All application and reporting forms are available through the Research Services Portal.
Informed Consent Forms
For all HREB studies:
Please ensure that any Informed Consent Forms submitted meet the requirements set out in the checklist below (PDF). If they do not, it is likely that they will be returned to you requesting changes before they are approved for use.
Informed Consent Requirement for U.S.-Funded Clinical Trials
Effective March 7, 2012, ICF Compliance now enforced for all U.S.-funded clinical trials. Updated US/FDA regulations require an additional statement to be included in consent forms for all applicable clinical trials.
Under 21 CFR 50.25(c), the following statement must be reproduced word-for-word in informed consent documents in applicable clinical trials:
“A description of this clinical trial will be available on http://www.clinicaltrials.gov/, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this website at any time.”
For more information, and a definition of 'applicable clinical trial,' see this guidance document (PDF) from the U.S. Food and Drug Administration.
Data Flow Diagram
All studies should include a diagram demonstrating the flow of data during the study.
BC Common Informed Consent Template for Clinical Research
As of September 12, 2013, the BC Ethics Harmonization Initiative (BCEHI) agreed on the attached template as a standard to be used for creating an Informed Consent Form in clinical research.
Protocol Required for HREB applications
If you do not have one, please use the protocol template provided. Please contact the Research Ethics office if you have any questions on how to complete it. If there are discrepancies between the HREB application and the protocol, for the purposes of ethical review and approval, the application will be considered the primary document.
Informed Consent Template for HREB applications
A Health Research Informed Consent Template should be used when creating an informed consent form that will be submitted to the HREB for review and approval. Please contact the Research Ethics office if you require assistance with the use of this template.