Question

Researcher wants to conduct a secondary analysis using a centers for disease control and prevention (cdc) database that was collected by the agency solely for surveillance purposes from 1996-2006. the researcher did not participate in the initial collection of the data. the database is publicly available. the database does not include any identifiers. the irb makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects.

Answer 1

The considerations that  was relevant to the IRB's determination that this activity does not constitute research with human subjects is "The researcher will not be interacting/intervening with subjects and the data has no identifiers".


Generally, any human subjects inquire about that is directed by VDH, by outside examiners in a joint effort with VDH, or by outside agents utilizing VDH information, is liable to survey and endorsement by the VDH Institutional Review Board. However, not all examinations require IRB review. 

Answer 2

The answer is "The irb makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects." Those data will be reviewed by the IRB and they will determine if those data met the federal definition of human subjects to allow the research proceed his or her study.