Gunsalus C K
Office of the University Counsel, College of Law, 342 Law Bldg., University of Illinois, 504 E. Pennsylvania Avenue, Champaign, IL 61820, USA.
Ethics Behav. 2004;14(4):369-82. doi: 10.1207/s15327019eb1404_7.
Without any systematic data or evidence of a problem, or even a thoughtful analysis of costs and benefits, the application of the human participant review system within universities is overreaching at the same time that some risky experimentation on humans outside of universities is unregulated. This article questions the purpose, feasibility, and effectiveness of current IRB approaches to most "2 people talking" situations and proposes scaling back the regulatory system to increase respect accorded it by researchers and its ability to protect human participants of research from real versus imagined harms. In too many cases, the focus is on form over ethical substance: counting what can be counted, rather than focusing instead on what counts. Some disciplines--oral history and journalism, for example--simply do not belong within the scope of institutional review board jurisdiction. Others, such as survey research, informational interviews, and informal interactions, call for a shift from centralized review to more departmentally based (i.e., rooted in disciplinary ethics) oversight, and clearer guidelines on what requires advance review as opposed to provision of post hoc complaint systems.
在没有任何系统性数据或问题证据，甚至没有对成本和收益进行深入分析的情况下，大学内部人类受试者审查系统的应用有些过度，与此同时，大学外部一些涉及人类的风险实验却未受到监管。本文对当前机构审查委员会（IRB）处理大多数“两人交谈”情况的方法的目的、可行性和有效性提出质疑，并建议缩减监管系统，以提高研究人员对其的尊重程度，以及其保护研究中的人类受试者免受实际伤害和想象伤害的能力。在太多情况下，重点放在了形式而非伦理实质：关注可计数的东西，而不是关注真正重要的东西。有些学科——例如口述历史和新闻学——根本不属于机构审查委员会的管辖范围。其他学科，如调查研究、信息访谈和非正式互动，则需要从集中审查转向更多基于部门（即植根于学科伦理）的监督，并明确规定哪些需要事先审查，哪些只需提供事后投诉系统。
