Polices & Procedures

The Sunnybrook Research Ethics Board (REB) has adopted a national set of Standard Operating Procedures (SOPs) called the N2/CAREB REB SOPs. The Network of Networks (N2) and the Canadian Association of Research Ethics Boards (CAREB) have collaboratively developed a standardized set of Canadian REB SOPs that are available via open access and are compliant with applicable Canadian and US regulatory and ethics guidance criteria. The adoption of the N2/CAREB REB SOPs will facilitate a single standard for REBs in Canada.

Note that some of the SOPs have an associated Sunnybrook REB Addendum that is to be used in in conjuction with the applicable N2/CAREB REB SOP. Addendums have been developed to reflect processes specific to Sunnybrook while maintaining compliance. There are no substantive change to content between the previous set of Sunnybrook REB SOPs and the N2/CAREB REB SOPs.

Policies are internal documents available through the hospital intranet. Archived Policies and SOPs are maintained by the Research Ethics Office.

All files are in PDF.

N2/CAREB REB SOPs

100 GENERAL ADMINISTRATION (101-108)

SOP#/VersionTitle
N/AInstitutional Authorization to Adopt (PDF)
101.004Authority and Purpose (PDF)
102.004Research Requiring REB Review (PDF)
103.004Training and Education (PDF)
*SOP 103 Addendum – Training and Education (PDF)
104.004Management of REB Office Personnel (PDF)
105A.004Conflicts of Interest – REB Members and REB Office Personnel (PDF)
*SOP 105A Addendum – Conflicts of Interest – REB Members and REB Office Personnel (PDF)
105B.004Conflicts of Interest – Researchers (PDF)
105C.004Conflicts of Interest – Organizations (PDF)
106.004Signatory Authority (PDF)
107.004Use and Disclosure of Personal Information (PDF)
108.004Standard Operating Procedures and Maintenance (PDF)

200 REB ORGANIZATION (201-204)

SOP#/VersionTitle
201.004Composition of the REB (PDF)
*SOP 201 Addednum – Composition of the REB (PDF)
202.004Management of REB Membership (PDF)
203.004Duties of REB Members (PDF)
204.004 – N/AREB Office Personnel Serving as REB Members (N/A at Sunnybrook)

300 FUNCTIONS AND OPERATIONS (301-303)

SOP#/VersionTitle
301.004REB Submission Requirements and Administrative Review (PDF)
302.004REB Meeting Administration (PDF)
*SOP 302 Addendum – REB Meeting Administration (PDF)
303.004Document Management (PDF)
*SOP 303 Addendum – Document Management (PDF)

400 REVIEWS OF RESEARCH (401-407)

SOP#/VersionTitle
401.004Delegated Review (PDF)
402.004REB Review Decisions (PDF)
*SOP 402 Addendum – REB Review Decisions (PDF)
403.004Initial Review – Criteria For REB Approval (PDF)
404.004Ongoing REB Review Activities (PDF)
*SOP 404 Addendum – Ongoing REB Review Activities (PDF)
405.004Continuing Review (PDF)
*SOP 405 Addendum – Continuing Review (PDF)
406.004Research Completion (PDF)
407.004Suspension or Termination of REB Approval (PDF)
*SOP 407 Addendum – Suspension or Termination of REB approval (PDF)

500 REVIEWS REQUIRING SPECIAL CONSIDERATION (501)

SOP#/VersionTitle
501.004REB Review During Publically Declared Emergencies (PDF)

600 REB COMMUNICATION AND NOTIFICATION (601-602)

SOP#/VersionTitle
601.004Communication – Researchers (PDF)
602.004Communication – Research Participants (PDF)

700 INFORMED CONSENT (701)

SOP#/VersionTitle
701.004Informed Consent Form Requirements and Documentation (PDF)

800 RESPONSIBILITIES OF INVESTIGATORS (801)

SOP#/VersionTitle
801.004Researcher Qualifications and Responsibilities (PDF)
*SOP 801 Addendum – Researcher Qualifications and Responsibilities (PDF)

900 QUALITY MANAGEMENT (901-903)

SOP#/VersionTitle
901.004Quality Assurance Inspections (PDF)
903.004Non-Compliance (PDF)

OTHER DOCUMENTS

SOP#/VersionTitle
N/AGlossary of Terms (PDF)
N/AReferences (PDF)
Policy NumberSunnybrook Policy (available on Sunnynet)
TOR-0033Sunnybrook REB Policy: Terms of Reference
ADM-055Sunnybrook REB Policy: Appeals Process