Doctoral Dissertation Research: Evaluating Research in the Age of Human Subjects Regulation

Mario SmallLaura SharkPrinceton University使用人类受试者的科学研究实践如何被定义为道德上可接受或不可接受？这篇博士论文改进项目使用历史和人种学方法来探讨这个问题，重点是社会和行为科学，这在研究伦理学的研究中经常被忽视，以及欺骗的实践。该项目首先解释了20世纪60年代和70年代美国如何制定关于人类受试者治疗的具体联邦法规。历史部分整合了三个档案馆的材料，关注了联邦法规中的利益和认识论假设（例如，关于人性的不同观点在各个学科中占主导地位）。该项目的第二部分分析了大学人类受试者委员会的成员如何在日常实践中解释这些联邦法规。本节分析了从国家样本（n=30）中抽取的与人类受试者委员会（也称为机构审查委员会或IRB）主席的访谈，以及对三所大学IRB一年内会议的观察结果，以及与三个委员会成员的访谈。本节询问董事会成员如何评估研究方案，向同事证明这些评估的合理性，并共同授权对科学家的研究提案进行具体修改。该项目为几个文献做出了贡献。它解决了社会学家和科学史学家提出的关于道德承诺对科学知识生产的影响的问题。此外，该项目响应了对审议团体（如IRB和资助小组）社会学日益增长的兴趣。最后，本项目的目的是有助于更好地理解IRB决策的机制。虽然现有的关于IRB的研究主要报告调查结果，并表明物质投资将改善IRB的缺点，但本项目分析了IRB内部的流程，并可能为在资金限制和时间限制范围内工作的IRB提供实用建议。

Mario SmallLaura SharkPrinceton UniversityHow have scientific research practices using human subjects come to be defined as morally acceptable or unacceptable? This doctoral dissertation improvement project uses historical and ethnographic methods to explore this question, with a focus on the social and behavioral sciences, which are often neglected in research on research ethics, and on the practice of deception. The project explains first how specific federal regulations on the treatment of human subjects were crafted in the USA during the 1960s and 1970s. Integrating materials from three archives, the historical section gives attention to the interests and epistemological assumptions (for example, different ideas about human nature dominant in various disciplines) that were built into the federal regulations. The second part of the project analyzes how members of university Human Subjects Committees interpret these federal regulations in everyday practice. This section analyzes interviews with the chairs of Human Subjects Committees (also called Institutional Review Boards or IRBs) drawn from a national sample (n=30) and observations of the meetings of three university IRBs over the course of one year, as well as interviews with the three boards' members. This section asks how board members go about evaluating research protocols, justifying these evaluations to their colleagues, and collaboratively mandating specific changes to scientists' research proposals. This project contributes to several literatures. It addresses questions raised by sociologists and historians of science about the influence of moral commitments on scientific knowledge production. In addition, this project responds to a growing interest in the sociology of deliberative groups like IRBs and funding panels. Finally, this project aims contribute to a better understanding of the mechanics of IRB decision-making. While existing research on IRBs primarily reports findings from surveys and suggests that material investments will improve the shortcomings of IRBs, this project analyzes processes within IRBs and could potentially offer practical suggestions to IRBs working within funding limitations and time constraints.