When Do I Need a Human Ethics Protocol?

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)

Research Requiring Research Ethics Board (REB) Review

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.

VPRI Contact


General Inquiries: Human Research & Ethics Unit (HREU)

Research Oversight & Compliance Office (ROCO)
(416) 946-3273

Other Resources