Standard Operating Procedures (SOP's)
Section 1: General
- REB SOP 101 - Introduction
- REB SOP 102 - Glossary
- REB SOP 104 - Activities Requiring REB Review
- REB SOP 105 - SOP Policy Development and Maintenance
Section 2: REB Organization
- REB SOP 201 - Duties of Research Ethics Board Members
- REB SOP 202 - Education and Training of REB members and REO Staff
- REB SOP 203 - Disclosure and Documentation of Conflict of Interest
- REB SOP 204 - Authorized Signatory/Signing Authority
- REB SOP 205 - Ad Hoc Ethics Reviewers
Section 3: Function and Operations
- REB SOP 301 - REB Meeting Administration
- REB SOP 302 - Administrative Review and Distribution of Materials
- REB SOP 303 - Documentation and Document Management
Section 4: Review of Research
- REB SOP 401 - Criteria for REB Approval
- REB SOP 402 - Review of Decision Determinants
- REB SOP 403 - REB Delegated Review Procedures
- REB SOP 404 - Protocol Amendments, Notifications, and Ongoing Communications
- REB SOP 405 - Protocol Deviations
- REB SOP 406 - Continuing Review (REB Renewal) Process
- REB SOP 407 - Non-compliance and Ethical Impropriety
- REB SOP 408 - Administrative Holds, Terminations and Suspensions of Approval
- REB SOP 409 - Adverse Event Reporting
- REB SOP 410 - Study Completion
- REB SOP 411 - Appeals Process
Section 5: Reviews Requiring Special Consideration
- REB SOP 501 - Special Categories of Research
- REB SOP 502 - Vulnerable Populations
- REB SOP 503 - REB Review during Publicly Declared Emergencies
- REB SOP 504 - Human Genetic Research
- REB SOP 505 - Processes Concerning Research Protocols During the COVID-19 Pandemic
- REB SOP 506 - Surveillance Research
Section 6: Communications
- REB SOP 601 - REB and Research Office Communication to Researchers
- REB SOP 602 - REB and Research Office Communication to Participants
Section 7: Informed Consent
- REB SOP 701 - General Requirements of Informed Consent
- REB SOP 702 - Waiver of Informed Consent
- REB SOP 703 - Documentation of Informed Consent
Section 8: Responsibilities of Investigators
- REB SOP 801 - Investigator Qualifications and Responsibilities
Section 9: Quality Assurance
- REB SOP 901 - Audits and Inspections
- REB SOP 902 - Remote Monitoring During a Publicly Declared Emergency
Section 10: Privacy and Confidentiality
- REB SOP 1001 - Use and Disclosure of Personal Health Information
Guidelines & Regulations
Regional
- PHIA Toolkit for Custodians: A Guide to the Personal Health Information Act. Halifax (NS) - Department of Health and Wellness; 2013.
- PHIA – Personal Information International Disclosure Protection Act-Nova Scotia Bill 19
National
- TCPS-2 – Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2022. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada.
- CIHR Best Practices for Protecting Privacy in Health Research - Ottawa (ON): Canadian Institutes of Health Research; 2005.
- Secondary Use of Personal Information in Health Research - Case Studies. Ottawa (ON): Canadian Institutes of Health Research; 2002.
- ICH – GCP - International Council on Harmonization – Good Clinical Practice
- Food and Drug Regulations: Division 5 - Clinical Trials - Health Canada.
- Drugs & Health Products - Acts and Regulations - Health Canada.
- Drugs & Health Products - Enforcement Activities - Health Canada.
International
- Handbook for Good Clinical Research Practice - World Health Organization (WHO), 2005.