The Human Tissue Act came fully into force on 1 September 2006, and the first six of the Human Tissue Authority Codes of Practice (www.hta.gov.uk) are now in use. It is therefore timely for Medical Schools and other organizations to review relevant procedures, and to develop a Standard Operating Procedure. This document was written using the Draft Codes of Practice available at August 2005. If the codes change, it may need to be reviewed.
Much medical research relates to the use of stored blood (or other tissue) samples linked to personal health information. An example is research on the health of mother and baby, including screening for conditions such as Down’s syndrome requires the taking and storage of blood samples that are used for three purposes. The first of these is for clinical advice to an individual pregnant woman as to her risk of Down’s syndrome, and this is the primary purpose for which a woman will give a blood sample. The second strand is audit of the process and training to make sure that the clinical service is operating as well as possible. The third strand is for further research, for example the development of new markers for Down’s syndrome, or to develop screening for other antenatal conditions. All women using the service benefit from the interplay of these three activities.
Requirement for consent
Consent is not required for storage and use of samples for several, specified purposes: clinical audit; education or training relating to human health; performance assessment; public health monitoring and quality assurance. This covers activities for the smooth running of the service.
Consent is required for storage and use of tissue for obtaining scientific or medical information about a living or deceased person which might be relevant to any other person, including a future person (if this is the purpose of storage, rather than an incidental happening); research in connection with disorders or the functioning of the human body; or transplantation. It is the second of these, research, which is of relevance to the Wolfson Institute. However, in the case of research, the Act allows tissue to be used without consent, provided that
- the tissue is anonymised; and
- the research is approved by a Research Ethics Committee.
In addition, it is recommended that, although consent is not needed, establishments collecting tissue should nevertheless take suitable opportunities to make patients aware of the potential use to which their samples may be put, for example through notices in waiting areas, or in patient information literature. The wishes of any patient specifying they do not wish their samples to be so used should be respected.
The Human Tissue Authority Codes of Practice published on the website www.hta.gov.uk state that
“The Act indicates that patient consent is not needed for the use of residual tissue in research provided that the research project has ethical approval and that the researcher cannot identify the tissue donor and is not likely to be able to do so in the future.”
Anonymisation of tissue
The code further specifies that, in the case of research, the Act allows tissue to be used without consent provided that the tissue is anonymised, in that research is 'carried out in circumstances such that the person carrying it out is not in possession, and not likely to come into possession, of information from which the person from whose body the material has come can be identified'. (It should be noted that this does not mean that samples must be permanently and irrevocably unlinked, nor that the person holding the samples cannot themselves carry out the research. Links may be retained to the relevant clinical or patient records, but the researcher must not, in conducting the research, hold information from which he or she can identify the individual as a result of the research use of that sample. The anonymisation of the samples will therefore need to be carried out prior to the commencement of the research activity.)
This means that those carrying out research, either in the laboratory or analysing data subsequently, should not at that point be able to identify the individual. This will necessitate the use of a study code during these activities, rather than patient-identifiable information. Results of laboratory analyses should be recorded against the study code, and then entered onto or linked with a database which has been suitably anonymised for research purposes, with patients labelled only by their study code.
The identifying details relating to samples and the health status of the individuals who had provided the samples will be held by a “Data Keyholder” who is not a researcher engaged in the projects involving the data being used. The Data Keyholder will be a senior computer manager (with a deputy to cover in the event of his or her absence) and/or a senior laboratory manager. The researcher will simply receive anonymised linked data for his or her research.
Approval of research by a Research Ethics Committee
A condition of using samples without consent is that a Research Ethics Committee has approved the research. According to the glossary, this is likely to be defined under regulations for the Act as a local or multi-centre Research Ethics Committee (LREC or MREC).
An issue to be resolved is whether research ethics approval needs to be sought for every individual new laboratory analysis, or whether a broader permission could be obtained, for example the class of investigation, all of which use a given set of samples and rely only on new examination of existing data or samples without contacting the research subject. This has been put to the Central Office for Research Ethics Committees to determine whether research ethics committees would give class approval for sets of investigations that arise only because the analysis is different and a given dataset is used to study, for example, one congenital malformation rather than another. In this way, the ethics committee would consider the application for a category of research in a particular unit at a particular institution, say for a specified period (perhaps five years). Then the unit could apply to have the approval extended for another five years.
Medical research needs to comply with the Human Tissue Act. The appointment of Data Keyholders is needed so that all data are anonymous to the researchers. Agreement is needed for Tissue Bank Class approval from research ethics committees for observational-only studies.
8 March 2006
Revised 20 October 2006
Revised (new web format only) 23 November 2007