Researchers can apply directly to the Office of Research Ethics by emailing submissions to [email protected]. Internal submissions must originate from the Principal Investigator’s Brock e-mail or, if submitted by another research team member, clearly show that the Principal Investigator has been cc’d.

There are two levels of research ethics review: full board and delegated.

Full board is the default review process for all human research. Full board reviews are assessed at regularly scheduled monthly meetings of the REB.

Applications determined to be at or below the threshold of ‘minimal risk’ may be sent the route of delegated review and assigned to a sub-committee of the REB. Delegated reviews are conducted on a rolling basis throughout the year.

‘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 encountered in everyday life that relate to the research.

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

Group Vulnerability

Pre-existing vulnerabilities associated with proposed participant groups, that might be exacerbated as a result of participation, including (but not limited to) the following:

• 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 (but not limited to) 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, subpoena, or breach of confidentiality)

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 review 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.

Amendments are planned or anticipated modifications or changes to a study that occur after the study has received ethics clearance. To make a change to an approved REB application you must submit an Amendment Request Form and get revised REB clearance, prior to implementing the change. Your submission should include all modified project materials (e.g., application, consent form) with proposed changes highlighted.

Examples of changes that may require an amendment include (but are not limited to):

• adding and/or removing a research team member (e.g., co-investigator, student researcher, research assistant, etc.)
• changing the participant group, inclusion/exclusion criteria and/or sample size
• altering or adding a new procedure, method, measure, or questionnaire
• changes to study documents (e.g., revisions to the information letter or consent form, recruitment materials, etc.)

If changes are substantial, the REB may request that you submit a new application. Examples of amendments that may require a new application include (but are not limited to):

• changes that do not align with the original study objectives
• changes that are substantial (e.g., a new phase or sub-study being added)
• changes to a study’s purpose, aims, or objectives

If you are unsure whether you should submit an amendment or a new application, please contact the Office of Research Ethics for advice.

The TCPS2 requires that ongoing research be monitored, at minimum, on an annual basis. REB clearance is granted for a period of not more than one year. The date of expiry is listed on the certificate issued by the Office of Research Ethics (ORE). The ORE will send researchers a reminder prior to their expiry date. At that time, researchers must either apply for Continuing Review to renew ethics clearance or submit a Final Report, to close their project file. These forms are mandatory. No research can occur under an expired clearance certificate.

In addition, throughout your research, you must report promptly to the REB:

• Any changes that might increase risk to the participant(s) and/or affect the conduct of the study
• All adverse and/or unanticipated experiences or events that may have real or potential unfavourable implications for participants
• New information that may adversely affect the safety of the participants or the conduct of the study
• Any changes in project funding