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)
Describe the function of the CCAC. [3]
Canadian Council on Animal Care
- Purpose is to act in the interests of people of Canada
- Ensure that use of animals, where necessary for research → teaching and testing employs optimal care according to scientific standards
- Promote an increased level of knowledge, awareness and sensitivity to relevant principles.
Describe ethics of animal research. [3]
- REPLACEMENT → avoid animal use or replace animals with another model
- REDUCTION → use fewer animals
- REFINEMENT → modify procedures to minimize distress and enhance welfare
All studies using animals must get ethics committee approval.
Describe an animal ethics review. [4]
Proposal must include:
- Proposal and merit of study
- Animal numbers
- All methods and protocols must consider 3 Rs (social interaction, environmental enrichment etc.)
- Monitoring of procedures: adverse effects of treatments, weight gain/loss
Describe animal research at UBC.
- UBC animal care committee
- Trained to all staff and students (must be completed before allowed entry)
- Site visits
- Standard operating procedure
- Ethics and protocols approval
- Trained to all staff and students (must be completed before allowed entry)
How do we determine which species is ‘best’ for a particular research question?
Which animals are commonly used in nutrition research?
- Considerations → doubling of birth weight
- 3D in chicks
- 7D in rats
- 14D in mice
- 20D in piglets and puppies
- 50D in kittens
- Commonly used:
- Rodents (mice, rats, including transgenic)
- Pigs
- Non-human primates
Describe rodents used in research. [15]
- Used in many basic studies, including nutrition studies.
- Most common = mice, rats, guinea pigs
- Fairly easy to maintain colonies
- Short reproductive period
- sequenced genomes (mice & rats)
- Nocturnal
- Nibblers → not ‘meal-eaters’
- Major lipoprotein = HDL (in humans it is LDL)
- Coprophagy (they eat their poop)
- No appendix or gallbladder
- Development:
- Multiparous
- Less developed at birth
- Very little fat (adipose) at birth
- Faster growth rate
- Rodent milk higher in fat and much higher in protein
Describe genetically engineered animals.
Spontaneous mutant (Ob/Ob → used as a model in obesity and diabetes research)
Transgenic: gain of function, knock-out, tissue specific knock-out
Describe how animal research can be a model of disease.
Ob/Ob mouse used in obesity and diabetes research
Used to study function of a particular gene
Important to be aware how the gene mutation affects organism (Is nutrient absorption/metabolism affected? Effects in organs?)
Describe pigs used in research. [5]
- More similar to humans than rodents:
- Digestive and gastrointestinal systems
- Lipid and lipoprotein metabolism
- Often used for studies in early development → bottle feeding / parental nutrition
- Pigs are multiparous, have a shorter gestation time than humans, and offspring grow rapidly.
Describe non-human primates in research.
Research is rare → most similar to humans
Describe animal research design.
Most animal research uses true experimental design (treatment & control group; randomized)
Treatment = manipulation of diet in nutrition studies
What is ad-libitum?
Food available at all times with the quantity and frequency of consumption being the free choice of the animal.
Describe the treatment in animal nutrition research. [5]
- Treatment = diet
- Different amounts of diet
- Ad-libitum, specific amount, caloric restriction
- Different diet composition
- Timing of feeding
- pair-feeding
What is pair feeding?
If treatment causes an increase or decrease in caloric intake (e.g., animals given alcohol tend to eat less); the difference in calories between groups could be a confounder
Solution → have ‘pair fed’ group that are given the same calories as treatment group, but no treatment (e.g., no alcohol)
Discuss experimental diets in animal research.
- CHOW → natural ingredient or standard diet (e.g., corn, oats)
- PURIFIED → each nutrient from a refined source (e.g., sucrose, starch, vitamins); enables more precise control of nutrient content
What are experimental diet considerations in animal studies? [3]
- Physiological or pharmacological dose of nutrients (e.g., fish oil and long chain n-3 fatty acids → AMDR 0.05-0.12% energy; some studies feed animals 20-50X AMDR
- Research animals typically fed same diets for each meal every day → enables good control of nutrient intake BUT translation to human?
