1. Coroners Act and Rules Human Tissue Act and Authority
Adam Christian

2. Coroners
Pre-Norman system of coroners mentioned in the reign of Alfred the Great ( )
Coroners that are the origin of todays are from 1194, during the reign of Richard the Lionheart
Needed a lot of tax to fund crusades
Coroner was a local official to “hold the pleas of the crown”

3. Coroners
These pleas would then be presented to the General Eyre, touring judiciary
Also investigated sudden death
Held inquests – all males from surrounding town had to attend
Required to view the body (up until 1980)
From 1836 could pay for medical witness (i.e. a PM) 3

4. Coroners Act 1988 Repealed Acts of 1844, 1887, 1892
Set out coroners qualifications, districts, deputies, inquests, juries, treasure

5. Coroners Rules
1984
Set of instructions for coroners, where PM’s can take place, content of PM reports, juries

6. Coroners Amendments Amendments to the 1984 Rules
2005, Rule 9 – preservation of material
Material must be preserved if it has a bearing on the cause of death
Coroner must be notified
Coroner then seeks opinions from relatives for disposal once inquest closed
Bury/cremate, return to family, research
Coroner must be notified once this is done

7. Coroners Amendments Amendments to the 1984 Rules 2008, Rule 43
Prevention of future deaths
Coroners must write to anyone capable of preventing future deaths and Lord Chancellor

8. Coroners Act New Act Coroners and Justice Act 2009
Royal Ascent November 2009
Rules still stand

9. Changes to current system
Death certification
Senior/Chief Coroners
Medical Examiners

10. Create a new national coroner service, led by a new chief coroner
The Act received Royal Assent on 12 November 2009 and includes measures to:
Reform and clarify the law on homicide, in particular to the partial defences
Update the language of the offence of assisting suicide
Establish a new Sentencing Council for England and Wales, with a strengthened remit to promote consistency in sentencing practice
Create a new national coroner service, led by a new chief coroner
Create a new system of secondary certification of deaths that are not referred to the coroner, covering burials and cremations
Enable the courts to pass an indeterminate sentence for public protection for certain terrorist offences
Prevent criminals from profiting from publications about their crimes
Amend the Data Protection Act to strengthen the Information Commissioner's inspection powers
Re-enact the provisions of the emergency Criminal Evidence (Witness Anonymity) Act 2008 so that the courts may continue to grant anonymity to vulnerable or intimidated witnesses where this is consistent with a defendant's right to a fair trial
Allow the courts to grant Investigative Witness Anonymity Orders in certain gun and knife crime cases
Extend the use of special measures in criminal proceedings, such as live video links and screens around the witness box, so vulnerable and intimidated witnesses give their best evidence

11. Details of Act Duty to investigate To ascertain
Violent or unnatural deaths
Unknown cause of death
Death in custody
To ascertain
Who the deceased was
How, when and where they came by their death

12. Details of Act Jury called if
Death in custody (violent/unnatural/unknown)
Act or omission of the police
Death following a notifiable accident, poisoning or disease
Any reason they see fit
If investigation lasting more than 1 year they must notify the Chief Coroner 12

13. Details of Act
Medical examiners are appointed by the PCT/LHB (must be 5 yrs registered)
National Medical Examiner appointed to give guidance to ME’s
Single system for burial and cremation
(single fee!) 13

14. PM report back to Coroner
Details of Act
Medical Certificate of the Cause of Death
Known COD
Unknown COD
Certificate written
Referred to Coroner
Coroner can refer to ME
or request PM
Certificate goes to ME
ME can write certificate
PM report back to Coroner
Body buried or cremated 14

15. Details of Act Treasure still under Coroner control
Abolishment of the Coroner of the Queen’s Household 15

16. Scottish System No direct coroner equivalent
They have Procurators Fiscal
Investigate sudden and suspicious deaths
Fatal accident enquiries
Criminal complaints against the Police
Prosecute most crimes (like CPS)
Allowed to view the body and issue a certificate without PM (less limited than UK), more like the ME may become

17. Human Tissue Act
The Human Tissue Act 2004 (HT Act) repeals and replaces the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplants Act 1989
Bulk of it came into force in 2006

