Chapter 3: Designing Ethical Research

Question 1

What are research ethics?

Answer 1

field of ethics focused on analyzing the ethical and legal questions pertaining to conducting research with human or animal participants

Question 2

What is the primary focus of research ethics?

Answer 2

to ensure that the interests and well-being of research participants are protected

Question 3

What are Canada’s Tri-Council Policy Statement’s three ethical principles when involving human participants?

Answer 3

1. respect for persons
2. concern for welfare
3. justice

Question 4

What is respect for persons?

Answer 4

researchers must respect participants’ autonomy and allow free and informed choice to participate in research

Question 5

What is concern for welfare?

Answer 5

researchers must, wherever possible, minimize the risk to participants

Question 6

What is justice?

Answer 6

researchers must treat individuals fairly and equitably, and should appeal to diverse range of people as research participants

Question 7

What are the different ways of designing studies around the three principles?

Answer 7

1. informed consent -> respect for persons
2. risk-benefit analysis -> concern for welfare
3. promoting equity in research -> justice

Question 8

What is informed consent?

Answer 8

potential research participants must be fully informed about all aspects of the study that may influence their decision to participate in advance of making this decision

Question 9

What does a complete consent form include?

Answer 9

• the purpose of the study
• the procedures of the study
• risks & benefits of participating
• how confidentiality will be protected
• voluntary nature of participation
• right to refuse and/or end participation without penalty

Question 10

When is it okay to not fully inform?

Answer 10

• purely observational research
• special populations
• research requiring deception

Question 11

When is research requiring deception okay?

Answer 11

if researcher believes the participants’ behaviour or responses would change if they knew the true goal of the study

Question 12

What is risk-benefits analysis?

Answer 12

the potential benefits of participating in the research are greater than the potential risks to participating in the research

Question 13

What are potential benefits to participants?

Answer 13

• direct (learning skill, treatment, reward)
• indirect (satisfaction with contributing to knowledge, helping others in future)

Question 14

What are potentials to society?

Answer 14

• knowledge gained may benefit other individuals or groups
• cost of not doing the research

Question 15

What are possible areas of risk?

Answer 15

• risk of physical harm
• risk of psychological stress
• risk of losing privacy and confidentiality (data must be kept confidential and anonymous wherever possible)

Question 16

What is promoting equity in research?

Answer 16

all individuals and groups have fair access to benefits of research and participation, and experience same level of potential risks

Question 17

How must research be reviewed?

Answer 17

by the Research Ethics Board

Question 18

What are Research Ethics Boards (REBS)?

Answer 18

committees of scientists, non-scientists and legal experts who review proposed studies’ procedures and deem them ethically acceptable or unacceptable

Question 19

How are studies submitted to REB review categorized?

Answer 19

• exempt
• minimal risk
• greater than minimal risk

Question 20

What counts as an exempt study?

Answer 20

• study poses no risk to participants (no review)
• e.g., purely observational studies, analysis of publicly available data, anonymous archival data, meta-analyses & literature reviews

Question 21

What counts as a minimal risk study?

Answer 21

• participants experience no more risk than in day to day life (individual REB member review)
• e.g., survey studies in competent adult samples

Question 22

What counts as a greater than minimal risk study?

Answer 22

• participants experience risk higher than day to day life (full REB review)
• e.g., survey study on sensitive topic, research with vulnerable populations

Question 23

What is the REB Review Process?

Answer 23

Apply
- researcher applies for ethics approval from REB
- REB assess application for risk & assigns review

Review
- REB member review ethics application
- REB communicates reviews and decision to researcher

Revise
- researcher responds to REB’s reviews
- process is iterative, continues until REB approves the study

Approve
- REB approval is granted, re-approval needed anually
- research may begin

Question 24

What are professional ethics researchers must practice?

Answer 24

• do not commit data fraud
• conduct ethical data analysis
• support publication reform (can replicate study)