BIOTECHNOLOGY REGULATIONS EXAM
QUESTIONS AND THEIR EXPECTED
CORRECT ANSWERS
What are ethics?
The philosophical study of principles used in moral
decision making.
When comparing new drugs, we always compare to
what?
The best existing drug
True or False: An ethical reviewer has the
responsibility to comment on the science of a trial
they review
False, they are not allowed to comment on the science
The point of a clinical drug trial is to
Find a diff between a placebo and the drug
Should we test new drugs on pregnant woman?
Yes otherwise the drug won't be able to be used on them
True or False: If you want to sell the drug in Europe,
you have to do a trial on European people.
True
This amount of money is ethical to give to trial
participants
Zero
What are morals?
Morals are personal beliefs
,Are people usually accepting of change?
Generally no
True or False: Public morals change
True
Three main ethical decision models studied in class
Consequentialism, Deontological, Virtue Ethics
This ethical method is under Consequentialism
Utilitarianism
Does utilitarianism qualify or quantify?
Quantify
"The ___ justify the ____"
ends, means
This method looks at net benefits to all stakeholders
Utilitarianism
Utilitarianism is subject to this flaw
Bias in making benefit/cost analysis
True or False: The individual has the most power
under utilitarianism
False, they are grouped
This is also known as duty ethics
Deontological
Deontological approach focuses on these
principles which cannot be broken
Kant argues that deontological approach is not about
the means but the...
motive
Deontological ethics can fall into this pitfall
Paradoxes, subjective situations,
Virtue ethics describe this
Inherent personal traits that you know good from evil
,This ethical standpoint focuses on common sense
decision making
Virtue ethics
A common pitfall of virtue ethics
self-centred thinking, sometimes clashes with logic
The three pillars of ethical decision making
Get informed, consider risks, respect others
What do bioethics study?
The implications of biological research for social and moral
outcomes.
True or False: a technology needs to exist before it's
ethics can be discussed
False, theoretical questions are necessary
Testing on other mammals means a drug is safe for
humans?
No
True or False: All clinical trial data should be public
True, it helps other companies not do repeat studies.
Why might a company hide clinical trial data?
Make them look bad to investors, or others may steal data,
they used a lot of lab animals and don't want PETA getting
mad
Which is more specific: rules or principles?
Rules
Prima Facie means
All principles are equally important
The 4 major principles of bioethics
Autonomy, Non-maleficence, Beneficence, Justice
Which of the 4 major principles are under
consequentialism?
, Non-maleficence, beneficence (looking at outcomes, doing
the best one)
Elements of informed consent
Competence
Voluntariness
Disclosure
Recommendation
Understanding
Decision
Sometimes being fully informed would ruin the clinical
trial - how?
Telling them they're in the control group, or if it's a
psychological test and the participant knows what they're
looking for
Should drug addicts, who cannot make reasonable
decisions, be included in trials?
Yes, otherwise the drug can't be used on them
Forms of Non-autonomous
Drug addicts, children, patients with psychiatric conditions
True or False: Harm can be done through commission
only
False, can be done through omission
True or False: Subjecting patients to risks is ok if
nothing goes wrong
False
What is the diff between non-maleficence and
beneficence?
Non-maleficence is NOT doing bad, beneficence is
ACTIVELY doing good
Is beneficence the same as benevolence?
QUESTIONS AND THEIR EXPECTED
CORRECT ANSWERS
What are ethics?
The philosophical study of principles used in moral
decision making.
When comparing new drugs, we always compare to
what?
The best existing drug
True or False: An ethical reviewer has the
responsibility to comment on the science of a trial
they review
False, they are not allowed to comment on the science
The point of a clinical drug trial is to
Find a diff between a placebo and the drug
Should we test new drugs on pregnant woman?
Yes otherwise the drug won't be able to be used on them
True or False: If you want to sell the drug in Europe,
you have to do a trial on European people.
True
This amount of money is ethical to give to trial
participants
Zero
What are morals?
Morals are personal beliefs
,Are people usually accepting of change?
Generally no
True or False: Public morals change
True
Three main ethical decision models studied in class
Consequentialism, Deontological, Virtue Ethics
This ethical method is under Consequentialism
Utilitarianism
Does utilitarianism qualify or quantify?
Quantify
"The ___ justify the ____"
ends, means
This method looks at net benefits to all stakeholders
Utilitarianism
Utilitarianism is subject to this flaw
Bias in making benefit/cost analysis
True or False: The individual has the most power
under utilitarianism
False, they are grouped
This is also known as duty ethics
Deontological
Deontological approach focuses on these
principles which cannot be broken
Kant argues that deontological approach is not about
the means but the...
motive
Deontological ethics can fall into this pitfall
Paradoxes, subjective situations,
Virtue ethics describe this
Inherent personal traits that you know good from evil
,This ethical standpoint focuses on common sense
decision making
Virtue ethics
A common pitfall of virtue ethics
self-centred thinking, sometimes clashes with logic
The three pillars of ethical decision making
Get informed, consider risks, respect others
What do bioethics study?
The implications of biological research for social and moral
outcomes.
True or False: a technology needs to exist before it's
ethics can be discussed
False, theoretical questions are necessary
Testing on other mammals means a drug is safe for
humans?
No
True or False: All clinical trial data should be public
True, it helps other companies not do repeat studies.
Why might a company hide clinical trial data?
Make them look bad to investors, or others may steal data,
they used a lot of lab animals and don't want PETA getting
mad
Which is more specific: rules or principles?
Rules
Prima Facie means
All principles are equally important
The 4 major principles of bioethics
Autonomy, Non-maleficence, Beneficence, Justice
Which of the 4 major principles are under
consequentialism?
, Non-maleficence, beneficence (looking at outcomes, doing
the best one)
Elements of informed consent
Competence
Voluntariness
Disclosure
Recommendation
Understanding
Decision
Sometimes being fully informed would ruin the clinical
trial - how?
Telling them they're in the control group, or if it's a
psychological test and the participant knows what they're
looking for
Should drug addicts, who cannot make reasonable
decisions, be included in trials?
Yes, otherwise the drug can't be used on them
Forms of Non-autonomous
Drug addicts, children, patients with psychiatric conditions
True or False: Harm can be done through commission
only
False, can be done through omission
True or False: Subjecting patients to risks is ok if
nothing goes wrong
False
What is the diff between non-maleficence and
beneficence?
Non-maleficence is NOT doing bad, beneficence is
ACTIVELY doing good
Is beneficence the same as benevolence?
