Appendix B: Examples

(NOTE these are examples from the new draft code for research)

If there is no intention to use or store human cellular material for research, and the only holding of cellular material is temporary and for the purpose of obtaining material which does not contain cells, then no storage licence is required

a)     Examples where a HTA storage licence would not be required:

Example 1

A researcher wants to undertake a study looking into immunological responses to breast cancer. To do this clotted blood samples will be spun down to collect the serum. As the blood will be spun down within a matter of days and any residual cells disposed of to leave serum that is not relevant material, the blood does not need to be stored under a HTA licence.

Example 2

A whole blood sample is taken and this is then immediately sampled for blood lactate levels in the plasma, then the sample is disposed of about five minutes following the sample being taken.

Conclusion: No storage of relevant material for research would be taking place.

Example 3

A whole blood sample is taken and this is then immediately processed for various tests that day, some of which includes testing directly on the cells themselves. All samples are disposed of when the tests are complete, later that day.

Conclusion: No storage of relevant material for research would be taking place.

Example 4

A whole blood sample is taken and made acellular immediately, and only serum is retained for research.

Conclusion: No storage of relevant material for research would be taking place.

Example 5

An experiment is conducted over a 6 day period. Whole blood samples are provided by volunteers throughout the sample collection period. All the samples are made acellular by day 7, only serum being stored for subsequent research.

Conclusion: There is no intention to use or store human cellular material for research, and the only holding of cellular material is temporary (a few days) and for the purpose of obtaining material which does not contain cells.

b)    Example where a HTA storage licence would be required:

Blood samples from healthy volunteers are collected from two groups of participants as part of a research study over a two-day period.  After each collection, the samples are stored in a refrigerator and then analysed, as a batch, once all have been collected. All samples are used and disposed of within seven days of the first collection. The project involves healthy volunteers and has not been approved by a recognised REC.

Conclusion: Although the storage period is only for 2-3 days, relevant material samples are being stored for the purpose of research within the scope of the Act; a HTA storage licence is therefore required.

Please note that even if the research use of the relevant material (the analysis) also destroys the cells as part of that process, this does not alter the point that prior licensable storage would have taken place.