临床试验的伦理审查:风险与受益分析

Ethic review in clinical research: risk/benefit analysis

伦理委员会的主要职责之一是评估所提议临床试验的风险和受益。伦理审查对风险与受益分析一般采取以下步骤 :风险的鉴别与评估 ,确定风险已在可能的范围内最小化 ;预期受益的评估 ,确定风险与受益比是合理的 ;公开风险与受益 ,跟踪审查。

One of the major responsibilities of the I RB is how to assess the risks and benefits of proposed research. The IRB's assessm ent involves a series of steps, including identification and assessment of risks , determination of minimized risks, assessment of anticipated benefits, determin ation of reasonable risks in related to anticipated benefits, disclosure of risk s and benefits, and continuing review.