兒童參加臨床試驗是促進兒童用藥健康發(fā)展和用藥安全的重要手段，但邀請兒童參加臨床試驗面臨的風險高于成人。為了保護兒童的利益，使其免受傷害，作為保護受試者權益重要措施的知情同意和知情同意書，在遵循一般醫(yī)學倫理學原則基礎上，還應考慮兒童心理、思維發(fā)育尚未完全的特點，本著保護兒童這一弱勢群體合法權益、尊重兒童意愿的精神進行設計與操作。

Clinical trial for children plays an important role to evaluate the efficacy and safety of medication for children. However, the risk to recruit children weighs more than to invite adults in clinical trial. In order to protect their rights and keep them away from harms, the informed consent procedure and written informed consent form, based on the general principle of medical ethics, would be fundamental to the clinical trial. What’s more, to conduct the clinical trials in children, the protocol design and trials implementation should always take into account that children, as the disadvantaged group, are physically and psychologically underdeveloped, and thus their interests will be above everything.

國家科技重大專項十二五“重大新藥創(chuàng)制”課題“兒科中藥新藥臨床評價研究技術平臺規(guī)范化建設”（2011ZX09302-006-03）