RSD 1: Human and Animal Research Ethics

Question 1

How do we weigh risks against benefits in the setting of clinical trials? What kinds of benefits are there?

Answer 1

• There are individual benefits (to the subjects as a result of being in the trial), and social benefits (as a result of the data obtained).
• Risk should always be minimised
• According to many guidelines, risk should be outweighed by potential for individual benefit
• If there is no possible clinical benefit, risk should be outweighed by potential for social benefit

Question 2

What is the Good Clinical Practice guidelines? What is their purpose (not: what are they)?

Answer 2

• International ethical and scientific quality standard for clinical trials
• Dictate how trials are designed, conducted, reported

Question 3

What are the principles of good clinical practice in clinical trials?

Answer 3

• Rights, safety, and wellbeing of participants is the highest consideration
• All participants must give informed consent
• All data should be stored in a way that allows source verification
• Participant confidentiality should be maintained at all times

Question 4

What are the principles of informed consent in clinical trials?

Answer 4

• Information must be approved by human research ethics committee
• Consent must be freely given (no coercion/influence allowed)
• Information that should be communicated includes purpose of trial, procedures, risks/benefits, expenses etc.

Question 5

What are the four Rs that govern scientific research involving animals?

Answer 5

• Respect: use only when justified, minimise harm/pain
• Refinement: improve techniques wherever possible to reduce suffering
• Replacement: only use when required; of can be replaced, do so
• Reduction: minimum number of animals to obtain statistically relevant outcomes

Question 6

Why is monitoring important in clinical trials involving animals?

Answer 6

Monitoring to ensure adverse effects/suffering can be dealt with in a way that maximises animal wellbeing within the confines of experimental design.

Question 7

Why is reporting important in clinical trials involving animals?

Answer 7

Reporting of unexpected adverse events ensures that they can be prevented from occurring in the future, maximising the wellbeing of animals involved.

Question 8

Are young/dependent/cognitively impaired people allowed to be in clinical trials? How is the consent process altered?

Answer 8

• Yes. These people have a right to be in clinical trials.
• Their level of vulnerability needs to be determined, and factored into the informed consent process.

Question 9

List some principles of ethical human medical research

Answer 9

• Informed consent
• Can withdraw at any time
• Risks outweighed by benefits
• Aimed at the good of society