Some clinical activities outside the immediate realm of diagnosis and treatment are affected by this Act. The important thing to understand about this rather impenetrable piece of legislation is that it impinges very little on the everyday diagnosis, investigation and treatment of surgical disease. These activities are governed by the rules that govern obtaining a patient's consent, as provided by the common law and the Mental Capacity Act 2005
, very helpfully laid out as guidance by amongst others, the General Medical Council.9
The HTA 2004 is applicable only to scheduled activities listed in . Crucially, it will be seen that there is no mention of diagnosis or investigation or treatment. Thus, considering the blood tests performed as a diagnostic or pre-operative exercise, or the tissue taken at biopsy, or during excisional surgery, none of these appear on the schedule and they are, therefore, excluded from the remit of the Act. However, when considering any clinical activities, it must be recognised that legal rules may be derived from many sources, the identity of which may not be apparent. If the content of the Department of Health consent form is considered, some sections will be necessitated by common law, some by the Mental Capacity Act 2005 and still more by the HTA 2004.
Included in the HTA 2004 is the storage and use of relevant material from a living person and the removal, storage and use of relevant material from a dead person for ‘scheduled purposes’ with ‘appropriate consent’.
Relevant material is defined as ‘material, other than gametes, which consists of or includes human cells’.10
Hair and nails from a living person, and embryos outside the human body, are excluded by the Act.
Scheduled purposes are defined as those purposes that generally require consent under the Act, whilst material used for other purposes is excluded from the remit of the Act. Thus, as indicates, using a tissue sample for health-related education or training, clinical audit, or quality assurance does not invoke the Act if the sample is taken from a living person. Readers whose hospitals use the Department of Health consent forms will recognise the requirements for patients to consent for their tissues to be examined for diagnostic purposes, teaching, audit and research, and may thus question why these responses should be sought, if the HTA 2004 excludes these purposes in the living patient? This is necessary to conform with the regulations that govern the necessity for consent in general; however, it would also be essential evidence of consent for the scheduled purposes should the patient subsequently die, since specimens separated from a dead patient will be ‘caught’ by the Act, whereas tissue separated from a living patient is not.
The HTA 2004 prescribes rules concerning the storage and use of relevant material in circumstances covered by purposes 1–12
Consent during life (for activities described in the scheduled purposes) is provided by the patient in the normal way. Although the Act does not stipulate written consent in every case, it is required, wherever possible, for post-mortem activities, and is always required (together with the signature of a witness) for anatomical examination and specimens for public display. The Department of Health consent form commonly prompts the patient to consent or refuse for their tissue to be used for some of the purposes (e.g. audit, research, public health surveillance, quality control and education). Determining the cause of death is, understandably, not addressed.
The HTA makes an exception for purposes 8–12 for tissues taken from living patients, since the use of a patient's tissues for these purposes is considered intrinsic to the patient's care, and consistent with public policy;11
consent is, therefore, not required (from the perspective of the HTA 2004) for living patients, but it is nevertheless included in the Department of Health form.
If the patient is not competent to provide consent, then the HTA 2004 directs the surgeon straight to the Mental Capacity Act 2005 (MCA 2005), so the process of taking consent for the scheduled purposes is incorporated in, and effectively inseparable from, the consent for the procedure from which the tissue will be derived. The MCA 2005 prescribes the necessary formalities in recording consent.
If the patient has not provided their consent during life, after death, none of the activities listed 1–7 can be lawfully carried out on their tissue without appropriate consent being obtained. For activities 8–12 consent requirements depend on whether the tissue was acquired during life or after death. It is lawful to store and use tissue from the living for audit, quality control, education etc. without their consent and then use these tissues after death without permission. However, if the tissue is taken and stored after death then appropriate consent must be sought.
This appropriate consent is defined in terms of the person who provides it. It may have been provided by the patient before his or her death, or by a representative nominated by the patient. In the absence of consent from this source, a person with a qualifying relationship with the patient may be identified by the clinician. The HTA 2004 provides eight ranks of people with a qualifying relationship, with spouse or partner ranked first, parent or child second, brother or sister third, the intervening rankings dealing with common family linkages, and ‘friend of longstanding’ last.
The practical application of this is that, if educational, audit or research activity involves tissue taken from a patient after death, consent to store and use the tissue is required, but that the consent can be sought in a methodical way. There is ample anecdotal evidence of the frustration of surgeons who have been unable to get access to dead people's tissue when trying to pursue such work, and find themselves blocked by an authoritative, yet nebulous, refusal from departments of pathology. Doubtless, these departments have been diligent in ensuring that the rights of deceased patients and their families should be respected but, since the advent of the HTA 2004, neither clinicians nor trusts who are holding the specimens need to be concerned that they are doing the wrong thing in releasing relevant material tissue for scheduled purposes, providing appropriate consent is in place.
Tissue used for diagnosis
Importantly, under the HTA 2004, scheduled purposes exclude the use of relevant material for diagnosis and treatment, so these activities are not governed by the Act and remain covered by common law. However, the Act does cover the use of one person's material to make a diagnosis where it is primarily for the benefit of another person. Using one person's material for the benefit of another (usually to allow more accurate risk prediction or diagnosis in a relative) has been relatively rare to date, but is likely to become more common as ‘genetic medicine’ expands. For example, performing immunohis to chemistry on a colonic tumour would not invoke the Act if it were to make a primary diagnosis in that person. However, if the test were mainly to benefit a relative (who might want appropriate screening or a predictive genetic test) after the death of the index patient, the Act would be engaged. However, because the HTA 2004 governs only samples that include human cells, extracted DNA (which is acellular) is exempt, so a diagnosis from DNA in one person for the benefit of a relative does not have to conform to the Act.
These apparent contradictions could, in the absence of consent, lead to the irony of the prevention of a cheap and easy test, such as immunohistochemistry, whilst the complex and expensive DNA sequencing is exempt.
Tissue used for audit and quality assurance
As scheduled purposes, these require consent for tissue derived from dead people, although as far as the act is concerned, not for tissue separated from the living. However, since all the terms are defined loosely and overlap, it can be very difficult to distinguish between audit, quality assurance and research. Different decision matrices have been designed to enable those devising projects to determine how the activity is categorised. In general terms, if doubt exists, it is prudent to obtain appropriate consent; if the project is research, consent is mandatory.
When the law was enacted, there was great concern that researchers might be deterred by the new bureaucracy, and the point was made that research that is not performed ‘remains invisible, and nobody will know what we have lost’.12
Tissue used for transplantation
This topic will be covered later in the series.