REB Application Submission Checklist

Full Board application packages must be received in the Research Ethics Office (REO) 76 Grenville Street, Room 6341 by 4:00pm on the day of the deadline. Delegated review requests can be submitted on any date. Please also send an electronic submission to the Research Ethics Coordinator . Packages received after the deadline will be deferred for processing until the next deadline. Please note full board applications require 4 hard copies and delegated review applications require 2 hard copies.
Incomplete packages may result in delay of the REB review.

1) Full Study Title:

2) Submit this completed checklist along with the following documents:

(Double side documents when possible)

Included / Pending / N/a / Enclosed documents
TAHSN Application Form with signatures (Note: The PI and the Dep/Div/Program Head must have a WCH appointment)
Full study protocol (must include version date: DD-MMM-YYYY in footer & page numbers)
Itemized Budget (including per patient costing breakdown and WCRI overhead)
Informed Consent Form(s) (ICF) (must include WCH letterhead, page numbers, and a version date: DD-MMM-YYYY in footer. Please use the WCRI consent checklist)
Participant Documents (documents that will be given to, read to, or seen by participants)
(e.g. non-standardized questionnaire/survey, information sheets, diary, advertisement, interview guide, focus group guide, telephone script, etc…)
List Documents (include version date: DD-MMM-YYYY):
Proof of an External Scientific or Peer Review (see Science Review Requirements SOP)
Documentation of REB approval and REB correspondence/comments from another institution where research will also be conducted.
Letters of support from departments/services within Women’s College Hospital that this study may impact (i.e. medical imaging, pharmacy, laboratory services).
Other (e.g. Data Collection Form(s), DSMB Charter, etc…)
List Documents:
Product monograph(s) or Investigator’s Brochure (IB) or Medical Device Instructions
Clinical Trials Registration Number
Health Canada No Objection Letter/Investigational Testing Authorization (ITA)/Notice of Authorization (NOA)

3) Type of Review Requested
Full Board Review: 4 hard copies of all study documents (double-sided, stapled) and 1 electronic copy sent to:

Delegated Review: 2 hard copies of all study documents (double sided, stapled) and 1 electronic copy sent to:

4) Principal Investigator CV:
The principal investigator’s CV must be made available if requested to document the qualifications for the conduct of this study. The CV is on file with:
WCRIResearch Ethics Office PI Other (where):

5) Educational Requirements:
Please ensure that all members have completed the appropriate WCH requirements for education in research ethics training modules. Please note that the REB will not give final approval until educational requirements have been completed by all WCH-affiliated research team members.

All research team members have completed and submitted proof of completion of all applicable educational requirements

All research team members will complete applicable training requirements prior to REB Approval (Please note that the REB will not give final approval until educational requirements have been completed by all WCH-affiliated research team members)

6) Contracts:
If any money, data, or material (biological or otherwise) is being transferred outside of or between institutions/parties, a contract/agreement may be required. If the above applies to this study, contact to facilitate any contracts/agreements:

WCH Contracts Office has been contacted
WCH will be contacted prior to conducting the study
This study does not involve transfer of money, data or material (biological or otherwise).

7. Is this an Industry-Sponsored/Supported study?

No
YesIf YES, complete the below table

Invoicing Information for Industry-Sponsored/Supported Studies
Full Board REB review: $3000.00 CAD
Annual renewals & full board amendments: $500.00 CAD
Invoice to the Following Company:
Contact Name:
Telephone: / Email:
Street Address: / Suite:
City: / Province/State:
Country: / Postal/Zip Code:

INSTITUTIONAL REVIEW FORM

Questions:

  • What areas of WCH will this study impact? Please submit a Clinical Impact Assessment Form
  • Does this study have any Conflicts of Interest? Please refer to the WCH Conflict of Interest Policy.
  • Does this study have any privacy or IT related concerns? Please submit a Privacy Impact Assessment Form
  • Does this study have a:

WCH Affiliation

Does this package include documents supporting the following:

Supporting Documentation from Internal Stakeholders

Scientific Review

Financial Resources/Management

Research Agreements

Peer Review

Research Ethics Training

Basic Biomedical Ethics

GCP

RCR

TCPS2

Other

(Please note that the REB will not give final approval until educational requirements have been completed by all WCH-affiliated research team members)

LOCAL PRINCIPAL INVESTIGATOR:

FOR OFFICE USE ONLY

Decision:

Approved – ready for submission to the WCH REB

Approved – pending modifications

Not Approved – return to PI for further modification/clarification related to the following:

Name:

Signature:

Version: February 2016

Women’s College Hospital Research Ethics Board-76 Grenville Street, Room 6341, Toronto, Ontario M5S 1B2

Tel: 416-351-3732 x2723 Website: