SOP 204 - REB Office Personnel Serving as REB Members

Research Ethics at ³ÉÈË´óƬ Standard Operating Procedure

Title: REB Office Personnel Serving as REB Members

SOP Code: 204.004

Effective Date: 05/15/2023

Site Approvals:

NAME TITLE DATE (MM/DD/YYYY)
Meera Sidhu Research Ethics Manager 12/01/2023
Steven Smith Deputy Vice-Principal Research 12/04/2023
Jacob Brower Chair GREB 05/08/2024
Dean Tripp Chair HSREB 05/07/2024

 

1.0 PURPOSE

This standard operating procedure (SOP) describes the duties of REB Office Personnel as members of the Research Ethics Board (REB).

2.0 SCOPE

This SOP pertains to REBs that review human participant research in compliance with applicable regulations and guidelines.

3.0 RESPONSIBILITIES

All REB members and REB Office Personnel are responsible for ensuring that the requirements of this SOP are met.

The REB Chair or designee is responsible for clearly articulating all required duties associated with membership to the REB to potential and current REB members.

REB members and alternates are responsible for fulfilling their duties as specified in this SOP.

4.0 DEFINITIONS

See Glossary of Terms.

5.0 PROCEDURE

The primary duty of each REB member is the protection of the rights and welfare of the individual human beings serving as the research participants. To fulfill their duties, REB members must be versed in regulations governing human participants’ protection, biomedical research ethics, and policies germane to human research participant protection.

5.1    Duties

5.1.1    REB Office Personnel designated as Board members may attend convened meetings and participate in discussions. Still, they shall not be counted in determining a quorum, and they shall not participate in any votes.

5.1.2    REB Office Personnel who have been appointed to serve as REB members may perform delegated review in accordance with the delegated review procedure.

5.1.3    The assignment of these tasks to REB Office Personnel will be documented.

REB Office Personnel are currently delegated to perform the following tasks on behalf of the REB:

  • Acknowledgement/Approval of Minor Administrative Changes
  • Administrative Review of Initial Applications and Event Forms
  • Acknowledgement/Approval of Team Member Changes (not for PI changes)
  • Acknowledgement/Approval of Study Closures
  • Acknowledgment of Protocol Deviation/Adverse Events
  • Approval of Renewals with no changes/increase in risk
  • Approval of Case Report Forms
  • Approval of Non-Recruitment/Secondary Data Use Protocols
  • Preliminary Reviews of LOI/CFs
  • Preliminary Reviews for New Applications Requiring Full Board Review
  • Preliminary Reviews for Amendments Requiring Full Board Review
  • Preliminary Reviews for New Applications Requiring Delegated Review
  • Preliminary Reviews for Amendments Requiring Delegated Review
  • Preliminary Principal Investigator (PI) Responses to Delegated Reviews
  • Preliminary Reviews for PI Responses to Full Board Reviews
  • Preliminary Reviews for Protocol Deviations/Adverse Events/Serious Adverse Events
  • Participate in the Level of Risk Determination for Application

Delegation of duties and tasks for the Research Ethics Staff are filed and retained by the Research Ethics Manager.

5.2    Appointment Criteria

5.2.1    REB Office Personnel serving as REB members shall have knowledge, experience, and training comparable to what is expected of REB members. The REB shall ensure that Office Personnel can fulfill their responsibilities as REB members independently.

5.4    Training and Education

5.4.1    REB Office Personnel serving as REB members are expected to additionally follow training and education procedures for REB members.

5.5    Conflict of Interest

5.5.1    REB Office Personnel serving as REB members are additionally expected to follow conflict of interest procedures for REB members. REB Office Personnel will sign a confidentiality agreement and a conflict of interest agreement. This documentation is electronically filed and retained by the Research Ethics Manager on Queen’s supported secured servers.
 

6.0 REFERENCES

See References.

SOP Code Effective Date Summary of Changes
SOP204.001 09/15/2014 Original version
SOP204.002 03/08/2016 No revisions needed
SOP204.003 10/08/2019

No revisions needed

SOP204.004 05/15/2023 No revisions needed
SOP204.004 12/01/2023 Queen’s Specific Revisions/Clarifications added to the N2 SOPs