Scientific review board
The mandate of the Division of Haematology/Oncology Scientific Review Board is to review all research studies that involve three or more patients (or patient-related material) of the Clinical Division of Haematology/Oncology prior to submission to the SickKids Research Ethics Board. Use of innovative therapies (as defined below) does not require a Scientific Review Board review, though such review is highly recommended where possible. The distinction between innovative practice and research may be taken as follows: The use of innovative practice is justified by consensus clinical judgment that the particular intervention, while not considered standard evaluated therapy, is recommended in a particular case. Innovative practice is usually recommended only when all recognized standard therapies have been shown to be ineffective. Such interventions are sometimes used on compassionate basis. The informed consent of the competent child or patient/guardian is required. Peer review of a clinician’s use of an innovative therapy is recommended. Since innovative therapies are matters of clinical judgment, their use must be reported to the division chief and the chair of SickKids Research Ethics Board or delegate. Continued use of the innovative intervention beyond three patients in the absence of its validation through an appropriate clinical trial is not considered ethically acceptable.
To accomplish these goals, the following directives will be applied:
- All protocols will undergo a rigorous scientific review process prior to submission to SickKids Research Ethics Board.
- All protocols approved by the Scientific Review Board will be entered into a database and information on study populations will be cross-referenced between ongoing studies. Burden to patients, as well as to resource allocation within the Division of Haematology/Oncology, of competing studies will be considered in review of study protocols.