CHIPER Standard Operating Procedures

On xxx, RITHIM has adopted the Research Ethics Board (REB) Standard Operating Procedures (SOPs) developed by the Network of Networks (N2) and the Canadian Association of Research Ethics Boards (CAREB).  These SOPs are compliant with applicable Canadian and US regulatory and ethics guidance criteria.  They provide a model which will facilitate the distribution, adoption and maintenance of a single standard for REBs in Canada. 

Use of SOPs also ensures that the ethics board is constituted appropriately and conducts its processes in a way that protects the rights and safety of study participants. 

100 GENERAL ADMINISTRATION (101-108) 

SOP 101 Authority and Purpose 

SOP 102 Research Requiring REB Review 

SOP 103 Training and Education 

SOP 104 Management of REB Office Personnel 

SOP 105A Conflicts of Interest REB Members and REB Office Personnel 

SOP 105B Conflicts of Interest Researcher 

SOP 105C Conflicts of Interest Organization 

SOP 106 Signatory Authority 

SOP 107 Use and Disclosure of Personal Information 

SOP 108 Standard Operating Procedures Maintenance 

200 REB ORGANIZATION (201-204) 

SOP 201 Composition of the REB 

SOP 202 Management of REB Membership 

SOP 203 Duties of REB members 

SOP 204 REB Office Personnel Serving as REB Members 

300 FUNCTIONS AND OPERATIONS (301-303) 

SOP 301 REB Submission Requirements and Administrative Review 

SOP 302 REB Meeting Administration 

SOP 303 Document Management 

400 REVIEWS OF RESEARCH (401-407) 

SOP 401 Delegated Review 

SOP 402 REB Review Decisions 

SOP 403 Initial Review Criteria for REB Approval 

SOP 404 Ongoing REB Review Activities 

SOP 405 Continuing Review 

SOP 406 Research Completion 

SOP 407 Suspension or Termination of REB Approval 

500 REVIEWS REQUIRING SPECIAL CONSIDERATION (501-503) 

SOP 501 REB Review During Publicly Declared Emergencies 

600 REB COMMUNICATION AND NOTIFICATION (601-602) 

SOP 601 Communication Researcher 

SOP 602 Communication Research Participants 

700 INFORMED CONSENT (701) 

SOP 701 Informed Consent Form Requirements and Documentation 

800 RESPONSIBILITIES OF INVESTIGATORS (801) 

SOP 801 Researcher Qualifications and Responsibilities 

900 QUALITY MANAGEMENT (901-903) 

SOP 901 Quality Assurance Inspections 

SOP 902 External Inspections or Audits 

SOP 903 Noncompliance 

Glossary of Terms 

References 

Table of Concordance – October 2019 

Table of Contents (pdf) 

Download the Standard Operating Procedures zip file