Terms of Reference
The Ontario Cancer Research Ethics Board (OCREB) was introduced in December 2003 in response to a need to improve and streamline ethics reviews of multi-centre oncology trials. The creation of OCREB stems from extensive provincial consultation involving REB chairs, cancer centres and hospitals, researchers, bioethicists, clinical research coordinators and collaborating organizations such as Cancer Care Ontario, the National Council for Ethics in Human Research, the Canadian Association of Research Ethics Boards and the Canadian Institutes of Health Research.
Several key issues were identified during this consultation process. In particular, the large number of new cancer therapies entering clinical trials has considerably increased the workload of REBs. Furthermore, complex and changing regulations make reviews and oversight more difficult and time consuming, and many local REBs identified the challenge of maintaining sufficient expertise.
Purpose of OCREB
- Enhance the protection of research participants by providing uniform, high quality ethics review and ongoing oversight of multi-centre oncology research by an expert provincial cancer-specific research ethics board;
- Improve access to oncology research for participants and their physicians by reducing the overall time to initiate multi-centre research across Ontario;
- Reduce the workload and administrative burden on local REBs and investigators;
- Foster collaboration with the research ethics community through communication and exchange of information.
In reaching its decisions, OCREB follows the ethical principles cited in the Tri-Council Policy Statement:
- Respect for human dignity;
- Respect for free and informed consent;
- Respect for vulnerable persons;
- Respect for privacy and confidentiality;
- Respect for justice and inclusiveness;
- Balancing harms and benefits.
Authority and Accountability
Institutions establish an affiliation with OCREB through a Letter of Intent (LOI). Each institution must maintain a Federal Wide Assurance (FWA) and designate OCREB as an REB responsible to the institution under the institution’s FWA. The institution authorizes the use OCREB as Board of Record on a study-by-study basis by executing a Board of Record Study Agreement, which includes the division of responsibilities between OCREB and participating institutions. In this Board of Record capacity, OCREB serves as a Research Ethics Board of the institution.
OCREB is independent of the researchers and the organizations sponsoring and conducting the research reviewed by OCREB, and is accountable to a Governance Committee and to the Ontario Institute for Cancer Research (OICR) Board of Directors through the OCREB Governance Committee.
As the Research Ethics Board of Record, OCREB may approve, reject, propose modifications to, put on hold or terminate research at its sole discretion. OCREB can also recommend the suspension of ongoing research on the basis of new relevant information.
In acting as the REB of Record, OCREB shall act in accordance with its responsibilities set out below. It shall also act in compliance with the requirements of: The Tri-Council Policy Statement on Ethical Conduct of Research Involving Humans; The International Conference on Harmonization of Good Clinical Practices; Part C Division 5 of the Food and Drug Regulations of Health Canada; and the provisions of the Ontario Personal Health Information Protection Act 2004 and its applicable Regulations.
OCREB is constituted in accordance with all applicable laws and is registered with the U.S. Office for Human Research Protections (OHRP).
- To act as Research Ethics Board of Record on a study-by-study basis as authorized by institutions that have entered into a formal relationship with OCREB;
- To provide ethics reviews of multi-centre oncology research within its jurisdiction. Evaluation will take into consideration the scientific value and validity of the research, the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, the importance of the knowledge gained or to be gained, and the appropriateness of the methods used to obtain free and informed consent;
- To review (using a proportionate approach), approve, reject, propose modifications to, or terminate any proposed research or ongoing research under its jurisdiction;
- To ensure that an ongoing monitoring plan is in place, which includes, but is not necessarily limited to an annual review of the approved research (or more frequently at the discretion of OCREB), ongoing review of serious adverse events, review and approval of amendments/modifications to the research;
- To maintain adequate documentation of its activities and make all such documents accessible to the institution;
- To maintain a current list of members and maintain written policies and procedures;
- To promptly notify the institution if the research is placed on hold or terminated;
- To promptly notify the institution of any policy decisions or regulatory matters that might affect the institution’s reliance on OCREB reviews or ongoing oversight of the research;
- To keep current on ethical issues related to research involving human subjects and serve as a resource to the research community, communicating and advising researchers on guidelines, procedures and other matters relating to the ethical conduct of research with humans;
- To keep the institutions, the OCREB Governance Committee and the President and OICR Senior Executive informed of substantive issues in terms of policy, process and compliance and to submit a written report annually on the activities of OCREB.
