SOP 204 - REB Office Personnel Serving as REB Members

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.