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The Human Tissue Act 2004 Notes

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The Human Tissue Act 2004 The background to the Act

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Doctors and Body Parts o Doctors tend, when they do an operation on someone, either throw bits away
? or if the organ or bit of organ was particularly unusual, they might store it for educational purposes or research o The old law was very vague on whether this was permitted
? It talked about needing lawful permission for retaining organs, but didn't say what it meant

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Alder Hey scandal o This concerned a hospital where it was found that many surgeons were retaining organs from operations many of which were from children's bodies -
? but often they were being taken without permission of the parents,

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or taking a whole liver or heart when saying that they were taking "tissue" (which parents thought meant small samples) o Many parents were shocked and distressed as they thought they had buried their children's bodies whole but had found out they had not
? Felt that they had been disrupted in that last parental task of properly disposing of their children's' bodies.

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Many doctors were flabbergasted by the parents' reaction to it - they were throwing away bits of organs all of the time. Lawfully storing or using bodily material Lawful Activities with relevant material

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What is relevant material?
o HTA 2004 s.53:
? Relevant material is tissue, cells and organs of human beings

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Excluding gametes, embryos outside the body, hair and nails from a living person
? S.54(7) Cells lines are also excluded

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What Activities are Lawful?
o HTA 2004 s.1
? (1)The following activities shall be lawful ...

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(a) + (b) [the storage or use of a whole body]

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(c) + (e) + (g) [Remove, store or use human material from a deceased person]

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(d) + (f) [the storage/use of human material from living people]
? [Providing that]

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(1)...[there is] appropriate consent

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The act was done for a Schedule 1 purpose What is appropriate consent?

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Qualifying relationships s.27(4) o [If there is call for consent from a qualifying relationship, the relationships are ranked in this order, with the higher (if in existence and present) having the final say]
? (a) spouse or partner
? (b) parent or child
? (c)brother of sister
? (d) grandparent or grandchild

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o

o

o

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o o

? (e) child of a person falling within para (c) [niece or nephew]
? (f) stepfather or stepmother
? (g) half brother or half sister
? (h) friend of longstanding Children - s.2 S.3(a)Where the child is alive
? [and](b)neither a decision of his to consent to the activity, nor a decision of his not to consent to it, is in force, and
? (c)either he is not competent to consent or has not dealt with the decision

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"appropriate consent" means the consent of a person who has parental responsibility for him (7)Where the child concerned has died and ...subsection (5) [does not apply]
? "appropriate consent" means ---

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(a) ...a decision of his consent/non-consent was in force immediately before he died

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OR (b)if paragraph (a) does not apply---
o (i)the consent of a person who had parental responsibility for him immediately before he died, or o (ii)where [there is]no person ...the consent of a person who stood in a qualifying relationship to him at that time. (4)Where the child concerned has died and ... subsection (5) applies,
? "appropriate consent" means his consent in writing.

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(5)This subsection applies to an activity involving storage for use, or use, for the purpose of---
o (a)public display, or o (b)where the subject-matter of the activity is not excepted material, anatomical examination

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(6)Consent in writing for the purposes of subsection (4) is only valid if---
o (a)it is signed by the child concerned in the presence of at least one witness who attests the signature, or o (b)it is signed at the direction of the child concerned, in his presence and in the presence of at least one witness who attests the signature. Adults with capacity s.3: (2)Where the person concerned is alive
? "appropriate consent" means his consent. (3)Where the person concerned has died ... subsection (4) applies ,
? "appropriate consent" means his consent in writing.
? (4)This subsection applies to an activity involving storage for use, or use, for the purpose of---

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(a)public display, or

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(b)where the subject-matter of the activity is not excepted material, anatomical examination.
? (5)Consent in writing for the purposes of subsection (3) is only valid if
---

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(a)it is signed by the person concerned in the presence of at least one witness who attests the signature,

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