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Document Title (Editable via „Slide Master‟) | Page 1
HLTEN514B
Apply Research Skills Within a
Contemporary Health Environ...
Document Title (Editable via „Slide Master‟) | Page 2
Topic 2
Ethics and Morals
Document Title (Editable via „Slide Master‟) | Page 3
Ethics & Morals in Research
• Why do we need it?
– History tells us ...
Document Title (Editable via „Slide Master‟) | Page 4
In the beginning….
Jenner did not get ethical approval
for his inocu...
Document Title (Editable via „Slide Master‟) | Page 5
The 20thC….
• WWII – Nazi
„medical research
• Mass horrific human
ex...
Document Title (Editable via „Slide Master‟) | Page 6
….First ethical guidelines for
conduct of research
• Nuremburg Code ...
Document Title (Editable via „Slide Master‟) | Page 7
Continuation of unethical
research….
• Tuskegee Syphilis Study
USA –...
Document Title (Editable via „Slide Master‟) | Page 8
Ethics & Morals in
Research• NZ research on women with cervical carc...
Document Title (Editable via „Slide Master‟) | Page 9
Ethics & Morals in
Research• 1992 Tamoxifen Breast Cancer prevention...
Document Title (Editable via „Slide Master‟) | Page 10
1964 Declaration of
Helsinki
• World Medical Assembly; revised 1975...
Document Title (Editable via „Slide Master‟) | Page 11
In Australia:
• In Australia the National Health & Medical Research...
Document Title (Editable via „Slide Master‟) | Page 12
Who needs to apply
for human research ethics
clearance?• Human rese...
Document Title (Editable via „Slide Master‟) | Page 13
Who needs to apply
for human research ethics
clearance?• More speci...
Document Title (Editable via „Slide Master‟) | Page 14
Types of human participation in
research
• As research subjects
(on...
Document Title (Editable via „Slide Master‟) | Page 15
Types of human participation in
research
• As people who might be i...
Document Title (Editable via „Slide Master‟) | Page 16
Ethics & Morals in
Research
The new National Statement
• Protection...
Document Title (Editable via „Slide Master‟) | Page 17
The new National
Statement• Is composed of 5 sections:
– Values and...
Document Title (Editable via „Slide Master‟) | Page 18
Ethics & Morals in
ResearchProtecting Human Rights
• Human rights a...
Document Title (Editable via „Slide Master‟) | Page 19
Ethics & Morals in
ResearchRight to Self Determination
Autonomous a...
Document Title (Editable via „Slide Master‟) | Page 20
Ethics & Morals in
Research
Right to Privacy & dignity
• Principle ...
Document Title (Editable via „Slide Master‟) | Page 21
Ethics & Morals in
ResearchRight to Fair Treatment
• Based on justi...
Document Title (Editable via „Slide Master‟) | Page 22
Participants have a right to
• Refuse
• Withdraw at any time
• Be t...
Document Title (Editable via „Slide Master‟) | Page 23
Participants have a right to
• Anonymity and confidentiality
• Prot...
Document Title (Editable via „Slide Master‟) | Page 24
Ethics & Morals in Research
Ethics Committees –
• Review research &...
Document Title (Editable via „Slide Master‟) | Page 25
Ethics & Morals in
ResearchEthics Committees look at five levels of...
Document Title (Editable via „Slide Master‟) | Page 26
References
Beanland, C., Schneider, Z., LoBiondo-
Wood, G., Haber, ...
Document Title (Editable via „Slide Master‟) | Page 27
References
Crotty, M. (1998). The Foundations of
Social Research: M...
Document Title (Editable via „Slide Master‟) | Page 28
References
Kumar, R. (1996). Research Methodology:
A step-by-step g...
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Research ethics

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Transcript of "Research ethics"

  1. 1. Document Title (Editable via „Slide Master‟) | Page 1 HLTEN514B Apply Research Skills Within a Contemporary Health Environment www.tastafe.tas.edu.au
  2. 2. Document Title (Editable via „Slide Master‟) | Page 2 Topic 2 Ethics and Morals
  3. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
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