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HLTEN514BApply Research Skills Within a Contemporary Health Environment

www.tastafe.tas.edu.au

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Topic 2Ethics and Morals

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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

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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 SchultzMember, Human Research Ethics CommitteeResearch Ethics AdvisorFaculty of HealthThe University of Newcastle

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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 SchultzMember, Human Research Ethics CommitteeResearch Ethics AdvisorFaculty of HealthThe University of Newcastle

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….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)

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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 hepatitis virus

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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

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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

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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)

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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/e72syn.htm

• There is also a document on that site “What is new in the National Statement…”

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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

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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

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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 surveys, psychological or other types of testing

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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

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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

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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

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Ethics & Morals in Research

Protecting 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 Rights1. Right to Self Determination2. Right to Privacy & Dignity3. Right to anonymity & confidentiality4. Right to Fair Treatment5. Right to protection form discomfort & harm

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Ethics & Morals in Research

Right to Self Determination

Autonomous agents who is informed & has the freedom to choose whether or not they will participate or not

• Informed Consent

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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

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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.

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Participants have a right to• Refuse

• Withdraw at any time• Be treated with dignity, respect and sensitivity• Privacy• Complain• Be involved• Access findings

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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

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Ethics & Morals in ResearchEthics Committees –

• Review research & rights of participants• Monitor ongoing projects• Maintain records of research conducted

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Ethics & Morals in Research

Ethics Committees look at five levels of (potential) harm

1. No anticipated effects 2. Temporary discomfort 3. Unusual level of temporary discomfort4. Risk of permanent damage 5. Certainty of permanent damage

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ReferencesBeanland, 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.

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ReferencesCrotty, 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.

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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.