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SOPs, Guidelines & Regulations

SOPs 

 

Section 1: General

Table of Content

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 Rearch Ethics BoardMembers

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

 

Secton 3: Function and Operation

REB SOP 301 - REB Meeting Administration

REB SOP 302 - Administrative Reveiw 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 Supensions 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 Catergories of Research

REB SOP 502 - Vulnerable Populations

REB SOP 503 - REB Review during Publicly Declared Emergencies

REB SOP 504 - Human Genetic 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 or Alteration 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

 

Section 10: Privcy and Confidentiality

REB SOP 1001 - Use and Disclosure of Personal Health Information

 

Guidelines and 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, December 2010. 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
 

Health Canada - Food and Drug Regulations: Division 5  - Clinical Trials
 

Health Canada - Drugs & Health Products-Acts and Regulations 
 

Health Canada - Drugs & Health Products-Enforcement Activities 

 

 

International

World Health Organization (WHO) – Handbook for Good Clinical Research Practice

The IWK Health Centre is respected for its world-class research into disorders and diseases affecting women, children, youth and families and is home to many leading research centres. 

Learn more about our research centres by visiting one of the links below.