13 ETHICS E1

Nursing Research
Ethics in Nursing Research
Copyright © 2018, 2013, 2008 Pearson Education, Inc. All Rights Reserved
Development of Ethical Codes and
Guidelines
• Ethical aspects take precedence over any other areas of

proposed research studies.
• Rights of study participants must be protected.
Guidelines
• Historical Overview
– Unethical research studies at German concentration
camps
▪ World War II prisoners’ wounds deliberately infected
with bacteria
– Drug effectiveness on wounds
• Sulfanilamide
▪ Nurses were expected to participate; some did.
▪ Study to attempt prediction of skeletal size from
photographs
▪ Victims not “real” people
Guidelines (7 of 12)
• Ethical Research Guidelines

– Ethics is concerned with rules and principles of
human behavior.
▪ Human behavior is complex; rules are difficult to
formulate.
– The Ten Commandments
– Principles frequently change with time.
Guidelines
• Founding Principles of Ethical Research
– Present ethical standards based on guidelines developed after
WWII.
– The Nuremberg Code, 1947
▪ Criteria for research identified:
1. Researcher must inform potential subjects.
2. Research for the good of society
3. Research should be based on animal experiments
4. Researcher must attempt to avoid injury to subjects.
5. Researcher must be qualified to conduct research.
6. Subjects or researcher can stop study if problems occur.
Guidelines
– Other ethical codes

▪ Universal Declaration of Human Rights, 1948
▪ Declaration of Helsinki, 1964
Guidelines
▪ The Belmont Report, 1979
– National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research
– Respect for persons
• Research subjects should have autonomy and
self-determination.
– Beneficence
• Research subjects should be protected from
harm.
– Justice
• Research subjects should receive fair treatment.
Institutional Review Boards (1 of 6)
• Administrative body established to review and approve

research intended to study human subjects
• Research is defined as “a systematic investigation,
including research development, testing and evaluation,
designed to develop or contribute to generalizable
knowledge” (DHHS, 2009, 45 CFR 46.102d).
• Human subjects are defined as “living individual(s) about
whom an investigator conducting research obtains (1)
data through intervention or interaction with the
individual, or (2) identifiable private information” (DHHS,
2009, 45 CFR 46.102f).
• An investigative plan that does not fit the definition of research with
human subjects may not need to be submitted for IRB review.
– Contention around quality improvement (QI) initiatives in clinical
care settings
– Attributes associated with QI relate to:
▪ Improvements not consistently being implemented at a
specific site.
▪ Plans for interventions and analysis within a specific system.
▪ Specifying a potential local institutional benefit.
▪ Risks limited to privacy or confidentiality of health information
and not physical or psychological harm.
▪ System-level outcomes specific to the setting.
• Members of Institutional Review Boards

– Federal regulations
▪ Each IRB should have at least five members
– Backgrounds support an adequate review of
the types of research activities usually
conducted by the institution
▪ IRB should be qualified through the expertise of its
members.
▪ No IRB may consist entirely of members of one

profession.
▪ At least one member must have primary concerns
in scientific areas.
▪ At least one member must have primary concerns
in nonscientific areas.
▪ At least one member should be not affiliated with
the institution of record.
• IRB Review
– Type depends on anticipated risk of potential harm to human
subjects.
– May be identified as exempt, expedited, or a full review
▪ Exempt
– Procedures do not link subjects’ responses with their
identities.
– Disclosure of data could not reasonably place the subjects
at risk of harm.
▪ Expedited
– Protocol might cause minimal risk to a participant who may
identify one’s self.
– Survey questions may relate to somewhat sensitive material
▪ Full
– Would be expected for a research study that
involves more than minimal risks to the
participant
– Necessary if the study included members from
a vulnerable population
• Pregnant women, children, fetuses, and
infants
Elements of Informed Consent (1 of 13)
• Concerns a participant’s participation in research in which

they have full understanding of the study before the study
begins
• Basic elements of informed consent should include:
1. Explanation of research purposes, description of
procedures, and duration of participant activities
2. Description of foreseeable risks
3. Description of benefits to the subject or others
4. Disclosure of appropriate alternative procedures
5. Statement describing how confidentiality of

participant’s records is maintained
6. Explanation of how foreseeable injuries will be
handled
7. Explanation of who to contact with questions relevant
to the study
8. Statement that participation is voluntary, and refusal
to participate or prerogative to withdraw can be
assured at any time, with no negative consequences
• Description of Purpose of Study and Study Procedures

