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FSHN3100 Research Methods 2012

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CHRIS Scarlett

on 13 August 2013

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Transcript of FSHN3100 Research Methods 2012

Research Methods

Course Introduction
Experimental Design & Methodology
Literature Reviews:
Hypotheses and Aims

Scientific Writing for Publication
Health & Safety
How do we do research??
Presenting Scientific Data
Course Coordinator and Lecturer
Dr Chris Scarlett
Ph: 4348 4680
Room: SO E1.46
Consultation Hours: Upon appointment
Please check regularly
Course outline:
Assessment (Turnitin)
Policies on Plagiarism, Adverse circumstances, ……
Tutorial details
Lecture notes
Assessment Items
Discussion Forum
Other Resources
Blackboard Communication
Course Outline
Lecture notes available on Blackboard
Not a substitute for lecture attendance

Lectures Tuesday 11am-1pm [O_LT1]
Tutorials Tuesday 1pm-3pm [O_CS201]
Wednesday 3pm-5pm [O_CS207]
Material additional to the Blackboard notes will be delivered in lectures
and tutorials

Students who miss lectures/tutorials may not be able to satisfactorily
complete assessment items/exams and may fail the course

Students who experience timetable clashes should see the course coordinator
Summary of Tutorials
All assignments are to be handed into the assignment box FSHN3100 in the Science Offices
Attach an assessment cover sheet
Must tick the academic integrity box
All assessments must be attempted
Policies of lateness apply
General Information
Due date – 6th September 4pm
Weighting - 35%
1500-2000 words (excl. refs)
Turnitin Assignment
Identify a research question
involves human participants
More detail on Blackboard
Research Proposal/Literature Review
Clearly define your hypotheses & aims
Review the current literature on your topic
Structure & Organise
Provide justification/importance
Write in a formal scientific style
Include an accurate list of references in the APA reference style
Research Proposal/Literature Review
Will be open in week 6
Dates to be confirmed
Weighting - 5%
Questions will be a mixture of multiple choice and short answers
Questions will be related to the first 5 weeks of the course
On-line Quiz
Due date – 20th September 4pm
Weighting 20%
~1200 words
Turnitin Assignment
Design and describe the experimental methodology you would employ to address your hypothesis/hypotheses
Experimental Methodology
Restate your hypotheses & aims
Structure & Organise
Address all parts of the study
Think about what is feasible?
Correctly reference
More detail on Blackboard
Experimental Methodology
This will occur during the tutorial in week 8 – 16th Sept under exam conditions
Weighting - 15%
Write an abstract and propose a title for a given journal article, where the abstract & title have been removed
Refer to writing for publication lecture
Abstract writing
Due date - 15th October 9am
Weighting - 20%
Submit as a coloured A4 poster
Design a research poster based on your research proposal
Present results you may expect to see for your research proposal i.e. make them up!
More detail on Blackboard
Research Poster
Structure & organise carefully
Present your poster to the class
5mins (wks 10-12)
Critically evaluate each other’s posters
Refer to presenting data lectures
Be creative!
Research Poster
Will be open in week 12
Dates to be confirmed
Weighting 5%
Questions will be a mixture of multiple choice and short answers
Questions will be related to all lecture/tutorial material
On-line Quiz
Human/Animal Ethics
Publish Data!!
Conduct the experiments
Validate techniques, recording, collection, storage & analysis of data

Safety Clearance
Apply for money to conduct research
Design the methodology
Search the literature
Write a review

Natural order of events...
What is Science?
Identifying a research problem
Scientia (Latin - knowledge)
Scire (Latin – to know)

Different classifications of science
Empirical Science (aka. experimental science)
Knowledge is based on observed phenomenon
Validity can be tested by other researchers
Science – What is it? What does it mean??
Natural Science
Study of natural phenomena, including biological life
Social Science
Relationship between human behaviour and societies
Applied Science
Application of scientific research to specific human needs (Health Sciences/Sports Science/Food Science)
Relationship between society and tools & crafts (engineering, electronics, computer science……)
Empirical Science
Theories, laws (ie. Newton’s Law), models, suggested hypotheses (predictions that are testable by experiment or observations using scientific method), experimental design, pure mathematics, …….
Formal/Hard Science
Creative and systematic way of thinking
Need to have an organised thinking process
Asking and answering questions in an organised & logical manner
Like having a map, you need logic and organisation or you’ll get lost.
Acquiring knowledge based on scientific method
Searching peer reviewed literature
Methods of Scientific research include:
Generation of hypotheses
Experiments to test these hypotheses under controlled conditions
Publication of information/results for others to verify and build upon
A creative process based on curiousity
Questions that point to the existence of an unknown
Questions that lead to potential answers…….
Graziano and Raulin (1993) sum this up nicely:

“The essence of modern science is the way of thinking, the disciplined way in which questions are posed and answered in order to understand natural events. It is the logical processes and demands for evidence, not the technologies, that characterise science. It is an intellectual process.”
A curious development….

“Scientists exhibit a heightened level of curiosity….They go further and deeper into basic questions showing a passion for knowledge for its own sake.”

European Research Council, 2007
What is a Scientist?
Creative Tool Kit
They have to think outside the box and approach the problem from different angles
“must have a vivid imagination, for new ideas are not generated by deduction, but by an artistically creative imagination” Max Planck
 “This makes scientific abilities seem like part of a ‘tool kit’ that is not specific to science itself” ---- A PROCESS
Colin Allen
Scientists seek to understand various aspects of the natural world (and more..)
How do they do this?
Ask questions
Make observations
Manipulate conditions
Observe the effects of these manipulations
Develop explanations from the data
“The formulation of a problem is often more essential than its solution, which may be merely a matter of mathematical or experimental skill. To raise new questions, new possibilities, to regard old questions from a new angle, requires creative imagination and marks real advances in science.”
Albert Einstein

A. Einstein and L. Infield: The Evolution of Physics, 1938.
Identifying a Research Problem
Observe something that doesn’t seem to have a reason.
Want to know the reason for something that is unknown.
Observing something that doesn’t appear to fit an explanation.
A personal interest.
A gut feeling…….

