Ethics Standard Operating Procedures (SOPs)

Queen’s standard operating procedures (SOPs) are approved by the Vice-Principal (Research). They set clear expectations for research conduct in our academic community and offer guidance on complex ethical research practices. SOPs are reviewed and updated on an ongoing basis. 

View all standard operating procedures in the shared folder. 

View Glossary of Terms and References 

 

SOP number SOP category SOP description Related document
N2 SOP 101 Authority and Purpose
  1. States the organizational authority under which the Research Ethics Board (REB) is established and empowered;
  2. Defines the purpose of the REB;
  3. States the principles governing the REB to assure that the rights and welfare of participants are protected;
  4. States the authority of the REB.
 
N2 SOP 102 Research Requiring REB Review Describes research activities that require REB review and research activities that do not. Please also review Queen’s SOP Addendum 102
N2 SOP 103 Training and Education Describes the training and education requirements for REB members and office personnel. Please also review Queen’s SOP Addendum 103
N2 SOP 104 Management of REB Office Personnel Describes the overall management of the REB office personnel.  
N2 SOP 105a Conflicts of Interest REB Members and REB Office Personnel Describes potential Conflicts of Interest (COI) for REB members (including the REB Chair and any ad hoc advisors) and REB office personnel, and describes the requirements and procedures for disclosure and management of COI.  
N2 SOP 105b Conflicts of Interest - Researcher Describes potential COI for researchers and research staff engaged in human participant research, and the requirements and procedures for disclosure and managing COI. Please also review Queen’s SOP Addendum 105b
N2 SOP 105c Conflicts of Interest - Organization Describes potential Conflicts of Interest (COI) in the relationship between the organization establishing the Research Ethics Board (REB) and the REB itself, and the requirements and procedures for disclosure and for managing potential COI within this relationship.  
N2 SOP 106 Signatory Authority Specifies who has the authority to sign documents on behalf of the Research Ethics Board (REB) and describes the responsibilities of such individuals, and the circumstances under which signing authority may be delegated. Please also review Queen’s SOP Addendum 106
N2 SOP 107 Use and Disclosure of Personal Information Describes the duties of the Research Ethics Board (REB) and the REB office in the protection of the Personal Information (PI) of research participants. Please also review Queen’s SOP Addendum 107
N2 SOP 108 Maintenance by Network of Networks and CAREB Describes the processes for establishing and maintaining written SOPs. The purpose of having written SOPs is to promote quality and consistency in the ethics review process; ensure compliance with the principles, guidelines and regulations applicable to the ethics review and oversight of research involving humans; and facilitate training of new personnel. The REB SOPs are prepared and distributed by N2.  
SOP 109 Alteration to Existing Guidelines, Policies, SOPs, and Procedures The goal of this SOP is to ensure that all potential alterations to existing guidelines, policies, SOPs, and procedures are reviewed in a consistent, transparent, and timely manner.  

Access General Administration SOPs (101 - 109)

SOP number SOP category SOP description Related document
N2 SOP 201 Composition of the REB Describes the membership composition requirements of the Research Ethics Board (REB).  
N2 SOP 202 Management of REB Membership Describes the management of the membership of the Research Ethics Board (REB). Please also review Queen’s SOP Addendum 202
N2 SOP 203 Duties of REB Members Describes the duties of the members of the Research Ethics Board (REB). Please also review Queen’s SOP Addendum 203
N2 SOP 204 REB Office Personnel Serving as REB Members  Describes the duties of REB Office Personnel serving as members of the Research Ethics Board (REB).  

Access REB Organization (201-204) SOPs

SOP number SOP category SOP description Related document
N2 SOP 301 Submission Requirements and Administrative Review Describes the Research Ethics Board (REB) submission requirements and the administrative review procedures. This SOP applies to all submissions including, but not limited to: applications for initial review, amendments or changes to approved research and any new information. Please also review Queen’s SOP Addendum 301
N2 SOP 302 REB Meeting Administration Describes the required activities for the preparation, management and documentation of Full Board meetings of the Research Ethics Board (REB). Please also review Queen’s SOP Addendum 302
N2 SOP 303 Document Management Describes the requirements for document management, including document retention and document archiving. This SOP applies to documents submitted to the Research Ethics Board (REB) for initial or for continuing review, as well as to all REB administrative documents.  

