Human Tissue Authority

The regulator for human tissue and organs

Policy on consent for post-mortem examination and tissue retention under the Human Tissue Act 2004

This policy sets out the legal requirements of the HT Act with regard to consent for post-mortem examination, tissue retention and storage of tissue from the deceased.

Description

The HTA is aware, through enquiries and site-visit inspections, that those taking consent for hospital (or 'consented') post-mortem (PM) examinations are not clear about the extent to which they should assure themselves that they are obtaining consent from an ’appropriate’ person defined by the Human Tissue Act 2004 (HT Act), i.e. from a person in a qualifying relationship. This policy outlines the responsibilities of the Designated Individual (DI) within this process and the approach that HTA staff should take when communicating with establishments regarding consent for hospital PM examination and tissue retention.

Purpose

This policy states the legal requirements of the HT Act with regard to consent for PM examination, tissue retention and storage of tissue from the deceased. It seeks to ensure that there is clarity for those involved in seeking consent within licensed establishments.

In addition, the guidance provided, if followed, will help assure the HTA that those who obtain consent for PM examinations ‘reasonably believe’ that an appropriate individual has given consent so that no offence will be committed under section 5 of the HT Act.

Background

Consent under the HT Act 

Under the HT Act, consent is required for the storage and use of the body of a deceased person and the removal, storage and use of material from the body of a deceased for use for all scheduled purposes, including determining the cause of death. The HT Act is clear about what constitutes ‘appropriate consent’, which is determined by who may give consent.

Consent under the HT Act must be from, in order, the person in life, their nominated representative, or, in the absence of either of these, someone in a qualifying relationship with them immediately before they died - in which case a hierarchy applies (section 27(4)).

Consent for PM examinations carried out under the authority of a coroner

Consent is not required for PM examinations or the storage of material retained during PM examinations, where there is authorisation from a coroner; however, consent is required under the HT Act for the continued storage or use of tissue once the coroner’s purposes are complete.

Under the Coroners Rules 1984 (the Rules), coroners are required to inform a 'properly interested person' (PIP) of the options with regard to disposal and retention of tissue removed during a PM examination. A PIP may be anyone of the following: parent, child, spouse or civil partner and any personal representative of the deceased. In the Rules, there is no hierarchy of relationships and the PIP with whom the coroner is in contact may not be the appropriate person as defined by the HT Act.

Consent in the wider healthcare arena

The term 'next of kin' is widely used but has no definition and no legal standing in relation to healthcare within the UK health services. The term originally derives from Roman Law and was devisedto apportion property between male relatives of a family. It became irrelevant in Britain after the Administration of EstatesAct 1925 established a different convention for transferringproperty after death.However, the term 'next of kin' continues to be used in medical settings as if it were a legal entity.

For example, hospital records consistently document the name of the patient’s next of kin but, in thecase of unconscious patients, someone identified as next ofkin has no legal right to consent toor refuse treatment on behalf of the patient. Likewise, the person identified as next of kin may not be the appropriate person under the HT Act to give consent to a hospital PM examination.

Current issues with seeking consent

Within the current UK health service, when a person is admitted to a hospital, they are asked by hospital staff to give details of their next of kin, i.e. the person who should be contacted in the case of an emergency. In the scenario where the patient is incapacitated and unable to give the details, the person accompanying the patient is asked to give this information to hospital staff on the patient’s behalf. This information is entered into the patient’s hospital notes and the information follows the patient through their hospital admission.

If the patient dies and their clinical team wishes to undertake a PM examination, the next of kin information is used to identify the person from whom to seek consent. The named next of kin may not be the person in the highest ranking qualifying relationship under the HT Act. It is not standard practice within the health service to ask the consent giver whether they are the most appropriate person to be speaking to. The exception to this is when obtaining consent for organ and tissue donation, where the Transplant Coordinator asks if they are speaking to the appropriate person in a qualifying relationship.

Training on obtaining consent for hospital PM examinations can be inconsistent. Moreover, processes for seeking consent are not standardised throughout the health service. In many situations, the clinician in charge of the care of the patient is involved in seeking consent. More recently, Trusts have appointed bereavement staff, who are becoming more involved in this process.

Advice for Designated Individuals and those involved in the consenting process

In order to comply with the HT Act, codes of practice and HTA standards, Designated Individuals (DI) are required to assure themselves that appropriate consent is obtained for hospital PM examinations.

Hospital staff should take the opportunity, when seeking consent for a hospital PM examination process, to explain the significance of the qualifying relationship under the HT Act to the next of kin. They should then ask the next of kin if they are the person in the highest ranking qualifying relationship. If they are not, information should be requested about who is the highest ranking person and reasonable efforts made to contact the person prior to the PM examination taking place. This information should be documented on the consent form.

There may be situations where it may not be possible to seek consent from the person in the highest ranking qualifying relationship. The HT Act allows for this person to be omitted from the hierarchy if they cannot be located, declines to deal with the matter or is unable to give valid consent; for example, because they are a child or lack capacity to consent. In such cases, the next person in the hierarchy would become the appropriate person to give consent. This process should be documented on the consent form.

Where consent from a person in a qualifying relationship can not be obtained, the PM examination can not proceed.

To support staff taking consent for hospital PM examinations, the DI should ensure that:

  • the consent form used during the consent process includes a question to prompt the consent seeker to ask the consent giver about their suitability in relation to a qualifying relationship (the HTA model consent form, which includes this question, can be obtained from this website)
  • those who take consent for hospital PM examinations are trained in aspects of the HT Act relating to seeking consent for hospital PM examinations, including the hierarchy of qualifying relationships under the HT Act, the role of the Nominated Representative (NR) and the role of the consent seeker in asking the consent giver about their suitability in relation to a qualifying relationship
  • there is a documented standard operating procedure for staff that requires the consent seeker to record that they have explained the hierarchy of qualifying relationships under the HT Act and the role of the Nominated Representative (NR) and that this is recorded on the consent form.

The HTA may raise awareness of this issue through its website and e-newsletter; in addition consideration may be given to providing an e learning module on the website specifically on consent training.

Enforcement

For details of enforcement action relating to regulatory non compliance, please refer to the HTA’s enforcement policy.

Issued March 2010

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