兒童參加臨床試驗(yàn)是促進(jìn)兒童用藥健康發(fā)展和用藥安全的重要手段，但邀請(qǐng)兒童參加臨床試驗(yàn)面臨的風(fēng)險(xiǎn)高于成人。為了保護(hù)兒童的利益，使其免受傷害，作為保護(hù)受試者權(quán)益重要措施的知情同意和知情同意書，在遵循一般醫(yī)學(xué)倫理學(xué)原則基礎(chǔ)上，還應(yīng)考慮兒童心理、思維發(fā)育尚未完全的特點(diǎn)，本著保護(hù)兒童這一弱勢群體合法權(quán)益、尊重兒童意愿的精神進(jìn)行設(shè)計(jì)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(xiàng)十二五“重大新藥創(chuàng)制”課題“兒科中藥新藥臨床評(píng)價(jià)研究技術(shù)平臺(tái)規(guī)范化建設(shè)”（2011ZX09302-006-03）