– Study purpose
▪ Presented clearly in the participant’s language and
reading level
– Not always necessary to describe entire nature
of study
▪ Enough information for informed consent
▪ When and where

▪ Time commitments
▪ All activities subject will perform
▪ Debriefing if necessary
– Meeting with participants after study to ensure
understanding of reasons and justification for
procedures
• Description of Unforeseeable Risks

– Risks that might influence decision to participate
▪ Physical and psychological risks or discomforts
▪ Invasion of privacy
▪ Consultation with experts
• Description of Benefits
– Nuremberg Code
▪ Research must be for good of society.
– Potential to benefit society
▪ Subjects as well as others
– Compensation
▪ Monetary should be avoided in nursing
▪ Avoid bias
• Disclosure of Appropriate Alternative Procedures

– Explanation of alternative procedures or treatments
that may be received by others in the study
▪ Treatment
▪ Control group
– Hawthorne effect
▪ Phenomenon that brings about changes in
subjects because they are aware that they are
participants in a study
• Description of Maintenance of Confidentiality or Anonymity
– Anonymity
▪ No link between subjects and data
– Confidentiality
▪ Protects subjects’ identities
– Data are coded.
– Subjects’ names and code numbers are kept in a
separate location.
▪ Deletion of identification information
▪ Subjects and site should be described in general terms
▪ Data reported in aggregate.
• Plans for Unforeseeable Injuries

– Explanation of what participant would expect if an
injury related to study occurs.
▪ Monetary compensation or medical treatments
• Contact Information for Questions Relevant to the Study

– Researchers identify themselves and describe
qualifications.
– At time of informed consent
– Potential subjects must always be given opportunity
to ask questions.
▪ Available by phone or e-mail
▪ Always there to answer questions
– Research subjects should always be given
opportunity to obtain study results.
• Assurance of Freedom to Volunteer for or Withdraw from

the Study
– All participation in nursing research must be
voluntary.
– No penalty for withdrawal
– Able to withdraw at any time, for any reason
▪ Particularly important in experimental studies in
which treatment is involved
• Documentation of Informed Consent

– Required
– Usually provided when participant signs an IRB
approved written consent form
– In some cases, documentation of informed consent is
unnecessary.
– Oral permission must be witnessed by a third person.
– If subject cannot give informed consent, assent is
required.
▪ Legal representative
– 45 CFR 46.117
▪ If subject does not want documentation that links
subject to research, subject's wishes will govern this
decision.
– Milgram study, 1963
▪ Obedience and authority
▪ Electrical shock administration
▪ Researcher deception
Integrity in Research
• Research misconduct
– Fabrication of data or results
– Falsification of data and results
– Plagiarism
– Can occur at any stage of research project
• Data fabrication
– Making up data for purpose of deception
• Data falsification
– Willful distortion of results of study or reported
collection of data
• Plagiarism
– Near or verbatim copying of texts or ideas without
identifying original source of citation
• Conflicts of interest (COI)

– May occur when nurses receive payments from
companies that sponsor research
– Use of a company’s product could create a bias.
– Federal regulations require universities to obtain
disclosures from researchers about any financial
relationships they may have with industry.
• If patients will be subjects, or patient charts must be

collected
– Researcher must approach setting as a complete
stranger.
– Permission must be obtained to use patients’ records,
even if nurse has full access to record in clinical
practice.
– Authorization for use and disclosure must be obtained
in writing from the person involved.
Research Guidelines for Nurses (1 of 5)
• American Nurses Association (ANA) Research and

Studies Commission
– Human Rights Guidelines for Nurses in Clinical
and Other Research
▪ Published guidelines in 1968
▪ Revised in 1975 and 1985
– Code of Ethics for Nurses with Interpretative

Statements
▪ Published in 2015
▪ Research nurse’s role as a patient advocate
should include:
– Assurances of fulfillment of human rights
through process of ongoing informed consent.
– Continual assessment of risk versus benefit for
research participants and the prevention of
harm.
▪ Duty to question and, if necessary, report any

researcher who violates a participant’s rights or is
involved in ethically questionable research
▪ Duty to advocate for anyone who wishes to decline
from participating in a study
– Advocacy
• Act or process of pleading for, supporting or
recommending a cause or a course of
action
• Nurse Researcher as a Patient Advocate

