Burdens on Research Imposed by Institutional Review Boards: The State of the Evidence and Its Implications for Regulatory Reform

作者：Silberman George; Kahn Katherine L^*

来源：Milbank Quarterly, 2011, 89(4): 599-627.

DOI：10.1111/j.1468-0009.2011.00644.x

• Institutional review board
• clinical trials
• research ethics
• government regulations
• research costs

Context: Federal regulations mandate independent review and approval by an institutional review board (IRB) before studies that involve human research subjects may begin. Although many researchers strongly support the need for IRB review, they also contend that it is burdensome when it imposes costs that do not add to the protections afforded to research participants and that this burden threatens the viability of research. The U.S. Department of Health and Human Services recently announced its intention to reform the regulations governing IRB review.

• 出版日期2011-12