Needs originality (relates to Literature Review/Research Proposal assessment item)
Identifying a Research Problem
Generate an idea. --- Easy in principal but where from??
Conclusions from your previous work
Recent articles and reviews
Discussion with colleagues
Attendance at scientific conferences (and lectures!)
Skimming through the databases and surfing the internet
Documentaries and interview programs
Newspapers and magazines
Personal interest
Where do you start??
First and most important step --- it identifies your direction and destination
The more specific and clear the better
This allows for a thorough, careful and critical evaluation.
Need to take into account:
Finances and resources at your disposal
Time available
Yours, and your Supervisor’s, expertise
Formulating a research problem
Existence questions
How long has the problem been around? Why does it occur?
Questions of description and classification
What types of problems occur?
Questions of composition
What is known about the problem?
Relationship questions
Is there an association between A and B? How is A associated with B?
Descriptive-comparative questions
Is method A comparable with method B?
Causality questions
How is the problem caused? How can it be fixed
What next? Generate Questions!
Determine the wider significance of the question.
What makes the question/s worth asking?
Needs justification.
What makes a good question?

Base your search on the concepts of your question.
Is there sufficient scientific knowledge, or adequate methodology developed to investigate the question?
From your search, and your own thinking, carefully conceptualise and phrase your research question/s.

You can now generate your hypothesis.
Where to start
Think about and choose your topic (human research)
Identify what you’d like to know
Generate questions
Think about the significance of the research
Scan the literature to ensure there’s enough information for you to write your literature review on your chosen topic.
This may evolve your questions/ideas.
For next week…..
Gender differences in health
Ethnic differences in health
How nutrients affect health
Health effects of food – animal protein, wholegrains, cholesterol containing foods, …..
Food/drink supplements – energy drinks
Food processing and nutrient bioavailability
Sports drinks and performance
Compression gear and performance/endurance
Comparison of strength/endurance training programs
Oral Presentations
Poster Presentations
Purpose of a literature review
What is a literature review?
Searching the literature
Selecting/Interpreting literature
Organisation & Structure of a lit review
Critical language
The Literature Assignment – Checklist & tips
To become confident & knowledgeable about a topic

To determine what level of understanding has been established on a topic

Identify gaps in existing knowledge

To identify strength & weaknesses

To refine & build upon work of those who have come before
Purpose of a Literature Review
It is usually part of a report, a thesis or a grant application
(even though you are doing this as a separate assignment)

An account of what has been published on a topic by accredited scholars and researchers
Identifies key researchers in the area

Provides a background to new research, &links new research to what precedes it.

Justifies the need to conduct new research
Identifies effective practice (current methodologies & theories)
What is a Literature Review?
Be related directly to the question/topic area
No unrelated content – need to be selective

Provide a summary of knowledge
What is/is not known

Organise facts into a coherent pattern (Needs structure)

Identify and explain relevant relationships between facts
Why is there a relationship?

Identify areas of controversy
Why does one group’s data differ from another?
Literature Reviews must:
Other things to include/consider
Identify shortfalls/limitations in the literature (errors in stats/sample numbers/methodology…)
Can this information be trusted – reliable source?
Formulate accurate and precise questions for further research
Literature Reviews must:
It should include an overview of significant research related to your topic, which is then evaluated to show the contribution of each, and to point out any shortcomings.
A catalogue of studies with a brief description of each:

“…in which everything merits a one paragraph entry…..
Bloggs (1975) found this. Smith (1976) found that. Jones (1977) found the other.”

Haywood and Wragg (1982)
Literature Reviews are not:
Define your topic (your assignment): now need to do lit review. But how/where do I start?
Identify your search words (to help search the literature)
Find relevant key words/alternate names/scientific names/word combinations/authors & experts in the field
Plan your research strategy
Where to search (where are you going to look??) http://www.newcastle.edu.au/service/library
Searching the Literature
Useful online databases:

PubMed (Biological & Life Sciences)

Foodnet Base (Food Industry Handbook)

SPORTDiscus (Full text from sports/sports medicine journals)
Searching the Literature
Plan your research strategy continued…
Time period
Choose a time period (eg. 2000 to the present)
Start with most recent (most up-to-date) and work back
Journal articles will reference most prominent/relevant papers from the past
If one paper keeps being referred to – look it up!

Keep records
Need to record/identify and store
Underline important points in articles
Write notes in margins/or separate notepad as you read.
Use referencing databases
Endnote (library; free for students)/Papers/etc…
Free workshops/demos through the library services (August 7 11-12.30pm)
Searching the Literature
Takes practice!
Read and evaluate the abstract
Check out previous reviews
Only use relevant material
What contribution has this material made to the development of your ideas/arguments?
Is it from a reputable source?
Has the material been peer reviewed?
Is the material still relevant/up-to-date?
Is the recent literature included?
Selecting the Literature
Develop a plan
Needs to logical and coherent
Divide into sections according to main points
Start with some questions you want to address

Categorise the literature
Put literature you collect into categories/files (piles?!
Eg. A group of papers on the background, another with refs that support your hypothesis, or go against your hypothesis, relevant methodology info, etc…

Use a numbering system to order information
Work on one section at a time
Organising the Literature
Example: Theme Bubbles

3 main components of the review:

Structuring the Literature Review
Title can be general
Wholegrain consumption and human health
Energy drinks and sport performance
Folate supplementation and human health


More specific
Think of examples
Should never be stated as a question
Does vitamin C prevent colds? (NO)
Megadoses of vitamin C prevents colds and flus (YES)
Megadoses of vitamin C acts as Pro-oxidant (YES)

Is hydrotherapy a good replacement for land-based therapy? (NO)
Hydrotherapy is more effective than land-based therapy for recovery following an injury (YES)
Should be a statement with an explanation following it
If X, then Y
States what the experimenter thinks will occur
The investigator must not know the outcome of the test
Accepted as a basis for further verification
Working Hypothesis
Accepted as likely to be true
Key elements:
The ability to explain observations
The power to predict outcomes of future experiments
Hypotheses cont.
Need to test the significance of your idea (But How??)

