Lecture 22 - Ethics

Question 1

Why we need ethics

Answer 1

• historically, Since reachers have undertaken experiments which are unethically acceptable to achieve their research aims
• In hierarchal organisations, there is more of unacceptable behaviours and processes
• Out of respect for authority, people will consent to or participate in things that are unacceptably harmful (cannot reply on individual choice and conscience to ensure people are sufficiently safe)

Question 2

Key considerations for research ethics commitees

Answer 2

What we need for the research to be considered:
1. Assess the benefits and harms and ensure the ratio acceptable (non-maleficence and beneficence)
2. Be aware of potential vulnerabilities of participants (link to principles)
3. Avoid or manage conflicts of interest (respect for person and justice)
4. Obtain informed consent from participants (links to respect for persons)
5. Consider how the benefits and burdens of the research should be shared across society (justice)

Question 3

General policies for balancing benefits and harms

Answer 3

Ethic committees require applicants to show:
- An awareness of the various costs or harms to participants, including time, resources, and etc
- Strategies to address these harms or costs
- An awareness of potential cultural sensitivities
- Evidence of the scientific validity

Question 4

Be aware of Potential Vulnerabilities of participants

Answer 4

A vulnerable person is any person who is at more risk of exploitation because of social and physical disadvantages:
1. Financially off
2. Racial or religious discrimination
3. People who are less educated
4. Older people, children, ill

Question 5

Conflicts of interest

Answer 5

This is where the results of study can be swayed by researchers whom may have vested interest in the outcome of the study.
- It can be a professional, political, financial, or academic related (researchers being biased)

Question 6

Informed Consent

Answer 6

• Informed consent is ordinarily required when participants are enrolled in research studies.
• Consent of research must be in writing
• ongoing consent, can pull out at any given time
• Informed consent requires:
  1. disclosure of the purpose, risk and process
  2. Reasonable efforts from the researcher to explain this information
  3. Person is competent to give consent (not in comma)
  4. Absence of coercive factors (bribery, money)

Question 7

Justice

Answer 7

Justice requires that any study within a population fairly distributes the benefits and burdens of participation in the study.
- Vulnerable individuals should not bare the unfair burden of participating

Question 8

Diversity:

Answer 8

Diversity is an ethical concept requires that researchers understand, respect and recognise the diversity of the population they are researching
- Must consider the needs, cultural values and beliefs

Question 9

Respect

Answer 9

Respect for persons, to have self governance (control over oneself) and autonomy (independence).
- right to have consent
- Protection of the vulnerable

Question 10

Integrity

Answer 10

As an ethical concept, integrity means it is essential that researchers strive to produce viable, untampered results in studies

Question 11

Beneficence and non-maleficence

Answer 11

• Beneficence refers to the fact that the study must be of some benefit either to individuals or whole population
• Non-maleficence refers to no harm (or atleast the harm is clearly outweighed by the potential benefits)

Question 12

Clinical Equipoise

Answer 12

• A concept related to beneficence and non-maleficence
• This is the requirement, that researchers must be genuinely uncertain what the outcome of the trial will be and whether the intervention will be worse or better than the current treatment
  -The participants should not be subjected to ant disadvantage from being in the study
  -Studies can be stopped prematurely if the study is showing benefits or risks to being in the intervention group