The Human Tissue Act An open question for Research Ethics Committees Part 1

The Human Tissue Act, aside from the existence of Research Ethics Committees themselves is perhaps the most complained about thing currently in the UK research environment. It is easy to see why, it is an extremely complicated act, covering many different areas, not just research. In this series of posts I want to explore some of the implications of the HTA for research and for National Health Service Research Ethics Committees (RECS).

In this particular post I want to explore something that the Human Tissue Act explicitly thrusts onto RECS. This is deciding when researchers do not need to get consent to use human tissue for research purposes. The act makes it lawful to use (note not collect, this is governed by common law) human tissue for research purposes if it is properly anonymised, and if it is approved of by a recognised research ethics committee. This like many items in the act is presumably intended to play a balancing role between the need to foster good quality research on one hand and on the other to respect people's rights to control their body and material derived from their body.

However this leaves a REC in the uncomfortable position of deciding when they ought to allow research to proceed, and when they ought to require explicit consent. It could be the case that RECs should simply allow all such research since it would be lawful, but this misses the point of requiring REC approval, if it was just a rubber stamp then why require it legislatively?

Surprisingly there has been no guidance issued by the National Research Ethics Service and there is little in the literature specifically about this. (Although there is much which indirectly bears on it.)

The next entry in this series will speculate on some cases when a REC should permit this, and some cases when it should reject this.