SOP 103 - Training and Education

1.0 PURPOSE

This standard operating procedure (SOP) describes the training and education requirements for Research Ethics Board (REB) members and REB Office Personnel. 

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.

4.0 DEFINITIONS

See Glossary of Terms.

5.0 PROCEDURE

REB members, REB Office Personnel, and others charged with the responsibility for reviewing, approving, and overseeing human participant research should will be well-versed in the regulations, guidelines, policies, and ethical principles applicable to human participant research. Adequate training and education in these areas is critical for the REB to fulfill its mandate to consistently protect research participants' rights and welfare. 

5.1 Training and Education – REB Members

5.1.1    The REB Chair or designee will provide new REB members with a general overview of the policies and procedures pertinent to REB meeting functions and REB member expectations, as well as an orientation to the principles and guidelines for research ethics.

5.1.2    New REB members are required to complete the TCPS online tutorial and will received a formal orientation process, that will include, but is not limited to:

• Background on the REB (e.g., Terms of Reference, governance structure,
• annual reports, process flowchart).
• Policies and Procedures (e.g., relevant SOPs and associated forms, consent form template, consent form checklist).
• Member information (e.g., meeting schedule, membership list,
• information and guidelines for members, reviewer guide).
• Regulatory and guidance documents.
• Other member-specific information (e.g., copy of signed confidentiality and conflict of interest agreement, membership appointment letter).
• Resource information (e.g., list of training and education references,
• relevant articles, etc.).
• Queen’s University’s HSREB and GREB will administer a virtual or in-person orientation session with new members. This will provide the necessary background and helpful tips to remember as a reviewer of a study.
• Queen’s University’s HSREB and GREB will require new members to be mentored through the review of delegated applications (minimum of 3 rounds) before they commence independent review applications.

5.1.3    As part of their orientation, new REB members will be offered the opportunity to observe at least one REB meeting before commencing their REB member duties.

5.1.4    REB members are encouraged to attend conferences and other educational sessions pertaining to human participant research protection, such as the Canadian Association of Research Ethics Board (CAREB) annual general meeting and CAREB regional meetings. The REB office will support such activities to the extent possible and as appropriate to the responsibilities of REB members. Conference attendance is based on funding availability and other practical considerations (e.g., timing, conference location).

5.1.5    Ongoing ethics education in areas germane to the REB members’
responsibilities may be provided at REB meetings.

5.1.6    New or revised policies and SOPs will be disseminated to all REB members.

5.1.7    REB members are encouraged to engage in self-directed learning in research ethics and in the conduct of research to enhance their ability to fulfill their responsibilities.

5.2    Training and Education – REB Office Personnel

5.2.1    The REB Chair or designee will provide new REB Office Personnel with an overall orientation to the REB, including a general overview of the policies and procedures pertinent to their role in support of the REB.

5.2.2    New REB Office Personnel will receive an orientation package. Before commencing their official duties in the REB office, REB Office Personnel are expected to read and become familiar with the information.

5.2.3    New REB Office Personnel will receive training on the REB SOPs and will be expected to be knowledgeable and compliant with the SOPs.

5.2.4    New REB Office Personnel are required to complete the TCPS online tutorial. They are encouraged to complete additional and ongoing relevant education and training in research ethics and the conduct of research.

5.2.5    REB Office Personnel are encouraged to attend conferences and educational sessions pertaining to human participant research protection, such as the CAREB annual general meeting and CAREB regional meetings. The REB office will support such activities to the extent possible and as appropriate to the responsibilities of REB Office Personnel. Conference attendance is based on the availability of funding and other practical considerations (e.g., workload, staffing, conference location).

5.2.6    New or revised policies and SOPs will be disseminated to the REB Office Personnel.

5.2.7    REB Office Personnel are encouraged to engage in self-directed learning to enhance their ability to fulfill their responsibilities.

5.3    Documentation of Training and Education

5.3.1    The REB office will retain copies of the CVs of all REB members and REB Office Personnel, as well as signed copies of the respective conflict-of- interest statement, the confidentiality agreement, and the letter of appointment by the Vice-Principal Research.

5.3.2    REB members and REB Office Personnel will record their relevant training and education and provide copies of their certificates of completion. Training records will be kept on file in the REB office.

5.3.3    REB members and REB Office Personnel are encouraged to retain copies of agendas of relevant workshops, seminars and conferences attended.

5.3.4    REB agendas and minutes will record the distribution of any educational materials presented at the REB meetings.

6.0 REFERENCES

See References.