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1.0 PURPOSE

This standard operating procedure (SOP) describes the management of the Research Ethics Board (REB) membership.

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 monitors and manages the REB membership.

4.0 DEFINITIONS

See Glossary of Terms.

5.0 PROCEDURE

REB membership (e.g., appointment, terms) must be adequately managed to meet applicable regulatory composition requirements and maintain the appropriate diversity, experience, and expertise for the type and volume of research reviewed.

5.1    Appointments – Regular Members and Alternates

5.1.1    REB members are appointed as per the organization’s REB terms of reference.

5.1.2    Community members (meeting membership requirements) are solicited from the greater local community.

5.1.3    Each REB member selected is approved by the REB Chair or designee, or as determined by the organizational REB terms of reference. After the support of the REB Chair, the Vice-Principal Research will officially appoint a new member to REB or extend the appointment terms of an existing REB member.

5.1.4    Candidates selected to serve on the REB will be asked to sign a letter of appointment and a Confidentiality of Information and Conflict of Interest Agreement.

5.2    Appointments – REB Chair and Vice-Chair

5.2.1    The REB Chair is appointed as per the organization’s REB terms of reference.

5.2.2    The REB Vice-Chair is appointed per the organization’s REB terms of reference.

5.2.3    The REB Chair and Vice-Chair will be asked to sign a Confidentiality of Information and Conflict of Interest Agreement.

5.3    Ad hoc Advisors/Affiliate Members

5.3.1    At their discretion, the REB Chair or designee may invite individuals with competence in particular areas to assist in reviewing issues that require expertise beyond or in addition to that available on the REB.

5.4    Terms of Appointment

5.4.1    Each REB member will serve for a term specified by the organization.

5.4.2    Re-appointment of an REB member for (an) additional term(s) is allowed by mutual agreement of the REB member and the REB Chair or designee.

5.4.3    The REB Chair and Vice-Chair will serve for a term specified through discussions and an agreement with the organization.

5.4.4    Terms will be overlapping to preserve the experience level, expertise, and continuity of the REB.

5.5    Qualifications and Training of REB Members

5.5.1    Each member of the REB will follow qualification and training procedures.

5.6    Resignations and Removals

5.6.1    An REB member may resign before their term's conclusion upon providing notice to the REB Chair or designee.

5.6.2    An REB member may be asked to step down if they consistently miss 50% or more of the scheduled Full Board meetings per calendar year.

5.6.3    An REB member will be asked to resign immediately upon determination of research misconduct, mismanaged conflict of interest, or any other relevant behaviour that could be perceived as compromising their ethical judgment by the REB Chair. The member may also be suspended from active duties during these investigations. Note that suspension of an REB member would not count against missed meetings.

5.6.4    Every effort will be made to recruit a similarly qualified replacement before the departure of a REB member to preserve the level of experience and expertise, and to ensure the continuity of the functions of the REB.

5.7    Compensation

5.7.1    Compensation and reimbursement of expenses for REB members will be according to organizational policies.

5.8    Liability and Coverage

5.8.1    All REB members are insured for their research ethics review-related work by the organization’s insurance policy, subject to the terms and conditions of that policy.

5.9    Documentation

5.9.1    The REB Office Personnel will maintain an updated electronic REB membership list

5.9.2    The REB membership list is reviewed and updated as required or with the initiation of new or conclusion/termination of existing terms

5.9.3    The current REB membership list and archived lists are maintained and available through the REB Office

5.9.4    CVs, other supporting documents related to education and expertise, signed members’ letters of appointment and confidentiality agreements for all current and past REB members will be maintained in the REB Office

5.9.5    The REB Chair or designee will maintain the REB membership roster, which includes name, degree(s), area(s) of expertise and organizational affiliation(s), role on the REB (e.g. scientific, nonscientific), sex, Canadian citizenship status, and indications of experience such as board certification, licenses, etc. sufficient to describe each member’s chief anticipated contribution to REB deliberations (as applicable)

5.9.6    A detailed membership list will be kept in the REB Office. This list will contain REB member contact information and additional information on areas of expertise for communication and reviewer assignment. It will be kept confidential for access only by REB members and the REB Office Personnel

5.9.7    When applicable, the REB Chair or designee will update the REB registration with the US Office for Human Research Protection (OHRP).

6.0 REFERENCES

See References.