Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (HSREB) Standard Operating Procedures (SOPs)

100 GENERAL ADMINISTRATION (101-108)

SOP# Title Effective Date
101  Authority and Purpose (PDF 251 KB) January 6, 2022
102  Research Requiring REB Review (PDF 72 KB) January 6, 2022
103  Training and Education (PDF 309 KB) January 6, 2022
104  Management of REB Office Personnel (PDF 187 KB) January 6, 2022
105A   Conflicts of Interest – REB Members and REB Office Personnel (PDF 301 KB) January 6, 2022
105B  Conflicts of Interest – Researcher (PDF 312 KB) January 6, 2022
105C  Conflicts of Interest – Organization (PDF 202 KB) January 6, 2022
106  Signatory Authority (PDF 172 KB) January 6, 2022
107  Use and Disclosure of Personal Information (PDF 207 KB) January 6, 2022
108  Standard Operating Procedures Maintenance (PDF 174 KB) January 6, 2022

200 REB ORGANIZATION (201-204)

SOP# Title Effective Date
201  Composition of the REB (PDF 230 KB) January 6, 2022
202  Management of REB Membership (PDF 283 KB) January 6, 2022
203  Duties of REB Members (PDF 224 KB) January 6, 2022
204  REB Office Personnel Serving as REB Members (PDF 261 KB) January 6, 2022

300 FUNCTIONS AND OPERATIONS (301-303)

SOP# Title Effective Date
301  REB Submission Requirements and Administrative Review (PDF 199 KB) January 6, 2022
302  REB Meeting Administration (PDF 258 KB) January 6, 2022
303  Document Management (PDF 242 KB) April 20, 2022

400 REVIEWS OF RESEARCH (401-410)

SOP# Title Effective Date
401  Delegated Review (PDF 202 KB) January 6, 2022
402  REB Review Decisions (PDF 292 KB) January 6, 2022
403  Initial Review Criteria for REB Approval (PDF 289 KB) January 6, 2022
404  Ongoing REB Review Activities (PDF 420 KB) January 6, 2022
405  Continuing Review (PDF 218 KB) January 6, 2022
406  Research Completion (PDF 161 KB) January 6, 2022
407  Suspension or Termination of REB Approval (PDF 216 KB) January 6, 2022
408  Protocol Deviation (PDF 159 KB) January 6, 2022
409  Research Requiring Federalwide Assurance (FWA) (PDF 164 KB) January 6, 2022
410  Reporting Adverse Events (PDF 208 KB) January 6, 2022

500 REVIEWS REQUIRING SPECIAL CONSIDERATION (501-503)

SOP# Title Effective Date
501  REB Review During Publicly Declared Emergencies (PDF 227 KB) January 6, 2022
502  Review of Biological and Reproductive Materials (PDF 155 KB) January 6, 2022
503  Review of Human Genetic Research (PDF 139 KB) January 6, 2022

600 HSREB COMMUNICATION AND NOTIFICATION (601-602)

SOP# Title Effective Date
601   Communication Researcher (PDF 248 KB) January 6, 2022
602   Research Communication (PDF 251 KB) January 6, 2022

700 INFORMED CONSENT (701)

SOP# Title Effective Date
701  Informed Consent Form Requirements and Documentation (PDF 453 KB) January 6, 2022

800 RESPONSIBILITIES OF INVESTIGATORS (801)

SOP# Title Effective Date
801  Researcher Qualifications and Responsibilities (PDF 398 KB) January 6, 2022

900 QUALITY MANAGEMENT (901-903)

SOP# Title Effective Date
901  Quality Assurance Inspections (PDF 224 KB) January 6, 2022
902  External Inspections or Audits (PDF 186 KB) January 6, 2022
903  Non-Compliance (PDF 233 KB) January 6, 2022

OTHER DOCUMENTS

Title Effective Date
Glossary of Terms January 6, 2022
Table of Concordance (PDF 596 KB) January 6, 2022

*PDF files can be viewed using Adobe Reader .