– Nurses assisting in clinical trials have central role as
patient advocates.
– Nurses should consider protecting interests of
patients who have agreed to be in studies.
– Entails an ethical obligation

▪ Evaluate and communicate participant’s
understanding
▪ Answer questions that will support patient needs
– Must be especially careful of risks associated with
conflicts of interest
– Should be familiar with any clinical trials that are
being conducted in their work setting
Critiquing Ethical Aspects of a Study (1 of 2)
• Difficult task
– Little space given in report
• Ethical nature of studies may be inferred or implied.
Critiquing Ethical Aspects of a Study (2 of 2)
• Guidelines for critiquing

– Study 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?
REPUBLIC ACT NO. 10532
• “Philippine National Health Research System Act of

2013”
• Protect and promote the right to health of the people,
instill health consciousness among them and improve the
quality of life of every Filipino through health research
and development initiatives.
Reference: https://www.officialgazette.gov.ph/2013/05/07/republic-act-no-10532/
• (a) Health shall refer to a state of optimal physical, mental

and social well-being and the ability to function at the
individual level.
• (b) Health Research Stakeholders shall refer to the
national and the local public and private
agencies/organizations, policymakers, the academe,
medical and health societies, people’s organizations and
others who are concerned with and affected by health
and development.
• (c) National Unified Health Research Agenda shall refer to a
set of research priorities determined by the country’s
stakeholders which addresses the health needs of the
population vis-a-vis the health sector’s goal for universal
health care. This agenda is a platform to advocate for local,
national and international support.
• (d) Philippine Council for Health Research and Development
(PCHRD) shall refer to one of the sectoral planning councils of
the Department of Science and Technology (DOST) which
provides central direction, leadership and coordination in
health science and technology (S&T).
• (e) Philippine Health Research Ethics Board (PHREB) shall refer
to the national policymaking body on health research ethics,
created under DOST Special Order No. 091, which is mandated
to ensure that all phases of health research shall adhere to the
universal ethical principles that value the protection and
promotion of the dignity of health research participants.
• (f) Philippine National Health Research System (PNHRS) shall
refer to a framework anchored on the principles of Essential
National Health Research on inclusiveness, participation, quality,
equity, efficiency and effectiveness, which connect to, and
converge with, the wider health, economic, political, educational
and S&T systems of the country.
• (g) Regional Health Research Systems shall refer to the
regional health research consortia or communities in all the
regions of the country which mirror the PNHRS framework at
the regional level.
• (h) Research shall refer to the development of knowledge with
the aim of understanding health challenges and mounting an
improved response to them. This covers the full spectrum of
research in five (5) generic areas of activity: (1) measuring the
problem; (2) understanding its cause(s); (3) elaborating
solutions; (4) translating the solutions or evidence into policy,
practice and products; and (5) evaluating the effectiveness of
solutions.
Reference: https://www.officialgazette.gov.ph/2013/05/07/republic-act-no-10532/
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13 ETHICS E1

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Nursing Research

Ethics in Nursing Research

• Ethical aspects take precedence over any other areas of

• Ethical Research Guidelines

– Other ethical codes

• Administrative body established to review and approve

• Members of Institutional Review Boards

▪ No IRB may consist entirely of members of one

• Concerns a participant’s participation in research in which

5. Statement describing how confidentiality of

• Description of Purpose of Study and Study Procedures

▪ When and where

• Description of Unforeseeable Risks

• Disclosure of Appropriate Alternative Procedures

• Plans for Unforeseeable Injuries

• Contact Information for Questions Relevant to the Study

• Assurance of Freedom to Volunteer for or Withdraw from

• Documentation of Informed Consent

• Conflicts of interest (COI)

• If patients will be subjects, or patient charts must be

• American Nurses Association (ANA) Research and

– Code of Ethics for Nurses with Interpretative

▪ Duty to question and, if necessary, report any

• Nurse Researcher as a Patient Advocate

– Entails an ethical obligation

• Guidelines for critiquing

• “Philippine National Health Research System Act of

• (a) Health shall refer to a state of optimal physical, mental

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