RESEARCH PRELIMS REVIEWER
general principles.
Introduction to Nursing Research
Traditional Practices
– practices that have been passed down
from earlier nurses, often taught in
nursing programs.
- Problem with this approach is that some
practices may not prove to be effective
anymore.
Authority
- Students often look to teachers to share
information about clinical practices.
- Information provided by authorities may
not have been systematically tested.
Gilbert and colleagues (2005) – he estimated
that if medical advice had been guided by
research evidence, over 60,000 infant deaths
might have been prevented.
Personal Experiences
- When managing a clinical problem
nurses will sometimes use similar,
former experiences to aid their decision
making.
- Personal experiences help nurses build
expertise.
Institution – closely related and is a hunch that
people will use to guide their actions.
Trial and error
- Occurs when nurses try several options
until one works and solves their
problem.
- Downside: ineffective and unsystematic.
Inductive Reasoning
- Reasoning requires the use of analytic
abilities to think about how to solve the
problem.
- It moves from specific information to
- Example: a nurse notes pain control is of
critical concern to the parents/she cares
when they return from surgical
procedures.
Deductive Reasoning
- Moves from general principles to
specific situations.
- Example: a nurse might work from the
general premise that surgical
procedures cause trauma to tissue that
in turn cause pain.
Research – systematic inquiry that uses
disciplined methods to answer questions and
solve problems. The goal is to gain knowledge
that would be useful for many people.
Nursing research – systematic inquiry designed
to develop trustworthy evidence about tissues of
importance to nurses and their clients.
Characteristics of Nursing Research:
- Systematic
- Research is a process
- Involves both inductive and deductive
reasoning.
- Provides confirmation and results in
refining knowledge.
- Strives to be objective.
Goals for Conducting Nursing Research:
- Promote evidence-based nursing
practice.
- Ensure credibility of the nursing
profession.
- Provide accountability for nursing
practice.
- Document cost effectiveness of nursing
care.
Promote evidence-based nursing practice
- Major reason is to foster optimum care
for clients.
- Clinical decision based on: Best research
evidence, nurses clinical expertise,
health care preferences of clients.
- Aim to provide best possible care based
on the best available research.
- Nursing profession exists to provide a
service to society.
- Should be based on accurate knowledge.
- Research determined to be the most
reliable means of obtaining knowledge.
Ensure credibility of the nursing profession
- Establishing own body of knowledge
distinct from other disciplines.
- Research helps determine what makes
nursing profession unique.
Provide accountability for nursing practice
- Increased independence brings a need
for more accountability.
- Nurses must have a sound rationale for
their actions.
- Nurses have responsibility of keeping
knowledge base current.
Document cost effectiveness of nursing care
- Difficult for nurses to consider the cost
effectiveness of nursing care.
- Goal to help people achieve or maintain
health, regardless of cost.
- Reality has forced nurses to think in
monetary terms.
Roles of Nurses in Research
1. Principal investigator
2. Member of research team
3. Identifier of researchable problems
4. Evaluator of research findings.
5. User of research findings.
6. Patient/client advocate during studies.
7. Subject/participant in studies.
Ethics in Research
Nuremberg Military Tribunals
- held in 1947 that became known as The
Doctors’ Trial, in which 23 physicians
from the German Nazi Party were tried
for crimes against humanity for the
atrocious experiments they carried out
on unwilling prisoners of war.
- Many of the grotesque medical
experiments took place at the Auschwitz
concentration camp, where Jewish
prisoners were tattooed with
dehumanizing numbers onto their arms;
numbers that would later be used to
identify their bodies after death.
Nuremberg Code
1. Voluntary consent is essential
2. The results of any experiment must be
for the greater good of society
3. Human experiments should be based on
previous animal experimentation
4. Experiments should be conducted by
avoiding physical/mental suffering and
injury
5. No experiments should be conducted if
it is believed to cause death/disability
6. The risks should never exceed the
benefits
7. Adequate facilities should be used to
protect subjects
8. Experiments should be conducted only
by qualified scientists
9. Subjects should be able to end their
participation at any time
10. The scientist in charge must be prepared
to terminate the experiment when
injury, disability, or death is likely to
occur.
Tuskegee Syphilis Study (1932-1972)
- Investigated the progression of syphilis
among 400 poor African-American men.
Medical treatment was deliberately
withheld to study the course of disease
progression
- In 2010, it was discovered that a doctor
from the Tuskegee study inoculated
prisoners in Guatemala with syphilis in
the 1940s to replicate the study
Declaration of Helsinki
- Set of ethical principles regarding human
experimentation developed originally in
1964 for the medical community by the
World Medical Association (WMA)
- It is widely regarded as the cornerstone
document on human research ethics
- Combined the Nuremberg code with the
Declaration of Geneva, addressing
