The Human Tissue Act 2004 (the HTA) states that consent must be obtained for the removal, storage and use of material from the deceased. Consent must be valid and appropriate, and is required for all Scheduled Purposes.
What are the Scheduled Purposes?
Consent is required for all Scheduled Purposes where there is removal, storage or use of material from the deceased. The HTA lists the scheduled purposes in relation to the deceased as follows:
- Anatomical examination;
- Determining the cause of death;
- Establishing, after a person's death, the efficacy of any drug or other treatment administered to them;
- Obtaining scientific or medical information, which may be relevant to any person, including a future person;
- Public display;
- Research in connection with disorders, or the functioning of the human body;
- Clinical audit;
- Education or training relating to human health;
- Performance assessment;
- Public health monitoring;
- Quality assurance.
Please note: Consent is not required for a post mortem examination (see below).
What constitutes valid consent?
The HTA defines giving consent as a positive act. Any consent given must be valid and appropriate. To be valid, consent must be voluntary and be given by an appropriately informed person who has the capacity to agree to the particular purpose. Consent should be sought in relation to each separate activity. For example consent for use of organs for transplantation will have to be separate to consent for the storage of tissue for research.
Does consent have to be written?
The HTA does not specify that consent should be written, apart from where there will be anatomical examination or public display. A signature on a form does not automatically make consent valid. If consent is obtained orally, it should be clearly recorded in patient or laboratory records, specifying when and for what purpose it was obtained. Written consent should usually be obtained.
A decision on the NHS Organ Donor Register constitutes the consent or refusal of the person. This decision should be shared with family and friends in case the person has later made a different decision.
Who can give consent?
For consent to be appropriate, it must be given by one of the following individuals:
The individual prior to death
Where an adult has given valid consent whilst alive, that consent is satisfactory. However where, for example, a close friend or relative objects to the use of the tissue, the healthcare professional should address this with them in a sensitive manner, gently indicating what the wishes of the deceased were, and encouraging them to accept these wishes. Importantly, the objecting person has no legal right to override the deceased's wishes.
If the deceased had neither consented to, nor objected to the removal, storage or use of tissue for any scheduled purpose, then the healthcare professional should ask whether a nominated representative was appointed.
A nominated representative
A nominated representative may consent to a post-mortem being carried out, and to all of the scheduled purposes apart from anatomical examination or public display. Their consent cannot be overridden by other individuals, including family members.
A nominated representative may be disregarded if, for example, it is not practical to contact the nominated representative within the timescale available.
A person in a qualifying relationship
Where the deceased did not indicate any consent or objection, and there is no nominated representative, then a person who was in a 'qualifying relationship' with the deceased immediately prior to their death may give consent.
The HTA lists qualifying relationships in the following order, with the highest first:
- Spouse or partner (including civil or same sex partner). The HTA states that a person falls under the definition of a partner if they live as partners in an enduring family relationship;
- Parent or child (the child may be of any age and include a biological or adopted child);
- Brother or sister;
- Grandparent or grandchild;
- Niece or nephew;
- Stepfather or stepmother;
- Half-brother or half-sister;
- Friend of long standing.
Consent is only required from of these people and should be obtained from the person ranked the highest. If the person ranked highest does not give consent, consent cannot then be requested from a person lower down the list.
Where relationships are given equal value, for example brother and sister, then consent is only required from one of these parties. If there is a conflict between equally ranked individuals, the HTA technically requires consent from only one of them. However given the delicate nature of such a conflict, the healthcare professional should ensure that this is discussed sensitively with the conflicting parties.
A person's relationship shall be disregarded if:
- They do not wish to deal with the consent;
- They are unable to deal with the consent (eg they are a child or lack capacity);
- It is not practical to communicate with that person within the time available.
In these cases consent should be sought from the next person in the hierarchy.
Is consent always required?
There are two situations in which consent is not needed. The first is where a Coroner is carrying out an investigation into the cause of death. The second is where the tissue is retained under the Coroner's authority after a post-mortem, which should be for a period no longer than needed for the Coroner to discharge their statutory function.
Consent would then be required once the Coroner's authority has ended for the removal, storage or use of tissue for a scheduled purpose. This also applies to all tissue removed for the purposes of the port-mortem.
Can consent be withdrawn?
Consent can be withdrawn at any time, and should be discussed with the individual at the time the consent is being sought. However, once the tissue has been used, the withdrawal of consent cannot be effective.
The Human Tissue Authority provides further guidance on consent in their Code of Practice on which this article is based.
How can Bevan Brittan help?
We can provide assistance and support on a wide range of issues in connection with the Human Tissue Act.