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Process Changes
24 June 2019
Full Board Submission Requirements & Consent form templates:
What is new?
All new applications submitted for full board review (greater than minimal risk studies) with consent forms and assent forms will be required to use the Clinical Trials Ontario templates for consent and assent forms. The templates are found on the CTO website.
There are 9 required changes to the consent form template and 1 required change to the assent form template that can be found on the CHEO REB website under templates.
This is not applicable to OCREB reviewed studies; they will follow the previous requirements.
Why is this being done?
This requirement will allow for streamlined review of consent and assent forms offering the opportunity to provide increased efficiency in REB review timelines and ensuring consistency in consent and assent form language across CHEO-OCTC & CHEO RI as well as through Institutions in Ontario.
What this means for you:
On the 17th of September 2019, the submission deadline for the October Full Board REB meeting, all full board initial applications with consent and assent forms will be screened for use of the CTO consent and assent form template language. Should the application not use the CTO template language, the application will not be accepted onto the Agenda for the next meeting and the application will be returned to the research team indicating as such. The application will only be accepted once the research team uses the CTO template language. This will be the same process for every full board initial application thereafter.

Process Changes
14 June 2018
Annual renewal notification process:

What is new?
All studies will now receive two notices prior to the expiry date of REB approval: A 60-day reminder notice, in addition to the current 30-day notice prior to the expiry date of REB approval. Both notices serve to remind the research team to file and obtain approval of either an annual renewal or study closure event form prior to the REB approval expiry date.

Why is this being done?
The 60-day notice is being piloted to assist researchers in avoiding lapses in a REB approval.

What this means for you:
All research studies will receive a notice at 60 days prior to the expiry date of REB approval.

Within the delegated review stream, the notice serves as reminder only. Action is required by the researcher only within the 30-day window prior to expiry of REB approval. This is to ensure the accuracy of the information provided. Delegated annual renewal event forms that are submitted more than 30 day prior to the expiry date will be returned to the research team. The research team will be asked to re-submit the event with up-to-date information less than 30 days prior to the expiry date.
Within the full board review stream, the 60-day notice will remind the research team approximately 30 days prior to the submission deadline for the upcoming REB meeting.

Initial Applications & investigator responses process:

What is new?
The investigator may be required to complete a two-step response process within ROMEO to address REB feedback on an event.

Why is this being done?
This is being done to ensure the accuracy and consistency of applications and the study documentation. Over the last year, the REB has seen an increase in the inconsistencies between the application, protocol and patient documents following the update to all of the REB initial application in early 2017.

What this means for you:
Should the investigator response require a two-step response process, the REB feedback letter will reflect this requirement. The letter will separate the changes requested for each of the steps. Please see the attached document for an example of this type of letter.
The two-steps:
• Step one will be modifying the application itself to match the responses and/or other documents submitted. The investigator will have the application sent back to them, and should modify the application and re-submit prior to completing the second step. Please do not submit modified documents in this step. Here is a link to the ROMEO Rigorous Reference Manual ; refer to page 57-Returned Applications.
• Step two is the investigator response event. This event requires an investigator response letter responding to all REB feedback, as well as tracked changes and clean version of all modified documents. Here is a link to the ROMEO Hasty Handbook ‘Responding to REB feedback’.

BORN applications

What is new?
The BORN application form is being de-activated in ROMEO.

Why is this being done?
This is being done to minimize the confusion surrounding when to use the BORN application form or the Prescribed Entity or Prescribed Registry Application form in ROMEO. This will also reduce the number of applications within ROMEO.

What this means for you:
All BORN initial study applications should submit to the REB using the Prescribed Entity or Prescribed Registry Application form in ROMEO.

Mandatory Training

08 August 2017

As part of our efforts to promote research excellence, and to ensure compliance with relevant research guidelines and regulations, the CHEO Research Institute & CHEO Research Ethics Board are announcing a new mandatory education requirement.
*Effective September 5, 2017, REB initial approval for regulated research studies (drug, device or natural health product) will only be granted to those
investigators and their staff listed on the REB application who show evidence of completed training on the adopted N2 CHEO RI Standard operating procedures.*

The SOPs are posted on CHEONET under the Research Institute. After review of the SOPs, please complete the REDCap testUpon completion of a passed test, you will receive a certificate of completion, and the Quality and Risk Management office will be notified.  
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