Who is this for?
Information about the need for a human ethics protocol is relevant to those in the following roles.
- Professors and faculty members, postdoctoral fellows, research team members, and students who are conducting human research for potential submission to the Research Ethics Board (REB)
- Course instructors and undergraduate students conducting course-based human research
- Researchers with Toronto Academic Health Science Network (TAHSN) hospital REB approvals that involve the University of Toronto (U of T)
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.