When Do I Need a Human Ethics Protocol?

The following activities, conducted at or under the auspices of U of T require a human ethics protocol review and must be approved by a  U of T REB* prior to their commencement.

• Research involving living human participants
• Research involving human biological materials, human embryos or fetuses, fetal tissue, reproductive materials and stem cells, from both living and deceased individuals
• Research involving the secondary use of personal information, whether collected for research purposes from a previous study, or through other activities (clinical, administrative), regardless of whether the data will be identifiable or de-identified
• Research involving the secondary use of human biological materials whether collected for research purposes from a previous study, or through other activities (clinical), regardless of whether the specimens will be identifiable or de-identified
   

To learn which research activities do not require REB review, please see Activities Exempt from Human Ethics Review. 

‘Research’ is defined as “an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation”. (TCPS 2 Article 2.1)

‘Human participants’ are “those individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question.” (TCPS 2 Article 2.1)

‘At or under the auspices’ means where research will be conducted by faculty, staff and/or students in their capacity as U of T members and/or where recruitment or collection of data will take place physically on the U of T campus. Approval by a non-U of T REB for research that involves U of T members is not sufficient to cover the research activity.

*Research involving a TAHSN hospital may be reviewed through the Administrative Review process.

• Provide advice and guidance on what requires REB review and how to complete a protocol.