Human ethics Flashcards
what classes as human research
any direct study with volunteer, any clinical data, biological material or material derived from human tissue
what is the declaration of Helsinki and when did it occur
1964 - developed by world medical association. principles on human experimentation (current version 2008)
name the 3 basic principles of human ethics
respect the right for self determination (can make own informed decisions)
welfare > interest of society
increased vulnerability needs special vilagence
which require approval?
clinical audit, service evaluation, and research
clinical audit and service evaluation DONT
when do we need ethical approval for human research?
1) patients in the NHS (+IVF)
2) special requirements under legislation (adults lacking capacity, human tissue, ionising radiation, investigational medical devices and products)
3) healthy volunteers (under local regulation e.g. notts uni, or under legislation)
what does NRES stand for and who is involved
national research ethics service
- REC (NHS research ethics committee) (volunteer members)
- coordinators + local managers
aims of NRES
- protect the rights, safety and dignity and wellbeing of participants
- promote ethical research of benefit to.. science, society, and participants
role of REC
review applications for research, give opinion if ethical (35-60 days)
monitor throughout
issue amendments
what must applications for REC contain
protocol, consent forms, patient info sheet, advertising material
In Local NHS / R&D approval what must the NHS organisation ensure:
1) adequate arrangements and responsibilities (documented)
2) a sponser has taken control (uni, local NHS, pharm companies)
3) its received ethical approval + clinical trial authorised
4) legislation followed
5) contractual arrangements in place
When doing an audit/ service evaluation where do you need to seek approval from
Local NHS organisation R&D department
responsibility of chief researcher:
- protect life, privacy, dignity
- JUSTIFY research
- rigorous approved protocol
- complete accurate records
- only appropriate subjects
- fully informed volunteers with consent
what is PIS and PIL
patient information sheets and leaflets
what must be done to ensure valid consent
PIS/PIL must be within 24h, taken by investigator, consent form must be signed by person doing discussion
Children under 16 in clinical trials…?
parental or legal consent - must represent assumed consent of child. info given if capacity (childs wishes considered)
who makes decisions for incapacitated adults
personal (guardian relative) and professional (doc) representative
what does the data protection act involve
- subjects informed of controller of their info
- data only for lawful purposes - not processed any other way
- security of data vital
how do they safeguard data
locked password
non identifiable patient code
dont keep for longer than necessary
only appropriate access
offences of human tissue act 2004
removing storying or using tissue without consent using tissue for other purposes trafficking tissue for transplantation must have HTA licence having DNA analysed without consent
