Doctoral Dissertation Research: Measuring the Impact of the Legal and Regulatory Task Environment on Biomedical IRB Performance

每年有超过230万美国人参与临床试验。监督和批准临床研究项目的科学和伦理适当性的团体，即机构审查委员会（“IRB”），在经验上研究不足，公众和研究参与者基本上看不到。使用混合方法的方法，本研究探讨了生物医学IRB如何将灵活的监管任务转化为业务活动，以及IRB如何应对环境压力。它将照亮IRB，这将提高公众对科学和卫生政策问题的认识和参与，并赋予患者权力。调查分两个阶段进行：第一，对IRB成员进行全国性调查以进行定量分析，第二，对生物医学IRB和IRB成员的有目的样本进行观察和半结构化访谈以进行定性分析。该项目扩展了对法律法规的组织响应的理论理解，并提供了有关IRB的实践知识。

More than 2.3 million Americans participate in clinical trials annually. The groups that oversee and approve the scientific and ethical appropriateness of clinical research projects, institutional review boards ("IRBs"), are empirically understudied and largely invisible to the public and research participants. Using a mixed methods approach, this study explores how biomedical IRBs translate flexible regulatory mandates into operational activities, as well as how IRBs respond to environmental pressures. It will shine a light on IRBs, which will increase public literacy and engagement around science and health policy issues, and empower patients. The investigation proceeds in two phases: first, administration of a national survey to IRB members for quantitative analysis, and second, observation of and semi-structured interviews with a purposive sample of biomedical IRBs and IRB members for qualitative analysis. This project extends theoretical understandings of organizational responses to law and regulation, and contributes practical knowledge about IRBs.