clinical research ethics

Question 1

ethics

Answer 1

• branch of philosophy dealing with values pertaining to human conduct
• rightness and wrongness
• what defines values, morals, obligations
• justice

Question 2

Nonmalefience

Answer 2

“do no harm”, physicians must refrain from proving ineffective treatments or acting with malice towards patients

Question 3

benefience

Answer 3

• action that is done to benefit others
• to prevent/remove harm or improve situation of others

Question 4

autonomy

Answer 4

• “self rule”
• physicians must respect a patient’s right to make decisions regarding his medical care

Question 5

goals of clinical research

Answer 5

• develop generalizable knowledge to improve health
• develop generalizable knowledge to increase understanding of human biology
• human subjects who participate in research are the means to obtaining generalizable knowledge

Question 6

ethical requirements for clinical research

Answer 6

• by placing some people at risk of harm for good of others, clinical research has the potential for exploitation of human subjects
• ethical requirements for clinical research ain to minimize the possibility of exploitation

Question 7

unified framework

Answer 7

• 7 requirements
• systemic framework for determining whether clinical research is ethical
• coherent framework for determining whether clinical research is ethical
• meant to be universal
• assume general ethical obligations
• not limited to a specific tragedy or scandal

Question 8

value

Answer 8

• clinical research must be valuable

clinical research can:
- evaluate an intervention that can lead to improvements in health or well-being
- be a preliminary study to develop such an intervention
- test a hypothesis about human biology

Question 9

scientific validity

Answer 9

• in order to be ethical, research must be conducted with rigorous methods
• research asking valuable questions can be designed poorly/conducted poorly
• results can be unreliable/invalid
• methods must be valid and appropriate
• methods must be practically feasible
• the research must have a clear scientific objective
• the research must be designed using accepted principles and practices
• the research must have sufficient (statistical) power to definitively test the objective
• a data analysis plan must be in place
• it must be possible to actually conduct the study

Question 10

fair subject selection

Answer 10

• the selection of subjects must be fair
• inclusion/exclusion criteria
• which communities/groups will be approached?
• the scientific goals of the study are the primary basis for deciding subjects

Question 11

favourable risk benefit ratio

Answer 11

3 conditions must be filled
- the potential risks to individual subjects are minimized
- the potential benefits to individual subjects are enhanced
- the potential benefits to individual subjects and society are proportionate to the risks

Question 12

Independent review

Answer 12

• study design and execution are reviewed by individuals unaffiliated with the research of the study
• required for social accountability
• ensures society people are being treated ethically

Question 13

what protects clinical participants

Answer 13

• research ethics boards (REB)
• safeguard the trial participants

Question 14

informed consent

Answer 14

purpose
- ensure that the participants control whether they enrol or not
-ensure participants only participate when the research is consistent with their values and preferences

• consent is voluntary
• consent is informed
• consent is ongoing

Question 15

respect

Answer 15

• individuals must continue to be treated with respect in trials

Question 16

how do you evaluate ethics in a clinical trial

Answer 16

• value
• scientific validity
• risk-benefit ratio