week 8: ethics Flashcards
what are the 4 components of nuremberg code 1948?
1) consent
2) able to withdraw anytime
3) minimal risk
4) protected against harm
explain the 4 componenets of declaration by helsinski 1964
Research protocols should be reviewed by an
independent committee prior to initiation
▪ Informed consent from research participants is
necessary
▪ Research should be conducted by medically/
scientifically qualified individuals
▪ Risks should not exceed benefits
what are the 3 components of belmont report 1979?
Belmont Report (1979)
3 Research ethical principles
▪ Beneficence
▪ Respect for Human Dignity
▪ Justice
what is beenficence?
Beneficence
▪ The right to freedom from harm and discomfort
▪ The right to protection from exploitation
what is respect for human dignity?
Respect for Human Dignity
▪ The right to self-determination
▪ The right to full disclosure
❖ Informed consent
what should the consent process include ?
❖ The consent process must include three
elements:
✓ Information
✓ Comprehension
✓ Voluntariness
what does justice mean?
Justice
▪ The right to fair treatment
▪ The right to privacy
what should the selection of subjects be based on? 3.
Selection of subjects should be based on:
❖ Random sample
❖ Randomisation
❖ Allocation concealment
What makes Clinical research Ethical? 7
▪ Value
▪ Scientific validity
▪ Fair subject selection
▪ Favourable risk-benefit ratio
▪ Independent review
▪ Informed consent
▪ Respect for enrolled subjects
name the 3 institutional review boards in singapore:
Research Ethics Committee
▪ Institutional Review Boards (IRB)
✓ NHG -DSRB (Domain Specific Review Board)
✓ SingHealth - CIRB (Centralised Institutional Review
Board
✓ NUS – NUS IRB, DERC (Department Ethics Review
Committee)
what is the role of IRB
▪ Role:
✓ ensure the protection of the rights, safety and well-
being of subjects
✓ provide public assurance