- Hidden confounding → e.g., want to compare a high fat with low fat diet → problem: when the proportion of fat decreases, carbs and/or protein must increase (not only studying fat)
What are two other considerations regarding animal studies?
Minimize stress (minimize traffic through room, excess noise, handling)
Minimize distress (procedures to reduce discomfort)
Discuss sample size in animal studies. [3]
Smaller sample size required than in human studies (e.g., n = 6 may be sufficient for rodent study)
Animals are more homogenous (= genetically similar) than humans
Similar exposures (e.g., diet, housing, enrichment, etc.)
Discuss animal health and weight gain.
- Monitoring animal health is important for both animal welfare and study outcomes
- Proper weight gain important determinant of animal health
- For nutrition studies → differences in weight gain across groups could also be a confounder
BOTTOM LINE → weights should be reported in any nutrition animal study
Name 5 considerations for animal studies.
- Was the most appropriate animal model shown?
- Nutrient diet composition → relevant to human diets? do nutrients differ between groups?
- Was food intake / weight gain monitored?
- How does this relate to humans?
- What can we learn from this study?
Summarize the importance of animal research.
Animal research is important for helping us to understand mechanisms of nutrient action, BUT, remember animals are not humans → use caution in translating results from animal studies directly to humans.
What is qualitative research? [3]
Why is quantitative research not always sufficient?
Research that derives data from observations, interviews, or verbal interactions and focuses on the meaning of the participants.
A naturalistic approach that seeks to understand phenomena in uncontrolled, context-specific settings.
Helps to understand the how and why of human behaviours
Quantitative research → reduces results down to averages/means, however there is more going on! Goal → to define predictable relationships between variables that we can generalize to populations → but what about relationships be can’t describe through quantitative techniques? (e.g., human experience can’t be reduced down to a number)
What is qualitative research useful for?
Going deeper to understand complex issues
Generating new hypotheses/ideas/themes
What is mixed methods research?
Combines qualitative and quantitative methods to answer a research question.
Describe how a qualitative research question is set up.
Go in with exploratory mentality
The question or purpose of qualitative research is often more broad, recognizing that the researcher will learn as they gather data → research may be adaptive
Compare deductive and inductive reasoning.
Deductive: Theory → hypothesis → observation → confirmation
Inductive: Observation → pattern → tentative hypothesis → theory
Describe the planning phase of qualitative research.
Research question → broad / more of a ‘purpose’
Initial research setting, participants, data collection strategies
Describe the data collection phase of qualitative research. [4]
Continues until ‘saturation’ reached
Simultaneous sampling, data collection, and data analysis
Interpretation of data as they are collected
Development of new research questions
Describe data analysis and reporting in qualitative research. [3]
Researcher is much more involved than in quantitative research; more subjective
Answers to questions can differ among qualitative researchers
Research methods used and write-up styles will vary depending on the study design and researcher’s approach
What is ethnography?
The study of a social system, culture, social life, and activities of daily life, through observation.
What is grounded theory?
Systematic analysis of qualitative data with the aim of generating theories.
What is phenomenology?
Attempt to understand people’s emotions, attitudes, thoughts, meanings, perceptions, and bodily experiences as or after they have experienced a phenomena.
What is it like through their eyes?
Describe sampling in qualitative research. [6]
Non-probability → goal is not to generalize to the population → focused on in-depth info
Often (not always) smaller sample sizes than quantitative research
- Convenience → whoever can be found
- Snowball → participants identify others they know
- Purposive → choice selection of individuals (hand-picked for specific reason)
- Theoretical sampling → continue sampling until ‘nothing new’ is being heard (can be used in tandem with convenience, snowball, and purposive)
Describe data collection in qualitative research. [6]
- Participant observation → researcher (may embed themselves) as a participant in the group
- Individual interviews → open-ended (no planned questions); semi-structured (most common); structured (defined list of questions)
- Focus groups → small groups (e.g., up to ~8) → group dynamics
- Artifact collection → photographs or other objects
- Analysis of written documents
- Social media
Describe data analysis in qualitative research. [5]
- Systematic processes that transform many pages of raw data into new knowledge (= lots of work!)