The OCREB membership will be in compliance with Health Canada (Division 5, Part C.05.001 of the Food and Drug Act), TCPS (Article 1.3), ICH GCP (3.2.1), PHIPA (S. 15), US FDA CFR (56.107) and OHRP (46.107). Members will include men and women, a majority of whom are Canadian citizens or permanent residents and who collectively have the qualifications and experience to review and evaluate the science, medical aspects and ethics of the proposed research.
As an oncology-specific provincial REB, OCREB will consist of broad representation from across Ontario and include medical and radiation oncologists, nurses with clinical and/or research experience in oncology, informed community members and/or cancer survivors, and members with expertise in research ethics, relevant law, privacy legislation, and other related disciplines such as pharmacy, epidemiology, biostatistics and surgical oncology.
At its discretion, OCREB may invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on OCREB. These individuals may not vote with OCREB. When necessary, subcommittees of OCREB will be established.
Selection and Terms of Office
The Chair and Vice-Chair of OCREB were originally appointed by the President and CEO of the Ontario Cancer Research Network (now the Ontario Institute for Cancer Research) on the basis of recommendations from a search and selection committee and the OCREB Oversight Committee (now the Governance Committee).
OCREB appoints its members based on nominations from OCREB members or the broader oncology research community, and following consultation with the OCREB Chair and its members. Institutions using OCREB as an REB of record will be encouraged to appoint representatives to serve on OCREB.
The members of OCREB will serve for renewable terms of two to three years. Terms will be overlapping to preserve experience and continuity of function of the board.
Meetings are usually held monthly. Additional meetings may be called by the Chair as the need arises. A majority of the meetings will be held in Toronto, although occasional meetings may take place at other centres in Ontario. With adequate notification, representatives from local Research Ethics Boards or other institutional representatives may participate as observers, provided that a confidentiality agreement is in place.
Detailed proceedings and minutes of OCREB deliberations and decisions will be securely maintained by the OCREB Office and will be considered strictly confidential.
OCREB will provide proportionate review for all research protocols as detailed in the Tri-Council Policy Statement. For protocols that do not qualify for an expedited review process, a full review will take place at a formal OCREB meeting. OCREB will make a decision based on the submitted documentation and its deliberations.
Submissions to OCREB may receive approval, approval pending minor revisions or clarifications, provisional approval to review the investigator responses prior to a final determination, deferral to obtain further information or consultation, or rejection (as submitted). If a submission is rejected, OCREB will provide the investigator with a detailed list of the deficiencies so that any resubmission will meet the standards needed for an appropriate OCREB review. OCREB approvals will be valid for up to 12 months, unless otherwise stipulated.
All communication to investigators will be through the OCREB Chair and/or OCREB office.
When the full REB review procedure is used, these decisions will be made by a consensus of the REB members who are present at a convened meeting at which there is a quorum. Quorum shall consist at least five members of OCREB - including both community member(s) and individual(s) who are independent of the institution - who collectively have sufficient expertise in the scientific, methodological and clinical areas of the research being considered and are knowledgeable about relevant ethical and legal matters. Alternate members may substitute for regular members in the same membership category to make quorum.
Conflict of Interest
All members shall be without conflict of interest in the review process and shall disclose actual, perceived or potential conflicts of interest at the outset of the meeting. Members with a conflict of interest must not participate in the initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the REB.
Resolution of Disagreements with OCREB's Decision
In the event of disagreement with OCREB’s decisions regarding a submission, OCREB will act in accordance with the institution’s documented process for resolving such conflicts with its own REB, provided that such process is in compliance with the Tri-Council Policy Statement.