The document discusses the history and importance of ethics in research. It describes some past unethical research studies involving human experimentation without consent, such as the Tuskegee Syphilis Study. This led to the development of ethical guidelines like the Nuremberg Code in 1947 and the Declaration of Helsinki in 1964 to protect human rights and require ethics committee approval. The document outlines the role of ethics committees in reviewing research and the rights of research participants.

1. Document Title (Editable via „Slide Master‟) | Page 1
HLTEN514B
Apply Research Skills Within a
Contemporary Health Environment
www.tastafe.tas.edu.au

2. Document Title (Editable via „Slide Master‟) | Page 2
Topic 2
Ethics and Morals

3. Document Title (Editable via „Slide Master‟) | Page 3
Ethics & Morals in Research
• Why do we need it?
– History tells us that if research is not ethically
approved, humans will attempt devastating and
immoral practices on the vulnerable to determine
outcomes
– Past unethical/moral dilemmas highlight this
– All research must now go before an ethics committee
for approval
– Protect the vulnerable – human & animal
– Protection of human rights

4. Document Title (Editable via „Slide Master‟) | Page 4
In the beginning….
Jenner did not get ethical approval
for his inoculation research….yet it
led to the eradication of
smallpox….ongoing debate about
risks of research and benefits and
harms balance…do you think
Jenner‟s research was justified?
Lorinda Schultz
Member, Human
Research Ethics
Committee
Research Ethics Advisor
Faculty of Health
The University of
Newcastle

5. Document Title (Editable via „Slide Master‟) | Page 5
The 20thC….
• WWII – Nazi
„medical research
• Mass horrific human
experimentation by
German and
Japanese (in Unit
731) doctors and
scientists on
concentration camp
victims during
WW2….led to…Lorinda Schultz
Member, Human
Research Ethics
Committee
Research Ethics
Advisor
Faculty of Health
The University of
Newcastle

6. Document Title (Editable via „Slide Master‟) | Page 6
….First ethical guidelines for
conduct of research
• Nuremburg Code was developed in 1947 following the
mistreatment of human subjects by Nazis
• The Nuremberg Code (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
– Right to withdraw consent
– Research must stop if harm is resulting
(no specific mention of children, unconscious people, or
others who may not be competent to give consent)

7. Document Title (Editable via „Slide Master‟) | Page 7
Continuation of unethical
research….
• Tuskegee Syphilis Study
USA – African American
males were not treated for
syphilis
• Tuskegee Syphillis study
(Alabama, 1932-
1972, n=400)
http://www.cnn.com/US/9704/
08/tuskegee/
• Willowbrook hepatitis study
(New York, 1950s-1970s) –
disabled children
deliberately infected with

8. Document Title (Editable via „Slide Master‟) | Page 8
Ethics & Morals in
Research• NZ research on women with cervical carcinomas -
“Unfortunate experiment” (National Women‟s
Hospital, New Zealand, 1959-1987, n=948 (Group
1, 817 treated, 1.5% invasive cancer; Group 2,
131 untreated, 22% invasive cancer, 6 died)
• Jewish Chronic Diseases Hospital Study – to see
patient‟s rejection response to live cancer cells
• Nuclear radiation experimentation in Australia
1950s-1970s “Australia's radiation safety authority
has confirmed that the bodies of thousands of
children and adults were used in scientific nuclear
tests without parental consent.”
http://news.bbc.co.uk/2/hi/asia-pacific/1380766.stm

9. Document Title (Editable via „Slide Master‟) | Page 9
Ethics & Morals in
Research• 1992 Tamoxifen Breast Cancer prevention Study
• In UK 40 year study of hearts of children post mortem
• ? The same in Australia

10. Document Title (Editable via „Slide Master‟) | Page 10
1964 Declaration of
Helsinki
• World Medical Assembly; revised 1975, 1989, 2000
– Therapeutic vs non-therapeutic research
– Adequacy of research design
– Protection from risk/harm
• 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
• 1966 - First university course in research ethics (human
experimentation)
(Henry K. Beecher, Yale University)

11. Document Title (Editable via „Slide Master‟) | Page 11
In Australia:
• In Australia the National Health & Medical Research
Council (NHMRC) use the principles of the
Nuremburg Code & Helsinki Declaration as a frame
work for ethical conduct
• National Statement on Ethical Conduct in Human
Research (2007)
• http://www.nhmrc.gov.au/publications/synopses/e72sy
n.htm
• There is also a document on that site “What is new in
the National Statement…”

12. Document Title (Editable via „Slide Master‟) | Page 12
Who needs to apply
for human research ethics
clearance?• Human research is “research which is
conducted with or about people, or their
data or tissue” (p.3 National Statement on
Ethical Conduct in Human Research)
• 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

13. Document Title (Editable via „Slide Master‟) | Page 13
Who needs to apply
for human research ethics
clearance?• More specific definitions and guidelines
on what constitutes human research on
p7-8 of National Statement
• Institutions that receive Australian Govt
research funding must have a Human
Research Ethics Committee (HREC) to
review and approve human research
before it commences.
• Research must comply with National
Statement on Ethical Conduct in Human
Research

