week 5

Question 1

What is the main goal of research ethics?

Answer 1

to protect participants and promote good, responsible science.

Question 2

Why is ethics review required in Canada?

Answer 2

Funding depends on compliance with ethical standards

Question 3

What are the four consent principles?

Answer 3

Voluntary, informed, ongoing, and right to withdraw.

Question 4

What must researchers disclose?

Answer 4

Purpose, risks, benefits, and how data will be handled.

Question 5

What are the 3 key tensions in research ethics?

Answer 5

1. Balancing (scientific vs ethics)
2. international settings (should ethic guidlines be universal)
3. new practices and technologies

Question 6

When should ethics reflection happen?

Answer 6

Before, during, and after research.

Question 7

What was significant about the Prussian Guidelines?

Answer 7

First legal recognition of informed consent.

Question 8

Who was excluded from experiments under Richtlinien?

Answer 8

Children, dying persons, and those who could be replaced by animals.

Question 9

What were the two aims of the 1931 Richtlinien?

Answer 9

Protect subjects and encourage safe experimentation.

Question 10

Why was the Nuremberg Code created?

Answer 10

Response to WWII Nazi atrocities.

Question 11

What is its central principle? of the nuremberg code

Answer 11

voluntary consent of the human subject is absolutely essential

Question 12

What must be avoided according to the Nuremberg Code?

Answer 12

Unnecessary suffering, high risk without proportionate benefit. (no death or great injruy)

Question 13

What was Beecher’s main claim?

Answer 13

Misconduct stems from carelessness, not evil intent.

Question 14

What two safeguards did Beecher propose?

Answer 14

Informed consent and virtuous researchers.

Question 15

What did Beecher’s work lead to?

Answer 15

Institutional Review Boards (IRBs) and federal rules.

Question 16

What led to the Belmont Report?

Answer 16

national research act and US scandals like Tuskegee.

Question 17

What are the 3 Belmont principles?

Answer 17

Respect for persons, beneficence, and justice.

Question 18

What is TCPS2?

Answer 18

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2018).
- Canadian policy framework for research involving humans

Question 19

What are TCPS2’s 3 core principles?

Answer 19

Respect for persons, concern for welfare, and justice.

Question 20

Principle 1 – Respect for Persons

Q: What does this principle focus on?

Answer 20

Autonomy and voluntary, informed participation.

Question 21

What does ongoing consent mean?

Answer 21

Participants can withdraw anytime, especially if new info arises.

Question 22

Who needs extra protection? TCPS2 respect for persons

Answer 22

outh, cognitively impaired, and others with diminished autonomy.

Question 23

consent must be…

Answer 23

1. voluntary (no coercion)
2. informed (disclose risk, benefits, purpose)
3. ongoing

Question 24

consent may be ________ at any time

Answer 24

withdrawn

Question 25

Principle 2 – Concern for Welfare Q: What does concern for welfare assess?

Answer 25

Risks vs benefits for physical, mental, social, and spiritual wellbeing.

Question 26

what are examples of risks and benefits in concern for welfare?

Answer 26

risks: stigmatization, impact on employment, right to privacy benefits: greater understanding of self, treatment, aid etc

Question 27

Principle 3 – Justice Q: What does justice require?

Answer 27

Fair treatment and equal sharing of research burdens and benefits.

Question 28

for principle 3 justice: What should be avoided in recruitment?

Answer 28

Unfair exclusion or exploitation.

Question 29

What is an REB?

Answer 29

A committee ensuring research meets ethical standards.

Question 30

Who sits on an REB?

Answer 30

2 scientists, 1 ethicist, 1 community member, 1 non-scientist.

Question 31

What can an REB do?

Answer 31

Approve, reject, modify, or terminate research.

Question 32

What is proportionate review?

Answer 32

Higher-risk research = more rigorous review.

Question 33

REB Evaluation Guidelines Q: What must proposals include?

Answer 33

Researcher identity, risk minimization, consent, and privacy protection. (and inclusive recruitment of subjects) Conflicts of interest and how they’re managed.

Question 34

When can deception be used?

Answer 34

Only if necessary, with later debriefing.

Question 35

What types of research are exempt from REB?

Answer 35

Public data (StatCan, CBC), quality improvement studies (eg: is company computer satisfactory) , public observations (no interventions , anonymized data (no way to identify individuals)

Question 36

When does the exemption of REB end?

Answer 36

When data are reused for broader research.

Question 37

What are the 8 universal requirements for ethical research?

Answer 37

Social value Scientific validity Fair subject selection Favorable risk-benefit ratio Independent review Informed consent Respect for subjects Collaborative partnership

Question 38

What moral theories guide research ethics?

Answer 38

Deontology (duties), Utilitarianism (outcomes), Virtue ethics (character).

Question 39

What is the core moral value?

Answer 39

Respect for human dignity—people are never just “means.”