Palo Alto Medical Foundation Research Institute, Palo Alto, CA 94301, USA.
Med Care. 2012 Jul;50 Suppl:S74-6. doi: 10.1097/MLR.0b013e318257ddd8.
Comparative effectiveness research is sometimes best done using routinely collected data from multiple real world settings. This raises important issues with respect to the authorizations to use the data, dealing with the multiple IRBs that may have oversight authority, and protecting it from breaches. Careful delineation of what is quality improvement vs. research-driven interventions can help with IRB reviews, especially for low-risk projects. It is impossible to totally de-identify data without markedly reducing its value for research, but creative strategies can markedly reduce the risk of advertent disclosures of patient identities.
比较实效研究有时最好利用来自多个真实环境的常规收集数据来进行。这就提出了一些重要的问题，涉及到使用数据的授权、处理可能具有监督权限的多个 IRB，以及保护数据不被泄露。仔细区分什么是质量改进与研究驱动的干预措施，可以帮助 IRB 审查，特别是对于低风险项目。如果不显著降低数据对研究的价值，就不可能完全去除数据的可识别性，但创造性的策略可以显著降低患者身份被无意披露的风险。
