Topic

Determine If a Protocol Qualifies for Delegated Review

Who is this for?

Delegated review for human ethics protocols is relevant to individuals in the following roles at the University of Toronto (U of T).

  • Professors/faculty members, postdoctoral fellows, research team members, and students who are conducting human research for submission to the Research Ethics Board (REB)
  • Course instructors and undergraduate students conducting course-based research

What do I need before I can begin?

Please prepare a draft research plan with a description of participants, research methods, and the research question.

Full or Delegated Review?

Full review at a Research Ethics Board (REB) meeting is the default review process for all human research.

The delegated review process, which is conducted by a subcommittee of the board, may be used when the research is determined to be at or below the threshold of ‘minimal risk’.

‘Minimal risk’ is defined as the probability and magnitude of possible harms implied by participation in the research can reasonably be expected by participants to be no greater than those encountered by the subject in those aspects of his or her everyday life that relate to the research, or during the performance of routine physical or psychological examinations or tests.

To evaluate risk for your proposed research, consider the following.

  • Group Vulnerability Any pre-existing vulnerabilities associated with proposed participant groups, including the following.
    • E.g., relating to pre-existing physiological or health conditions
    • Cognitive or emotional factors
    • Socio-economic or legal status
       
  • Research risk The probability and magnitude of harm participants may experience as a result of the proposed methods to be used and types of data to be collected, including the following.
    • Physiological or health issues such as clinical diagnoses or side effects
    • Cognitive or emotional factors such as stress or anxiety during data collection
    • Socio-economic or legal ramifications such as stigma, loss of employment, deportation, or criminal investigation (e.g., in the event of duty to report intent to cause serious harm, subpoena, or breach of confidentiality)
       

    The assessments of group vulnerability and research risk (i.e., low, medium, high) can then be used through the Risk Matrix to determine REB process.
     

Risk Matrix

Group Vulnerability

Research Risk

Low

Medium

High

Low

Delegated

Delegated

Full

Medium

Delegated

Full

Full

High

Full

Full

Full

Using the Risk Matrix can help guide you in determining when to submit your protocol, however, the REB makes the final determination whether a protocol is reviewed through delegated or full board process. Other factors that the REB considers in assigning a protocol to full board may include the following.

  • Involvement of clinical tests or interventions
  • Use of personal health information (PHI) without participant consent
  • Research complexity
  • Large participant populations or data subjects

VPRI Role

  • Advise in determining the risk level and use of the Risk Matrix
  • Provide information on the full board and delegated review processes

VPRI Contact

Staff

Mariya Gancheva

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

Staff

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