Commentary: Protecting human subjects and their data in multi-site research

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 breach...

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Bibliographic Details
Published inMedical care Vol. 50 Suppl; p. S74
Main Author Luft, Harold S
Format Journal Article
LanguageEnglish
Published United States 01.07.2012
Subjects
Confidentiality
Electronic Health Records
Ethics Committees, Research - organization & administration
Humans
Multicenter Studies as Topic
Peer Review, Research
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Summary: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.
ISSN:1537-1948
DOI:10.1097/MLR.0b013e318257ddd8