Access Functions and Operations (301-303) SOPs

SOP number SOP category SOP description Related document
N2 SOP 401 Delegated Review Describes the processes for determining when research meets the criteria for delegated ethics review and the associated delegated review procedures. Please also review Queen’s SOP Addendum 401
N2 SOP 402 REB Review Decisions Describes the decisions that the Research Ethics Board (REB) may make resulting from its review of proposed research for ethical acceptability. Please also review Queen’s SOP Addendum 402
N2 SOP 403 Initial Review Criteria for REB Approval - Describes the minimum requirements that research proposals involving human participants must meet in order to be approved by the Research Ethics Board (REB), independent of the review pathway (i.e., Full Board or delegated review). Please also review Queen’s SOP Addendum 403
N2 SOP 404 Ongoing REB Review Activities Describes the procedures for the ongoing review activities that occur after the initial Research Ethics Board (REB) approval of a research project and prior to the formally scheduled continuing review of the research project. Please also review Queen’s SOP Addendum 404
N2 SOP 405 Continuing Review Describes the procedures for the continuing review of research that is overseen by the Research Ethics Board (REB), and the criteria for continued REB approval. Please also review Queen’s SOP Addendum 405
N2 SOP 406 Research Completion Describes the procedures for the closure of research with the Research Ethics Board (REB). Please also review Queen’s SOP Addendum 406
N2 SOP 407 Suspension or Termination of REB Approval Describes the procedures associated with the suspension or termination of the Research Ethics Board’s (REB) approval of research (including the suspension or termination of approval) Please also review Queen's SOP Addendum 407
N2 SOP 408 Streamlined Multi-Jurisdictional Research Application Pathway Describes the requirements that research proposals involving human participants must meet to use the Streamlined Multi-Jurisdictional Research Application pathway.  

Access Review of Research (401-408) SOPs

SOP number SOP category SOP description Related document
N2 SOP 501 REB Review During Publicly Declared Emergencies Describes the research ethics review procedures during a publicly declared emergency.  

Access Reviews Requiring Special Consideration (501) SOP

SOP number SOP category SOP description Related document
N2 SOP 601 Communication - Researcher Describes the Research Ethics Board’s (REB) communication with the Researcher and with his/her research team.  
N2 SOP 602 Communication - Research Participants Describes the Research Ethics Board’s (REB) communication with research participants.  

Access REB Communication and Notification (601-602) SOPs

SOP number SOP category SOP description Related document
N2 SOP 701 Informed Consent Form Requirements and Documentation Describes the requirements for the informed consent form and the process for waiving or obtaining and documenting initial and ongoing informed consent. Please also review Queen’s SOP Addendum 701

Access Informed Consent (701) SOP

SOP number SOP category SOP description Related document
N2 SOP 801 Researcher Qualifications and Responsibilities Describes the qualifications and responsibilities of the Researcher who engages in research involving human participants. Please also review Queen’s SOP Addendum 801

Access Responsibilities of the Investigators (801) SOP

SOP number SOP category SOP description Related document
N2 SOP 901 Quality Assurance Inspections Describes the processes for monitoring, evaluating and improving the effectiveness of the human research protection enterprise.  
N2 SOP 902 External Inspections or Audits Describes the procedures to be followed before, during and following an external inspection or audit.  
N2 SOP 903 Non-Compliance Describes the Research Ethics Board’s (REB) process for responding to reports of non-compliance and the actions that the REB may take as a result of its review of reports of serious and/or continuing non-compliance. Please also review Queen’s SOP Addendum 903

Access Quality Management (901-903) SOPs