7. Ethics and Clinical Research

Question 1

Ethics definition

Answer 1

A branch of philosophy dealing with values pertaining to human conduct, considering the rightness and wrongness of actions

Question 2

Justice

Answer 2

fairness and equality

Question 3

Nonmaleficence

Answer 3

means to “do no harm” (The pertinent ethical issue is whether the benefits outweigh the burdens)

Question 4

Beneficence

Answer 4

action that is done for the benefit of others

Question 5

Non exploitation

Answer 5

we should not exploit one group for the benefit of others

Question 6

Autonomy

Answer 6

“self rule” - Physicians must respect a patient’s right to make decisions regarding his medical care.

Question 7

A Historical Events of Ethical Misconduct

Answer 7

Nazi physicians conducted experiments that resulted in about 200,00 deaths

Question 8

The Nuremberg Code

Answer 8

The voluntary consent of the human subject is absolutely essential

Question 9

The Nuremberg Code

Answer 9

The voluntary consent of the human subject is absolutely essential

Question 10

7 GUIDELINES IN A UNIFIED FRAMEWORK

Answer 10

1. Value
2. Scientific Validity
3. Fair subject selection
4. Favourable risk-benefit ratio
5. Independent Review
6. Informed consent
7. Respect

Question 11

Why must clinical research have VALUE?

Answer 11

• Fundamental reason #1:
  – Responsible use of finite resources
  – Doing all possible research diverts resources
  from other worthy pursuits
• Fundamental reason #2
  – Avoidance of exploitation

Question 12

Examples of research with no value

Answer 12

• research that will lead to ungeneralizable results
• Research with an already proven, trifling or trivial hypothesis
• Research in which the intervention could never be practically implemented, even if effective

Question 13

What is required for research to have scientific validity

Answer 13

research must be conducted with rigorous methods

Question 14

Clinical equipoise

Answer 14

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)

Question 15

Requirements for fair subject selection

Answer 15

• unbiased subject selection
• fair distribution of risk and benefits
• inclusion and exclusion criteria

Question 16

inclusion criteria

Answer 16

the factors that allow a person to participate in a study,

Question 17

exclusion criteria

Answer 17

are the factors that disqualify a person from participating

Question 18

Requirements for a study to have a favourable risk-benefit ratio (3 conditions)

Answer 18

A) the potential risks to individual subjects are minimized
B) the potential benefits to individual subjects are enhanced
C) the potential benefits to individual subjects and society are proportionate to the risks

Question 19

How to have a favourable risk-benefit ratio

Answer 19

• Avoid extraneous benefits
• Specify potential benefits

Question 20

Requirements for a study to be independently reviewed

Answer 20

Before a clinical trial can start (e.g. at a hospital or clinic), the principal investigator must submit a detailed application to the local REB for approval (to make sure that a researcher’s legitimate multiple interests do not affect the study design)

Question 21

Key Components to an REB application

Answer 21

Recruitment, consent, balancing risk vs. benefit, fairness/equity, conflicts of interest, and confidentiality

Question 22

REB

Answer 22

research ethics board

Question 23

IRB

Answer 23

Institutional review board

Question 24

What is required for a study to have informed consent

Answer 24

autonomy

Question 25

What does REB need to see to confirm that a study has a valid form of informed consent

Answer 25

• Consent is voluntary
• Consent is informed
• Consent is ongoing

Question 26

Consent form must haves

Answer 26

1) Contact info
2) Risks & benefits
3) Clearly defined purpose
4) Statement of confidentiality
5) Statement or voluntary consent
6) Summary and signatures
7) Updated version

Question 27

5 forms of respect in a study

Answer 27

1) Information privacy
2) Subjects can change their mind
3) New information during course of research
4) Welfare of subjects is monitored throughout
5) Subjects contributions should be recognized

Question 28

3 Requirements that are especially relevant to evaluate the ethics of this clinical trial:

Answer 28

1) Value
2) Scientific validity
3) Risk-benefit ratio

Question 29

Example of a study that had no value

Answer 29

• Existing anti-emetic (anti-vomiting) medications of the time: effective, but not completely effective