Categories of ethics approval and validity
Approval or approval for initial stage only
Normally this refers (i) to the stage (within a research grant application) during which the research instruments are to be developed, with re-evaluation necessary before they are taken into the field or used on human participants, or (ii) to the first stage of a multi-phase project in which the research instruments which will be used in later phases are dependent on the results of the initial phase.
Delayed approval
Some concerns must be addressed before approval is given. The REB could mandate its Chair or the Protocol officer, with or without other members, to grant ethics approval when the concerns have been satisfactorily addressed.
Decision deferred
Based on the documentation provided, the REB is unable to make a decision. The decision is deferred pending receipt of supplementary information or documentation as specified by the REB. The ethics application needs to be submitted again for a complete evaluation by the REB.
Not approved
The reasons will be provided.
Validity of ethics approval
Generally speaking, ethics approval applies for one (1) year. However, fundamental changes to the research method must first be approved by the appropriate REB before the research can proceed.
The appropriate REB must receive an annual status report for ongoing projects. To this end, ten months after receiving initial approval, the investigator or research supervisor must submit a status report to the Protocol officer who then presents the report at the next regular meeting of the Research Ethics Board. Renewals apply for one (1) year. A three-year (3) limit applies to the possibility of extending ethics approval for active research project without making a new and complete application to the appropriate REB.
