SOPs, Guidelines & Regulations

SPECIAL NOTICE

Processes Concerning Research Protocols During the COVID-19 Pandemic

Purpose: With the activation of SOP 5.503 (REB Review During Publicly Declared Emergencies), the REB may, during a publicly declared emergency “follow a modified review and operations plan”. The purpose of this Standard Operating Procedure (SOP) is to inform the processes concerning research protocols during the COVID-19 Pandemic.

IWK Research Services Standard Operating Procedures Research Ethics

SOP's, GUIDELINES & REGULATIONS

Standard Operating Procedures (SOP's)

Section 1: General

• Table of Contents
• REB SOP 101 - Introduction
• REB SOP 102 - Glossary
• REB SOP 103 - IWK REB Policy: Terms of Reference
• 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 - Training and Education: REB Members and REO Staff
• REB SOP 203 - Disclosure and Documentation of Conflict of Interest
• REB SOP 204 - Signing Authority

Section 3: Function and Operation

• REB SOP 301 - REB Meeting Administration
• REB SOP 302 - Administrative Review and Distribution of REB Material
• REB SOP 303 - Documentation and Document Management

Section 4: Review of Research

• REB SOP 401 - Initial Review - Criteria for REB Approval
• REB SOP 402 - Research Review Determinants
• REB SOP 403 - Delegated Review Procedures
• REB SOP 404 - Amendments, Notifications, Ongoing Communication Review Procedures
• REB SOP 405 - Protocol Deviations
• REB SOP 406 - Continuing Review (REB annual renewal of approval)
• REB SOP 407 - Non-compliance
• REB SOP 408 - Administrative Holds, Terminations and Suspensions of Approval
• REB SOP 409 - Safety Reporting/Submitting External (non-local) Safety Reports to the REB
• REB SOP 410 - Study Completion
• REB SOP 411 - IWK REB Policy: 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

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 or Alteration of Informed Consent
• REB SOP 703 - Documentation of Informed Consent

Section 8: Responsibilities of Investigators

• REB SOP 801 - Investigator Qualifications and Responsibilities
• REB SOP 802 - Researcher Education and Training

Section 9: Quality Assurance

• REB SOP 901 - Reviews and Inspections

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, 2018. 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)

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