Phase I Research in the Georgian Legal Order
A phase I clinical trial in Georgia is associated first of all with healthy volunteers, and this is precisely why its approval demands particular precision. Article 5¹ of the Law of Georgia on Drugs and Pharmaceutical Activities provides that preclinical and clinical research into pharmacological agents is conducted in accordance with the standards and guidelines approved by the relevant Minister, and that the start of research requires a permit. For the planner of a phase I study this defines the entire subsequent work — from the protocol to the reporting.
The law separately emphasises the protection of participants: the rights of patients and healthy volunteers participating in clinical research are protected by the legislation of Georgia. Research conducted on a healthy volunteer is exactly the case in which the participant receives no direct therapeutic benefit, which makes the legal guarantees especially significant here.