Commentary: Protecting Human Subjects and Their Data in Multi-site Research

Harold S. Luft, Palo Alto Medical Foundation Research Institute



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.