Why do we need ethics policies in human research?
To protect human participants, prevent harm, ensure informed consent, and promote responsible, transparent research.
What was the Nuremberg Code created in response to?
War crimes and unethical human experimentation by physicians during WWII (Nuremberg Trials, 1946–47).
Why is the Nuremberg Code significant?
It established foundational bioethical principles requiring voluntary consent and protection of participants.
What was the Tuskegee Study?
A 40-year US Public Health Service study observing the “natural course” of untreated syphilis in Black men, without providing treatment.
What made the Tuskegee Study unethical?
Participants were misled, denied effective treatment (penicillin), harmed, and exploited.
When was the Tuskegee Study finally stopped, and how?
1972, after a whistleblower leaked the information to the New York Times.
What unethical nutrition experiments occurred in Canadian residential schools?
Children were denied vitamins, had milk rations reduced, and were used as subjects without consent; dental care was withheld for measurement.
What is the Tri-Council Policy Statement (TCPS2)?
Canada’s national ethical framework for research involving humans, developed by CIHR, NSERC, and SSHRC.
What is the purpose of the TCPS2?
To promote ethical conduct, protect human participants, and enhance accountability in research.
Basic Principles of Ethical Research
- Respect for Persons
- Concern for Welfare
- Justice
What is the principle of “Respect for Persons”?
It acknowledges participant autonomy and the right to make free, informed choices about participation.
What factors can reduce participant autonomy?
Lack of information, fear of consequences, pressure to participate.
What makes consent “free and voluntary”?
No coercion, no unreasonable incentives, no penalties for refusing or withdrawing.
What must informed consent include?
Nature of study, procedures, risks/benefits, confidentiality, voluntariness.
What is “decision-making capacity”?
Ability to understand study information, consequences, and make informed decisions.
What happens if a participant lacks capacity?
A third-party provides consent; research must be minimal-risk or offer demonstrable benefit.
Why is it unethical for an instructor to offer bonus marks + $100 for student participation?
It violates Respect for Persons by introducing undue influence and coercion.
What does “Concern for Welfare” mean?
Protecting participants’ physical, psychological, social, economic, and spiritual well-being
What types of harm must be considered?
Physical, psychological, social, economic.
What types of benefits may justify research?
Direct benefits to participants and indirect benefits to society/knowledge.
What does “minimal risk” mean?
Risk no greater than that encountered in everyday life.
What are researchers required to do regarding effective treatments?
Cannot withhold proven effective therapies from control groups.
What must researchers do when a treatment is found harmful?
Stop the intervention.
What is the requirement for confidentiality?
Maintain anonymity when possible, secure data, and collect only with permission.
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Importance of Research for Professional Practices8
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Finding the Evidence18
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Research Dissemination25
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Importance of Sampling22
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Measurement Reliability22
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Reliability Validity19
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Descriptive Statistics30
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Inferential Statistics Part 130
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Inferential Statistics Part 221
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Ethics36
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Qualitative Research39
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Cross Section + Survey Research30
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Case Control Studies26
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Cohort Studies16
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Animal Models in Human Nutrition15
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Experimental Design pt.117
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Experimental Design Pt.218
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Review Studies & Meta-Analysis19
