Terms of reference
Reporting Relationship
The REB will report to the Board of Trustees of The Hospital for Sick Children via the Medical Advisory Committee (MAC). Minutes of REB meetings will be sent to the MAC Chair monthly. The REB Chair will report annually at a meeting of the MAC. When immediate reporting to the MAC is required, the Chair of the REB will report directly to the Chair of the MAC. In addition, correspondence pertaining to investigations, reports, dispositions and appeal/final reviews of allegations of research protocol violations will be copied as requested to the Chair of the MAC and / or the Chief of Research.
The REB will report to the VP, Research Operations for operational purposes, including human resource requirements, office space and client service support.
MANDATE
The Hospital for Sick Children (SickKids) recognizes that research is an essential component in the provision and enhancement of the care of children. The Hospital also recognizes that special considerations exist when conducting research involving children. The ethical assessment of research on children at SickKids will be conducted taking into consideration the ethical standards of the various professions represented, the standards reflected in the bioethics literature and statements of recognized national and international bodies, and the personal and community values as represented by the REB members.
The REB has the mandate to approve, reject, monitor, propose modifications to, or terminate any proposed or ongoing research involving human subjects which is conducted within, or by members of, SickKids.
The Research Ethics Board has therefore been established:
- to ensure that all research carried out at SickKids or by investigators associated with SickKids meets the highest scientific and ethical standards prior to activation of the research, and
- to ensure that safeguards are developed which provide the greatest protection to patients and members of the community who serve as research subjects.
Membership
The Chair is appointed by the President and CEO in consultation with the Chair of the MAC for a term of 5 years, usually from current or past members of the REB. The REB will consist of a core group of 5 members as described in the Tri-Council Policy Statement, and additional members with broad expertise. New members will be selected from the Hospital and from the community by the Chair of the REB and the Vice-President, Education and Quality (delegate of the President / CEO) in consultation with the Chair of the MAC. Those who are SickKids staff will represent a cross section of the Hospital community including two representatives from the Department of Paediatrics. Those who are not SickKids staff will include an individual with legal expertise, and at least one representative of the lay public. The term of membership is three years renewable once. Representatives may be reappointed beyond six years. A member of the REB is appointed by the Chair to serve as Vice-Chair. The role of the Vice-Chair is to assume the duties of the Chair in the Chair's absence, to participate as a reviewer of protocols that undergo expedited review, and to Chair the REB Subcommittee on Continuing Review.
Functions & Responsibilities
1. To recommend policies and procedures governing:
- who may conduct research at SickKids;
- access to research subjects;
- requirements for project approval;
- disciplinary action;
- such other issues as relate to the ethical conduct of research.
2. To assure that all health-related research protocols presented to the REB receive appropriate ethical and scientific review. Scientific review is delegated to in-house expertise.
3. To assure that records of ethical and scientific reviews on projects are available through the Research Institute.\
4. For industry sponsored research, contract review is delegated to in-house expertise.
- To monitor the ethical conduct of research at SickKids, as a shared responsibility with the Department Chiefs, through:
- sharing responsibility with the Department Chiefs or their delegate to monitor research in their Departments;
- providing, with the Department Chiefs, for more frequent and/or rigorous monitoring in specific cases;
- requiring researchers to report significant changes, including adverse events, or unforeseen results in their research in a timely fashion;
- requiring researchers to provide an annual progress report which must be signed by the Department Chief or his/her delegate;
- informing researchers of the consequences of failing to comply with these requirements
- delegating responsibility to the Clinical Research Secretariat to supervise the monitoring of clinical trials which require close monitoring.
5. To participate in education of researchers and trainees through:
- ensuring that all members of the REB are provided with a basic understanding of the principles involved in research ethics review through educational workshops and information packets given to new members;
- including an educational component as part of the regular meetings, from time to time, in order to keep members informed of new developments in the area of research ethics;
- acting as a resource to researchers on issues of ethics;
- undertaking an education role throughout the research community including, but not limited to, holding information sessions with researchers
6. To act as a resource for other University of Toronto-affiliated or non-affiliated institutions
Frequency of Meetings
The Board meets monthly until mid 2007 when it will begin to meet twice per month.
QUORUM
Quorum for a meeting will consist of 5 members including both men and women of whom at least 2 members who have broad experience in the areas or methods of research, at least 1 member who is knowledgeable in ethics, at least 1 member who is knowledgeable in the relevant law related to biomedical research, and 1 member who has no affiliation with the institution but is recruited from the community served by the institution.
Process for Decision Making
Decisions will usually be made by consensus. In the absence of achieving consensus, decisions will be made by a majority vote of the members of the REB. The Chair will only cast a vote should there be a tie.
Investigators who are members of the REB will leave the room during the consideration of their proposal as will any member(s) with any conflict of interest relating to the proposal under consideration. A notation will be made in the minutes reflecting that the member left the room.
In special circumstances when a decision is needed before the regularly scheduled meeting of the REB and in circumstances outlined in the REB policy on expedited review, the Chair is empowered to make a provisional decision of acceptance or rejection. In such cases, the REB will be notified of the Chair's decision at its next meeting, to review the proposal and to make a final decision.
Where appropriate, the REB will form subcommittees to deal with issues more effectively. Subcommittees will report their findings and recommendations to the REB.
RECONSIDERATION
After review, individual proposals will be referred back to the primary investigator with comments and/or suggestions for revision. The primary investigator will respond in writing if he/she wishes the REB to reconsider a decision relating to a proposal. Investigators may be invited into a meeting of the REB to respond to questions about their proposals or to argue that the REB reconsider a decision, but will not be present during the decision or reconsideration process.
An appeal of a negative decision can be requested by a researcher to an appeal board at the University of Toronto. The University Health Network REB Chair is the appeal board secretary.
ADMINISTRATION
Staff support and record-keeping will be provided by the Research Institute.