Community Health and Prevention, Drexel University School of Public Health, 1505 Race Street, Bellet Building, 11th Floor, Philadelphia, PA 19102, USA.
J Med Ethics. 2012 Jul;38(7):423-7. doi: 10.1136/medethics-2011-100194. Epub 2012 Feb 25.
Determining whether a research risk meets or exceeds a regulatory standard of risk acceptability is difficult. Recently a framework called the systematic evaluation of research risks (SERR) has been proposed as a method of comparing research risks with predetermined standards of acceptability. SERR purports to offer a systematic and largely determinate (definite) way to compare risks and say whether a specific research risk falls below or above an acknowledged standard of acceptable risk. Here the authors review some philosophical problems with this framework, which they take to be representative of determinate approaches to risk comparison, and conclude that it should not be used in a stand-alone or determinate fashion. Instead, the authors suggest that a deliberative approach may be a more viable candidate for future development. Such an approach could be informed by methods such as SERR without being rigidly bound to them.
确定研究风险是否符合或超过监管可接受风险标准是困难的。最近,提出了一种称为研究风险系统评估(SERR)的框架,作为将研究风险与预定可接受标准进行比较的方法。SERR 旨在提供一种系统且基本确定(明确)的方法来比较风险,并确定特定研究风险是否低于或高于公认的可接受风险标准。在这里,作者审查了该框架的一些哲学问题,这些问题被认为是确定性风险比较方法的代表,并得出结论认为,不应以孤立或确定性的方式使用它。相反,作者建议审议方法可能是未来发展的更可行的候选方法。这种方法可以借鉴 SERR 等方法,但不受其严格限制。