弱势人群概念探析及其对受试者保护的启示

Study on the Concept of Vulnerable Population and Its Reflections on Human Subject Protection

医学研究中的弱势人群保护一直是受试者保护最重要的话题之一。目前,国内外相关法规、指南中对弱势人群概念界定和使用的模糊性不利于指导弱势人群保护的实践。通过列举特定群体对弱势人群概念进行说明不但不利于理解弱势人群本身的构成性特征,还容易导致对部分个体的成见。借助对脆弱性概念的理解对弱势人群的概念进行澄清,强调弱势人群在面临特定伤害的风险时没有足够的能力和/或有效的途径保护自己,基于此,在受试者保护实践中,弱势人群的保护应该更多地引入对研究风险和责任的考虑。

The protection of vulnerable population in health related research is the very topic hotly discussed in human subject protection. Currently, the vagueness of vulnerable population concept and its use in laws, regulations and guidelines, both domestically and internationally, negatively affected the practice of human subject protection. In this article, the author claimed that listing particular groups not only maked limited help to understand the intrinsic features of vulnerable population, but also raised the prejudice to some individuals of a certain group easily. The author also tried to clarify the concept based on the understandings of vulnerability, stated that vulnerable population is incapable and/or lack of effective way to protect themselves when facing risks of particular harms. Therefore, in the practice of human subject protection, the research related risks and accountability should be more seriously considered to protect the vulnerable population.