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Decision Process
This content was archived on June 24, 2013.
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Criteria
Research involving humans can be ethically justified only when:
- the research is scientifically sound;
- the potential benefit significantly outweighs the potential for harm;
- there is an adequate process for informed consent along with the child's assent to participation (where applicable) and
- there is justice or fairness in selection of participants.
Where there is a question of whether or not an application should be submitted to Health Canada's Research Ethics Board (REB), the researcher should contact the Research Ethics Board Secretariat for clarification.
Decision
The research under review will receive one of the following decisions from the REB:
- Approval: Ethical approval is given in writing only. Research cannot commence until ethical approval is received in writing. Approval is given for one year. Approval must be renewed annually until the research is complete. A copy of the Annual Progress Report application should be submitted to the REB Secretariat.
- Approval with revisions: The study is given approval on the condition that revisions are made, as summarized in the letter from the Chairman of the REB. Approval will not be considered by the REB until the revisions are received, therefore, a revised copy of the protocol should be submitted to the REB Secretariat. It is the responsibility of the researcher to promptly respond to REB concerns.
- Not approved: If there are a significant number of outstanding issues, the protocol may not be approved. The REB will assist the researcher in an effort to resolve these issues. If a satisfactory solution is not reached, the researcher may be invited to a subsequent REB meeting to discuss the issues further.