14. Document Title (Editable via „Slide Master‟) | Page 14
Types of human participation in
research
• As research subjects
(on whom experiments, including testing
of new drugs, are conducted)
• As persons whose body organs or tissues
are obtained and/or retained for research
– Eg, blood, saliva, urine, biopsy
specimens
• As research participants from whom
information is obtained
– Eg, through
observation, interviews, focus
groups, questionnaires, telephone

15. Document Title (Editable via „Slide Master‟) | Page 15
Types of human participation in
research
• As people who might be identified in official
documents
– Eg, employment records, student records,
police records, court documents, medical
records.
• As people whose information (identified or de-
identified) is part of an existing, unpublished
source
– Eg, a researcher wishing to use all, or part
of, an unpublished data-base obtained by
another researcher for a different research
project

16. Document Title (Editable via „Slide Master‟) | Page 16
Ethics & Morals in
Research
The new National Statement
• Protection of Human subjects & their rights
– Major ethical principles
• Respect for persons – right to self
determination & treatment as autonomous
agents. Freedom to participate or not
• Principle of beneficence – to do good & to
do no harm & maximise the benefits.
Decisions are respected & ensure
wellbeing
• Principle of Justice – treated fairly in terms
of risks & benefits. Not imposed upon
unduly
• Research merit and integrity

17. Document Title (Editable via „Slide Master‟) | Page 17
The new National
Statement• Is composed of 5 sections:
– Values and principles of ethical conduct
– Themes in research ethics; risk, benefit and consent
– Ethical considerations specific to research methods or
fields
– Ethical considerations specific to participants
– Process of research governance specific to
participants

18. Document Title (Editable via „Slide Master‟) | Page 18
Ethics & Morals in
ResearchProtecting Human Rights
• Human rights are the claims & demands that have been
justified in the eyes of an individual or by consensus of a
group of people
Five Rights
1. Right to Self Determination
2. Right to Privacy & Dignity
3. Right to anonymity & confidentiality
4. Right to Fair Treatment
5. Right to protection form discomfort & harm

19. Document Title (Editable via „Slide Master‟) | Page 19
Ethics & Morals in
ResearchRight to Self Determination
Autonomous agents who is informed & has the freedom to
choose whether or not they will participate or not
• Informed Consent

20. Document Title (Editable via „Slide Master‟) | Page 20
Ethics & Morals in
Research
Right to Privacy & dignity
• Principle of respect & to determine the time, extent &
circumstances which information is shared or withheld
Right to anonymity & confidentiality
• Identity cannot be link, even with the researcher, with
his or her individual responses
• Information will not be publicly divulged & are harmful
to the subjects

21. Document Title (Editable via „Slide Master‟) | Page 21
Ethics & Morals in
ResearchRight to Fair Treatment
• Based on justice – people must be treated fairly &
receive what they are due or owed.
• Fair selection of subjects with equal benefits
• Age, race, socioeconomic level (not like in the past)
Right to protection from discomfort & harm
• Based on beneficence
• Need to take an active role on promoting comfort &
good & preventing harm
• May be emotional, physical, social & economic.

22. Document Title (Editable via „Slide Master‟) | Page 22
Participants have a right to
• Refuse
• Withdraw at any time
• Be treated with dignity, respect and sensitivity
• Privacy
• Complain
• Be involved
• Access findings

23. Document Title (Editable via „Slide Master‟) | Page 23
Participants have a right to
• Anonymity and confidentiality
• 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

24. Document Title (Editable via „Slide Master‟) | Page 24
Ethics & Morals in Research
Ethics Committees –
• Review research & rights of participants
• Monitor ongoing projects
• Maintain records of research conducted

25. Document Title (Editable via „Slide Master‟) | Page 25
Ethics & Morals in
ResearchEthics Committees look at five levels of (potential) harm
1. No anticipated effects
2. Temporary discomfort
3. Unusual level of temporary discomfort
4. Risk of permanent damage
5. Certainty of permanent damage

26. Document Title (Editable via „Slide Master‟) | Page 26
References
Beanland, C., Schneider, Z., LoBiondo-
Wood, G., Haber, J. (1999). Nursing
Research: Methods, Critical Appraisal and
Utilisation. Artamon: Mosby.
Borbasi, S., Jackson, D., Langford, R.
(2004). Navigating the Maze of Nursing
Research. Marrickville: Mosby.
Burns, N., & Grove, S. (1995).
Understanding Nursing Research.
Pennsylvania: W.B. Saunders Company.

27. Document Title (Editable via „Slide Master‟) | Page 27
References
Crotty, M. (1998). The Foundations of
Social Research: Meaning and
Perspective in the Research Process. St
Leonards: Allen & Unwin.
Daly, J., Kellehear, A., Gliksman, M. (1997).
The Public Health Researcher: A
Methodological Guide. South Melbourne:
Oxford University Press.
Elliott, D., & Burr, G. (2000). Study Guide
to Accompany Nursing Research:
Methods, Critical Appraisal and Utilisation.
Marrickville: Mosby.

28. Document Title (Editable via „Slide Master‟) | Page 28
References
Kumar, R. (1996). Research Methodology:
A step-by-step guide for beginners.
South Melbourne: Addison Wesley
Longman.
Peace, S. (1990). Researching Social
Gerontology: Concepts, Methods and
Issues. SAGE Publications: London.
Punch, K. (1998). Introduction to Social
Research: Quantitative & Qualitative
Approaches. SAGE Publications:
London.