week six Flashcards
The Nuremberg Code
what is it
- The first international statement on the ethical treatment of human subjects in research
- Developed in 1947 after WW2 to assess crimes performed by experimenters
Summary of the key points of Nuremberg Code
· Voluntary consent is ESSENTIAL
· The research should be beneficial for society
· Experiments should be well designed in line with current knowledge, including from animal studies
· Experiments should avoid all unnecessary risk of suffering or injury to participants – Risk/benefit analyses should justify the research
· Experiments should only be conducted by qualified scientists demonstrating “the highest degree of skill and care”
· The research should cease if the subject withdraws consent or there is reason to believe the continuation of the research will be harmful
What are Australias ethical rules
In Australia we have the National Health and Medical Research Council’s (NHMRC) National Statement on Ethical Conduct in Human Research (2007)
Respect for persons
Application one: consent
Needs to be:
- Informed – all information provided
- Voluntary – free from coercion
- Comprehension – plain language
- Right to refuse/withdraw – no reason required
Respect for persons
Application Two: Maximise Autonomy and Human dignity
- Participants have the freedom to decide what will happen to them
- Respect for different cultural/religious beliefs
- Responsibility to protect those with diminished autonomy e.g. children, medically-dependent people, confined populations, etc.
Respect for persons
Application Three: maintain confidentiality
- Ensure participant records are kept secure
- Autonomous decision-making is not possible in the absence of privacy
- Identifiable, re-identifiable and non-identifiable records pose different problems for patient rights
- Data storage and access procedures
Non Maleficence
Application: First, do no harm - Risk/benefit analyses
- Avoid psychological, physiological and social harm to participants
- Participant welfare trumps scientific discovery
Beneficence
Application: Maximise all possible benefits
- The research must not only avoid harm but must contribute something positive to society
- Risk must be kept to a minimum AND must be justified in terms of potential benefits
Justice
Application: Fair selection of participants
- Fair distribution of burdens and benefits of the research
- Transparent, non-discriminatory recruitment procedures and inclusion/exclusion criteria
scientific integrity one
Application: publication of results for scrutiny
- Methodology should be clearly explained so experiments can be independently repeated
- Results should never be fabricated/concealed
- Selection of participants should be justified and unbiased – no under or over-representation
scientific integrity two
Application: Valid and rigorous methodology
- Sample sizes must be capable of yielding statistically significant results
- Poor research methodologies are unethical as they waste resources, time and show disrespect for participants