Hypotheses (null) – H0
There is no relationship between variables
Vitamin C does not prevent colds
There is no difference in recovery between hydrotherapy & land based therapy

Alternative Hypotheses – H1
The negation of the null hypothesis
Eg. Vitamin C prevents colds and flu
Eg. Hydrotherapy is more effective than land-based therapy for recovery following an injury

These two cannot be simultaneously true
Hypothesis Testing
Testing works by collecting data and measuring how probable the data is, assuming that H0 is true

We test to reject H0 in favour of H1
Until tested, H0 is accepted
H1 is the one we are trying to prove

Use statistics to determine how probable H0 is
A change in observation – a statistically significant change between when the drug/nutrient is administered.
How likely it is that the overall effect would be observed if no real relationship exists.
If the data is very improbable (observed less than 5% P<0.05) it is concluded that the H0 is false – rejection of H0
Hypothesis Testing
Think of hypotheses (null & alternative) related to this project:

“This project aims to investigate the relationship between the health of Australian children and their lifestyle”
Hypothesis Examples
Most important function of the introduction is to signal to the reader what you are intending to discus in your writing
‘Statement of intent’ - Aim
This can be placed at the beginning OR end of the introduction

Key words include:
investigate, examine, explore, determine
Include background/introductory information
Define the general topic, could include figures, history of disease/condition, etc…

Show/state why the topic is important, relevant and worth exploring (gives the reader a reason to read it!)
Address the significance of your topic
Gap in the literature/conflicts in theory/new perspective/recent media attention….

May give an indication of the structure of the review
Introduction cont.
Organise the body into paragraphs by themes
Common denominators/themes (conclusions of authors/comparisons/topics…)
Each paragraph should contain a topic sentence
A main idea
Eg. Despite the obvious benefits, there are still major concerns about the safety of genetically modified foods (Murray & Hughes, 2008).
Each paragraph should include several references
Evidence of support
End paragraphs by a concluding sentence
Try to link paragraphs
Body of Review
Provide some critical analysis
Shortcomings of the research/information (good/poor quality research?)
Positive aspects
Disagreements between authors
Summarise individual studies with as much or as little detail as each merits
Could include tables, figures, diagrams
Introduction and body should include definition, description, classification, cause-effect, comparison and contrast, argumentation
Body cont.
Summarise the findings in the literature in relation to your aim & hypotheses
What have you concluded? Do your hypotheses stand?
Identify limitations in the research
Methodology flaws, inconsistencies in theories/findings
Identify any gaps in the research
What is not yet known
Address implications and recommendations
Suggestions for further research/future direction
NO new information should appear in the conclusion
Throughout the review we use evidence to support our arguments so the role of referencing includes:
Acknowledging another person’s work
Gives credit where it is due
If not – plagiarism (BAD; check University Policy on Course Outline) – Easy to avoid.

Allowing the reader to find the same source of information

Providing a means by which readers can check sources of accuracy

Making it clear when you have used evidence to support your ideas
Referencing – Why?
Citing references in text
In a reference list or bibliography
All refs that appear in the text MUST be in the reference list
How? Be consistent.
Many different styles
APA, Harvard, Vancouver, Journal Specific…..
Referencing cont.
Using the direct words of an original source
Short quotation
Long quotation

Can be used for:
Definitions of key terms/concepts
Significant wording
Introduce your quote
X (2010) states that “blah blah blah….”
FSANZ’s Australian User Guide to Mandatory Folic Acid Fortification states “that all wheat flour for making bread, with the exception of flour represented as organic, must be fortified with folic acid from 13 September 2009” (FSANZ Standard 2.1.1 2009, p1)
Example of a Quote
An alternative way of portraying the ideas of others
Expresses the ideas using your own voice
Shows an understanding of the text

Make sure:
It flows smoothly and expresses the original idea accurately
The source is acknowledged
From September 2009, all wheat flour for making bread (except organic) is required to be fortified with 2-3mg of folic acid per kilogram of wheat flour, according to the Mandatory Folic Acid Fortification Standard (FSANZ Standard 2.1.1 2009)
Example of Paraphrasing
Sentence structure
Information focus
Just focuses on the information present

Author focus
Scarlett et al (2012) report that…….

Non specific author
A number of researchers have reported that……
(Taaffe, 2009, Dascombe 2010, Stathopolous et al 2010, Scarlett et al 2012)
Critical Language
Write clearly and concisely and create smooth-flowing text by combining sentences
Use transition words and phrases
(see Teaching and Learning document on Blackboard)

and, or, but, yet, so, for
although, because, if, unless, when, whereas
Critical Language
Type of vocabulary
saw observed
shows illustrates, indicates
so therefore, consequently
but however, nevertheless
people subjects, participants
big large, considerable, substantial
seems appears
important significant
Critical Language - Formality
Write in the third person
Don’t use “I”
I found that… (NO): It was found that…. (YES)
I found the results interesting because….(NO): The results were interesting because…. (YES).
I take this to mean….. (NO): This suggests that….. (YES)

Avoid informal language (slang words)

Do not use contracted forms
No it’s, they’re, don’t, etc…
Use gender-neutral language
Use transition words and phrases
Critical Language - Formality
Checklist and Tips (on Blackboard)
Assessed items
Hypotheses & Aims
Evidence of research & preparation
Originality & Justification
Structure of review
Knowledge, understanding & argument
Style, grammar & spelling
Your Assignment
Introduction to research design
Types of studies
Methodological, Epidemiological
Descriptive and Analytical
Influencing Factors
Study design, including:-
Lots of things to consider:
Sampling methods, recruitment strategies, power calculations, methodologies & data collection and data analysis, etc., etc…….
CRITICAL to the foundations of the project.
Extremely important when publishing in peer reviewed journals, applying for grants, ethics approval, etc.

Provides a frame work that holds the project together
Underpins the whole study

Gives structure to the research

Describes how to conduct the study and the methods used to collect and analyse data

Provides the reader with an idea of the validity of the data.
Research Design
Be linked directly to the specific aims & hypotheses

Be robust & flawless

Use the most reliable methods to collect the data
How do you know they are reliable? Evidenced based, peer reviewed papers?

