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E N R NURS 3010: Thics in Ursing Esearch
E N R NURS 3010: Thics in Ursing Esearch
E N R NURS 3010: Thics in Ursing Esearch
NURS 3010
3
HISTORICAL BACKGROUND
1930s & 1940s – Germany - research on humans
testing their endurance and reaction to disease
and drugs – humans exposed to permanent
physical harm and death, participants could not
refuse to be part (Nazi medical experiments)
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HISTORICAL BACKGROUND
1960’s – USA - injection of live cancer cells in
elderly patients without their consent ( Jewish
Chronic disease Hospital, Brooklyn)
1960’s – USA – children infected with the
hepatitis virus
1980s – New Zealand – patients with carcinoma
in situ were not given treatment in order to study
the natural progression of the disease (Dr
Herbert Green of National Women’s Hospital,
Aukland)
Many more, maybe not as large or obvious 5
CODES OF ETHICS
Codes of Ethics have been developed in response to
these violations of human rights
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CODES OF ETHICS
Many organizations or disciplines have established
their own code of ethics
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ETHICAL PRINCIPLES
THREE (3) primary ethical principles according to the
Belmont Report
1. Beneficence
2. Respect for Human Dignity or Autonomy
3. Justice
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ETHICAL PRINCIPLES - BENEFICENCE
Researcher should:
Dimensions
a. The right to protection from harm and
discomfort (Nonmaleficence)
b. The right to protection from exploitation
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ETHICAL PRINCIPLES – BENEFICENCE
Dimensions
The right to protection from harm and
discomfort (Nonmaleficence)
Researcher has a duty to avoid, prevent or
minimize harm to participants
Should not be subjected to unnecessary risks
of harm or discomfort
Participation must be essential to achieving
scientifically and societally important aims
Harm can be – physical, emotional, social or
financial
(Polit & Beck, 2006)
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ETHICAL PRINCIPLES – BENEFICENCE
Dimensions
The right to protection from
exploitation
What does this mean?
(Polit & Beck, 2006)
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ETHICAL PRINCIPLES –
RESPECT FOR HUMAN DIGNITY
Includes:
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ETHICAL PRINCIPLES - RESPECT FOR
HUMAN DIGNITY
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ETHICAL PRINCIPLES - RESPECT FOR
HUMAN DIGNITY
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ETHICAL PRINCIPLE - JUSTICE
The principle of justice is synonymous with
fairness and equity and researchers are
obliged to treat participants fairly and
equitably before, during and after the
research Study.
(ABA, A. B. A. 2007)..
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VERACITY
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PROTECTION OF STUDY PARTICIPANTS
Principle Application
1. Respect for Persons 1. Obtain informed consent
1. Treated as autonomous 1. Give participants the
opportunity to choose what
agents will happen to them.
2. Vulnerable persons Include:
should be protected 1. Information
Voluntariness
Beneficence
2.
2. 3. comprehension
1. Participants should not 2. Conduct risk/benefit
be harmed assessments – should be done
2. Benefits should be in a systematic manner.
maximized and harms Review of the study by Ethics
Committee.
minimized to
participants
3. Selection of participants –
3. Justice establish fair procedures for the
1. Benefits and risks selection of participants
must be distributed
fairly 21
(I)INFORMED CONSENT
Central to this process is that individuals have the right to
decide for themselves (principle of Respect for persons)
This means:
Adequate information has been given to
participants
They understand the information – simple
language
They have the power to make a free choice
They can consent voluntarily
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CONSENT FORM
4. Reason the person is being asked to
participate
5. Explain clearly the purpose of the study
6. Detailed description of the procedures
(describe what will happen in the study, amt
of time required, if hospitalization is
required, if blood will be taken or any lab
procedures will be done, how long it will take,
instruments to be used, etc)
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CONSENT FORM
7. Potential risks to the subjects (psychological,
social, physical). Explain likely severity and
steps taken to protect them
8. Potential benefits of the study (desired benefits
to society and individuals)
9. Economic considerations (any additional cost to
persons as a result of participating)
10. Confidentiality considerations
11. Freedom of persons to ask questions and
withdraw from the study at any time without
penalty 25
(II)ETHICS COMMITTEE
Major responsibility of com’t’e or IRB
Review research proposals at convened meetings to
ensure that ethical guidelines are followed
Ensures no violation of human participant
The committee will include scientists, research
experts, lay persons, lawyers, ministers of religion
Review procedures of selection, protection, voluntary
consent, confidentiality
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(III)RISK/BENEFIT ASSESSMENTS
Used to assess the ethical aspects of the study by
reviewer
Determine if the benefits of participating are in
line with the physical, emotional and financial
cost
(see doc with major benefits and risks – p92)
Determine if risks to participants are
commensurate with the benefits to society and
the profession
Minimal risk – those anticipated; ordinary risks
encountered in daily life or during routine tests27
•Right to anonymity and
confidentiality
•Freedom for coercion and deception
•Voluntary participation
Informed consent
Institutional review
board /Ethics
committees
28
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REFERENCES
1. ABA, A. B. A. (2007). Guidance to nurses and midwives
regarding ethical conduct of nursing and midwifery
research.
2. Polit, D.F., & Beck, C.T. (2010). Essentials of nursing
research: Appraising the evidence for Nursing practice.
Philadelphia: Lippincott, Williams & Wilkins. (Chap 5)
3. Gerrish, K., & Lacey, A. (2010). (Eds.), The research
process in Nursing. UK: Wiley-Blackwell. (Chap 8)
4. James A Fain. (1999). Reading, understanding, and
applying nursing research: A text and workbook.
Philadelphia, FA Davis Co.
5. http://www.emro.who.int/publications/pdf/healthresearc
hers_guide.pdf (chap 3.1)