Quiz 2 Content Flashcards
Describe the Nuremberg code and its principles.
Developed because of injustice by physicians towards inmates in concentration camps in Germany in WWII.
10 principles concerning:
- Voluntary consent
- Design based on sound evidence
- Minimizing risk to participants
- Willingness of participants and researchers to end the study if harm is observed
Describe the Tuskegee study. [4]
- 40 year long study done on African American males
- Observation of natural syphilis progression (long-term)
- Researchers did not give penicillin after it was shown to be an effective treatment (inhumane!)
- Birthed the 1979 Belmont report (ethical guiding principles)
Describe the 1979 Belmont report.
- Ethical guiding principles borne from the inhumanity of the Tuskegee study
- Respect for persons
- Beneficence
- Justice
Who sets ethical guidelines? [6]
- Federal bodies
- Provincial bodies
- International declarations (e.g., Declaration of Helsinki)
- Universities
- Professional associations
- Funding agencies (Tri-council policy statement)
What are the three councils in the tri-council?
CIHR (health research)
NSERC (nutrition science engineering research)
SSHRC (social sciences and humanities research)
What is the tri-council policy statement? [4]
- ‘Evolving’ document → established by 3 councils
- Intended to (1) promote high standards of ethical conduct, (2) advance the protection of human research participants and (3) enhance accountability.
Describe ‘respect for persons’. [6]
- Consider participant autonomy (includes informed consent)
- Participation should be voluntary, informed, and ongoing
- Consider factors that can diminish participant autonomy:
- Not enough info
- Fear of consequences from non-participation
- Pressure to participate (power relationships)
Describe consent. [9]
- Free (avoid incentives that are large enough to encourage recklessness, power relationships, and undue influence)
- Informed and ongoing → must provide info on:
- Nature of research
- Procedures of study
- Risks/benefits of study
- Confidentiality procedures
- Assurance of voluntary participation
- Investigator contact information
- Written consent forms must be included with ethics applications and written at accessible literacy level (~ grade 6 literacy)
Describe decision-making capacity.
What happens if the participant lacks the capacity to make informed decisions? [3]
Decision making capacity refers to the ability of participants to understand relevant information presented and to appreciate potential consequences of their participation.
Without capacity to make informed decisions (i.e., children):
- Involve participants to greatest extend
- Maintain consent from authorized 3rd parties
- Demonstrated benefits or minimal risk
Describe concern for welfare. [9]
- Aspects of welfare that researchers and regulatory ethical bodies need to consider include:
- Physical, mental, and spiritual health
- Physical, economic, and social circumstances
- Privacy and the control of personal information
- The treatment of human biological materials according to donor’s consent
- The possible affect of the research on the welfare of the participants’ friends, family, or other groups
- Therapies that are known to be effective cannot be withheld from control group
- Treatments that are found to be harmful must be discontinued
- Benefits must outweigh risks
- Privacy / confidentiality must be maintained
“Do no harm” (Hippocratic oath) → beneficence / non-maleficence
Discuss types of benefits and risks. [6]
How much risk is too much?
- Benefits
- Direct
- Indirect → e.g., advancement of knowledge
- Risks
- Physical harm
- Psychological harm
- Economic harm
- Social harm
Need to consider → probability and magnitude of risk
The proportionate approach → higher risk = higher level of scrutiny in review
Minimal risk = no more risk than participants would encounter in every day life.
“Do no harm” (Hippocratic oath) → beneficence / non-maleficence
Discuss types of benefits and risks. [6]
How much risk is too much?
- Benefits
- Direct
- Indirect → e.g., advancement of knowledge
- Risks
- Physical harm
- Psychological harm
- Economic harm
- Social harm
Need to consider → probability and magnitude of risk
The proportionate approach → higher risk = higher level of scrutiny in review
Minimal risk = no more risk than participants would encounter in every day life.
Describe the privacy / confidentiality aspect of ‘concern for welfare’. [3]
- Maintain anonymity
- Do not collect data without permission
- Store data properly
Describe justice. [3]
- Fairness → treating people with equal respect and concern for their welfare
- Equity → proportional distribution of benefits and burdens of research participation (compared to equality → equal distribution of benefits and burdens of research participation)
Describe appropriate inclusion / exclusion. [2]
- Should include all participants that might benefit from the research
- Must justify why participants are excluded from research studies.
What do researcher’s owe their participants?
- Research dissemination → findings disseminated to participants in a way they can understand
Describe research involving First Nations peoples of Canada, both historically and moving forward.
- Historically:
- Defined by non-indigenous researchers
- Research has not benefited Indigenous people
- Indigenous people are apprehensive of research
- Moving forward, must consider:
- Respect for persons → interconnection between humans and the natural world (includes obligations to maintain, and pass on to future generations, knowledge received from ancestors as well as innovations devised in the present generation)
- Concern for welfare → emphasis on collective welfare as a complement to individual well-being.
-
Justice → avoid abuses stemming from research such as:
- Misappropriation of sacred songs, stories, and artefacts
- Devaluing Indigenous people’s knowledge as primitive or superstitious
- Violation of community norms regarding use of human remains
- Failure to share data and resulting benefits
- Dissemination of information that has misrepresented or stigmatized entire communities
- Community engagement → establishes interaction between a research team and the Indigenous community → signifies intent to collaborate → communities may choose to actively engage, refuse engagement, or simply not object
Summarize the basic principles of ethical research. [3]
-
Respect for persons
- No coercion
- Informed consent
-
Concern for welfare
- Benefits must outweigh risks
- Do no harm
- Protect privacy
-
Justice
- Fairness and equity
- Appropriate inclusion / exclusion criteria
What is the purpose of a research ethics board (REB), and what is it comprised of?
- Assess the ethical acceptability of human research
- Independent committees established by the university, comprised of:
- Experts in relevant disciplines
- Ethics and law experts
- Community members with no affiliation to the university
Describe what is meant by ‘ethics in all aspects’. [5]
- Voluntary participation of subjects
- Ethical treatment of subjects
- Meaningful research
- Truthful data reporting
- Acknowledgement of conflicts of interest
Describe the ethics in research reporting. [8]
- The investigator must:
- Truthfully report and fully disclose methods of data collection and results
- Present data accurately, properly analyzed and responsibly interpreted
- Do not report results selectively
- Use appropriate statistical analysis
- Do not over-interpret results
- Cite material properly
- Disclosure of conflicts of interest
- Report potential CoI in any publication / presentation
- Sign and submit disclosure statement
Describe animal research in the hierarchy of evidence.
LOW → can’t place a lot of weight on animal research in terms of clinical decisions simply because animals are not humans
Describe alternatives to animal research.
- Human research → limited by samples available (blood, hair, cheek cells, urine), timeline (chronic diseases take years to develop), ethical considerations, and variability and compliance (differences in how humans respond to different diets; not everyone will comply with an intervention)
- In vitro/cell culture research → Cells studied in isolation; useful for understanding the effects of nutrients on specific tissues. However cells cannot be generalized to a whole organism → important effects are missed (e.g., digestion, absorption of nutrients, effects of hormones and behaviour)
Describe the utility of animal research. [4]
- Study effects of diets on whole organisms (access to tissues not available in human studies.
- Precise control of diet
- Multi-generational effects
- Better understanding of the mechanism of nutrient action (=mechanistic studies of nutrient action) → nutrient effects on metabolic pathways, gene expression
- Nutrient interactions
- Nutrition and disease
- Discovery of essential nutrients (e.g., thiamine → beri-beri in chickens fed polished rice; essential fatty acids → scaly skin and no growth in rats fed fat-free diet)