Lecture #26 - Ethics

Question 1

We should always have what when we do a clinical trial?

Answer 1

Equipoise

Clinical equipoise is the assumption that there is not one ‘better’ intervention present (for either the control or experimental group) during the design of a randomized controlled trial (RCT). A true state of equipoise exists when one has no good basis for a choice between two or more care options.

Question 2

In the case study 1 - Making a killing

1. The restriction of not being able to switch from allocated drug violated which ethical thing? Why?
2. What were the three ethical failures

Answer 2

1. Investigators should treat actual and potential study participants fairly both in relation to one another and in relation to similar placed non participants. This was because the subjects had fewer therapeutic options than they would have had outside the study

Question 3

How did the concept of research ethics come into existence; two histories:

1. A moral frame work…….
2. Violations of moral…….

History #1:

1. ______ _____ - 4th century BC
   - notion of what?
   - also talks about _____ confidentiality
2. Chinese and Great Physician Oath: 7th century
   - “thinking of _____” - put ____ in position of patient
   - This Hippocratic notion held until current times
3. Berlin Medical association 1928
   - Every doctor must keep what as his highest law?
   - Patient should be informed of _____ & _____ of particular therapeutic test (to do with _____)

History #2:

1. Nuremberg Code 1928
   - Developed following what?
   - Out of the 10 points, what was the first point about?

Answer 3

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Question 4

With the Tuskegee trial, according to the students what were the 7 ethical issues?

What were the 5 things wrong according to the lecturer?

Answer 4

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Question 5

The cervical cancer case study

1. What were the 4 ethical issues?
2. What role did the media play?

Answer 5

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Question 6

MMR vaccine case study

1. What were the three ethical failures there?

Answer 6

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Question 7

How do we prevent and stop unethical studies? (2)

Answer 7

0

Question 8

Codes and Guidelines

1. Two kinds - what are they?
2. NEAC guidelines - six parts - what are they?

Answer 8

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Question 9

What steps can we take to prevent unethical research?

Answer 9

• Ethics training in the education of researchers and professionals.
• Formal codes of practice and guidelines that must be adhered to by all
researchers.
• Researchers to formally consider ethical issues when designing studies.
• Research Ethics Committees to review all research for potential ethical issues in
studies involving people and/or animals.

Question 10

What are the ethical issues we need to consider when conducting research?

Answer 10

Respect: this includes respect for an individual’s autonomy and privacy, the necessity of obtaining informed consent from participants, and the right of participants to withdraw from a study at any time without personal penalty

Justice: to ensure there is a fair distribution of the benefits and burdens of participating in the study

Beneficence and non-maleficence: ‘Do no harm’; potential benefits should outweigh potential harms, and there must be genuine equipoise

Integrity: a commitment on the part of the researchers to conduct honest, thoughtful and rigorous research, and to accept responsibility for their actions

Diversity: that the investigators understand, respect and recognise the diversity among the participants/communities who participate in the research

Addressing conflicts of interest: this concerns many areas, including judgements regarding protecting the participants’ welfare vs. conducting a study with the highest possible internal validity (which may ultimately violate the rights of the participants), and being honest about the potential influence of secondary interests (e.g. industry sponsorship of research, personal/professional reputations, etc.)

Question 11

Why do we need to consider ethics when conducting research?

Answer 11

Ethics provides a moral framework for researchers to help guide their behaviour when working with study participants. The basis of ethical beliefs and behaviours goes back to the Greek physician Hippocrates (c. 460 – c. 370 BC), but was only formalised into official guidelines and codes of behaviour (The Nuremberg Code) for health research professionals after the appalling violations of basic human dignities during medical experiments conducted during World War II. Ethical guidelines help protect the rights of human and animal participants when conducting research.