³ÉÈË´óƬ

1.0 PURPOSE

This standard operating procedure (SOP) describes the overall management of the Research Ethics Board (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

The organizational officials, REB Chair or designee, and REB Office Personnel are responsible for ensuring that the requirements of this SOP are met. The organization is responsible for providing sufficient resources to adequately support the functions of the REB.

4.0 DEFINITIONS

See Glossary of Terms.

5.0 PROCEDURE

The REB Office Personnel provides consistency, expertise, and administrative support to the REB, and serve as a direct conduit between the REB and the research community. The REB Office Personnel are vital to ensuring the efficient and effective administration, and enforcement of REB decisions. Thus, the highest level of professionalism and integrity is expected.

5.1    Job Descriptions

5.1.1    Job descriptions will be developed to establish the role requirements for the REB Office Personnel in accordance with organizational policies and procedures.

5.1.2    Each REB Office Personnel will be provided with a copy of their job description, job expectations, and access to all applicable organizational policies and procedures.

5.2    Responsibilities

5.2.1    REB Office Personnel responsibilities may include:

• ethical and administrative pre-review of submissions and requests to the REB,
• quality management activities,
• management of administrative issues involving REB research ethics oversight as described by applicable REB policies,
• implementation of REB directives, and
• provision of advice and information to the REB.

5.3    Hiring and Terminating REB Office Personnel

5.3.1    The organization will determine responsibility for the recruitment, hiring, and termination of REB Office Personnel in accordance with organizational policies and procedures.

5.4    Delegation of Authority or Responsibility

5.4.1    Appropriate tasks or responsibilities may be delegated to the REB Office Personnel in accordance with organizational/REB policy if the individual has the expertise to carry out the task(s) as per applicable guidelines.

5.5    Performance Evaluations and Documentation

5.5.1    Performance feedback will be provided on an ongoing basis by the REO Manager.

5.5.2    The organization will determine responsibility for conducting formal performance evaluations in accordance with organizational policies and procedures.

5.5.3    The organization will determine responsibility for identifying, documenting and retaining formal REB Office Personnel interactions.

5.6    Periodic Evaluation of REB Office Human Resource Needs

5.6.1    A periodic evaluation of the adequacy of the REB resources will be conducted.

5.6.2    The evaluation will assess whether the REB Office Personnel, equipment, finances, and space are adequate to carry out its function in support of the REB.

5.6.3    The assessment takes into consideration the volume, complexity, and types of research studies projects administered by the REB Office Personnel and whether activities in support of the REB can be completed promptly.

5.6.4    The need for additional resources will be discussed with the appropriate Organizational Official.

6.0 REFERENCES

See References.