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Ethical Issues in
Nursing Research
Why Ethical Guidelines?

Face many ethical dilemmas in practice

Vulnerable participants or patients or clients

To protect people receiving health care and the


interventions and treatment regimes in the
system

To protect the public from harm


Historical Events

Need to discuss “unethical studies” – led to the


development of Ethical Codes and Regulations
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• Nazi Medical Experiments


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• Tuskegee Syphilis Study


• Willowbrook Study
• Jewish Chronic Disease Hospital Study
Nazi Medical Experiments

• 1933 to 1945 – unethical activities implemented by the


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Third Reich in EuropeLOGO

• Programs included:
Sterilization
Euthanasia
numerous experiments to produce a pop’n of pure
Germans & Aryans
Tuskegee Syphilis Study

• 1932 – US Public Health Service initiated a study of


syphilis in black men in the small rural town of Tuskegee,
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Cont’d for 40 years (to1962)
• To determine the course of syphilis in the adult black male
• 2 groups: n = 400 untreated syphilis (treatment group) n =
200 without syphilis (control group)
• Consent – participants not informed about the purpose
and procedures
• Deliberate steps to keep subjects from receiving treatment
• No effort to stop the study
Jewish Chronic Disease Hospital
Study

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• In 1960’s – purpose to determine the patients’ rejection


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responses to live cancer cells


• N = 22 – injected with a suspension containing live
cancer cells that had been generated from human cancer
tissue
• Rights of patients not protected, not informed, study was
never presented to the research committee of the Jewish
Hospital
What Happened?

• NUMERBURG CODE
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• DECLARATTION OF HELSINKI
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• CODE OF ETHICS
Nuremburg Code

• 1st internationally recognized set of ethical standards


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• Developed post-Nazi atrocities were made public during


the Nuremburg trials
Declaration of Helsinki

• Provided:
(a) Greater care should be exercised to protect subjects
from harm in non-therapeutic
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research
(b) Strong, independent justification is required for
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exposing a healthy volunteer to substantial risk of


harm just to gain new scientific info
(c) The investigator must protect the life and health of the
research subject
- 1964 – World Medical Assembly
Code of Ethics

• Most disciplines have established


- Canadian Nurses Association (1983) - “Ethical
Guidelines for Nurses in Research Involving Human
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- 2002 guidelines revised


- Health Canada – “Tri County Policy Statement: Ethical
Conduct for Research Involving Humans”
- Joint – MRC (Medical Research Canada), NSERC and
SSHRC
- Eight guiding principles of ethics
- Research Ethic Review Board (REB)
Perspectives for Assessing Ethical
Acceptability

• Utilitarian Perspective - the good of a project is


defined by the consequences of the results
• the greatest good for the greatest number
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• the end justifies the means


• each researcher may have a different idea about
what is “good”
Deontological Perspective

• Proposes absolute moral imperatives (Kant) (e.g.


dishonesty in experiments is never justified no matter
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what the positive contributions
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• Some deontologists are more flexible, making a


distinction between harm and wrong

• Harms can be compensated for but wrongs can not


Codes for Ethical Decision Making

• Nuremberg Code
• Declaration of Helsinki
• CAN Code of EthicsCompany
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• American Nurses Association Code of Ethics


• Code of Professional Conduct for the Nurse.
Midwife, and health Visitor (UKCC)
Principles of Ethical Research

• Respect for Persons


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• Beneficience &
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• Nonmaleficence
• Justice
Respect for Persons

• Forms the foundation of participant’s right to informed


consent, privacy, & confidentiality
• involves respecting autonomy
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or right to choose freely
• right to be free from pressure or coercion
• confidentiality & anonymity must be protected
• must have information to make informed choices (risks vs
benefits)
Beneficence & Non-maleficence

• Nonmaleficence - the duty • Researcher’s responsibility


to not inflict harm to minimize risk & maximize
benefits to participants
• Beneficence - the duty to
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promote good
Duty to care vs Duty to advance knowledge

• Research Imperative vs Therapeutic


Imperative Company

• When in doubt the therapeutic imperative


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must take precedence over the research


imperative
Justice

• People ought to be treated fairly


• Protection of participants from incompetence and
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access to research treatments are expectations of the
justice principle

• Random selection of participants avoids potential bias


and unfairness in sample selection
Methods of Protecting Human Subjects

• Informed Consent
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• Institutional Review Boards


Informed Consent

• Sufficient & appropriate information


• Comprehension of information
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• Voluntary participation
• An invitation to participate rather than an expectation
Process Consent

• In qualitative investigations the researcher negotiates the


consent and then renegotiates
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the consent as unforeseen
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• The participant is part of the decision making as the study


unfolds
Examples of Ethical Dilemmas

• Tuskegee Syphilis Study


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• Willowbrook Study
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• AIDS Research
Rules to Protect Participants

• Protect confidentiality
• Do not place pressure on participants
• Make participation free from harm & discomfort
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• Identify sponsors
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• Disclose the basis on which participants have been


selected
• Avoid hidden ID codes on questionnaires
• Honor promise to provide report
• Base participation on informed consent
• Debrief participants
Rules for Socially Responsible Nursing Research

• Distinguish between science & advocacy


• Do not search data in support of your views
• Be aware of potential sources of bias
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• Represent the literature fairly


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• Always seek to do the best research possible


• Acknowledge your sources
• Seek advise on ethical issues

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