Currently the Human Tissue Act 2004 defines tissue as: "The HT Act regulates removal, storage and use of human tissue – defined as material that has come from a human body and consists of, or includes, human cells."

The authority has interpreted this to mean any sample that could possibly contain a remnant of a cell, whether whole or destroyed, including serum, urine, sputum (phlegm), CSF if collected for research or archiving purposes.

In fact, serum is created by spinning the cellular material out of the sample, and most urine samples have very cellular content. The majority of samples stored are serum samples, and they fall under the HTA. I would argue that such a wide definition of the HTA creates a huge, and unnecessary workload for research hospitals, with no demonstrable gain to the public.

Why is this idea important?

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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