NCM 111- NURSING RESEARCH
BSN 3
TOPIC: ELEMENTS
OF RESEARCH ETHICS
Social Value
- relevance of the study to an
existing social or health problem
such that the results are
expected to bring about a better
understanding of related issues,
or contribute to the promotion of
well-being of individuals, their
families, and communities.
- significance of the study, i.e. how
the study will help arrive at a
solution.
- scientific validity, i.e. study
design, methodology, and data
collection, overall, should be able
to generate information
supportive of the objectives of the
study.
- dissemination plan
(appropriateness and
applicability) for the study results
shall be included in the protocol.
Informed Consent
- a decision of a competent
potential participant to be
involved in research after
receiving and understanding
relevant information, without
having been subjected to
coercion, undue influence, or
inducement
-
-
obtaining informed consent is a
process, i.e. respect for the
prospective participants’ dignity
and autonomy must be
manifested; researchers shall
have the duty to avoid deception,
undue influence, or intimidation
essential information must be
disclosed:
1. name and affiliation of the
researcher;
2. must be understood as an
invitation to participate;
3. reasons for considering
the potential participants;
4. voluntariness;
5. purpose of the research,
the procedures to be
carried out by the
researcher;
6. expected duration of the
individual’s participation;
7. any foreseeable risks, pain
or discomfort, or
inconvenience to the
individual, including risks
to the health or well-being
of the individual’s spouse
or partner;
8. direct benefits; whether
money or other forms of
material goods will be
provided in return for the
individual’s participation;
9. expected benefits of the
research to the community
or to society at large, or
contribution to scientific
knowledge;
10. respect for the privacy of
research participants and
the confidentiality of
records in which they are
identified;
11. participants are free to
withdraw from the
research at any time
without having to give any
reason
Vulnerability of Research Participants
- those who are relatively or
absolutely incapable of deciding
for themselves whether or not to
participate in a study for reasons
such as physical and mental
disabilities, poverty, asymmetric
power relations, and
marginalization, among others
and who are at greater risk for
some harms.
- shall not be included in research
unless such research:
1. is necessary to promote
the welfare of the
population represented;
2. cannot be performed on
non-vulnerable persons or
groups.
- Competent advice and
assistance shall be provided to
participants who, by virtue of
social, economic, political or
medical disadvantages, are liable
to give consent under duress or
without the benefit of adequate
information.
Risks, Benefits, and Safety
- the population from which the
participants are derived stand to
benefit from the research.
- there must be a careful
assessment of predictable risks,
burdens, and foreseeable
benefits to the research
participant or to others.
- a careful assessment of
predictable risks, burdens, and
foreseeable benefits to the
research participant or to others
must be done.
- acceptable positive benefit-risk
ratio.
- researcher/funder/sponsor shall
endeavor to ensure the
reasonable availability and
accessibility of favorable
research outcomes to the
community.
Privacy and Confidentiality of
Information
- researchers shall adhere to the
principles of transparency,
legitimate purpose, and
proportionality in the collection,
retention, and processing of
personal information (Data
Privacy Act of 2012).
- researchers must respect
participants’ right to privacy.
Unless required by law, the
confidentiality of information shall
at all times be observed.
-
-
-
-
-
records that link individuals to
specific information shall not be
released. This requirement shall
be included in the informed
consent form.
researchers shall refrain from
identifying individuals or groups
when release of information
about them can expose them to
possible harm or social stigma
unless required by law.
where there is some likelihood or
opportunity for the researcher to
observe the occurrence of illegal
or harmful behaviors (e.g., child
abuse, substance use, selfharm,
or suicide ideation),
the researcher shall
1. explicitly indicate the limits
of confidentiality in the
informed consent process
;
2. emphasize the right of the
respondent to withdraw
from the study or withdraw
his or her data, and to
refuse to answer any
question
3. Prepare a concrete and
realistic protocol for
reporting and referral in
the event that imminent
harm and/or a criminal act
is disclosed or discovered
in the process of data
collection.
researchers shall recognize that
collecting data using group
methods (e.g., FGDs) has
implications for the privacy and
-
-
confidentiality of individuals, i.e.
ensure that the nature of the
study and the questions would
cause minimal harm should
confidentiality or anonymity be
breached.
researcher shall describe his or
her data protection plan in the
protocol, including the steps to be
taken so that all who have access
to the data can safeguard privacy
and confidentiality
researcher shall provide
adequate and clear instructions
to research assistants,
transcribers of audio recordings,
or translators of transcriptions.
Justice
- there must equitable distribution
of both the burdens and the
benefits of participation in
research. That is, it should not be
the case that one group in society
bears the costs of research while
another group reaps its benefits,
i.e.
1. fair selection in the choice of
population, sampling, and
assignments;
2. provision of appropriate care
to research participants
regardless of their economic
status, gender, race, or creed;
3. just compensation for harms
brought about by participation
in the research;
4. reimbursement for lost
earnings, travel costs, and
other expenses incurred ;
-
5. participants may be given a
reasonable and appropriate
incentive for inconvenience
individuals and communities shall
have access to benefits related to
participation in the study
Transparency
- It is imperative for all parties to be
transparent about matters
relating to their involvement, i.e.
