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Ethical Aspects of Nursing Study - Pps

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REVIEWING THE

ETHICAL ASPECTS OF A
NURSING STUDY

1
Codes of Ethics
• Nuremberg Code
• Declaration of Helsinki
• Belmont Report
• Government-imposed codes
• Codes for professional disciplines (e.g., by
the American Nurses’ Association)

2
Ethical Dilemma in
Conducting Research:

• A situation in which the rights of


study participants are in direct
conflict with requirements for a
rigorous study.

3
Ethical Principles from the
Belmont Report
1. Principle of Beneficence: Above
all, do no harm
• Right to protection from harm and
discomfort
– Beneficence—maximize good
– Non-maleficence —minimize harm
• Right to protection from exploitation
4
Ethical Principles from the
Belmont Report (cont.)

2. Principle of Respect for Human


Dignity
• Right to self-determination (absence of
coercion)
• Right to full disclosure (absence of deception
or concealment)

5
Ethical Principles from the
Belmont Report (cont.)

3. Principle of Justice
• Right to fair treatment
• Right to privacy (confidentiality,
anonymity)

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Procedures for Protecting
Study Participants
• Risk-benefit assessments
• Informed consent
• Confidentiality procedures
• Debriefings and referrals
• Treatment of vulnerable groups
• Institutional Review Boards and
external reviews
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Box 5.2 Potential Benefits and
Risks To Study Participants

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Informed Consent

Informed consent means that


participants:
• have adequate information about the
research
• can comprehend that information
• have free choice in deciding whether to
participate in or withdraw from the study
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Informed Consent (cont’d)

• Typical documentation: A consent


form
• Implied consent (e.g., self-
administered questionnaires)
• Process consent (qualitative
studies)
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Confidentiality Procedures

• Anonymity
• Confidentiality Pledge

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Special Treatment of
Vulnerable Groups
• Children
• Mentally or emotionally disabled people
• Severely ill or physically disabled
people
• Terminally ill people
• Institutionalized people
• Pregnant women
12
External review

• Human subjects committees

• Institutional Review Boards (IRBs)

• Research Ethics Boards (REBs—in


Canada)

13
Other ethical issues

• Ethical use of animal subjects


• Research misconduct

14
SAMPLE QUESTIONS
• The regulations affecting the ethical
conduct of research sponsored by the
federal government were based on the:
a. Nuremberg code
b. Declaration of Helsinki
c. Belmont report
d. Code of Ethics of AMA

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SAMPLE QUESTIONS
• All the following are potential benefits from
participating in a study, except:
a. Monetary gains
b. Access to a new and potentially beneficial
treatment
c. Opportunity to discuss personal feelings
and experiences with an objective listener
d. Opportunity to collaborate on a study
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SAMPLE QUESTIONS
• The three primary ethical principles
described include the following,
except:
a. Beneficence
b. Respect for human dignity
c. Justice
d. Autonomy
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SAMPLE QUESTIONS
• If a researcher unobtrusively studies
interactions among patients in a psychiatric
hospital, which ethical principles may be
violated?
a. confidentilality
b. Freedom from harm
c. Right for self-determination
d. All of the above
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SAMPLE QUESTIONS
• The safeguard mechanism by which even
the researcher cannot link the participant
with the information provided is called:
a. confidentiality
b. Anonymity
c. Informed consent
d. Right to privacy

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SAMPLE QUESTIONS
• Confidentiality of study participants
can be increased by:
a. Avoiding the collection of any
identifying information
b. Avoiding introducing the participants
to any of the research personnel
c. Placing all identifying information on
computer files rather than manual files
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SAMPLE QUESTIONS
• Vulnerable subjects would include
a. women hospitalized for a mastectomy
b. Members of a senior citizens group
c. People who do not speak English
d. Pediatric clients

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SAMPLE QUESTIONS
• Informed consent is not obtained from
study participants when:
a. The researchers pays the subject a stipend
b. The researchers collects information
covertly
c. The risk/benefit ration is low
d. The study is determined to be exempt from
IRB review
22
SAMPLE QUESTIONS
• In a qualitative study that involves multiple
contacts between the researcher and study
participants, the researcher may negotiate
a (n):
a. Informed consent
b. Stipend
c. Process consent
d. Risk/benefit ratio
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SAMPLE QUESTIONS
• Facbrication of data:
a. Is an example of research misconduct
b. Would be reviewed by an IRB
c. Would be revealed in participant
debriefings
d. Cannot occur unless deception has
been used
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SAMPLE QUESTIONS
• There is never any justification for violating
the three ethical principles articulated in the
Belmont report:
a. True
b. False
Ethical dilemmas are not common in the
conduct of scientific research
a. True
b. False

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SAMPLE QUESTIONS
Minimal risks are ones that are no gretaer that
those a person normally confronts in daily
life
a. True
b. False
The principle of self-determination concerns
whether participation in a study was
coerced:
a. True
b. False
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SAMPLE QUESTIONS
Freedom from harm and the right to privacy are the two
principles on which informed consent is based:
a. True
b. False
Guaranteeing confidentiality to study participants
means that the researcher could never link the
data gathered to the person who supplied the data:
a. True
b. False

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SAMPLE QUESTIONS
• From a research standpoint, a person
who does not have the competence to
give his or her informed consent is
considered a vulnerable subject:
a. True
b. False

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