Iltis Ana
Saint Louis University, Center for Health Care Ethics, 221 North Grand Blvd., St. Louis, MO 63103-2006, USA.
Bioethics. 2006 Aug;20(4):180-90. doi: 10.1111/j.1467-8519.2006.00493.x.
Persons generally must give their informed consent to participate in research. To provide informed consent persons must be given information regarding the study in simple, lay language. Consent must be voluntary, and persons giving consent must be legally competent to consent and possess the capacity to understand and appreciate the information. This paper examines the relationship between the obligation to disclose information regarding risks and the requirement that persons have the capacity to understand and appreciate the information. There has been insufficient attention to the extent to which persons must be able to understand and appreciate study information in order to have their consent deemed valid when the information is provided in simple, lay language. This paper argues that (1) the capacity to understand and appreciate information that should be deemed necessary to give valid consent should be defined by the capacity of the typical, cognitively normal adult and (2) the capacity of the typical, cognitively normal adult to understand and appreciate the concept of risk is limited. Therefore, (3) all things being equal, potential subjects must possess a limited capacity to understand and appreciate risk to be deemed competent to consent to research participation. (4) In some cases investigators ought to require that persons possess a greater than typical capacity to understand and appreciate risk.
一般来说，人们必须在知情的情况下同意参与研究。为了提供知情同意，必须以简单易懂的通俗语言向人们提供有关该研究的信息。同意必须是自愿的，并且给予同意的人必须具有合法的同意能力，具备理解和领会这些信息的能力。本文探讨了披露风险信息的义务与人们具备理解和领会这些信息能力的要求之间的关系。当以简单易懂的通俗语言提供信息时，对于人们必须能够理解和领会研究信息到何种程度才能使其同意被视为有效，一直没有得到足够的关注。本文认为：（1）应被视为给予有效同意所必需的理解和领会信息的能力应由典型的、认知正常的成年人的能力来界定；（2）典型的、认知正常的成年人理解和领会风险概念的能力是有限的。因此，（3）在其他条件相同的情况下，潜在受试者必须具备有限的理解和领会风险的能力，才能被视为有能力同意参与研究。（4）在某些情况下，研究人员应该要求人们具备高于常人的理解和领会风险的能力。
