The Scottish Biorepository Network Flashcards
What needs to be considered during the chain of trust?
Safety - the risk of the patients/ participants
Rights
Dignity and well being
What is the issue with HeLa cells?
They were taken from Henreitta Lacks without consent
What is human tissue?
Any tissue or sample that has come from a human body and contains human cells from the living or deceased
- Organs
- Processed material that includes cells e.g. blood tests or saliva
- Bodily waste
- Tissue sections under microscope slides
What is the responsibility of the Scottish Biorepository Network?
Provide a resource of readily available human material for medical research
Create a structure for the governance of human tissue in Scotland
Ensure human tissue is collected, stored, used and disposed of in a responsible manner
When is ethical approval needed?
When researchers want to collect de-identified tissue samples from patients
When researchers when to use de-identified tissue from the pathology archive
If researchers want identifiable tissue from patients which is not part of the routine patient therapy
What is the assessment criteria?
1) Need approval for the us of human tissue within research projects
2) Data annotation for human tissue
3) Patient/ volunteer consent
4) Governance
5) Suitability of Premises for the storage and use of human tissue in research
6) Import/ export of tissue
7) ethics of project costs
What does the tissue application process contain?
Clarity of research proposal (why they want to use the human tissue)
What tissue they need
Justification of the sample number
Transparency of the research protocol
Technical and practical feasibility
Identification of ethical uncertainties
Provide a clear protocol as to what data is required
What are the rules of consent?
Need to provide the patient with all the information of the study which are relevant to them
Make sure the patients have enough time to make an informed decision
Decide is who responsible for gaining consent
Consent must be gained before the tissue is
Consent for genetic analysis
There is a clear policy for consent withdrawal
Consent forms are stored in a locked facility
What are the storage and suitability of premises?
Are the samples safe
Is there a back up freezer with samples in and the samples are separated between the 2 freezers
What equipment is needed
If they need to be taken off site, a specialised courier is used
What is the cost of gaining samples?
The samples are free but you have to pay for the preparation of the samples
