Research Methods in Nursing

(NUR 425)

Irbid National University-

Faculty of Nursing

1
 Chapter 2

ETHICAL ISSUES IN NURSING

RESEARCH

2
 Learning Objectives
1. Describe the history of ethics in nursing &
medicine.
2. Discuss the research guidelines for Nurses.
3. Discuss the ethical actions of researcher.
4. Identify the elements of informed consent
5. Appreciate The Role Of Institutional Review
Boards
6. Critique The Ethical Aspects Of A Study
 Ethics and nursing research

◼ Ethics are "norms for conduct that distinguish

between acceptable and unacceptable
behavior". When most people think of ethics
(or morals), they think of rules for
distinguishing between right and wrong.
 Definition of ethics

Research Ethics refers to the quality

of research procedures with respect to their
adherence to professional, legal, and
social obligations to the research
subjects.
 Codes of Ethics
1.Nuremberg Code was one of the first internationally
recognized efforts to establish ethical standards (1947).

2.Declaration of Helsinki was adopted in 1964 by the

World Medical Association and then later revised, most
recently in 2000.

3.American Nurses’ Association (ANA) put a

document in 1995 entitled Ethical Guidelines
 Other Ethical Codes
• Universal Declaration of Human Rights,
1948
• The Belmont Report, 1979
– Respect for persons
– Beneficence
– Justice
• The Department of Health and Human
Services (DHHS)
Guidelines included in
Nuremberg code
1. Voluntary consent
2. Withdrawal of subjects from studies
3. Protection of subjects from physical &
mental suffering, injury, disability and
or death
4. Balance of benefits and risks in a
study
Research Guidelines for
Nurses
◼ Human Rights Guidelines for Nurses in
Clinical and Other Research (1975,
1985)
◼ Protects subjects from harm
◼ Ensures privacy
◼ Preserves subject’s dignity
◼ Keep nurses fully informed
Research Guidelines for
Nurses
◼ Ethical Guidelines in the Conduct,
Dissemination, and Implementation of
Nursing Research (Silva, 1995)
◼ Research integrity
◼ Reporting scientific misconduct
 Ethical Actions

1. Protecting the human rights

2. Balancing benefits and risks of a study
3. Securing informed consent
4. Submitting the research proposal for
institutional review.
Examples of the experimental
projects of unethical treatment of
human subjects
1. The chronic disease hospital study
( 1960).
2. The tuskegee syphilis study (1932)
Protection of human rights

Human rights are claims & demands that

have been justified in the eyes of an
individual or by the consensus of a group
of individuals
Human rights that require protection
in research are:
1. The right to self determination
2. The right to privacy
3. The right to anonymity &
confidentiality
4. The right to fair treatment
5. The right to protection from
discomfort & harm
 Right to self determination
◼ The principle of self-determination means that
participants have the right to decide voluntarily
whether to participate in a study, without
risking any penalty or prejudicial treatment.
 Violation of the right to self
determination
◼ If he or she is coerced to participate in a study.
“coercion occurs when an overt threat of harm or
excessive reward is intentionally presented by one
person to another in order to obtain compliance.
◼ When he or she becomes a research subject
without realizing it.
◼ When the researcher use deception toward research
subjects.
 Persons with diminished
autonomy
1. Legally & mentally incompetent subjects:
children, the mentally ill & unconscious
pt’s are legally and /or mentally incompetent
to give informed consent.
2. Terminally ill subjects
3. Subjects confined to institutions
 Right to privacy

Privacy is the freedom an individual has to

determine the time, extent and general
circumstances under which private information
will be shared with or withheld from others

-Invasion of privacy: occurs when private

information is shared without an individual’s
knowledge or against his or her will
 Right to Anonymity & confidentiality

1. Anonymity exists if the subject’s identity

cannot be linked, even by the researcher,
with his or her individual responses

2. Confidentiality is the management of

private information
Protection of anonymity and
confidentiality

Researchers have a responsibility to

protect the anonymity of subjects and the
confidentiality of the data collected during
the study and after the study is completed.
 Breach of confidentiality
Breach of confidentiality occurs when a
researcher by accident or direct action
allows an unauthorized person to gain
access to raw data of a study
Effects:
◼ Identification of subject’s identity
◼ Violation of the right to anonymity
 Right to fair treatment

Right to fair treatment is based on ethical

principle of justice

This principle states that each person should

be treated fairly and that the person
should receive what he or she due or owed
 Fair selection of subjects

In the past, injustice in subject selection

resulted from social, cultural, racial, and
sexual biases in society.
 Fair treatment of subject’s during the
course of study

