Being a research tissue bank, Research Ethics Committee (REC) approval and patient consent is already in place for a broad range of laboratory-based research including genomic and functional genomic studies to investigate CLL biology and heterogeneity. However, researchers are required to confirm that the proposed work falls within the scope of the REC approval.
How to request samples
Researchers wishing to access samples are required to complete a sample request form giving information about the proposed research, together with the type and number of samples required. Information on sample availability is then added by the biobank manager, before the completed form is circulated to members of the Sample Access committee for consideration of approval. Depending on comments received, the proposal may be unconditionally approved, approved with conditions, or not approved, in which case a full explanation will be provided. A material transfer agreement is required before samples can be shipped.
How to access clinical data
One of the key strengths of the biobank is that samples are annotated with an extensive range of reliable clinical data including pre-treatment patient characteristics, treatment response and measures of long-term outcome such as progression-free and overall survival.
The clinical data for each sample resides with the CTU overseeing the study to which the sample is linked. Access to this data depends on the status of the trial, as well as the nature of the proposed research. In general, CTUs will agree to release all data from clinical trials where the primary outcome has already been published, but only baseline data for trials that have not yet been published. How best to link and analyse the clinical and laboratory data will be agreed between the researcher and CTU but, in general, data linkage and analysis will be performed by the CTU where the laboratory data is relatively simple and by the researcher for more complex (e.g. omics) datasets.
A data transfer agreement is required for both scenarios. Clinical data held by the CTU may also be used to select samples with a specific phenotype based on pre-treatment or longitudinal data. All enquiries and requests regarding clinical data will be routed via the biobank manager in the first instance.
It is important that all research governance requirements are fulfilled, that the biobank is informed of all research outputs and other impacts through the annual reporting process and that the biobank is acknowledged on all research outputs including publications and conference presentations. These and other requirements are detailed in the Material Transfer Agreement.
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