All research involving humans or confidential patient information within UHN requires approval of the UHN REB prior to the initiation of a research project.

Investigators from other institutions who wish to carry out research on UHN premises or with UHN patients or patient data must also apply to the UHN REB.

The definition of research is outlined in the Tri-Council Policy Statement. In summary, research involving humans is considered to include any of the following:

• if the researcher will administer a drug, take a blood sample, do a test or perform any procedure, clinical, therapeutic, or otherwise, upon the person of himself/herself or someone else, for research rather than treatment
• if the researcher will ask people information whether by telephone, letter, survey, questionnaire or interview
• if the researcher will review information from patient charts (even their own patients' charts) for research rather than clinical purposes
• if the researcher will use material derived from people (tissue samples, blood, DNA)
• if the researcher will be using non-public records (e.g. not the telephone book) which contain identifying information about anyone either directly or indirectly
• if the researcher will use information previously gathered about anyone, even if anonymized (secondary data analysis)
• if the researcherwill be observing anyone's responses or behaviour, either directly or indirectly

If you cannot determine whether an intended investigation constitutes research, contact the Chair of the REB or an Ethics Coordinator for assistance.

• Research involving only the use of published or publicly available information or materials
• Assessment activities such as quality assessment studies, performance reviews, or testing within normal educational requirements do not generally require REB review and approval

If you cannot determine whether an intended investigation constitutes research, contact the Chair of the REB or an Ethics Coordinator for assistance.

In accordance with the Tri-Council Policy Statement, the UHN REB conducts a proportionate review of research protocols: that is, the scale of the review is in accordance with the type of research proposed and with the potential for harm that the research may pose

The decision to delegate a research project is made by the Co-Chairs of the REB. Some criteria by which research may qualify for delegated review are:

• Protocols involving minimal risk or protocols where there are minimal incremental risks over standard procedures
• Minimal risk protocols where data are collected non-invasively such as questionnaires or direct/indirect observation
• Protocols primarily using previously-collected data such as chart reviews and database information
• Protocols using previously-collected tissue or other samples