Incorporate strategies to overcome problems of bias and confounding data.
Research Design should -
Be entirely feasible to conduct
Have adequate power
Use appropriate statistical methods
Ensure that the conclusions drawn will be justified by the data

Address any issues of feasibility
Eg. if small sample numbers, why?
Address ethical issues
Can it be done ethically? What harm will/may it cause? What about monitoring?
Consider budgets
Can it actually be done financially?
Research Design should -

The findings of a study are only as valid as the methodology used to produce them.

What do you think this actually means?
Used to establish the repeatability and/or the validity of new or existing pieces of equipment, questionnaires, medical instruments, protocols, ….
Key words: repeatability, validity, sensitivity, specificity, responsiveness

Used for measurement of estimates of incidence/prevalence, quantification of risk factors and effects of interventions.
2 main types:
Descriptive Studies – patterns/rates of disease
Analytical Studies – determinants of disease (risk factors)
Observational (non-experimental). These studies are designed to make comparisons between populations (case-control studies) over time (cohort studies).
Experimental (intervention). Establish the efficacy of a new treatment/therapy, etc.
Types of studies
Incidence: The number of new cases of disease in a population in a specified time period.
Prevalence: The proportion of a population who have a disease at any one time point.
Mortality: The proportion of the population that dies in a specific period.
Risk factors: The exposure factor that is associated with the injury or disease outcome.
Key Word Definitions
Quantitative: Studies in which data can be analysed using conventional statistical methods.
Qualitative: Studies in which information is provided from a participant’s perspective
Prospective: Data collected about a subject’s health status or exposures as the study progresses.
Retrospective: Data collected from the past either about health or exposures.
Key Word Definitions
Descriptive Studies
2 levels we need to consider:
Population-based studies
Form the basis of most governmental health analysis
Routine data analysis (mortality, incidence, hospital databases, …
Ecological studies – the strength of association at the population level between average risk factor exposure and the rate of disease occurrence.

Individual-based studies
Representative samples of defined populations
Cross-sectional studies – measure prevalence/burden of a disease in a community
Case series, case reports – more specific. A recording of interesting/unusual cases.
Descriptive Studies continued
Observational (non-experimental)
Involve observing exposure to a putative risk factor and a specific disease process:
Eg. smoking and lung cancer; poor technique and lower back pain, high calorie diet and cardiovascular disease, …….

The measurement of disease and the measure of exposure are very important issues

They are either case-control or cohort studies
Depends on timing of exposure (eg. 1-5 vs 20-40 years smoking)
Prospective or retrospective
Analytical Studies
Direction of inquiry

Exposed in the past

Never exposed
(never smoked)
Healthy volunteer
Eg. cancer
Exposed in the past

Never exposed
(never smoked)
Direction of inquiry

Develop Disease

Remain disease-free

Develop Disease

Remain disease-free
Comparison Overview
Case-Control Cohort
Description of the natural history of a disease in a population.

Hypotheses about causation and spread can be formulated.

Three basic questions of descriptive epidemiology:
Who? The person. Who get’s the disease? Who does it effect? Age, gender, race…….
Where? The place. Where does it occur? Geographical patterns/distribution and spread of the disease.
What? The time. When does it occur? Are rates increasing over time? Are they seasonal/variable?
Develop Disease

Remain disease-free

Exposed in the past

Never exposed
Exposed in the past

Never exposed
Direction of inquiry
Mainly a special case of a prospective cohort design
A group is identified (disease/injury free)
Exposures are measured in the present
Assigned to the subjects - intervention
Subjects are followed over time
Outcome is compared

Randomised controlled trial
The best interventional study
Cross-over, placebo, non-randomised,….
Analytical Studies
Experimental (Intervention)
Lost prior to follow-up

These studies evaluate the
The effect of treatment under ideal conditions in a research trial

Effect of treatment in routine clinical practice or in the community

Extent to which a new treatment is equivocal to an existing treatment

Relationship between the amount of resources needed to conduct a study and the results achieved.
……….of a treatment
Analytical Studies
Experimental (Intervention)
Sequences of studies for a new intervention
The association between exposure and outcome can be influenced by factors that are a direct result of the study design and the methods used.
Obesity, etc…
No exercise, etc…
True Association
Potential Influences

Random error - sampling error (maybe put a subject in the wrong group or measure something incorrectly – diagnose incorrectly)
Alternative explanations (factors associated with the outcome & the exposure being studied, but are not part of the causal pathway.
Influencing Factors
Selection bias
Sampling, non-response, self-selection, allocation, follow-up or withdrawal – inclusion and exclusion criteria
Intervention bias
Due to poor compliance, different treatment of groups.
Measurement bias
Observer or recorder – this is why we work blind/work with unidentified subjects, information, misclassification, recall or reporting
Analysis & Publication bias
Interpretation, assumption
Influencing Factors cont.
Simple, random, systematic, stratified, clustered
Convenience, quota, purposive, snowball
Extreme case, homogenous, maximum variation, opportunistic, typical

Need to carefully consider heavily researched groups & difficult-to-access groups

(These are some things you may want to consider for your next assignment).
Sampling Methods
Sample methods
Sample populations
Power calculations
Variables and constants
Methodologies & Data collection
Data Analysis


NB: used for any study, & as a guide for your experimental design assessment.
Study Design
Sample frame
Type of study – extensively covered (observational/interventional/cohort/case-control/pilot/….)
Selected population characteristics: Age, race, location, socio-considerations (occupation, income, education level, etc…)
How? Letter/questionnaires, in person, etc. CONSENT FORMS+ INFORMATION SHEETS
Where from? Electoral roll, clinics, sports clubs, gyms, ………
Who? – Need to think about Inclusion and exclusion criteria (age, gender, etc.)
How many? – Sample size

Consider selection bias, subject compliance, response rate, drop outs, cost of recruitment, feasibility
Sample Population
The power of a study is the chance of finding a statistically significant difference and therefore rejecting a false hypothesis
The chance that there will be a significant difference for cardiovascular risk between morbidly obese subjects and those that have a normal BMI

