Elements of Research Ethics in Nursing: A Comprehensive Guide, Lecture notes of Nursing

Nursing Research Notes for the whole Semester BSN 3

Typology: Lecture notes

2022/2023

Available from 01/02/2024

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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;
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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;
  1. expected benefits of the research to the community or to society at large, or contribution to scientific knowledge;
  2. respect for the privacy of research participants and the confidentiality of records in which they are identified;
  3. 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.
  1. 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.
  • Enough evidence to answer question?
  1. Appraise that evidence (level/strength)
  • Is evidence strong?
  1. Apply
  • Does evidence support practice change?
  • Can practice change be implemented?
  1. 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