If the interpretation of the HTA were much more narrowly drawn to include whole tissue and DNA extracts from clinical samples only, large sera banks would be excluded, saving large amounts of administrative time, and reducing the inspection workforce. It will reduce the cost of clinical research directly and indirectly by releasing time for actual research activity.
The interpretation of the HTA should not reflect the possibility of DNA being present as now, but rather the purpose of the sample collection being to enable whole tissue or DNA/RNA analysis on the sample, in contrast to samples taken for antibody, proteomic, metabolite or non-identifiable analyses.
There is also a case to made for anonymised collections to be take outside the HTA, as they cannot be traced back to given individuals.
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