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Chapter 4

NURS 2031H Chapter Notes - Chapter 4: Electrical Contacts, Random Assignment, Protective Factor

Course Code
NURS 2031H
Ellen Buck McFaden

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Legal and Ethical Issues 2031 Week 10 Lecture Chapters 4 &10
Ethics: Disciplined study of morality, branch of philosophy concerned with right and wrong
Morality: observed ways in which individuals or groups behave.
Theories of ethics:
Consequentialism- judge actions based on their production
Deontology- base actions on whether they are inherently right or wrong
Historical background that led to the development of ethical guidelines for the use of
human participants in research.
A. Nuremberg Code (1949)
a. Nazi experiments during WWII
b. Nuremberg trials: Allies prosecuted German military leaders, political officials,
industrialists, and financiers for crimes they had committed during world war II.
c. Respect for research subjects was recognised with the Nuremberg Code
B. Declaration of Helsinki (1964)
a. Universal approach to regulate human research
b. Modified several times
c. Historical Ethical Dilemmas – ethical principles were violated:
Nazi experiments
Untreated syphilis in black males (‘32-’73)
San Antonio contraceptive study (‘69)
Cameron’s LSD and brainwashing studies (‘50s-’60s)
Jewish chronic disease study (‘65)
Willowbrook Hospital—hepatitis studies (‘72)
Schizophrenia medication study (‘83)
Ivory Coast AIDS/AZT studies (‘94)
National Regulations and Policy
A. Canadian Nurses Association code of ethics
a. Promoting safe, compassionate, competent, and ethical care
b. Promoting health and well-being
c. Promoting and respecting informed decision making
d. Preserving dignity
e. Maintaining privacy and confidentiality
f. Promoting justice
g. Being accountable
Basic Ethical Principles (TCPS)
A. Respect for persons
a. Right to self-determination
b. Right to privacy and dignity
c. Right to anonymity and confidentiality
B. Concern for welfare (Beneficence)
a. Right to protection from discomfort and harm
C. Justice
a. Right to fair treatment
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Definition of Human participant
A. A living individual about whom an investigator conducting research obtains
a. data through intervention or interaction with the individual, or
b. identifiable private information.
Informed Consent
A. What it is
a. Ongoing process of communications and mutual understanding
b. Shared responsibility for protection
*No investigator may involve a human being as a research participant until the informed
consent has been obtained.
Elements of Informed Consent Form
A. Study involves research
a. Purpose of research
b. Expected duration for participant
c. Description of procedures
d. Identification of experimental procedures
B. Reasonably foreseeable risks or discomforts
C. Reasonably foreseeable benefits for participants or others
D. Alternative procedures or treatments
E. Confidentiality
F. Compensation for research-related injury
G. Who can answer questions
H. About study and research-related injuries
I. About participant’s rights
J. Voluntary participation
K. Present in consent that generally involves an intervention
a. May involve unforeseeable risks
b. Situations where researcher can terminate participant’s participation
c. Any additional costs
d. Consequences and procedures for participant’s early withdrawal
e. Revelation of new findings
L. Payment: total or prorated
M. Who has access to records?
N. Probability of random assignment
O. Special qualifications of investigator
NOTE: Informed Consent Form not valid unless participant understands
A. Responsibility for understanding rests with researcher, who must consider
a. nature of population.
b. type of information.
c. circumstance and timing.
d. language and culture.
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