- Involves iterative cycles of coding and analysis (describe/interpret new data)
- Conducted while data collection is still underway
- Generates concepts, themes, theories
- There is no one ‘right’ way of analyzing qualitative data → subjective technique!
How is validity and reliability assessed in qualitative research? [5]
- Trustworthiness / validity
- Triangulation → using other methods /sources to see if they lead to similar conclusions
- Respondent validation → analyze if data represents what was meant
- Comparison with quantitative findings
- Reflexivity → consider the role of the researcher in the collection
- Reliability → e.g., inter-rater
How is the quality of qualitative research assessed? [8]
- Are the research questions (purpose) clear?
- Are the research questions suited to qualitative inquiry?
- Are the following clearly described and appropriate to the research question?
- Sampling
- Data collection
- Analysis → approach can vary widely → transparency is key!
- Are the claims made supported by sufficient evidence? (e.g., direct quote from participant)
- Are the data, interpretations, and conclusions clearly integrated? (e.g., thought-process is well explained)
- Does the paper make a useful contribution?
Compare quantitative and qualitative research. [9]
-
QUANTITATIVE
- Deductive reasoning
- Testing of hypotheses and theories
- Conducted in controlled settings
- Large number of subjects
- Standardized numerical data collection
- Data gathered first, then analyzed
- Statistical analysis
- Explore outcomes due to treatments
- Often have lots of authors
-
QUALITATIVE
- Inductive reasoning
- Development of hypotheses and theories
- Conducted in natural settings
- Typically smaller number of targeted participants
- Textual, audio, and visual data collection.
- Simultaneous data gathering and analysis
- Content (textual, audio, visual) analysis
- Explore complex issues and interactions between humans, reasons for outcomes, and processes
Describe applications of qualitative research. [5]
- Decision-making process
- Sociocultural factors that influence nutrition-related behaviours
- Consumer and employee behaviour, attitudes, and perspectives in service
- Exploring unfamiliar cultures regarding their mores, traditions, and beliefs related to food and nutrition
- Theory → development and modification
What is survey research? [3]
Collection of information through a series of questions that are posed to subjects.
Typically cross-sectional (one time point); although may be used in many study types
Provides descriptive data and information to assess relationships between variables.
What are the four steps in survey research?
- Define objectives of survey
- Survey delivery method
- Identify/develop questions
- Pilot test and refine
How do we define objectives of a survey?
What is the purpose of doing the survey?
- Describe a population (e.g., vitamin supplementation in older adults)
- Assess relationships (e.g., determine whether vitamin supplementation is related to education level, income, etc.)
Describe survey delivery methods [4] and survey delivery method considerations. [3]
- Online
- Telephone → requires interviewer
- In-person → requires interviewer
- Consider:
- Cost
- Response rate
- Type of required info
What is the goal of developing survey questions?
To have reliable and valid questions that address the study objectives.
Give an example of an open and a closed ended question. What are closed-ended questions useful for?
Open → Why do you take vitamins?
Closed → The main reason I take vitamins is … (A, B, C, D) → useful for ease of response for participants, ease of coding for researcher, BUT may miss possible responses.
What is a Likert scale and how is it analyzed?
Responses provided on a scale (e.g., strongly disagree / disagree / neutral / agree / strongly agree)
Analysis → can create a summative score; need to be sure all questions ask about same underlying construct (i.e., relate to the same thing) → this may be tested by assessing internal reliability via split-half reliability or Cronbach’s alpha)
What’s wrong here?
‘I am in favour of changing FNH 398 grading scheme’
strongly agree / agree/ neutral / disagree / strongly disagree
Does not specify how grading will change → unclear
What’s wrong here?
‘When buying food, do you read the label?’
Yes / no
What label? Not all food even has a label! → unclear
What’s wrong here?
‘I am not concerned about not getting enough calcium in my diet’
strongly agree / agree / neutral / disagree / strongly disagree
Double negatives are confusing!
What’s wrong here?
‘ My diet’
a) Includes meat, fish, poultry, dairy, and eggs.
b) Includes dairy and eggs, but no meat, fish or poultry.
c) Does not include dairy, eggs, meat, fish, or poultry
Does not include all diets.
What’s wrong here?
