Center for Bioethics and Medical Humanities, the Medical College of Wisconsin, WI, USA.
J Law Med Ethics. 2012 Winter;40(4):990-6. doi: 10.1111/j.1748-720X.2012.00726.x.
Deception, cheating, and loopholes within the IRB approval process have received significant attention in the past several years. Surveys of clinical researchers indicate common deception ranging from omitting information to outright lying, and controversy surrounding the FDA's decision not to ban "IRB shopping" (the practice of submitting protocols to multiple IRBs until one is found that will approve the protocol) has raised legitimate concerns about the integrity of the IRB process. While at first blush these practices seem to cast aspersions on the integrity of clinical researchers, the moral issues raised go deeper than the ethics of cheating. To the extent that these practices are common, or represent an IRB system that places unreasonable burdens on those seeking IRB approval, we should consider whether non-compliance reflects problems of normative legitimacy for the IRB system itself.
欺骗、作弊和伦理审查委员会（IRB）批准过程中的漏洞在过去几年中受到了广泛关注。对临床研究人员的调查表明，常见的欺骗行为包括信息隐瞒甚至直接撒谎，而 FDA 决定不禁止“IRB 购物”（即提交方案给多个 IRB，直到找到一个批准方案的 IRB）也引发了人们对 IRB 程序完整性的质疑。虽然这些做法乍一看似乎对临床研究人员的诚信提出了质疑，但所引发的道德问题比作弊的道德问题更深层次。在这些做法普遍存在或代表一个对寻求 IRB 批准的人施加不合理负担的 IRB 系统的情况下，我们应该考虑不遵守规定是否反映了 IRB 系统本身的规范合法性问题。
