Operational Approval

The operational approval process allows for the review and approval of research projects conducted within Vancouver Coastal Health (VCH) facilities or with VCH resources. This includes, but is not limited to data, patients, staff, or the posting of research recruitment materials on its property and through its communication channels. Investigators must apply for and receive formal operational approval before they begin their research project. The stages of operational approval include:

• Application – Investigators must complete and sign the Application for Operational Approval to Conduct a Research Study and obtain signatures from managers of all the departments, units or clinics that are affected by the research.
• Renewal – Operational approval is valid for one year. If the research study remains active after one year, investigators must complete a request for Renewal of Operational Approval. 
• Closing – Once all data collection and analysis procedures have been completed, the study is considered closed and Notification of Study Completion or Termination must be submitted by investigators. 

Resources and Forms

Operational approval resources:

• Research Process Map: VCH Operational Approval & UBC Ethics
• Guideline for Obtaining Operational Approval of Research at VCH
• Application for Operational Approval to Conduct a Research Study
• Renewal of Operational Approval Application
• Notification of Study Completion or Termination

Research device resources:

• VCH Research Device Guidance
• Application for Market Device in Research
• Application for Non-Critical Research Device
• Application for Non-Market Research Device
• Application for Variance Market Device

Radiology resources:

• Radiology - Integrated Medical Imaging Research
• Radiology - Screening Checklist
• Radiology - CT Study Template
• Radiology - IR Study Template
• Radiology - MRI Study Template
• Radiology - Nuclear Medicine Study Template
• Radiology - US Study Template
• Radiology - X-ray Study Template

Other resources:

• VCH Data Application
• Research Ethics Board Checklist
• Recruitment Support Form
• Operating Room Research Form
• Specimen Collection for Research - Special Handling Instructions 
• Anatomic Pathology Laboratory Resource Utilization