Power depends on the level at which a difference is regarded as statistically significant - probability
Usually set at 5% (0.05) or 1% (0.01)
Statistical Power and Probability
Can be used to calculate the minimum sample size required to accept the outcome of a statistical test with a particular level of power
Can either be done before (a priori) or after (post hoc) the data collection
In general a power of 0.08 (or 80%) is considered accurate (80% chance of seeing a difference between groups)
Requires searching the literature for statistical information or conducting pilot studies
Statistical Power Analysis
Depends on:
Clinical importance
Variability – spread of the measurements
Resource availability – efficiency
Subject availability – recruitment, drop outs
Statistical power – precision
Ethics – balancing sample size against burden to subjects
Sample Size
Are needed because we do not have access to an entire statistical population
Are a rough estimate of the minimum numbers needed in a study
An adequate sample size ensures a high chance of finding that a clinically important difference between groups is statistically significant
In general, the larger the sample size, the smaller the error tends to be and the greater the power. However, there comes a point when increasing the sample size causes problems.
Sample Size Calculations
Independent Variable
Factor that will change during your experiment
concentration, temperature, time, frequency, intensity, treatments
Dependent Variable
Factor that you predict will change as a result of the variation in your independent variable
Factors that do not change
Variables and Constants
Methodology describes how you would conduct the experiment to then be able to collect the relevant data for analysis

It is usual practice to reference other researchers methodologies

Point out any limitations of the methodology

Consider cost and ethical issues
Methodology & Data collection
Sample methodologies & data collection
It is vital that the correct statistical analyses are used so that the results can be interpreted accurately and correctly
Statistical analysis include: (discussed in week 4)
Univariate methods
Bivariate methods
Mulitvariate methods
Once the data has been analysed it needs to be interpreted so that conclusions can be drawn
Lastly the findings are published
Data Analysis
A checklist will be posted on Blackboard

Assessed Items
Relevance to aims and hypotheses
Identification of type of study
Design & details of experiment
Structure & Organisation
Feasibility & Justification
Style, grammar & spelling
Your Assessment
Develop Disease
Remain Disease-free
Potential Influences
Understand what ethics is, why worry about research ethics?
The History
The National Statement
Understand who needs to apply for ethics approval
How to apply for ethics approval
Participant’s Rights
Beyond data collection
Discuss some challenging ethical issues in human research
A set of moral principles or values

Underpins all aspects of life

More than analysing right and wrong

In the context of research it is the moral obligation to uphold the highest standards of research practice, research conduct and intellectual honesty

Without ethical approval, there is no research!!
What is Ethics?
Meta-, descriptive-, normative-, applied ethics:
The “meaning” of ethical judgements. The study of what ethics and theories actually refer to. “What does right even mean?”
Descriptive ethics
The study of people’s beliefs about morality. Observations of actual choices made by moral agents in practice. “What do people think is right?”
Normative ethics
Studies of ethical theories that prescribe how people ought to act. What people should believe to be right and wrong. “How people should act.”
Types of Ethics
A discipline of philosophy that attempts to apply ethical theory to real-life situations
Identifies morally correct course of action in various fields of human life.
How we take moral knowledge and put it into practice.

Used in some aspect of determining public policies.
Eg. Is pregnancy termination immoral? Is euthanasia immoral? What are human rights, and how do we determine them? Do animals have rights too?.......
Applied Ethics
Human rights
Gender ethics, racism, sexism, …
Animal rights
(next week)
Business ethics
Financial, HR, production, ……
Environmental ethics
Duties towards environment, Global warming, ….
Sports ethics
Performance enhancing agents, etc.
Media ethics
Reporting the truth
International ethics
Responsibilities over poorer nations, …

Research Ethics
Areas of Applied Ethics
Principles involving Scientific Research
Design and implementation
Need to design methodology carefully
Data collection & storage
Secure, de-identified, backed-up
Academic scandal
Scientific misconduct, eg. Plagiarism, fabrication of data, IP
Research training, supervision, H&S

Not only protects the subjects but also the individual researcher & employing body
Research Ethics
Ethical Resistance
‘not the attempt to use power against itself, or to mobilise sectors of the population to exert their political power; the ethical resistance is instead the resistance of the powerless’
Philosopher, David Couzens Hoy, 2004

Where there are the powerless, ethical action will remain
The unborn
The aged
The terminally ill
The insane
Applied Ethics continued
In 1796, Edward Jenner tested his smallpox inoculation theory
He did not get ethical approval for his inoculation research….yet it led to the eradication of smallpox
There are ongoing debates about risks and benefits of research…do you think Jenner’s research was justified?
History – Blatant Abuses
“The voluntary consent of the human participant is absolutely essential”
Prior to 1906 there were no regulations regarding the ethical use of human participants in research
In 1946, a change in history occurred - Nuremberg Trial began
Horrific experimentation by German doctors on concentration camp prisoners (most died or disfigured) without consent during WWII
This led to the Nuremberg Code
The 20th Century
The first ethical guideline for conduct of research
10 Principles
Voluntary informed consent
Likelihood of some good resulting
Based on prior research (animal models)
Avoidance of physical or psychological injury or harm
Benefits should outweigh risks
Proper experience of researcher, proper facilities
Right to withdraw consent
Research must stop if harm is resulting
The Nuremberg Code - 1947
World Medical Association; revised 1975, 1983, 1989, 1996, 2000
Basis for good clinical practice, and defines rules for:
Research combined with clinical care
Therapeutic vs. non-therapeutic research
Led to establishment of ethics committees to oversee research
Trend towards requirement that research not be published without ethics approval
Many countries adopted principles of both Nuremburg and Helsinki in their own legislation
Declaration of Helsinki - 1964
Issues addressed:
Research with humans should be based on results from laboratory and animal experimentation.
Research protocols should be reviewed by an independent committee prior to initiation.
Informed consent from research participants in necessary.
Research should be conducted by medically/scientifically qualified individuals.
Risk should not exceed benefits.
Declaration of Helsinki - 1964
Thalidomide (1950s)
Used as a sedative in Europe (not approved by US FDA)
During pregnancy caused deformities in the foetus
Led to amendments of the Food, Drug & Cosmetic Act

Tuskegee Syphilis Study (1932-1973)
Participants were not told about their disease (even when a cure (penicillin) became available in the 1950s)
Participants were denied treatment, many died
Political embracement lead to an apology (1997, Clinton)
Other Unethical Research
Individuals can be harmed