Researcher & subject’s should have a

specific agreement about what the
subject’s participation involves and what
the role of the researcher will be.
 Right to protection from discomfort &
harm
◼ Is based on the ethical principle of
beneficence
◼ This principle states “ above all, do no harm”
and indicates that members of society should
take an active role in preventing discomfort
and harm and promoting good in the world
around them
 Reynolds (1972): levels of discomfort
& harm
1. No anticipated effects: in some studies, there are no
positive or negative effects that are expected for
the subject’s
2. Temporary discomfort: in which the discomfort
encountered is similar to what the subject would
experience in his or her daily life and ends with
termination of the experiment
3. Unusual levels of temporary discomfort: the
subjects frequently experience discomfort during
the study and after the study has been terminated
 Reynolds (1972): levels of discomfort
& harm
4. Risk of permanent damage: medical studies
of new drugs and surgical procedures do have the
potential to permanently damage the subjects.
5. Certainty of permanent damage: conducting
research that will permanently damage subjects
is highly questionable, regardless of the benefits
that will be gained
 Balance benefits & risks in a study
◼ Assessment of Benefits: the benefit of
knowledge to be gained from research can
affect the individual subject, but more
importantly, this knowledge can have an
influence on a discipline and numerous
members of society.
◼ Assessment of risks: researchers must
assess the type, degree and number of risks
the subjects experience or might experience
by participating in a study
 Balance benefits & risks in a study

◼ Maximizing benefits & minimizing risks:

after assessment, the researcher attempts
to maximize the benefits & minimize the
risks by making changes in the purpose
and / or procedures of the study.
 Secure informed consent

◼ Informing: is the transmission of essential ideas

and content from the investigator to the
prospective subject

◼ Consent: is the prospective subject’s agreement

to participate in a study as a subject, which is
reached after assimilation of essential information
 Elements of informed
consent
1. Essential information
2. Comprehension
3. Voluntary consent
 Essential information for
informed consent
1. Introduction of activities
2. Statement of care purpose-goals
3. Selection of clients
4. Explanation of procedures
5. Description of potential risk or discomfort
6. Description of the potential benefits
7. Disclosure of alternatives
8. Assurance of confidentiality
9. Offer to answer questions
10. Non-coercive disclaimer
11. Option to withdraw
12. Consent to incomplete disclosure
Comprehension of consent
information
◼ Informed consent implies not only
imparting of information but also the
comprehension of that information by
the client/family member.
◼ Care provider must take the time to
teach the prospective clients about the
care that will be intervened.
Comprehension of consent
information
◼ The consent information should be
written and verbalized in lay
terminology, not professional jargon
◼ Assessing subjects comprehension:
the researcher can take steps to
determine the prospective subject’s
level of comprehension
 Voluntary consent
◼ Voluntary consent means that the
prospective client has decided to take
part in a procedure of his or her own
volition without coercion or any
unique influence.
 Documentation of
informed consent
◼ Forms of documentation:
1. Short consent form can be used in
procedures that present no more than
minimal risk of harm to clients and
involve procedures that do not require
written consent
2. Long consent form includes all the
essentials information of informed
consent
Institutional Review Boards
(IRBs)
◼ 1981: DHHS published guidelines.
◼ Guidelines led to IRBs.
◼ Overseen by Office of Protection from
Research Risk (OPRR)
◼ Human research needs IRB approval.
Nursing Research and
Guidelines
◼ Nursing research committees
◼ Policies vary agency to agency.
◼ Be informed about institution’s specific
requirements
◼ Permission to conduct research can
take time.
 Submit proposal for institutional
review WHY?
◼ The rights and welfare of the
individual or individuals involved

◼ The appropriateness of methods used

to secure informed consent

◼ The risks and potential benefits of the

investigation.
Critiquing Ethical Aspects of a
Study
◼ Guidelines for critiquing
◼ Approved by IRB?
◼ Informed consent obtained?
◼ Provisions for anonymity and confidentiality?
◼ Vulnerable subjects?
◼ Coercion?
◼ Benefits outweigh risks?
◼ Subjects given opportunity to ask questions?
◼ Results made available to subjects?
REFERENCE
 FOUNDATIONS OF
NURSING RESEARCH
Sixth Edition

CHAPTER 2
Ethical Issues in
Nursing Research

Copyright ©2012 by Pearson Education, Inc.

Foundations of Nursing Research, Sixth Edition
Rose Marie Nieswiadomy All rights reserved.
The End