Human Tissue Act And Tissue Donation

Question 1

Why have a human tissue act?

Answer 1

Studying anatomy is important for medical education and research and donated bodies/tissues are a valuable resource for this. Also, they are generous gifts from people who want to do good so the nature and value of this resource must be treated safely, responsibly and with respect/dignity. Legislation and policy helps ensure the resources are handled appropriately.

Question 2

What was the events prior to legislation that encouraged a human tissue act to be made?

Answer 2

Controversy regarding organ/tissue retention at several hospitals in UK most notably Alder Hey and Bristol -> thousands of organs removed from dead children and retained without knowledge/consent of parents -> public outcry followed by a full investigation resulting in the redfern report (basically stating what had gone on and that organs can no longer be retained without knowledge or consent)

Question 3

What considerations must be taken into account in terms of making a human tissue act and tissue donation?

Answer 3

If you were to donate tissue/whole body after death, what things might you want to know?
What requirements/restrictions should be in place? Bare minimum? Desirables?
Legislation should permit activity important to medicine but also, provide safeguards and restrict unacceptable activity - guidance should strike a balance between these considerations

Question 4

What is the Human Tissue Act 2004?

Answer 4

HTAct regulates the removal, storage and use of human tissue in England, Wales and Northern Ireland. There is a Human Tissue Scotland Act 2006 applying to Scotland.

Question 5

HTAct established a regulatory body. What is its name and functions?

Answer 5

Human Tissue Authority has 3 principle functions:

1. To issue codes of practice
2. To issue licenses and inspect establishments
3. To approve living organ and bone marrow donations
   - > HTA regulates activity involving removal, storage, use and disposal of human tissue which the HTAct refers to as ‘relevant material’ - HTAct refers to these activities as scheduled purposes.

Question 6

What does the HTAct cover?

Answer 6

Covers the removal, use or storage of tissue for several scheduled purposes:

• Anatomical examination
• Determining cause of death
• Public display
• Transplantation
• Education/training relating to human health

Question 7

HTAct is supported by several codes of practice which provide detailed guidance on application of Act. What are they?

Answer 7

A: guiding principles and fundamental principle of consent
B: Post-mortem examination
C: Anatomical examination
D: Public display
E: Research
F: Donation of solid organs and tissue for transplantation
G: Donation of allogenic bone marrow and peripheral blood stem cells for transplantation

Question 8

What are the 4 guiding principles of the HTAct?

Answer 8

Consent
Dignity
Quality
Honesty and openness

Question 9

Why does the HTA licence and inspect organisations like medical schools?

Answer 9

Provide assurance to public that bodies/tissue from deceased are given with proper consent and managed appropriately

Question 10

What does the HTA do in terms of licensing?

Answer 10

HTA licenses establishments to remove, store or use relevant material for scheduled purposes:
Makes clear what activities licences are required
To whom licenses apply (each licensed establishment will have designated individual under whose supervision licensed activity is conducted)

Question 11

What are the HTA’s licensing requirements?

Answer 11

Licensed establishments should uphold various standards relating to:

• Consent forms
• Record keeping
• Premises, facilities and equipment standards
• Disposal of tissue
• > standards not necessarily stated in HTAct but consistent with intention of act

Question 12

Explain the fundamental principle of the HTAct; consent.

Answer 12

Consent is the fundamental principle for lawful storage and use of human tissue. Act makes clear requirement of consent and when it is considered valid. Consent requirements vary depending on what is donated and whether the donor is alive or dead. Appropriate consent i.e. who can give consent is stated. There is a section for children consent and one for adult consent. Valid consent by appropriate person is sufficient for activity governed by HTAct to proceed.

Question 13

What is the scheduled purpose anatomical examination?

Answer 13

The use of donated bodies to teach anatomy by dissection = macroscopic examination by dissection for anatomical purposes

Question 14

What is anatomical purposes?

Answer 14

Purposes of teaching or studying, or researching into, the gross structure of the human body

Question 15

What does the HTAct permit in terms of donation of bodies?

Answer 15

• Permits with appropriate valid consent the donation of whole bodies for anatomical examination
• Allows for storage and anatomical exam of body provided it is carried out by, or under direction of designated individual with appropriate valid consent and that death has been properly certified and registered
• Offence to undertake scheduled activities without appropriate consent

Question 16

What is appropriate consent in terms of the HTAct?

Answer 16

There is a hierarchy of qualifying relationships for giving consent for many purposes scheduled under the HTAct but for anatomical examination, consent can ONLY be given by individuals who choose to donate their body. Consent must be written; signed in presence of at least one witness, or at direction of person concerned in his/her presence and at least 1 witness. Can only be contained in will of concerned person.

Question 17

What are the different uses of a donated body?

Answer 17

Anatomical examination: teaching of the structure and function of human body to students or healthcare professionals

Research: scientific studies which improve the understanding of the human body

Education & training: training of
healthcare professionals usually those learning surgical techniques as opposed to anatomical examination

Question 18

How can the designated individual ensure the appropriate care of cadaveric material?

Answer 18

• Review of security of premises
• Registration system (including reason for visit, name of visitor & supervisor)
• Revising local code of conduct to reflect HTAct requirements and HTA code of practice on anatomical examination
• Declaration signed by all relevant visitors to confirm they have read and understood local code of conduct
• Prominent signs relating to important aspects of local code of conduct

Question 19

What counts as research?

Answer 19

HTAct does not include a definition BUT it is a study addressing defined questions, aims and objectives to discover and interpret new information/reach new understanding of structure, function and disorders of the human body. Research attempts to derive new knowledge and include studies that aim to generate hypotheses, as well as test them or develop practical applications or new knowledge.

Question 20

What is appropriate consent for research?

Answer 20

Consent is the fundamental principle
Broad and enduring consent is endorsed by MRC, HTA and HRA
Generic consent allows for samples to be used for other research; saves researchers going back and obtaining further consent & maximises potential value of obtained samples but must consider sensitive research areas and exclusion of some people from participating (how generic can consent be to still be informed?)

Question 21

What is the consent like for deceased donations of tissues (i.e. not whole bodies)?

Answer 21

HTAct hierarchy of consent can apply to deceased tissue donation as relatives can give consent for tissue donation. However, may lead to conflict between deceased patients wishes and relatives wishes.