The researcher’s reputation for integrity is harmed

The employing body’s reputation is harmed

Public trust in science and scientists is harmed
Consequences of unethical practices in research
National Statement on Ethical Conduct in Human Research (2007).
Developed by:
National Health and Medical Research Council (NHMRC)
Australian Research Council (ARC)
Australian Vice-Chancellor’s Committee (AVCC)
MUST BE ADHERED TO if you conduct research that is funded, or takes place under the auspices of these bodies

National Statement on Ethical Conduct in Human Research 2007

There is also a document on that site “What is new in the National Statement…”
Human Research Ethics in Australia

“’Ethical conduct’ is more than simply doing the right thing. It involves acting in the right spirit, out of an abiding respect and concern for one’s fellow creatures. The National Statement in ‘ethical conduct in human research’ is therefore oriented to something more fundamental than ethical "do’s" and "don'ts" - namely, an ethos that should permeate the way those engaged in human research approach all that they do in their research.”
The National Statement
Composed of 5 sections
Values and principles of ethical conduct
Themes in research ethics
Ethical considerations specific to research methods or fields
Ethical considerations specific to participants
Process of research governance and ethical review
Institutional responsibilities
Responsibilities of HRECs, other review bodies and researchers
Minimising duplication
Conflicts of interest
Handling complaints
Monitoring approved research
The National Statement continued
3.1 Qualitative methods
3.2 Databanks
3.3 Interventions and therapies
3.4 Human tissue samples
3.5 Human genetics
3.6 Human stem cells
National Statement –
Specific to Research Methods
4.1 Women who are pregnant & the foetus
4.2 Children and young people
4.3 People in dependent/unequal relationships
4.4 People dependent on medical care unable to give consent
4.5 People with cognitive impairment, mental illness
4.6 People who may be involved in illegal activities
4.7 Aboriginal & Torres Strait Islander Peoples
4.8 People in other countries
National Statement –
Specific to Participants
It is organised around four values:
Research merit and integrity



Respect for human beings
The National Statement continued
Human research is “research which is conducted with or about people, or their data or tissue” (p.3)

Any staff member or research student wishing to conduct any research involving:
Human participants
Human tissue
Personal records, or unpublished human research; must obtain ethics approval before the research commences

Institutions that receive Australian Govt research funding must have a Human Research Ethics Committee (HREC) to review and approve human research before it commences
Who Needs to Apply for Human Ethics Clearance?
Those on whom experiments are conducted
Undergoing psychological, physiological, medical testing
Those whose body organs, tissues or fluids are obtained and/or retained for research
Blood, saliva, skin, hair, bones, tumour (other biopsy) & even exhaled breath.
Those from whom information is obtained
Observation. Interview, focus groups, questionnaires, phone
Those who might be identified in official documents
Employment, medical, student, police records, court documents
Those whose information (identified or de-identified) is part of an existing, unpublished source
A researcher wishing to use all, or part, of an existing unpublished database obtained by another researcher for a different project
Types of Human Participants in Human Research
An agreement exists whereby decisions of HREC of one institution will be accepted by the other.

All staff & students of UoN planning to conduct human research requiring an ethics approval, or external researchers conducting human research at UoN, MUST obtain ethics approval from Uni Human Research Ethics Committee (HREC) BEFORE research can commence
University of Newcastle & HNEH
HNEH (Hunter New England Health)
Human Research – HNEHREC

HNEHREC will take lead if:
Staff, clients or patients of HNEH will be recruited as participants in the research
Records held by HNEH will be accessed
Human tissue samples held by HNEH will be accessed
If staff or student of Uni, must then register approval from HNEHREC with Uni committee
University of Newcastle
Human research - UoN HREC

UoN HREC will take lead if:
The involvement of HNEH is restricted to Uni staff or students accessing facilities, services or equipment in HNEH
No patients, clients or staff of HNEH will be participants in the research

e.g. The use of medical imaging or pathology services
Making an Application
Level of review = potential risk to participants
L1 – no appreciable risk – reviewed by Chair or Deputy Chair
L2 – low manageable risk – expedited HREC review panel
L3 – potential for significant risk – full HREC review (NEAF)
University Process is Governed by Level of Risk
Application Forms – L3 NEAF
Conditional Approval
Decision Pending
HREC Decisions Jan-June 2007
Reasons for Conditional Approval
& Deferments
Applications that are poor and don’t get through are:—
Don’t address important relevant ethical issues eg. privacy
Written without reference to National Statement and Guidelines
Omit questions
Provide superficial responses or insufficient information
Poorly written participant information letters
Applications - What to avoid doing
Explain WHAT you want to do clearly, logically, briefly and simply

Explain WHY in the same way. Having clear objectives and research questions is essential

Explain the PROCESS of what you intend to do in detail

Show HOW you are going to address the key issues of:
Balancing benefits and harms
Protection of participants from harm/risk
Applications - Make sure you…
Carefully consider potential risks to individuals
Harm from injury, emotional distress, loss of self-esteem, embarrassment…..

Small probability of risk does not equal “not significant”

Could be a whole range of potential harm/risks ranging from physical to psychological, and includes loss of privacy

Have to take into account participant vulnerability
Benefits & Risk
Fully informed & on-going consent
Participants MUST understand what you tell them about the study.
Participants MUST understand the purpose, methods, demands, risks, discomforts of the project.
MUST provide an information sheet for the participant – lay description

Un-coerced without inducement (time to consider)
Consider power relationships
Conflict of interest
Recruitment & Consent
To anonymity and confidentiality
Data stored safely/securely
If participant withdraws, MUST destroy material/data
Keep identity of participant private, not be personally identifiable to data

To protection from embarrassment, discomfort, pain, and from (lasting) harm

Assurance that research will be stopped if evidence of harm becomes apparent

Assurance that the wellbeing of the person takes precedence over the researcher’s need to know


To be treated with dignity, respect and sensitivity


To complain

Be involved

Access findings
Participants’ Rights
Genetic testing can be of great use in determining disease and possible risk factors

However, there has always been questions asked about its use

Modern technology is set to launch genetic testing into everyone’s life

Has huge implications in many aspects of our life

Examples of Ethical Issues:
Genetic Testing
The process of analysis involves decisions about:
Which data to use and what not to use
Interpretation of data and notes
Storage of the findings
The reporting of results
If the results will be shared with the participants
Beyond data collection
Reduce anxiety


To make informed lifestyle choices
Risk factor reduction, future planning

Risk of passing on genetic defects to offspring

Make decisions regarding medical treatments
Genetic Testing – Argument “For”
Prefer not to know
May affect health / other insurance
May affect employment options
May influence social prejudice
Religious beliefs
No cure or intervention for disease
Genetic Testing – Argument “Against”
HGP 2003, To identify all genes in human DNA, store sequences in secure databases, improve tools for data analysis, address ethical, legal, social issues that arise (~US$3 billion).
Need to consider:
Fairness in the use of genetic information
Who will have access and how will it be used?
?Insurers, employers, courts, schools, military, etc. ???

