The Research Ethics Board (REB) is a standing committee of the Children's Hospital of Eastern Ontario.  The REB reports directly to the Vice President of Research / Director, CHEO Research Institute, and the Board of Trustees through the Hospital Chief Executive Officer.

The REB provides independent, multidisciplinary ethics review of research involving humans that is conducted by staff of the Hospital or Research Institute, and, any research involving humans identified or recruited through CHEO.  It has the authority to approve, reject, request modifications to, or terminate any proposed or ongoing research.  The primary purpose of the REB is to ensure that research under its purview meets the highest ethical and scientific standards.  In carrying out its mandate, the REB is guided by the understanding that: 1) children, youth, and families are vulnerable populations that warrant special protections; and 2) obtaining a reliable answer to a scientific question is an outcome to be so valued that individual benefits can often be deferred or relinquished altogether.  For these reasons, the standards that apply to research should often exceed those that apply to clinical care in which a practitioner is guided by his / her fiduciary responsibility to protect the best interest of the patient.

The REB adopts as minimal standards the ‘Tri-Council Guidelines on Research with Human Subjects’, the ‘Good Clinical Practice’ (International Conference on Harmonization – E6), and the Health Canada Division 5 of the Food and Drug Regulations. Accordingly, the REB considers a number of factors in its review of research protocols including: social and scientific merit, the risks and benefits to subjects, subject selection and recruitment, privacy and confidentiality, record keeping, the consent and assent processes and documents, as well as the contract between the sponsor and the Primary CHEO Site Investigator.

Scope of Review

The REB overseas all human research conducted at or through the hospital.  In defining its scope, the REB adheres to Tri-Council definition of research as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation.  This is distinct from quality assurance activities that are intended to assess the performance of an organization or its staff, within the mandate of the organization.  Recognizing that there can be overlap between these two concepts, the REB must be consulted to determine whether or not a specific activity constitutes research.

Delegated Review

The REB espouses the principle of proportionate review.  Either the Chair alone or a small sub-committee of the REB can review studies presenting low or minimal risk to subjects.  Minimal risk is defined as risk, which is below that normally encountered by the research subject in daily life or during the performance of routine physical or psychological examinations or tests.  Examples of this type of research would include chart reviews or research with staff of the hospital.

Membership

The Director of the Research Institute and CEO jointly appoint the members of the REB for a term of three years.  The membership terms are renewable and are staggered in such a manner as to safeguard the continuity of the REB.  In appointing new members to the REB, the appropriate manager or administrator must be consulted (e.g., the Chief of Paediatrics and Chief of Staff for physician representatives or the Chief Nursing Executive for nursing representatives).  Members must show interest, knowledge and commitment to research ethics.  Members must also be able to critically appraise the research protocols under consideration by the board.  The Chair is appointed for a term of five years renewable. 

 The REB includes representation from the different sectors of the hospital and Research Institute.  The hospital bio-ethicist and the Pharmacy Representative are standing members of the REB.  In view of the prevalence of psychosocial / behavioural research and the importance of mental health issues to bio-medical research, the board must have a standing member from the mental health area.  Depending on the composition of the board, this may require the appointment of an additional REB member.  It is important to note that members of the REB can represent more than one sector of the hospital or Research Institute. 

REB meetings and review process

The REB convenes monthly (except in August) to review protocols submitted for its consideration. Full Board actions require the presence of a quorum of the membership. 

 The number of protocols reviewed per month is limited to ensure thorough review of each application. Protocols are generally reviewed on a first - come, first - served basis, although priority may be given to a proposal because of mitigating circumstances (e.g., the protocol offers treatment that would not be available otherwise and is considered urgent).  At these meetings, the Primary CHEO Site Investigator and CHEO co-investigators can be invited to address questions or concerns about the protocol. Collaborators, including those based at other institutions, as well as research coordinators may also attend. 

Executive Committee of the Board

The Board has established an executive committee to deal with urgent request for ethics review.  The executive committee is normally comprised of the Chair (Dr. Carole Gentile), the bioethicist (Dr. Michelle Mullen), lawyer, non-scientific community member (Mr. Paul Muirhead), representative from Medicine (Dr. Robert Klaassen), non-scientific community member (Mrs. Maria McGuire) would be requested to review protocols and make decisions on behalf of the full Board.  In the event of a conflict of interest, alternate members of the Board can be called upon to serve on the Executive committee.  The REB Chair or his/her proxy is consulted to determine whether or not a submission will be considered for this type of urgent review.  Decisions made by the Executive Committee would be presented and ratified at the next REB meeting.  The Executive Committee could also be called upon in the absence of the Chair. 

The executive committee of the REB can be convened to review a protocol under exceptional circumstances in which the standard of full review could not be met for compassionate reasons or because of the delays involved in full Board review would seriously compromise the research.  Examples of this type might include ‘natural experiments’ that merit immediate study such as the impact of a catastrophic event on the number and nature of mental health patients presenting to the ER.  Urgent requests for REB approval can also occur when a research protocol provides the only modality for eligible patients to access treatment and no other alternative treatment is available.   

Quorum, decision-making and attendance rules

The quorum rule is 50% + 1 of the membership.  In order to adhere to the above quorum rule, the REB has also adopted guidelines regarding attendance.  Attendance to the monthly meetings of the REB is considered compulsory.  Members must attend a minimum of 75% of the monthly REB meetings each year.  The REB recognizes, however, that committee members have many competing responsibilities.  Accordingly, if a member’s attendance drops below 75%, a meeting will be convened with the Chair.  In the event that a solution cannot be agreed upon, the REB member will be asked to forfeit his/her seat and another member will be appointed.

REB members vote on the disposition of protocols (approve, approve with major/minor modifications, or reject).  A majority vote of more than two-thirds of those members who are present and entitled to vote is required in order to approve a protocol.   Any significant minority view (i.e., two or more members) will be noted in the minutes.  The Primary CHEO Site Investigator will also be alerted to the ethical issues raised by the dissenting member.

In the Board’s final decision about a protocol, members may abstain rather than vote in favour or against approving the study.  By abstaining from the vote, the REB member indicates their ambivalence about the protocol, or mild disapproval with the project that does not rise to the level of active opposition against it.   Abstentions do not count in tallying the member votes either negatively or positively.  When members abstain, they are in effect attending only to contribute to a quorum.

Documentation

The REB minutes its meetings. The REB minutes are given to the members as well as the Vice President of Research, CHEO / Chief Executive Officer and Scientific Director, CHEO Research Institute.  The REB minutes include evidence of the discussion around a research proposal including both general and dissenting opinions and the committee’s final decision.  The minutes must also provide sufficient detail to facilitate accountability and transparency.  As well, the REB must provide written feedback to investigators.  These correspondences must also provide sufficient detail as to justify the decisions rendered.  

 Review procedures for ongoing Research

Ongoing research is subject to continuing ethics review by the REB. At minimum, this involves: an annual report, reports of adverse events, reports of subject recruitment, reports of any study amendments, notices regarding the implementation of safety monitoring committee, and a study termination report.  The Chair and the Pharmacy Representative (who is a standing member of the REB) reviews adverse event reports regularly. The REB can also audit research projects in order to evaluate compliance to the principles and protocols agreed to by the investigator.

Annual Renewals

The Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans requires that ongoing research be subject to continuing ethics review.  For protocols involving more than minimal risk, REB approvals contingent on submitting an annual renewal report that includes information about accrual, protocol revisions or deviations, unanticipated problems or toxicities, and any new information or findings relating to the risk/benefit of the study.