ETHICS IN NURSING RESEARCH
NURS 3010
Principles and Issues Pauline Anderson-Johnson, MSc, BScN, RN
2011, edited Jascinth Lindo 2012 & 2013
CLASS OBJECTIVES
1.
Discuss the historical background that guaranteed the
development of codes of ethics
2.
Identify the 3 primary ethical principles of the Belmont
Report and the important dimensions of each
3.
Identify procedures for adhering to ethical principles and
protecting human participants
4.
Develop consent forms for use in research studies
5.
Assess the ethical aspects of a research report
6.
Define and use new terms
2
WHY ETHICAL APPROVAL???

Research - includes any social science, biomedical
epidemiological activity that entails systematic
collection or analysis of data with the intent to
generate new knowledge, in which humans:
Are exposed to manipulation, intervention, observation, or
other interaction with investigators either directly or thru
alteration of their environment
 Become individually identifiable thru investigators
collection , preparation or use of biological material or
medical or other records (Casebook on ethical issues in
international health research, 2004)

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)
1930-1972 – USA – medical treatment
deliberately withheld in order to study the course
of untreated disease – (Tuskegee Syphilis study,
sponsored by US Public Health service)
4
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



1949 – Nuremburg code
1964 – Declaration of Helsinki accepted by the
World medical Assembly
2000 – Declaration of Helsinki revised
6
CODES OF ETHICS
Many organizations or disciplines have established
their own code of ethics


Nurses have developed their own Code

ANA – Ethical Guidelines in the Conduct ,
Dissemination and Implementation of Nursing
Research

ICN – Code for Nurses
The Belmont Report – a model for many guidelines
7
CODE OF ETHICS
The Belmont Report


Code of Ethics which was adopted by the
National Commission for Protection of Human
Subjects by the Federal Govt of the USA.
Used widely and many of the guidelines adopted
8
ETHICAL PRINCIPLES

THREE (3) primary ethical principles according to the
Belmont Report
1. Beneficence
2. Respect for Human Dignity or Autonomy
3. Justice
9
ETHICAL PRINCIPLES - BENEFICENCE

Researcher should:
minimize harm and
Maximize benefits
 Dimensions
a.
The right to protection from harm and
discomfort (Nonmaleficence)
b.
The right to protection from exploitation
10
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)
11
ETHICAL PRINCIPLES – BENEFICENCE
Dimensions
 The
right to protection from
exploitation
 What does this mean?

(Polit & Beck, 2006)
12
ETHICAL PRINCIPLES –
RESPECT FOR HUMAN DIGNITY
Includes:
 the
right to self determination
 the
right to full disclosure
13
ETHICAL PRINCIPLES - RESPECT FOR
HUMAN DIGNITY

Right to self determination
Right to voluntarily decide on
participation – without prejudiced
treatment
 Right to ask questions
 Freedom from coercion – explicit and
implicit threats of penalty from failing to
participate or excessive rewards as a
benefit to participate

14
ETHICAL PRINCIPLES - RESPECT FOR
HUMAN DIGNITY
 Right
to full disclosure
Full disclosure is required for participants to
make informed voluntary decisions
 Researcher should describe the nature of the
study fully, persons right to refuse, the risks
and benefits.


Full disclosure may create bias

Deception
15
ETHICAL PRINCIPLES - RESPECT FOR
HUMAN DIGNITY
 Full disclosure may cause bias
 Bias – affect accuracy
 Bias – affect recruitment of participants

Researchers may use:
Concealment
Deception

16
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)..
17
VERACITY
Veracity involves the concepts of truth about the
research study and the absence of deception.
 Individuals have the right to be told the truth and
not to be deceived about any aspect of the research.
 All aspects of a research project require explanation
by the researcher, who must make every effort to
ensure the participants understand the implications
throughout the study.
 The principle of veracity is linked with respect for
autonomy (Gillon, 1994).

18
FIDELITY AND CONFIDENTIALITY
Fidelity involves the concept of trust (ICN, 1996).
Participants place trust in researchers
 and this necessitates a commitment to protect
them. The researcher must ensure that the
 participants have an understanding of the risks,
and thus foster a trusting relationship.
 The researcher is responsible for ensuring
confidentiality and privacy of the research
 participants and the data obtained from them.
Personal information obtained by the

19
REVIEW CLASS EXERCISE
1.
Explain the THREE (3) primary ethical
principles according to the Belmont Report
2.
Describe two historical events which have
shaped the discussion regarding medical and
research ethics and state the year they occurred
20
PROTECTION OF STUDY PARTICIPANTS
Principle
1.
Respect for Persons
1.
2.
2.
1.
2.
Participants should not
be harmed
Benefits should be
maximized and harms
minimized to
participants
Justice
1.
Benefits and risks
must be distributed
fairly
Obtain informed consent
Give participants the
opportunity to choose what
will happen to them.
Include:
1.
Treated as autonomous
agents
Vulnerable persons
should be protected
1.
Beneficence
1.
3.
Application
2.
3.
2.
Information
Voluntariness
comprehension
Conduct risk/benefit
assessments – should be done
in a systematic manner.
Review of the study by Ethics
Committee.
3.
Selection of participants –
establish fair procedures for the
selection of participants
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
This process is documented by means of a Informed Consent
22
Form
CONSENT FORM
Should be divided into sections
 Should exclude medical/nursing jargon – should
be clear and readable
 Should include the following info:
1.
Title of the study
2.
Persons engaged in the study (PI, Co.I, RA)
3.
Invitation to participate (You are invited to
participate in the ….) and explain the purpose
of the study

23
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)
24
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

26
(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
Privacy and
dignity
Rights of
individuals
Freedom from
injury
Informed consent
Institutional review
board /Ethics
committees
28
Source: ANA guidelines for protecting human
rights
ETHICAL DILEMMA
NB: research that violates ethical principles are
most times not done to harm the subjects but is
due to a conviction that new and beneficial
knowledge will be gained
 The right of the participant and the demands of
the research are put in direct conflict = ethical
dilemma

29
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)