Privacy and confidentiality of genetic information
Who owns and controls genetic information?
Human Genome Project
Ethical, Legal and Social Implications
Psychological impact and stigmatization due to an individual's genetic differences
How does personal genetic information affect an individual and societies perceptions of that individual?
How does this information affect members of minority communities?

Reproductive issues including adequate informed consent for complex and potentially controversial procedures, use of genetic information in reproductive decision making, and reproductive rights
Do healthcare personnel properly counsel parents about risks/limitations on genetic technology?
How reliable/useful is foetal genetic testing?
What are the larger societal issues raised by new reproductive technologies?
Ethical, Legal and Social Implications
Clinical issues including education of doctors, health carers & patients on genetic capabilities, scientific limitations & social risks
How will genetic tests be evaluated and regulated for accuracy, reliability and utility?
How to we prepare healthcare professionals for the new genetics? Paradigm shift.
How do prepare the public to make informed choices?

Conceptual and philosophical implications regarding human responsibility, free will vs. genetic determinism, and concepts of health and disease
Do people’s genes make them behave in a particular way?
Can people always control their behaviour?
What is considered acceptable diversity?
Ethical, Legal and Social Implications
Johns, Zeps, Chantrill, Gill, Chang, Scarlett, Grimmond & Biankin, Pancreas, 40(8):1308-1366 2011
Returning Genetic Research Results to Individuals: The International Cancer Genome Consortium Experience
Disclosure of individual research results to participants has emerged as a complex and contentious issue.
Approaches and practices of research investigators, funding bodies and human research ethics committees are diverse.
The development and approval of ethically justified policies regarding the disclosure of results is important as genetic research is increasingly prevalent, and the focus has shifted from studying rare diseases to determining the role of genetics in common disorders such as cancer.
The Australian Pancreatic Cancer Genome Initiative (APGI) has employed a result-evaluation approach to returning results, which assesses the information and the context of the study in order to decide if results should be offered.
Using this approach the analytical validity and clinical utility of results are considered and help determine what information is disclosed, at what time point and to whom.
Another example:
International Cancer Genome Consortium (ICGC)
Reprogenetics – “designer babies”

Genetic Engineering

What are the social consequences?
Differ widely between societies/cultures, …

What does the future hold?
Other Examples
Legislation – general principles
The Animal Care and Ethics Committee
Responsibilities of researchers
What if something goes wrong
Special issues for students and junior researchers
Application forms – Quick overview
Monitoring & End points
Animal production for food
Companion animals
Animals used in sport & recreation
Animals used in entertainment & exhibition
Feral animals & pests
Animals used for work & education
Wildlife, laboratory & zoo animals
Scientific purposes
Legislation in Australia - animal welfare
State or Territory based legislation
May or may not be combined with legislation governing prevention of cruelty to animals
“Australian code of practice for the care and use of animals for scientific purposes”
Enacted under ALL State and Territory legislation.
NSW Animal Research Act (1985)
NSW Animal Research Regulation (2005)
Australian Code of Practice for the care and use of animals for scientific purposes (2004)
Animal research legislation in Australia
What is an “animal”
Vertebrate (excluding human beings)
Higher-order invertebrates (Cephalopods such as octopus and squid)
Covers embryonic and fetal forms
NSW: Animals must be obtained from a licensed animal supplier, with some exceptions

What is “research”
broad definition – any intervention in which an animal is used
some grey areas and dichotomies
AEC – Scientific Purpose
Definitions: “Animal” “Research”
Response to community concerns regarding animal research
Ensures animal research is humane, considerate, responsible and justified
Provides framework for actions
Unapproved research – prosecution under “Animal Research Act” and “Prevention of Cruelty to Animals Act” (POCTAA)
Research conducted in accordance with legislation
protection against undue criticism.
Legislation – Why is it there?
Section 1: General principles
Section 2: Responsibilities of Institutions and their ACECs
Section 3: Responsibilities of investigators and teachers
Section 4: Acquisition and care of animals
Section 5: Wildlife studies
Section 6: The use of animals in teaching
The Australian Code of Practice
“Emphasises the responsibilities of all those involved in the care and use of animals.”

“This embraces a duty of care that demands a genuine commitment to the welfare of the animals, a respect for the contribution the animals make to research and teaching and a desire to promote the animals’ wellbeing.”
General principles
Essential and justified on scientific or educational grounds
Approved by an Animal Ethics Committee
Performed by licensed person or organisation
Performed according to the principles of the 3 R’s
Conducted as if animals feel pain in a manner similar to humans
Animal research must be:
Replacement of animals with other methods

Reduction in the number of animals used

Refinement of techniques and procedures to minimise adverse impact on animals
General Principle: The 3 R’s
“Pain and distress cannot be easily evaluated in animals.”

“Investigators must assume that animals experience pain in a manner similar to humans unless there is evidence to the contrary.”

