Do I need REB approval to do research with secondary data?

The ‘secondary use of data’ refers to the use of information or a biologic sample of body tissue or fluid initially collected for a purpose involving a specified research project or for individual health care or education, but subsequently proposed for use in a different or extended research project. A project in which the secondary use of data is derived from information or a sample for which no direct linkage with an individual study subject is possible would not be subject to REB review.

However, the TCPS2(2018) Article 5 [5.5A] states that if personally identifiable information is accessible through any linkage with the data sample, REB approval shall be sought for the ‘secondary use’ of data without consent (see “Are my data identifiable?” if you’re unsure). To provide approval in such circumstances, REB must ensure that:

  • The potential to derive personally identifiable information is essential to the research
  • Appropriate measures are in place to protect the privacy of the individual by ensuring the confidentiality of the data
  • Potential harm to participants is minimized and unlikely
  • Participants have not objected to the secondary use of data
  • Seeking consent from participants is “impossible or impracticable” (note that the TCPS distinguishes impracticable from inconvenient and researchers must not decide it is impracticable to get consent just because it would be inconvenient)
  • The researchers have received any other required approvals to use the data (e.g., from the agency or institution that holds the data)
     

If your project involves ONLY secondary use of data, please fill out:

  • The University of Guelph REB Application form, omitting Sections F, H, J, K, L.
  • The Supplement II on Secondary Use of Data.
  • Send all documents to reb@uoguelph.ca

If your project involves other work as well as secondary use of data, please include the Secondary Use of Data supplement in your submission package.

Support info
Area: 
Human Ethics
Category: 
Determining when University of Guelph REB approval is required