| 英文摘要 |
Through looking at university research ethics review committee meetings and examining the documents that frame as well as are produced by the meetings, this article aims to understand how the research ethics review committee translates ethics principles into procedures and rules that can be executed. Most of the literature on research ethics review tends to focus on structural issues of the ethics review system, contending principles of research ethics in different academic fields, and critiques of institutional overreach. Relatively less attention has been paid to the review process and the way ethics regulations are interpreted and applied. This article draws on personal experience as a committee member to describe the actual process through which research ethics review committees arrive at decisions on research applications. Research ethics review committees encompass routine administrative work and research project reviews. The ethics officers, who affirm proper application of administrative laws, and the review committee members, who are trained in specialist areas, work together to implement the abstract concepts of research ethics and execute regulations and laws. While there are differences across committees, research ethics review committees share common configurations and methods of reaching decisions to ensure consistency within individual committees as well as across local committees. During the review process, committee members become temporary bureaucrats for the purposes of decision-making. They actively and constantly interpret research ethics review procedures, rules, categories, and terms while filling in forms and assessing research protocols. Moreover, decisions regarding research applications are made collectively so that they are, or appear to be, beyond individual judgements. Bringing the committee together to discuss research application documents, routine Institutional Review Board (IRB) meetings are where the principles of protecting human research subjects and advancing academic knowledge are actively negotiated. Committee members assess the risk involved in a research project by reading the researcher's application documents, deliberating on various scenarios to evaluate potential research-related harms, resolving disagreements, and reaching decisions as a group based on ethics principles as well as applicable rules. Therefore, IRB meetings are not only the mechanism that makes decisions on research proposals but also play a pivotal role in maintaining ethics guidelines and administrative laws, implementing and producing internal rules, establishing standard operational procedures (SOPs), and generating documents for the review system. The products of these meetings, that is, the meeting minutes, SOPs, and various documents, further frame how ethics reviews are conducted and the scope of the research ethics review. As the topics and methods of academic research are constantly evolving, the ethics review faces the possibility of research projects exceeding current rules, procedures, and categories. In order to accommodate more and more diverse research projects, meet review requirements, maintain consistency, and accomplish the goal of bureaucratic efficiency, review committees must consistently review and revise existing forms, procedures, and categories. Moreover, discussions and decisions made in meetings become precedents that are relied on to achieve consistent decisions. Through documents and meetings, ethics review committees align past precedents, current research, and future prospectuses, and articulate the diverse fields of international research ethics principles, state regulations, bureaucratic administration, and academic research. |