Policy and Procedures
Policy and Procedures for the Research Use of the Clinical Data Warehouse
- Investigators at BU or BMC, may request data for research purposes from the BMC Clinical Data Warehouse via the Clinical Data Warehouse Research Manager. These data may be used to prepare a research application, to secure counts of data or to get data for an approved protocol.
- Recipients of data must be certified in human subjects research. The CDW Research Manager confirms that investigators are certified and, when applicable, whether their protocol has IRB approval.
Types of Data Requests
- Counts Only
Requests for counts only must be accompanied by a HIPPA prep to research form, which will be reviewed and saved/filed by the Clinical Data Warehouse Research Manager. An example of counts: the number of hospitalized patients with pneumonia in 2006. The criteria for the counts must not be so specific as to identify patients. Counts <6 are not provided. Small counts are not reported because they risk identification (deductive disclosure: e.g., the number of patients with both hepatitis C and rabies seen in a 6 month period in the pediatric clinics). If this situation arises and actual counts are desired, the request requires IRB review (see below).
- All Other Requests
Requests for data beyond counts (de-identified/anonymous or identifiable) must be accompanied by evidence of IRB approval. a. The data being requested must match the data for which the INSPIR protocol was approved. b. For identifiable data, the IRB approval must allow for identified data. c. The appropriate HIPAA form must be a part of the approved IRB application.
Identified data are sent via email in password protected files. Web reports are password protected using Business Objects security. Business Objects is a provider of enterprise business intelligence solutions.