Initial Submission for Review

**All new applications submitted for full board review with consent and assent forms will be required to use the CTO consent and assent form template language. **

1. Applications deadlines are the Tuesday two weeks prior to Full Board meeting. The REB meets the first Wednesday of every month to review the submissions expect for August.
   
2. In most instances, the CHEO Site Investigator and their research coordinator will be invited to attend a board meeting of the REB to discuss their project.
   
3. The number of protocols reviewed per month is limited to ensure thorough review of each application. Protocols are generally reviewed on a first–come first–served basis, although priority may be given to a proposal because of mitigating circumstances (e.g., the protocol offers treatment that would not be available otherwise and is considered urgent).
   
4. Incomplete submissions will NOT be accepted. Investigators will be notified by email when an application is incomplete.
   
5. For multi-site studies, should the main protocol not contain all the required information, a separate site-specific protocol addendum should be developed.
   
6. Applications are to be submitted using Romeo.

An acknowledgement email will be sent to investigators once an application has been successfully submitted to and accepted by the REB.

A complete application minimally includes the following:

• Protocol
• Protocol addendum, if the main protocol does not contain all of the required information to complete an ethics review (e.g., recruitment, consent and assent process, data management, etc.)
• Scientific Peer Review (see below for more information)
• Consent and assent forms (as applicable), or information letter and/or verbal consent scripts
• Patient facing documents (e.g., surveys, non-validated questionnaires, recruitment materials, emergency contact cards, focus group script, interview questions, etc.)
• Demographic case report form/data collection sheet
• Budget
• DSMB charter
• Monitoring Plan
• Biobank Governance Document, as applicable
• Signed CHEO REB signature page
• Start Smart Step 2:  Pre-Institutional Approval PDF

For regulated trials, as applicable:

• Product Monograph and/or investigator brochure
• Device manuals
• Health Canada No-Objection letter (NOL) or notification of submission
  • Industry Sponsored Studies: the NOL must be part of the application
  • CHEO RI Sponsored studies: NOL may be pending, however is required prior to approval

Scientific Peer Reviews

Protocols that expose human research participants to more than minimal risk must show evidence that the study has undergone independent scientific peer review. The peer review process ensures that all research meets the highest scientific standards. In the absence of scientific rigour, there is no justification to exposing humans to research-related risk. Research that is poorly justified or designed cannot advance knowledge and should therefore, not be permitted.

The initial submission must include two independent scientific peer reviews for review by the Board.

 To qualify as an independent scientific peer review, a review must:

• Appraise the scientific merit and rigour of the study;
• Be conducted by qualified experts within the field;
• Be de-identified such that the name of the reviewer is not revealed to the study team; and be obtained independently (i.e., not through the study team).
• Studies with scientific peer review as part of their funding (e.g., CIHR): The Researcher should upload copies of the two required independent scientific peer reviews in their application to the Board.
• Studies that do not have accompanying scientific peer review from funding agencies or are unfunded: The Researcher must obtain a scientific peer review though the CHEO Research Institute peer review program (under special review).

The following submissions are excluded from this requirement:

• Research sponsored and initiated by Industry; and
  • Research sponsored and initiated by a recognized cooperative research group; e.g., Children’s Oncology Group.  

The REB reserves the right to request scientific peer reviews regardless of the Sponsor type, should they deem it necessary.

Projects that include only a Class II, Class III or Class IV device  (i.e., does not include an investigational drug, biologic or NHP) should be submitted using the investigational device projects application.  The review stream (Full Board or Delegated) of these studies will be determined on a case-by-case basis, however typically a class II device will be reviewed in the minimal risk delegated review stream.  The Research team will be notified by the REB office which stream the study will be reviewed under. This decision is based on the determination of risk (i.e., greater than minimal risk or equal to/less than minimal risk).

Protocols that present only minimal or very low risk to participants are reviewed by the Chair and a research ethics office staff (who is considered a non-voting member of the REB). Sometimes REB members with the relevant scientific expertise are asked to review in addition to the Chair and research ethics office staff.. Minimal or low risk is ordinarily taken to mean those risks normally encountered in everyday life by the research participant.

There are three (3) streams of delegated review:

• Prospective minimal risk projects (e.g., survey, focus group, interviews, low risk procedures for research, registries (prospective clinical data used for research purposes), Permission to Contact Registries containing PHI)
• Secondary use of information (e.g., retrospective chart review, secondary use of data or samples, secondary use of information collected as QI but now being used for research)
• Prescribed Entity or Registry

There are no submission deadlines for delegated reviews; they can be submitted at any time in Romeo.

Submissions that are incomplete or require modifications will delay this process. Incomplete submissions will NOT be accepted. Investigators will be notified by email when an application is incomplete.

Multi-site studies, where the main protocol does not contain all the required information for an ethics review (e.g., local recruitment and consent/assent procedures, local study procedures, data management) or where study conduct will be different at CHEO, a separate site-specific protocol addendum should be developed for approval.

An acknowledgement email will be sent to investigators once an application has been successfully submitted to and accepted by the REB.

A complete application minimally includes the following:

• Protocol
• Protocol addendum, if the main protocol does not contain all of the required information to complete an ethics review (e.g., recruitment, consent and assent process, data management, etc.) or where study conduct will be different CHEO
• Consent and assent forms, information letter, and/or verbal consent scripts (as applicable)
• Patient facing documents (e.g., surveys, non-validated questionnaires, recruitment materials, emergency contact cards, focus group script, interview questions, etc.)
• Case Report forms and/or data collection tools (i.e., all data fields to be collected for the study)
• Budget, as applicable
• Signed CHEO REB signature page
• Start Smart Step 2:  Pre-Institutional Approval PDF