human tissue in research Flashcards
What does the human tissue act (2004) cover?
replaces 1961 act in regards to post-mortem tissue includes - tissue from living people transplantation anatomy public display
What is meant by bodily material?
any tissue or sample that consists of human cells, this includes gametes, and hair and nails from the living or deceased. It excludes embryos outdoor the body, cells manufactured outside the body and/or any extracted cellular components where no whole cells remain (e.g. extracted DNA / RNA)
What is meant by relevant material?
Any tissue or sample that contains human cells. It excludes gametes, embryos outside the body, nails and hair from the living, cells manufactured outside the body and any sample that has been processed to render it acellular
What does the act cover?
storage and use of dead bodies
removal, storage and use of relevant material from dead bodies
storage and use of relevant material from the living
What does the act do?
To obtain, store or use relevant material or human body for certain “scheduled purposes” is lawful provided appropriate consent is in place
What is meant by consent?
The fundamental principle underpinning the lawful retention and use of relevant materials from the living or deceased for specified health-related purposes or public display
Which scheduled purposes is consent needed for?
anatomical examintion
determining cause of death (except coroner)
To establish the efficacy of a drug or treatment
Obtaining scientific or medical information about a living / deceased person that may be relevant to another person (including a future person)
public display
transplantation
Research in connection with disorders or function of the human body
What are the exceptions when consent is not required?
clinical audit education or training related to health public health monitoring quality assurance research on anonymised samples with project specific ethics storage and use of existing holdings
What does the human tissue authority (HTA) do?
regulates the storage, use and disposal of tissue from the living and deceased
Describe the human tissue (scotland) act (2006)
consistent with legislation in England, wales and NI
based on authorisation instead of consent
consent implies passive acceptance, authorisation gives power to the individual
Describe the human tissue banks in scotland accreditation scheme
standard of quality; consent, governance and appropriate premises
assessment tool
accredits NHS health boards
3 year rolling programmes of accreditation
Describe the lawful basis of the use of identifiable data
human rights act - right to privacy
common law : duty of confidentiality, consent, legal, public interest
data protection act
NHS act 2006; national information governance boards
Describe the legal basis of using identifiable data in Scotland
Caldicott guardian must authorise confidentiality and security advisory group REC approval Community health index advisory group Privacy advisory committee
describe the general data protection regulations (2018)
GDPR
strengthens obligations and accountability of organisations to handle personal data
need to be lawful, fair and transparent
need to state which lawful basis data is being collected and stored under
must ensure that patients are not identifiable from tissue or associated clinical information
What are the underlying principles of the legal framework for the use of tissue in research?
democracy
transparency
accountability - donor to end use
