Is it Research? (cont.)

What about secondary data files or enhancing a secondary data set?

This activity requires IRB review to verify that identifiability is not violated, and/or that an adequate data protection plan for confidentiality is in place.

What if a project intends to link data from a new survey to an existing individual-level secondary data?

The researcher should inform the research participants of this intention in the process of obtaining consent.

What if the project decides to link data from a new survey to existing individual-level data from public data sources after the survey has been completed?

If the level of confidentiality in the new data set created by the linkage is less than that in either of the pre-existing sets, then the change in research design must be examined by the IRB. The IRB, after evaluating the level of risk involved, can recommend waiving informed consent if risk of harm is low, adequate confidentiality procedures are in effect, and it meets all the regulatory criteria for waiver of consent.