Abstract
The Human Tissue Act 2004 has generated considerable confusion, and is perhaps not the easiest statute to read. This paper aims to give a short guided tour of its provisions, and to highlight some of the practical issues that have already arisen since it came into operation on 1 September 2006. It does so from the point of view of University researchers, and of University RECs which may have to advise on these issues.
References
1.
That is why we have legislation for no-fault divorce, which has never been ‘turned on’ (Family Law Act 1996); cf the Easter Act 1928, passed to ensure that Easter shall fall on the same date every year.
2.
Section 1 has to be read with Schedule 1 to get the full story; but these are the relevant activities covered by the section so far as University researchers are concerned.
3.
Section 1(6).
4.
Section 1 and section 54.
5.
Another feature of statutes is that subordinate legislation is usually tied to a particular section of the Act; this makes it easy to search for the relevant statutory instrument, by reference to the section from which it derives.
7.
The Exceptions Regs defines a REC that can give approval for the purpose of the exempting provisions of the Human Tissue Act as ‘(a) an ethics committee established or recognised in accordance with Part 2 of the Medicines for Human Use (Clinical Trials) Regulations 2004, or(b) any other committee established or person appointed (i) to advise on, or on matters which include, the ethics of research investigations on relevant material which has come from a human body, and (ii) recognised for that purpose by, or on behalf of, the (aa) Secretary of State, (bb) National Assembly for Wales, or (cc) Department of Health, Social Services and Public Safety'.
8.
Contrast the consent requirement, which is for storage and use.
9.
Again, contrast the consent requirement.
10.
This is particularly unhelpful drafting; the actual exemption is contained in the Exceptions Regs, which then refer back to section 1(9) of the Human Tissue Act for the definition of ethical approval; which in turn requires a reference back again to the Exceptions Regs for specification of that approval.
11.
The word ‘institution’ is used carefully here. It may not always be possible for a University to apply for a single licence, because the licence can only cover a site that the ‘designated individual’ (section 18) can supervise. Accordingly the licence is more likely to cover a School or Faculty or similar institution.
12.
See for example Code of Practice 5: http://www.hta.gov.uk/licensing/guide-to-licensing-and-application/late-licence-applications.cfm.
13.
Email correspondence with the writer.
14.
That this is legitimate and not a dodge, provided that the consent requirements are met, is more clearly seen when we consider the events that gave rise to Alder Hey etc, where the issue was the unauthorized retention of material.
15.
Sections 5 and 25.