‘How often do you refer to Canada’s Food Guide to Healthy Eating and the Dietary Reference Intakes (DRI) ?
a) Often
b) Sometimes
c) Never
Two items specified → can’t answer to both accurately unless the answer is the same for both
Response options are unclear → what is meant by ‘often’?
What’s wrong here?
‘I am comfortable with how fit my body appears to others’
Yes / No
Respondents tend to agree, so much include a positive and negative survey question.
‘When in a bathing suit, I often feel nervous about the shape of my body.’
Yes / No
Someone answering truthfully will have opposing answers.
What’s wrong here?
‘Given the importance of vitamin B12 for fetal development, do you agree that a B12 supplement should be recommended for pregnant women?
Yes / No
This is a leading question
What are the characteristics of good survey items? [6]
- Clear and unambiguous
- Straightforward (avoid double negatives)
- Considers all possibilities
- Asks only one thing
- When seeking opinions, include both positively and negatively worded items
- Avoids leading questions
How is survey research piloted and refined?
Determine reliability of the survey (test-retest / parallel forms / internal consistency / inter or intra rater (if interview is used))
Use an instrument or question that has been previously validated OR (better), validate the questionnaire before the study (face / content / criterion / construct)
What are some advantages of survey research? [3]
- Cheap and convenient
- Can survey a broad geographic area and large number of subjects
- Relatively inexpensive compared to other research methods
- May serve as a basis for hypothesis development and future research ideas.
What are limitations of survey research? [4]
- Non-response bias
- Interviewer bias
- Misreporting
- Poorly designed questions (may be misunderstood / might be asking the wrong thing)
What is non-response bias? [5]
Occurs when response rate to a survey is low.
Characteristics and opinions of responders may differ from non-responders
Generally responders are more interested in the topic and have higher socio-economic status
Results cannot be generalized with confidence to the population
Response rate matters! (e.g., 1000 responses from a sample of 5000 = 20% response rate versus 800 responses from a sample of 1000 = 80% response rate → 80% response rate is more trustworthy)
How can we avoid non-response bias? [7]
- Develop a good survey:
- Let respondents know why survey is important
- Interesting questions
- Easy to respond to
- Not too long
- Follow up (repeat mailings, telephone contacts)
- Incentives (e.g., Walmart receipt surveys → chance to win $1000)
What is interviewer bias? [2]
- In face-to-face or phone surveys → interviewer can subtly reinforce or discourage certain responses
- Interview training is crucial → neutralize questions; don’t bias participant
What is misreporting? [3]
- Social desirability
- Tendency to report the ‘right’ or ‘more acceptable’ response
- Underreporting intakes for example → more common in overweight/obese, physically active, and women vs. men
- In general, height is overestimated, and weight is underestimated
How do we address misreporting?
‘everybody lies’
- anonymity or confidentiality of responses → facilitate honesty
- in diet recalls → visual ads to estimate portion sizes; probe for ‘forgotten foods’
- When analyzing results → identify plausible reporters and see if conclusions change
What type of data is obtained in survey research?
- Descriptive statistics → mean/median nutrient intakes; proportions (e.g., % of people that answered ‘a’); prevalence/incidence of disease
- Assessing relationships → is ‘x’ associated with ‘y’?
Describe how variables may be expressed as continuous or categorical.
Age in years vs. youth/adult/elder
BMI in kg/m2 vs. underweight/normal/overweight
Fruit and veggie intake in servings/day vs. less than/meets/exceeds DRI
Give examples of two noteworthy nutrition surveys.
- Canadian Community Health Survey (CCHS)
- Annual survey of Canadians > 12 years old (random, representative sample)
- Collects info related to health status, health care utilization, and health determinants for the Canadian population
- In 2004 and 2015 nutrition was the specific focus
- National Health and Nutrition Examination Survey (NHANES) → USA
- Assesses the health and nutritional status of adults and children in the USA.
- Representative sample of US population → smaller sample size than CCHS
- Ongoing since the 1960s.
How is a statistical test chosen?
Independent → Dependent → statistical test
Categorical → Continuous → T-test (2 categories) / ANOVA (>2 categories)
Categorical → Categorical → Chi-squared
Continuous → Continuous → Correlation
