23rd Sept Flashcards
Belmont report’s 3 ethical concepts
Respect for persons
Justice
Beneficence
Potential sources of harm to participants
Biological = morbidity and mortality Psychological = distress Social = stigma Structural = excessive cost
How do we ensure ‘voluntary’ participation?
Informed participants Participant consent Reward free research Freedom to decline Freedom to withdraw Rights protection
Vulnerable individuals and groups
Participants with: limited agency eg children diminished autonomy eg dementia needs eg the poor, unwell unable to consent eg the unconscious
What is ethics, governance and consent?
Ethics: ensuring projects minimises risk and maximises benefit
Governance: ensuring projects have appropriate permission
Consent: ensuring participation is voluntary and without cost
What are high risk ethical issues?
Vulnerable participants
Covert data collection
Administering drugs
Data transfer outwith the EU
What does not require ethical approval?
Data already published
Projects on non humans
Projects using only existing service management data
Projects collecting new info only on existing service delivery
What projects do require ethical approval?
Non human subjects - animals
Service evaluations involving vulnerable participants
Projects involving a new intervention
Projects collecting new info on more than only existing service delivery
4 key principles of ethical research, audit and service evaluation
1) Project conducted in compliance with protocol
2) Authorised research ethics committee has approved protocol
3) Further research ethics committee approval requested if:
a) there are substantial changes to protocol
b) the project has unexpected deleterious effects
What is explicit project protocol?
Why project is necessary
What project will involve
How key ethical, legal and governance issues will be avoided, addressed or mitigated
What are authorised research ethics committees?
Institutional research ethics committees
Governmental agency ethics committees