“Decisions regarding the animal’s welfare must be based on this assumption.”
General principle related to pain & distress
What is the ACEC?
Primary responsibility: “Ensure that all care and use of animals is conducted in compliance with the Code”

“Applies a set of principles, outlined in the legislation, that govern the ethical conduct of people whose work involves the use of animals”

Role – “to ensure that the use of animals is justified, provides for the welfare of those animals and incorporates the principles of Replacement, Reduction and Refinement”
What does the ACEC do?
Considers applications to use animals for research or teaching purposes
Monitors approved projects
Inspects the animal facilities
Monitors acquisition, production and supply of animals
Conduct surveillance visits
Takes action if problems detected
Considers complaints or concerns regarding animal use
Provides reports, recommendations & consultation
What does the ACEC do? (continued)
Category A – Veterinarian (2)
Category B – Researcher (4)
Category C - Animal Welfare (2)
Category D – Independent (6)
Chairperson - Senior position (non-animal researcher)
Animal Technicians
Animal Welfare Officer
Balance of membership
Who is on the ACEC?
Personal responsibility for all matters related to the welfare of their animals
Begin at the allocation of animal to project
End at the time of disposal of animal

“This embraces a duty of care that demands a genuine commitment to the welfare of the animals, a respect for the contribution the animals make to research and teaching and a desire to promote the animals’ wellbeing.”
Responsibilities as Researchers
Conduct project in accordance with legislation

Maintain records of the use and monitoring of animals

Be competent
Responsibilities as Researchers (continued)
Aims to provide underpinning knowledge and practical skills to researchers & teachers

Provided by:
Animal Welfare Officer, Veterinary Manager, Animal Services Unit
Consists of 6 modules
The Training Program – RATS!
Institutions must establish an Animal Ethics Committee
Some institutions, including University of Newcastle: Animal Care and Ethics Committee
Implements the legislation at a local level
The University of Newcastle ACEC
Committee of the University Council
Not a “University” Committee
Alleviation of pain or distress “must take precedence over completing a project”

Autopsy “should be performed when animals die unexpectedly or is euthanased due to unforeseen circumstances”

Prompt notification to ACEC “of any unexpected or adverse or unexpected effects that impact on animal wellbeing”
What if something goes wrong?
Before being engaged in animal-based research, clarify own ethical position
Ensure Chief Investigator or supervisor knows all that is to be/is being done
Ensure the approved protocol, correspondence from the ACEC and Animal Research Authority is read
Training and/or supervision
Issues for researchers…
Three important points:
Write application to provide ACEC with information so that they can defend your project to the “average person in the street”

The approved protocol is an agreement between the researcher and the ACEC about what is going to happen

Bottom line in all the paperwork - The animal!
Application Forms
What does the ACEC really want?
Why you are doing it (Justification)
Why animals? (Replacement)
Why so many animals? (Reduction)
What you are doing? (Refinement)
Welfare of animals
potential effects on the animals and how these are minimised and managed (Refinement)
Principle areas of applications
Unrelieved pain and distress including where planned endpoints will allow for severe adverse effect to occur

Death as the end point

Reuse of animals

Prolonged restraint or confinement
Examples of situations where ethical issues must be addressed:
Pain, suffering or distress where anaesthesia or analgesia cannot be used because of the possible effects on experimental outcomes

Genetically modified animals where the modification is likely to cause pain or distress

Uncontrolled environments where the effects of the intervention cannot be addressed
Examples of situations where ethical issues must be addressed:
Why is it necessary to use animals?
Provide information on:
Techniques available to wholly or partially replace the use of animals for the scientific project
The non-animal alternatives that will be used in the project
Reasons why you have rejected others as unsuitable
Replacement – Why Animals?
Animals required

Give details of the number of the animals required.

SPF: Specific Pathogen Free
Genetic Status: N=Normal, M=Natural mutation, GM=genetically modified
Reduction - Why so many animals?
Provide justification for number of animals requested
Group sizes determined statistically
Groups sizes determined by quantity of harvested cells or amount of tissue required
Teaching project – animal/student ratio

How are numbers minimised?

Too few may be as much of a problem as too many because if not statistically valid, animals are wasted
Why so many animals? (continued)
Give an outline of how the project is designed to meet the aims of the project, and a step-by-step description of what will happen to each animal from the time they are obtained until the time the project is completed
Animal housing and management
Duration of animal use
Re-use of animals
Fate of animals
What are you doing? (Refinement)
Identify all aspects of the project that may impact on the wellbeing of the animals

Anticipate and describe any potential adverse effects of these factors on the welfare of the animals

What steps to take to avoid, minimise or mange any adverse effects - monitoring
Refinement – Animal welfare impact
Inform the ACEC of the extent to which the monitoring of animals and their care has been considered in the project design.

Address the following:
Who will monitor animal?
What will be monitored? How often?
Records of monitoring - Monitoring checklist
Actions to be taken if problems are observed
Intervention and humane endpoint criteria
Monitoring & Endpoints
Room temperature, humidity
Waters check
Feed check
Bedding and cages check
Light cycle
Monitoring – The environment
Normal appearance and behaviour of the species/strain
Normal appearance and behaviour of an individual animal
General signs of ill-health, pain or distress
Possible adverse effects of a procedure
Probable signs which result from adverse effects
Monitoring – The animal
Intervention and humane endpoint criteria
Had a procedure, or come to the end of their use
Any suffering, distress, illness & disease

Must address the signs used in making a decision on whether to intervene (monitor!)

What will the intervention be?
Endpoints - Examples
The training and technical ability of researchers and teachers is critical to minimising pain, distress and suffering in the animals they use

For each person, need information on:
Procedures to be performed and species to be used
Experience with these procedures and species
If no relevant experience, proposed training
Training/skill of each person
No information on specific experience with procedures and/or species to be used in the project

Experience with one species does not necessarily equate to experience with another species

Experience with procedure in one species does not necessarily equate to experience with a similar procedure in another species
Training/skills: Common problems
Comply with the Australian Code of Practise
Use of animals must address the 3 Rs
The animals have right to be respected and treated humanely
Researchers have the responsibility to monitor the animals at all times and watch for signs of distress
Records must be kept for every procedure
The Bottom line of all the paperwork…..
1. Introduction to the use of animals in research (online)
2. Monitoring, pain management and anaesthesia (online)
3. Developing and using a monitoring checklist (presentations)
4. Animal care, monitoring, handling, and basic research procedures (practical)
5. Principles of anaesthesia in rodents (practical)
6. Surgery and aseptic surgical techniques (practical)
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