Wednesday, June 27, 2007

The Human Tissue Act: When should applications to not require consent be approved?

This is a continuation of a series of posts on the Human Tissue Act in the UK. It is primarily aimed at trying to work out what the practical implications of the HTA are for members of National Health Service Research Ethics Committees (RECs) and especially highlight the responsibilities it places upon them.

In this post: Human Tissue Act: Intro I noted that the HTA had placed RECs in the potentially difficult position of having to decide when research on human tissue can take place without consent. In this post: HTA Reject I discussed which applications to use human tissue should be rejected. In this post I am going to discuss what sorts of research should be approved to not need consent for the use of human tissue. I should note though that there is definitely still a grey area here, and often whether a project is genuinely justifiable will rely in part on the good it might do.

Some reasonably clear cases:
1. Where there was prior consent to use this tissue for generic research purposes.
While this is arguably a form of consent, given the lack of information the consenter had, it is hard to see how this is informed consent. Nonetheless presuming the research is of worth, this seems straightforwardly the sort of project that could be approved under these provisions.

2. Where consent cannot now be obtained.
This may be because the tissue is a left over diagnostic sample from a person who is now dead. Or it could be that the tissue is old and contacting the person is nearly impossible. Or finally the tissue may have been anonymised so there is no link to the original owner of the tissue. In these cases again presuming the research is of some merit, it seems the REC should give consent.

Some grey areas:
1. Where contacting the donor would be possible but costly or tricky.
This is a grey area because it will depend on how much funding the project has, the merits of the project and how costly or difficult it will be to contact donors.

2. Distressed Proxy consent
These are case where the originator of the tissue cannot now consent for themselves, but another can who may be very distressed by the request. Take for example the parent of a child who has been admitted with acute septicaemia. While you could ask them for consent for their child’s left over blood samples to be used in a research project the quality of this consent would be likely to be poor given the stress they are under. Likewise the very request might cause great distress. It could be argued that this distress should be taken to outweigh the need for consent.

None of this should be taken as definitive, it is instead explorative.
I will explore these issues further in later posts in this series.

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