Databases refers to the use in research of data contained in a previously created data set, whether it is retrospective or prospective. Database projects often use the same data set to answer several, related research questions. The REB requires that investigators submit a general description of the project including all the elements specified above (study rationale, identifiers to be retained, etc.). The overall database project is reviewed under the ‘delegated’ stream (previously expedited review). In an addendum to the application, investigators must describe each publication or sub-study relating to the database.
Access to the database should be limited to the investigator and his/her delegates as outlined in the application. REB approval should be obtained prior to any release of the data to other investigators.
Authorization from the appropriate division head from which the database information would be obtained.