Research Ethics Application Process

Unity Health eREB

All submissions to the Unity Health REB should be done through the Unity Health eREB platform
(https://axiommentor.ca/login/axlogin.cfm?i=unityhealth).

Accessing the eREB

Please review the eREB System Access Guide for full details on accessing the eREB, including creating an account, logging in and changing your email address or name.

See below for summary information on logging in and creating an account.

Log In

• Website: https://axiommentor.ca/login/axlogin.cfm?i=unityhealth

• InstitutionID: unityhealth

• User: Your Unity Health Email address

• Password: If an account was created for you as part of the launch, on your first login, use the Forgot Password link to set a password

Create an Account

Account creation webpage: https://axiommentor.ca/unityhealth/newAccount

The Unity Health eREB is only for Unity Health staff, physicians, learners, visitors and volunteers.

To create an account:

• A Unity Health email address will be required

• Your Unity Health email will be your username

• You will need to be able to access your Unity Health email to complete the account creation process (to set a password)

• Once a password has been set, you can log into your account and set a primary email that is different from your Unity Health email (your username will continue to be your Unity Health email)

Submitting via the eREB

Once you have logged into the eREB, you will have access to several documents and guides to help you navigate the system and submit an application to the REB.

REB Meeting Dates and Application Deadlines

Delegated Review Applications

Delegated applications are accepted on a rolling basis and not subject to a submission deadline.

Full Board Review Applications

• Accepted for screening: Applications can be submitted for screening at any time.

• Accepted for Board review: Applications that have been screened and determined to be accurate and complete will be accepted for Board review.  They will be given priority scheduling for review at the Board meeting that falls after the next meeting deadline date.

Please consider submitting your applications well in advance of your planned meeting date, in the event that screening clarifications are requested. If clarification requests are not addressed prior to the deadline for a meeting, your application will not be scheduled for review at that meeting.

REB Submission Types

Initial Applications

Initial applications are required for any new study being conducted at or under the auspices of Unity Health. There are several types of initial applications.

Full Board Application

Studies that involve more than minimal risk to participants are reviewed by the entire Research Ethics Board (REB) and must be submitted through the full board application process.

Studies that are greater than minimal risk may include studies such as:

• clinical trials of drugs, devices, or natural health products

• those collecting significant personal health information

• those studies where the participant/patient population is particularly vulnerable

Delegated Prospective Application

Studies that collect data prospectively and are deemed to be of minimal risk over standard procedures are considered ‘delegated prospective’ studies. These studies are reviewed by a subset of the Board and are submitted to the Research Ethics Board (REB) through the delegated prospective application process.

Studies that qualify for delegated review as minimal risk research may include:

• research with no direct patient contact (i.e. chart review)

• database development

• questionnaires or surveys only

Delegated Retrospective Application

Studies that will only be accessing retrospective data and not collecting any information prospectively are considered ‘delegated retrospective’ studies and can be submitted to the Research Ethics Board (REB) using the delegated retrospective application process.  These studies will be reviewed by a subset of the Board.

• In order for a study to be considered retrospective, the end date of data collection must be before the date of submission to the REB.

Study Amendment

Any changes made to study documents or research processes that are approved by the Research Ethics Board (REB) must be submitted as an amendment and approved by the REB prior to being implemented.

Research Staff Change

Any changes to Unity Health study staff should be submitted to the REB as a staff change. In the eREB, staff changes are specific type of amendment.

Continuing Review / Annual Renewal

Studies are granted Research Ethics Board (REB) approval for a maximum of one year and must be renewed in order to continue. To extend REB approval for a further one year period, a continuing review request must be submitted to the research ethics office.  It is the responsibility of the principal investigator to ensure that a complete continuing review form is submitted to the REB prior to the study expiration date.

Serious Adverse Event / Unanticipated Problem

A serious, unexpected and related or possibly related adverse event (SAE) is an event that has occurred to a research participant in a study under the jurisdiction of the Unity Health Toronto Research Ethics Board (REB).

An unanticipated problem (UP) is any incident, experience, outcome that meets all the following criteria: unexpected in relation to the research and/or patient population and related or possibly related to participation in the research and points to increased risk/harm to the research participant.

All internal serious adverse events or unanticipated problem must be reported to the REB within 7 days of the study team’s awareness of the event/report or within 3 days if fatal or life threatening.

External serious adverse events or unanticipated problems that are reportable to the Unity REB must be reported to the REB within 15 days of the study team’s awareness of the event/report.

Not sure if you need to submit a report to the REB? Use the Quick Reference Tool for Reporting SAEs / UPs.

For more details, read the Guidelines for Reporting Serious Adverse Events /Unanticipated Problems.

Updated Safety Information

All updated safety information must be reported to the Research Ethics Board (REB).

Safety information includes:

• Data Safety Monitoring Board (DSMB) summaries,

• Periodic safety update reports,

• Safety alerts (e.g. black box warning, drug recalls, etc.),

• Any other relevant safety information.  

All updated safety information must be reported to the REB within 15 days of the study team’s awareness of the event/report.

Protocol Deviation

An unanticipated or unintentional divergence or departure from the expected conduct of an approved study that is not consistent with the current approved research protocol, consent document or study addenda. 

Deviations may or may not have a significant effect on the research participant’s rights, safety or welfare, or on the integrity of the data. Deviations are different from amendments in that they generally apply to a single occurrence or participant and are not intended at the time to modify the entire protocol.

All protocol deviations must be reported to the Research Ethics Board (REB) within 15 days of the study team’s awareness of the event.

For more details, read the Guidelines for Reporting Protocol Deviations.

Study Closure

A closed study is defined as one where the following is true for all Unity Health Toronto sites:

• All participant involvement is complete.

• All data collection is complete.

• All data clarification is complete.

• All data transfer is complete.

• All access to the participants’ medical records is complete.

• The clinicaltrials.gov registration has been updated and study team will post summary results within the required timelines.

If your study meets the above criteria, a study closure form can be submitted. In the eREB, a study closure is a specific sub-type of a renewal.

Frequently Asked Questions about REB Submissions

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