human tissue in research Flashcards
4 drivers for change that led to HTA 2004
public concern
patient focused care
eu/uk guidelines and legislation
research post genomic revolution
bristol 84-95
staff kept hearts of children upsetting patients families rightly so
what did 2004 human tissue act HTA cover
storage use removal of relevant tissues from dead and living also consent and purpose
bodily material
tissue or sample that consists of human cells
what does bodily material exclude
embryos or cells manufactured outside human body
cellular components when no whole cell remains eg dna or rna
relevant material
tissue or sample that contains human cells
what does relevant material exclude
gametes
embryos and cells from outside body
hair/nails from living
consent
lawful retention and use of relevant material for health related purposes and public display
when is consent required
anatomical examination
determine cause of death(not coroner)
public display
research for disorders and body function
when consent is required continued
establish efficacy of drug/treatment
for information that could be relevant for others now or future
transplantation
consent exceptions
clinical audit
performance assessment
quality assurance
storage and use of pre 2006 existing samples
consent exceptions continued
education/training
public health monitoring
research on anonymised samples
if deceased over 100years
human tissue authority
regulates storage
use
disposal
removal
license not needed
primary purpose diagnosis and research
license needed
possible future project
distribution to other researchers
offences
3yrs and or fine
failing to obtain or abusing consent
scotland human tissue act 2006 differences
based on authorisation as it gives power to the individual
doesnt regulate use of tissue from living for resarch
scotland tissue banks
ethically obtained consent
documented governed policies
management for access
traceability of tissues for data
ethical reviews
quality of informed consent
collection of tissues
info on prospective purposes
feedback on information gathered
ethical reviews continued
researcher access
data linked to sample
confidentiality
some uses of tissue samples
lab only studies(NGS or immunohistochemistry)
drug trials
uses in therapy eg graft
better than animal models
cell targets using LCM
laser capture microdissection
laser removes cell of interest leaving tissues intact