18. The HT Act regulates removal, storage and use of human tissue – defined as material that has come from a human body and consists of, or includes, human cells. Once the HT Act is in force, it will be unlawful to carry out these licensable activities without a licence.
The HT Act creates a new offence of DNA ‘theft’. Having human tissue with the intention of its DNA being analysed, without the consent of the person from whom the tissue came, will be unlawful from 1 September 2006.
The HT Act makes it lawful to take minimum steps to preserve the organs of a deceased person for use in transplantation while steps are taken to determine the wishes of the deceased, or, in the absence of their known wishes, obtaining consent from someone in an appropriate relationship.
The HT Act gives specified museums in England discretionary power to move human remains out of their collections, if the remains are reasonably believed to be those of a person who died less than 1,000 years ago.

19. Human Tissue Act 2004 brings into existence the Human Tissue Authority (HTA)
Grant licenses
Inspect
Regulates activities called “scheduled purposes”
Some of these require consent

20. Scheduled Purposes
The activities covered by the Act are referred to as “scheduled purposes”. They are divided into two groups:
Part 1:
• Anatomical examination
• Determining the cause of death
• Establishing after a person’s death the efficacy of any drug or other treatment administered to that person
• Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person)
• Public display
• Research in connection with disorders, or the functioning, of the human body
• Transplantation
Part 2:
• Clinical audit
• Education or training relating to human health
• Performance assessment
• Public health monitoring
• Quality assurance
The removal, storage and use of tissue from living individuals as part of their diagnosis or treatment does not fall within the scope of the Human Tissue Act and is covered by the usual ethical rules on consent to treatment

21. When is consent required?
The general rule is that Part 1 activities always require consent. Part 2 activities require consent if the material is from a person who was dead at the time the material was removed but do not require consent if the material is tissue taken from living individuals
There are a small number of exceptions to these general rules. Consent is not required where:
An investigation into the cause of death is carried out under the authority of a coroner
Material removed from a person after death is stored for coroners’ or criminal justice purposes
The material used is classed as “existing holdings” in that it was already in storage for a scheduled purpose when the Act came into force
Residual tissue from living individuals is used anonymously for research that has approval from a research ethics authority (see below) or approval is pending
The tissue has been imported or comes from a body that has been imported
The tissue comes from the body of a person who died before 1 September 1906

22. Who gives consent?
Where the activity to be undertaken is anatomical examination or public display, the individual’s own written and witnessed consent is required and nobody else has the authority to give consent.
For other activities covered by the Act appropriate consent means:
For competent living adults: the individual’s own consent
For living children who are able and willing to make a decision: the individual’s own consent
For children unable or unwilling to make a decision: A person with parental responsibility
For deceased people (who were competent before they died):
the individual’s own consent given before death; or
if an adult did not give consent, any person nominated by that person to make decisions after death; or
in the case of children, or where an adult did not nominate anyone, someone who was in a “qualifying relationship” (see below) with the individual before death.

23. The “qualifying relatives” ranked in order of priority are:
spouse or partner, including civil partner
parent or child
brother or sister
grandparent or grandchild
niece or nephew
stepfather or stepmother
half brother or half sister
friend of long standing

24. HTA Licenses What activities require a licence?
The Human Tissue Authority is established as the regulatory body to license a number of activities set out in the Act. The licensing requirement applies to all establishments whether operating within the NHS, a university or the private or commercial sector. It is unlawful to carry out the following activities without a licence from the HTA:
Both hospital and coroner’s post-mortem examinations
The removal, use and storage of material, organs or tissue after death (except for whole and part organs for transplantation)
Anatomical examinations
Storage of human bodies, body parts or human tissue (but see exceptions below)
Public display of human tissue.
There are some exceptions to the licensing requirement for the storage of tissue. A licence is required for the storage of tissues or organs removed from deceased patients, except:
storage for use in a research project that has research ethics committee approval (or pending approval)
storage of solid organs for transplantation.
A licence is not required for the storage of tissue from living individuals except:
storage for more than 48 hours for human use (both allogeneic and autologous transplantation)
storage for generic future research (both identifiable and anonymised).

