HREBA Standard Operating Procedures

On July 1, 2016, the Health Research Ethics Board of Alberta (HREBA) adopted the Research Ethics Board (REB) Standard Operating Procedures (SOPs) which have been 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.

Questions regarding the SOPs can be directed to info@hreba.ca

 

Standard Operating Procedures as one document (pdf)

Table of Contents (pdf)

 

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 – November 2016