What regulates the removal, storage and use of human tissue in England and Wales?
Human Tissue Act 2004
What is the Human Tissue Authority?
What are its 3 principal functions?
Established by the Human Tissue Act
3 principle functions:
- Issue codes of practice
- Issues licenses and inspect establishments
- To approve living organ and bone marrow donations
Regulates the removal, storage, use and disposal of human tissue which the Human Tissue Act regards as 'relevant material'. Licenses these activities.
HTAct refers to these activities as 'scheduled purposes'
What are 'scheduled purposes'
What do they include?
What are their codes of practice?
The activities involving human tissue governed by the Human Tissue Authority and HTAct including removal, storage, use and disposal of human tissue:
- Anatomical examination
- Determining cause of death
- Public display
- Education or training in relation to human health
What 4 principles is the Human Tissue Act founded on?
- Honesty and openness
What requirements do the Human Tissue Act require for licensing?
Licensed establishments must uphold standards relating to:
- Consent forms
- Record keeping
- Premises, facilities and equipment standards
- Disposal of tissue
Define anatomical examination (as defined by the Human Tissue Authority)
The Human Tissue Authority refers to 'anatomical examination' as scheduled purpose of the use of donated bodies to teach anatomy by dissection
Define anatomical examination and anatomical purposes
Anatomical examination: macroscopic examination by dissection for anatomical purposes.
Anatomical purposes: purposes of teaching or studying or researching into, the gross structure of the human body.
What does the Human Tissue Act require for tissue donation?
The donation of whole bodies can be donated for anatomical examination with appropriate valid consent.
The storage, anatomical examination of a body can be carried out by a designated individual who has appropriate valid consent , providing the death has been properly certified and registered.
What constitutes appropriate consent for whole body donation?
Consent can only be given by the individuals who choose to donate their body. This consent cannot be given by anybody else.
- Must be written consent
- Signed in the presence of at least 1 witness
- OR signed in the presence of the person concerned and in the presence of at least 1 witness
- OR be contained within the will of a person
What are the 3 main uses a donated body can be used for?
Anatomical examination (teaching of structure of human body to students and HCPs)
Research (scientific studies that improve the understanding of the human body)
Education and training (training of HCPs, usually those learning surgical techniques)
What does the Human Tissue Act state regarding the treatment of cadaveric material?
States that 'during anatomical examination and storage, all parts of the body should be treated with due respect and consideration'.
What are the pros and cons of generic consent for research?
- Maximises potential value of obtained samples
- Prevents researchers from having to go back and obtain further consent
- How general can consent be whilst still be considered informed?
- Sensitive research areas
- Runs the risk of excluding some people from research
What can relatives give consent for?
What may be complications of this?
Cannot give consent for whole body donation
Can give consent for tissue donation as HTAct's hierarchy of consent applies:
- May lead to conflict between wishes of patient and wishes of their relatives.