Session 4: Ethics in research

Question 1

Name and describe the four principles of biomedical ethics ( Belmont principles).

Answer 1

1. Autonomy - respect for persons
   - requirement to acknowledge autonomy AND requirement to protect those with diminished autonomy
   -
2. Beneficence
   - covers acts that go beyond strict obligation
   * do not harm
   * maximise possible benefits and minimise possible
   harm
3. Non-maleficence
   - instructs us not to harm others deliberately or negligibly
4. Justice
   - a fair distribution of burdens and benefits

Question 2

Name and briefly describe the four elements of informed consent.

Answer 2

1. Capacity
   * participants must be legally and mentally competent to participate in the proposed research
   * must meet age requirements
2. Disclosure
   * all relevant knowledge about proposed study must be
   disclosed to participants (including its purpose,
   potential risk, benefits and social implications)
   * investigators must seek guidance and approval from
   the research ethics committee where this is not
   feasible
3. Understanding
   * participants must understand the disclosure
   * disclosure made in participant language and technical
   terms should be explained in layman’s terms
4. Voluntary assumption of risk
   * participants must affirmatively volunteer to participate
   * intimidation/duress, undue inducement, therapeutic misconception and deception are factors that compromise the voluntary nature of consent