25. Persons to whom licence applies
The authority conferred by a licence extends to—
(a) the designated individual,
(b) any person who is designated as a person to whom the licence applies by a notice given to the Authority by the designated individual, and
(c) any person acting under the direction of—
(i) the designated individual, or
(ii) a person designated as mentioned in paragraph (b).
Duty of the designated individual
It shall be the duty of the individual designated in a licence as the person under whose supervision the licensed activity is authorised to be carried on to secure—
(a) that the other persons to whom the licence applies are suitable persons to participate in the carrying-on of the licensed activity,
(b) that suitable practices are used in the course of carrying on that activity, and
(c) that the conditions of the licence are complied with.

26. Cross over with Coroners
Do the consent provisions of the HT Act include coroners’ post mortems?
No. The coroner can authorise a post mortem without the consent of the family (see section 11 of the HT Act). This applies to “routine” and forensic post mortems. The HTA’s codes of practice provide advice and guidance on consent and post mortem examination.

27. Does any post mortem activity performed under the coroner’s authority come within the HTA’s regulatory remit?
Yes. Any autopsy that is authorised by a coroner must be carried out on premises licensed by the HTA.  

28. What should happen to tissue removed at coroner’s autopsy once the coroner’s authority has ended?
The Coroners Amendment Rules provide three options
Return the tissue to the family
Dispose of the material
Obtain the family’s consent to retain the tissue for research or other purposes listed in the HT Act

29. Whose responsibility is it to put these aspects of the Coroners Amendment Rules into practice?
The Ministry of Justice have responsibility for developing policy on the coroners service. The HTA is working with them to produce guidance on this matter. Broadly this boils down to dialogue and agreement between each coroner and the pathologists they work with. For example, a local agreement may be that, at the same time as explaining what a coroner’s case involves, the coroners officer might explain the options for dealing with tissue after the coroner’s authority has ended. If this is not possible or practicable because of local circumstances, the coroner and pathologist need to come to an understanding about an alternative procedure.
What matters is that each of the players understands and applies what has been agreed; that the requirements of the coroners rules have been followed; and that the pathologist is advised of the family’s wishes.

30. The Coroners Amendment Rules state that tissues from a coroner’s autopsy can be retained only with the family's consent once the coroner’s authority has ended. What happens to tissue at the end of a period specified by the coroner if there is no consent for further retention for a purpose listed in the HT Act (a “scheduled purpose”)? The coroner must meet the requirements of the Coroners Amendment Rules (see questions 3 and 4 above). The tissue should be disposed of using the guidance in the HTA’s code of practice on Disposal. .

31. Should all the practices and procedures set out in the HTA’s and others’ guidance apply to postmortem tissue removed before the Human Tissue Act came into force?
No. The HT Act came into force on 1 September 2006 and does not apply retrospectively. The HTA’s code of practice on Disposal sets out options for disposal of tissue removed before 1 September  

32. How should I dispose of blocks and slides removed at coroners’ autopsies, once the coroner’s authority has ended and relatives have requested disposal?
The HTA’s code of practice on disposal of tissue provides guidance on this matter but places responsibility on organisations to make their own decisions about the most suitable method of disposal. We encourage organisations to share their disposal policy with the public so that families know what to expect and are reassured that the tissues have been disposed of in an appropriate manner.
Unless the family has expressed a preference for disposal, it may be reasonable to incinerate blocks and slides no longer required for coroners’ purposes, but this must be a local decision, taken in the light of local facilities and practices. However, there may be difficulty in cremating slides, for example because of health and safety implications, but this varies from one crematorium to another. For more information see the Cremation (England and Wales) Regulations 2008.

33. Can I keep organs or tissue for research following coroners’ autopsies, for example to check the prevalence of CJD in the population?
The HT Act requires that consent from the deceased person, a person nominated by them, or a ‘qualifying person’ (typically the next of kin) is needed before post mortem tissue can be retained to carry out research, public health monitoring, or other activities listed in the Act (“scheduled purposes”).

34. Can I cold perfuse a body that is under the coroners’ authority?
The HT Act permits cold perfusion where removal of a solid organ may be considered for transplantation (i.e. there is no bar on cases that fall under a coroner’s authority). However, it is recognised that cold perfusion can inhibit or even prevent tests authorised by the coroner. Therefore it is essential that coroners and the medical staff (e.g. pathologists and staff in A&E and ITUs) reach an understanding about a procedure to be followed in these cases