clinical research in medical practice
International code of ethics for nurses
- was first adopted by the International
Council of Nurses (ICN) in 1953. It has
been revised and reaffirmed at various
times since, most recently with this
review and revision completed in 2012.
Nurses have four fundamental responsibilities:
1. to promote health
2. to prevent illness
3. to restore health
4. to alleviate suffering
International Council of Nurses (ICN) Code of
Ethics for Nurses
- Inherent in nursing is a respect for
human rights, including cultural rights,
the right to life and choice, to dignity and
to be treated with respect.
- Nursing care is respectful of and
unrestricted by considerations of age,
color, creed, culture, disability or illness,
gender, sexual orientation, nationality,
politics, race or social status.
- Nurses render health services to the
individual, the family and the
community and coordinate their
services with those of related groups.
4 Principal Elements:
1. Nurses and people - The nurse’s primary
professional responsibility is to people requiring
nursing care.
2. Nurses and practice - The nurse carries
personal responsibility and accountability for
nursing practice, and for maintaining
competence by continual learning.
3. Nurses and the profession - The nurse
assumes the major role in determining and
implementing acceptable standards of clinical
nursing practice, management, research and
education.
4. Nurses and co-workers - The nurse sustains a
collaborative and respectful relationship with co-
workers in nursing and other fields.
Ethical dilemmas exist when participants’ rights
and study quality are put in direct conflict
The Belmont Report - articulated three primary
ethical principles on which standards of ethical
research conduct are based: beneficence,
respect for human dignity, and justice.
BENEFICENCE
- imposes a duty on researchers to
minimize harm and maximize benefits.
- Human research should be intended to
produce benefits for participants or,
more typically, for others.
 Right to Freedom From Harm and
Discomfort:
- Researchers have an obligation to
prevent or minimize harm in studies with
humans.
- Harm and discomfort can be physical
(injury), emotional (stress), social (loss of
social support), or financial (loss of
income
The Right to Protection from Exploitation:
- Involvement in a study should not place
participants at a disadvantage.
Participants need to be assured that
their participation, or information they
provide, will not be used against them.
- For example, people describing their
economic situation should not risk loss
of public health benefits; people
reporting drug abuse should not fear
being reported for a crime.
RESPECT FOR HUMAN DIGNITY
- Respect for human dignity is the second
ethical principle in the Belmont Report.
This principle includes the right to
selfdetermination and the right to full
disclosure
The Right to Self-Determination
- The principle of self-determination
means that prospective participants
have the right to decide voluntarily
whether to participate in a study,
without risking prejudicial treatment. It
also means that people have the right to
ask questions, refuse answering
questions, and drop out of the study.
- A person’s right to self-determination
includes freedom from coercion.
Coercion involves explicit or implicit
threats of penalty from failing to
participate in a study or excessive
rewards from agreeing to participate.
The Right to Full Disclosure
- Respect for human dignity encompasses
people’s right to make informed
decisions about study participation,
which requires full disclosure.
- Full disclosure means that the
researcher has fully described the study,
the person’s right to refuse
participation, and potential risks and
benefits. The right to self-determination
and the right to full disclosure are the
two elements on which informed
consent is based.
- Full disclosure is not always
straightforward because it can create
biases and sample recruitment
problems.
- In such situations, researchers
sometimes use covert data collection
(concealment), which is collecting data
without participants’ knowledge and
thus without their consent.
- This might happen if a researcher
wanted to observe people’s behavior
and was worried that doing so openly
would change the behavior of interest.
Researchers might choose to obtain
needed information through concealed
methods, such as observing while
pretending to be engaged in other
activities.
- A more controversial technique is the
use of deception, which can involve
deliberately withholding information
about the study or providing participants
with false information.
- For example, in studying high school
students’ use of drugs, we might
describe the research as a study of
students’ health practices, which is a
mild form of misinformation.
JUSTICE
- The third principle articulated in the
Belmont Report concerns justice, which
includes participants’ right to fair
treatment and their right to privacy.
The Right to Fair Treatment
- One aspect of justice concerns the
equitable distribution of benefits and
burdens of research. The selection of
participants should be based on
research requirements and not on
people’s vulnerabilities.
- Potential discrimination is another
aspect of distributive justice.
The Right to Privacy
- Research with humans involves
intrusions into people’s lives.
Researchers should ensure that their
research is not more intrusive than it
needs to be and that privacy is
maintained.
- Participants have the right to expect that
