Transplantation and human tissues (2004)

What is the Transplatation and Human tissue act 2004?

Consistent legislative framework for issues of

• removal, storage, use and disposal of human material from deceased

• Storage and use of human material from the living

• Whole body donation and storage

Who’s is the regulator for human tissue?

Human Tissue Authority

What is the importance of consent in this act?

• fundamental part of legislation

• Varying consent due to the living and deceased

What human material does the act not cover?

• live gametes and embryos - covered in another act

• Hair and nails from the living

What two types of consent are needed for activity under the act?

• Valid consent

• Appropriate consent

What is appropriate consent?

It is a person who may give consent:

• the person concerned

• A nominated representative

• A person in a qualifying relationship before they died

What is deemed consent?

Allowing consent to be deemed after death - this modified approach to appropriate consent

What are the requirements for appropriate consent?

• Over 18

• If alive they must give consent

• After death advanced signed and written document for anatomical examination o body display

• A nominated person may give consent for seduced purposes

What are scheduled purposes requiring consent?

• anatomical examination

• Causing of death

• Efficacy of drug or other treatment

• Scientific / medical info that may be relevant to living or deceased

• Public display

• Research in connection to disorder/ functioning of the body

• Transplantation

What is a nominated representative?

In life an adult may make an appointment in life for the consent of storage, removal of there body and materials for schedules purposes

Where there are 2 or more they should act jointly

What is a qualifying relationship?

If the desciesed does not name anyone then a person with a close relationship can consent to the use of the descend human tissue

There is an order of heierachy - spouse - parent - siblings ect

When can material be taken without consent?

• Clinical audit

• Education or training relating to human health

• Performance assessment

• Public health monitoring

• Quality assurance