  The rights, safety, and well-being of the trial subjects are the most important considerations and shall prevail over interests of science and society .

(1)

See Section 2 of the Note for Guideline on Good Clinical Practice (CPMP/ICH/135/95) published by the European Agency for the Evaluation of Medicinal Products in July 2002.