Consent Flashcards
consent must be based on
complete information about the study
three components of informed consent
- information voluntary - procedures, risks and benefits
- comprehension- simple language
comprehension
simple language used- primary school level
- also provided in different languages
consent in practice
- info sheets- kept by participants
- consent forms- kept by researcher
- consent can be withdrawn at any time
- provide material in other languages
- test understanding
what if a person lacks capacity to consent?
- can be provided by an authorised representative or next of kin
assent
is a physical or verbal expression of willingness to participate e.g. wear an arm thermometer
dissent
is a physical or verbal expression of an unwillingness to participate
assent is
necessary but not sufficient
consent does
not overall dissent
a lack of capacity to consent does not mean research shouldnt be done e.g.
if the study is to do with pattern of children behaviour
which key principle does consent come under
respect