1. promotes confidence in the
research enterprise, even
when privacy and anonymity
need to be preserved about
sensitive matters;
2. entails disclosure of research
results.
- researchers must be transparent
about aspects of a study that may
have an impact on the rights,
health, and safety of participants,
or in respect to information that
may have a bearing on the
decision of participants to give or
withhold their informed consent.
- researchers must disclose
information about their affiliations,
financial interests, or other
loyalties that may affect their
objectivity and the integrity of
their research output.
- research participants need to be
truthful in declaring their health
conditions, and to be candid in
expressing their concerns about
their involvement in research.
Qualification of the Researcher
- persons engaged in research
involving human participants shall
have moral fortitude, scientific
competence, social awareness,
cultural sensitivity, intellectual
humility, vigilance, and
preparedness in safety issues.
- researcher shall have the
training, ability, and resources to
conduct the proposed study.
- researcher shall be
knowledgeable of the literature
on the research topic.
Adequacy of Facilities
- assurance that the research
environment for the specific
issues must be supportive of
protocol procedures and
well-being of participants; i.e.
library must make accessible the
peer-reviewed journals; equipped
laboratory facilities, pool of
experts; data analysts;
Community Involvement
- respect for local traditions and
culture, community
empowerment, acknowledgement
of participation.
- benefits must be made clear to
the individuals and to
communities that they represent
- research forum for the
stakeholders must be possibly
organized for the dissemination
of research results
TOPIC: EVIDENCE-BASED
-
-
-
-
-
During the 1980s the term
“evidence-based medicine”
emerged to describe the
approach that used scientific
evidence to movement the best
practice. Evidence based practice
movement started in England in
the early 1990s
Evidence-based medicine (EBM)
or evidence based practice
(EBP), is the judicious use of the
best current evidence in making
decisions about the care of the
individual patient
Evidence-based practice
represents both an ideology and
a method. The ideology springs
from the ethical principle that
clients deserve to be provided
with the most effective
interventions possible. The
method of EBP is the way we go
about finding and then
implementing those interventions
Evidence: it is something that
furnishes proof or testimony or
something legally submitted to
ascertain in the truth of matter.
Evidence based practice: It is
systemic inter connecting of
scientifically generated evidence
with the tacit knowledge of the
expert practitioner to achieve a
change in a particular for the
benefit of a well-defined client/
patient group (French 1999)
Evidence Based Practice Process
1. Identify a practice issue
2. Formulate an answerable
question
3. Search for best evidence
4. Critically evaluate the evidence
and clinical relevance
5. Make recommendations
6. Apply to clinical practice
7. Evaluate impact/effectiveness/
outcomes
-
EBP is a problem solving
approach to clinical practice that
integrates the conscientious use
of best evidence in combination
with a clinician’s expertise as well
as patient preferences and
values to make decisions about
the type of care that is provided.
What is Evidence-Based Practice?
- EBP is a problem solving
approach to clinical practice that
integrates the conscientious use
of best evidence in combination
with a clinician’s expertise as well
as patient preferences and
values to make decisions about
the type of care that is provided.
EBP in Nursing
-
“Process by which nurses make
clinical decisions using best
available evidence, clinical
expertise, & patient preferences
in the context of available
resources” (DiCenso, 1998)
Evidence based nursing
- It is a process by which nurses
make clinical decisions using the
best available research evidence,
their clinical expertise and patient
preference (mulhall, 1998)
Evidence based medicine or practice
- The conscientious, explicit and
judicious use of current best
evidence in making decision
about the care of the individual
patient (Dr. David Sackett,
Rosenber, 1996)
EBP in Nursing
Is a way of providing nursing care
that is guided by the integration
of the best available scientific
knowledge with nursing
expertise. This approach requires
nurses to critically assess
relevant scientific data or
research evidence and to
implement high quality
interventions for their nursing
practice (NLM PubMed)
Types of Clinical Evidences
1. External Evidence:
- Generated from rigorous
research
- Important question: Does the
evidence generated by
rigorous research still hold
true when translated to the real
world?
2. Internal Evidence:
- Generated from outcomes
management;
“practice-based evidence”
3. Other Sources:
- Text books, expert opinion,
professional organizations
Traditional Basis for Nursing
Practice
(Stetler)
❖ Rituals, unverified rules
❖ Anecdotes, isolated experiences
❖ Customs, opinions, unit cultures
❖ Physicians’ authority
Getting Started: The Five A’s of the
Evidence Cycle
1. Ask good clinical question
2. Acquire best evidence
-
Enough evidence to
answer question?
3. Appraise that evidence
(level/strength)
- Is evidence strong?
4. Apply
- Does evidence support
practice change?
- Can practice change be
implemented?
5. Assess/Re-assess
- How did practice change
impact outcomes?
Steps in EBP
Core Competencies
1. Search for evidence
2. Evaluate the evidence
3. Read and understand research
Levels of Evidence Hierarchy(Stetler et
al.)
Level I: Meta-analysis of multiple
RCTs
(‘gold standard’)
Level II: Individual RCTs
Level III: Quasi-experimental
Level IV: Non-experimental;
qualitative
Level V: Program evaluation; QI;
RU; case reports
Level VI: Opinion of respected
authorities
*modified slightly by Padula
Levels of Evidence Pyramid