The Ethic Research About Guarantee Of Safety For The Test Children During Drug Clinical Trial

To ensure public health and safety, medical progress should be speed up, especially in the field of new drug development. New drug development is a key to solve the problem of "drug shortage" for children, during which process clinical trial is the only route. Compared with adults, children have various unique characteristics including lacking autonomy, and being immature physically, mentally and cognitively. Therefore, the risk to participate in drug clinical trials is much higher for children than for adults, which may even be life-threatening. Thus, many ethical problems can be involved. Drug clinical trials in children must be guided by the ethical principles based on law and policy. It is important to establish and improve the protection system to ensure safety and health for children in tests.This paper can be divided into four parts: The first part briefly introduces the concept and stages of drug clinical trials,then state the particularity of carrying out drug clinical trials,at last the domestic and foreign development present situation were summarized.Part two analyzes the potential safety hazard faced by test children from three aspects: the testing institutions and its researchers, the test children and and the regulatory power of legal and ethical.The third part analyzes several ethical principles for the drug clinical trial in children,such as the principle of informed consent,do not harm and best interest for children.Based on the problems for drug trials in current China and the potential safety hazard faced by test children, above the ethic principle,Part IV puts forward several practicable measures from legal,policy and ethical regulation to guarantee safety for test children.