Week 13 Review

Question 1

List Ethical Principles

Answer 1

• Respect for human dignity
• Respect for free and informed consent
• Respect for vulnerable persons
• Respect for privacy and confidentiality
• Respect for justice and inclusiveness
• Balancing harms and benefits
• Right to full disclosure
• Right to self-determination

Question 2

Tri-Council: 3 major government funding bodies

Answer 2

1. The Social Sciences and Humanities Research Council of Canada
2. The Canadian Institute of Health Research
3. The National Science and Engineering Council of Canada

Question 3

Tri-Council Core Principles

Answer 3

1. Respect for persons
2. Concern for welfare
3. Justice

Question 4

Respect for Persons

Answer 4

• Respect the intrinsic value of human beings
• Incorporates respecting autonomy and to protect those with developing, impaired or diminished autonomy
• Respecting autonomy in research – obtaining informed, voluntary, on-going consent
• Diminished autonomy: lack of freedom to act due to controlling influences or coercion

Question 5

Concern for Welfare

Answer 5

• Welfare is the consideration of the impact of the research on a persons physical, mental and spiritual health and well as their physical, economic and social circumstances
• Researchers promote welfare by informing participants of any foreseeable risks associated with the research. Allow participant to weigh potential benefits and risks to determine their participation

Question 6

Justice

Answer 6

• Refers to the obligation to treat people fairly and equitably
• Equity requires distributing the benefits and burdens of research participation in such a way that no segment of the population is unduly burdened by the harms of the research or denied benefits from it
• Participation includes inclusion criteria that is justified by the research question
• A threat to justice is the imbalance of power that may exist in the relationship between the researcher and participant

Question 7

Informed Consent

Answer 7

• Voluntary agreement of an individual who has the legal capacity to give consent
• Exercises free power of choice, without undue constraint or coercion to participate
• Have knowledge of the anticipated risks and potential benefits to make an informed decision

Question 8

Assent

Answer 8

• Willingness to participate in research by persons who are by definition too young to give informed consent but old enough to understand the proposed research
• Assent itself is not sufficient - Informed consent must be given by parents/guardians

Question 9

Critical Appraisal Guidelines: Questions to Consider

Answer 9

1. Was the study approved by an REB or other agency committee members?
2. Is there evidence that informed consent was obtained from all participants for their representatives? How was it obtained?
3. Were the participants protected from physical or emotional harm?
4. Were the participants or their representatives informed about the purpose and nature of the study?
5. Where the participants or their representatives informed about any potential risks that might result from participation in the study?
6. Was the research study designed to maximize the benefit(s) and minimize the risks to participants?
7. Were participants coerced or unduly influenced to participate in this study? Did they have the right to participate or withdraw without penalty? Were vulnerable participants used?
8. Were appropriate steps taken to safeguard the privacy of participants? How have data been kept anonymous or confidential?