Forms and Templates
All application and reporting forms are available through the Research Services Portal.
You will find a link to the an example/working copy of the new form on the right. You may find this useful if developing your application with colleagues. We will not accept this MS Word document in lieu of completion of the application in the Research Portal.
Informed Consent Forms
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 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 Clinical Informed Consent Form Template and Guidance
In February 2019, Research Ethics BC (REBC) partners released an updated version of the attached template as a standard to be used across the province for creating a Consent Form in clinical research
Templates for all HREB Studies
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 Form Template
While informed consent is a requirement to participate in research, in health/socio-behavioural research, written consent is not a requirement. Oral (verbal), a verbal agreement, or a handshake are acceptable, rather than signing a consent form. Consent may also be demonstrated solely by the actions of the participant (e.g. through the return of a completed questionnaire). In all cases, the procedures used to seek consent must be documented and articulated to the REB.
Items to consider:
When collecting verbal consent, the researcher should have a script that is used to review the verbal consent. Submit this script to the REB with study documents for review.
At times verbal consent may also be logged using a consent log (this document would provide enough detail to log when and where consent was collected, but only as much information as needed to document and also protect the confidentiality of participants).
Please see TCPS 2 (2018) Article 3.12 for more detail about the range of consent procedures and when/how to use them.