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臺灣人類學刊 ScopusTSSCI

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篇名 研究倫理的形式:文件、會議、與研究倫理審查
卷期 19:1
並列篇名 Forms of Ethics Review: Document, Meeting, and IRB Review Process
作者 許文
頁次 063-102
關鍵字 會議文件研究倫理審查委員會倫理審查制度倫理審查程序meetingdocumentresearch ethics review committeeethics review systemethics review processScopusTSSCI
出刊日期 202107

中文摘要

研究倫理審查委員會由行政事務與審查事務構成,兩者共同運作,執行研究倫理的抽象概念、審查的規範、以及審查的制度。倫理審查會議是「保護被研究者」與「學術知識進展」的協商場合,也是生產表單、程序、與規範的場合。審查會議藉由提出各種預期可能性,來掌握研究計畫的風險,經由反覆討論而達成對倫理原則和應用的共識,並通過重新導向與安排文件的流程,來確保組織作業的一致性。這些會議的產物(文件)進一步框架了審查如何進行,以及研究倫理審查的範疇。無論做為審查程序的一部份、產生決定的途徑,或是建立倫理審查組織與運作的機制,研究倫理審查都與會議密不可分。本文透過會議以及和會議相關的文件,來看大學人類研究倫理審查委員會的執行過程,了解倫理審查如何將倫理原則轉化為可以執行的程序與規範,而會議與文件的形式又如何框架倫理審查。

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.

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