any data they provide will be kept in
strict confidence.
Risk/Benefit Assessment
- designed to evaluate whether the
benefits of participating in a study are in
line with the costs—i.e., whether the
risk/benefit ratio is acceptable
- Minimal risk is a risk expected to be no
greater than those ordinarily
encountered in daily life or during
routine procedures.
Major Potential Benefits to Participants
- Access to a potentially beneficial
intervention that might otherwise be
unavailable
- Reassurance in being able to discuss
their situation or problem with a
friendly, objective person
- Increased knowledge about themselves
or their conditions
- Escape from normal routine
- Satisfaction that information they
provide may help others with similar
problems
- Direct gains through stipends or other
incentives
- Physical harm, including unanticipated
side effects
- Physical discomfort, fatigue, or boredom
- Emotional distress from self-disclosure,
discomfort with strangers,
embarrassment relating to questions
being asked
- Social risks, such as the risk of stigma,
negative effects on personal
relationships
- Loss of privacy
- Loss of time
- Monetary costs (e.g., for transportation,
child care, time lost from work)
INFORMED CONSENT
- means that participants have adequate
information about the study,
comprehend the information, and have
the power of free choice, enabling them
to consent to or decline participation
voluntarily
- Researchers usually document informed
consent by having participants sign a
consent form.
- This form includes information about the
study purpose, specific expectations
regarding participation (e.g., how much
time will be required), the voluntary
nature of participation, and potential
costs and benefits
- Researchers may not obtain written
informed consent when data collection
 is through self administered
questionnaires.
- Researchers often assume implied
consent (i.e., the return of a completed
questionnaire implies the person’s
consent to participate)
CONFIDENTIALITY PROCEDURES
- Study participants have the right to
expect that the data they provide will be
kept in strict confidence.
- Anonymity, the most secure means of
protecting confidentiality, occurs when
the researcher cannot link participants
to their data.
- Confidentiality is a pledge that any
information participants provide will not
be publicly reported in a manner that
identifies them and will not be made
accessible to others.
- These include maintaining identifying
information in locked files, substituting
identification (ID) numbers for
participants’ names on records, and
reporting only aggregate data for groups
of participants.
TREATMENT OF VULNERABLE GROUPS Children
Children
- Legally and ethically, children do not
have the competence to give informed
consent, and so the consent of children’s
parents or guardians should be
obtained.
- However, it is appropriate—especially if
the child is at least 7 years of age—to
obtain the child’s assent as well.
- Assent refers to the child’s affirmative
agreement to participate.
Mentally or Emotionally Disabled People
- Individuals whose disability makes it
impossible for them to make informed
decisions (e.g., people in a coma) also
cannot legally provide informed
consent.
- In such cases, researchers should obtain
the consent of a legal guardian.
Terminally Ill
- Terminally ill people can seldom expect
to benefit personally from research, and
thus the risk/benefit ratio needs to be
carefully assessed.
Severely ill or physically disabled people
- For patients who are very ill or
undergoing certain treatments (e.g.,
mechanical ventilation), it might be
necessary to assess their ability to make
reasoned decisions about study
participation
Institutionalized People
- Nurses often conduct studies with
hospitalized or institutionalized people
(e.g., prisoners) who might feel that
their care would be jeopardized by
failure to cooperate.
- Researchers studying institutionalized
groups need to emphasize the voluntary
nature of participation.
Pregnant Women
- These requirements reflect a desire to
safeguard both the pregnant woman,
who may be at heightened physical or
psychological risk, and the fetus, who
cannot give informed consent.
Guidelines for Critiquing the Ethical Aspects of
a Study:
1. Was the study approved and monitored by an
Institutional Review Board, Research Ethics
Board, or other similar ethics review committee?
2. Were study participants subjected to any
physical harm, discomfort, or psychological
distress? Did the researchers take appropriate
steps to remove or prevent harm?

3. Did the benefits to participants outweigh any

potential risks or actual discomfort they
experienced? Did the benefits to society
outweigh the costs to participants?

4. Was any type of coercion or undue influence

used to recruit participants? Did they have the
right to refuse to participate or to withdraw
without penalty?

5. Were participants deceived in any way? Were

they fully aware of participating in a study, and
did they understand the purpose and nature of
the research?

6. Were appropriate informed consent

procedures used with all participants? If not,
were the reasons valid and justifiable?

7. Were adequate steps taken to safeguard

participants’ privacy? How was confidentiality
maintained?

8. Were vulnerable groups involved in the

research? If yes, were special precautions
instituted because of their vulnerable status?

9. Were groups omitted from the inquiry without

a justifiable rationale, such as women (or men)
or minorities?