Understand the process in obtaining approvals for your research project.
Our department works closely with researchers to coordinate all approvals, which includes contract negotiation for sponsored research, affiliation agreements with academic institutions, grant administration, protocol development and statistical support, library services and transfer support.
What approvals are required?
Principal investigators must ensure that they have the following approvals before contacting participants for their research (unless prior consent to contact has been received):
- Fraser Health Research Ethics Board Certificate of Initial Approval.
- Letter of Authorization to Conduct Research:
- Research can begin when the principal investigator receives our Letter of Authorization to Conduct Research signed by our director.
- This letter confirms that all approvals have been secured. This is required before the principal investigator can proceed with their study. Keep the letter on file.
Services from other departments
- Fraser Health departmental agreement for providing research-related services form
- Letter of Authorization to Conduct Research
Regulated sponsored clinical trials
- Executed clinical trial agreement between Fraser Health, principal investigator and sponsor
- Health Canada letter of no objection
- Clinical trial registration number with a non-profit clinical trials registry
Grant funded studies
- Grant contribution agreement
Affiliated academic researchers
- Research Collaboration Agreement between Fraser Health and the academic researcher’s institution (inter-institutional)
What happens when my study is approved?
Once all requested modifications and clarifications have been made to the Fraser Health Research Ethic Board's satisfaction, we will email the following to the principal investigator:
- Certificate of Initial Ethical Review, which is the official ethics approval documentation. Make sure to keep this on file for audit purposes and to meet regulatory requirements.
- Approved consent forms with the Fraser Health Research Ethics Board approval date. These approved versions are used for recruitment purposes. This does not apply to harmonized consent forms.
- Letter of Authorization to Conduct Research, if all other approvals have been received and are in order.
When can I start recruiting research participants or collect data?
Researchers are permitted to start recruiting participants and collecting data when the principal investigator receives the following:
- Fraser Health Letter of Authorization to Conduct Research.
- Certificate of Ethics Approval for single-site research or the Harmonized Certificate of Ethics Approval for multi-site harmonized studies.
- A Data Access Agreement from the Fraser Health Office of Information Privacy for the use of any data held or owned by Fraser Health for research purposes.
If a patient has signed a consent to contact form, contact can only start once the study has received ethical approval from the Fraser Health Research Ethics Board.
How long is a Certificate of Ethical Approval valid?
The Certificate of Ethical Approval is valid for one year from the approval date.
Researchers are not permitted to contact participants or start any research-related procedures until the Certificate of Initial Ethical Approval and the Letter of Authorization to Conduct Research have been issued.
How do I get a Research Ethics Board Attestation Form?
Health Canada does not require a separate signed Research Ethics Board Attestation Form if Research Ethics Board Certificates of Approval include the information stipulated by Health Canada for clinical trials.
- Certificates of approval include the following attestations which meet Health Canada regulatory requirements for clinical trials.
- Membership of the Fraser Health Research Ethics Board complies with the membership requirements for research ethics boards as defined in Division 5 of the Food and Drug Regulations and the Tri-Council Policy Statement.
- Board carries out its functions in a manner consistent with good clinical practices.
- Board has reviewed and approved the clinical trial protocol and the informed consent form for the trial which is to be conducted by a qualified investigator named at the specified clinical trial site.
- Fraser Health Research Ethics Board Attestation Standard Operating Procedure may be sent to sponsors who require this information.
How do I get a federal-wide assurance number for U.S. studies?
Under the United States Department of Health and Human Services Code of Federal Regulations 45: Part 46 A Protection of Human Subjects Section (refer to 46.103), every institution engaged in human subjects research supported or conducted by any United States Federal Department or Agency must have assurance of compliance approved by the United States Office for Human Research Protections. The Assurance formalizes the institution's commitment to protect human subjects.
The Fraser Health Research Ethics Board membership list includes the attestation information required for the Federalwide Assurance (FWA).
Office for Human Research Protections Database Federalwide Assurance and the Institutional Review Board assurance:
Registration Number: IORG: IORG0004093
Expiry Date: June 2018
Last Update: June 26, 2015 | Expires: June 26, 2018
How long must research records be kept by the site?
Regulated clinical trials
All records must be retained for a period of 25 years to comply with Health Canada regulations for drug, device and natural health products and the International Conference on Harmonization Good Clinical Practices (ICH GCP).
Researchers are required to keep all research-related records for five years.
For review of serious adverse event reports and protocol deviations/violations:
- Submit for delegated review as above.
- These types of submissions receive an acknowledgement by email from the Fraser Health Research Ethics Board coordinator as soon as possible.
- Refer to the guidance notes for unanticipated problems and protocol deviations.
Is there a different process for review of multi-site harmonized research studies?
Yes. Information on harmonized review for multi-site harmonized research studies can be found on the harmonized studies page.