Human ethics

Question 1

what classes as human research

Answer 1

any direct study with volunteer, any clinical data, biological material or material derived from human tissue

Question 2

what is the declaration of Helsinki and when did it occur

Answer 2

1964 - developed by world medical association. principles on human experimentation (current version 2008)

Question 3

name the 3 basic principles of human ethics

Answer 3

respect the right for self determination (can make own informed decisions)
welfare > interest of society
increased vulnerability needs special vilagence

Question 4

which require approval?

clinical audit, service evaluation, and research

Answer 4

clinical audit and service evaluation DONT

Question 5

when do we need ethical approval for human research?

Answer 5

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)

Question 6

what does NRES stand for and who is involved

Answer 6

national research ethics service

• REC (NHS research ethics committee) (volunteer members)
• coordinators + local managers

Question 7

aims of NRES

Answer 7

• protect the rights, safety and dignity and wellbeing of participants
• promote ethical research of benefit to.. science, society, and participants

Question 8

role of REC

Answer 8

review applications for research, give opinion if ethical (35-60 days)
monitor throughout
issue amendments

Question 9

what must applications for REC contain

Answer 9

protocol, consent forms, patient info sheet, advertising material

Question 10

In Local NHS / R&D approval what must the NHS organisation ensure:

Answer 10

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

Question 11

When doing an audit/ service evaluation where do you need to seek approval from

Answer 11

Local NHS organisation R&D department

Question 12

responsibility of chief researcher:

Answer 12

• protect life, privacy, dignity
• JUSTIFY research
• rigorous approved protocol
• complete accurate records
• only appropriate subjects
• fully informed volunteers with consent

Question 13

what is PIS and PIL

Answer 13

patient information sheets and leaflets

Question 14

what must be done to ensure valid consent

Answer 14

PIS/PIL must be within 24h, taken by investigator, consent form must be signed by person doing discussion

Question 15

Children under 16 in clinical trials…?

Answer 15

parental or legal consent - must represent assumed consent of child. info given if capacity (childs wishes considered)

Question 16

who makes decisions for incapacitated adults

Answer 16

personal (guardian relative) and professional (doc) representative

Question 17

what does the data protection act involve

Answer 17

• subjects informed of controller of their info
• data only for lawful purposes - not processed any other way
• security of data vital

Question 18

how do they safeguard data

Answer 18

locked password
non identifiable patient code
dont keep for longer than necessary
only appropriate access

Question 19

offences of human tissue act 2004

Answer 19

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