Creating or accessing a data bank
According to the TCPS 2 (chapters 5 and 12) the creation of a data bank or a biobank as well as the addition of data at an already existing bank require the approval of the REB. It is also important to note that the banks of data or biological material created initially for clinical purposes will also have to be approved by the REB if the data are used for purposes of research. If the research team intends to use the data for future research, it is recommended to add to the form of consent, a specific formulation to obtain an authorization to re-contact the participants in the future.
Secondary use of data
What should researcher to do research using identifiable information from a data bank.
- When consent has been obtained an application for delegated review is required when the investigator is the research database/registry information host.
- When consent has not been obtained the participants will need to consent for the use of their information and a new consent process is required and has to be reviewed and approved by the REB. The REB could approve a research using secondary use of data without requiring consent from the concerned individuals only if all the conditions listed in TCPS2 Article 5.5 a) - f) have satisfied.
When the data of the bank is anonymous (when impossible to make identification) it is not necessary to obtain a consent form because participants can’t be identified. However this would not apply if there is coupling of data.
The REB ensures that the databanks (data and biological material) already existing are complying with the current ethical standards at the time of their constitution and as possible, with the current standards.