Week 3

Ethics for Nursing Research and Evidence-based Practice

Objectives

• Ethics and research•Historic overview of ethics•Discuss the protection of Human

subjects• IRB•Review Lit review•Discuss Quantitative Research•Discuss Qualitative Research

Introduction

•Nurses obligated to do no harm to their patients•Researchers must understand all of the elements required to maintain the highest ethical standards•Requires specific ethical constraints and standards

Ethical vs. Unethical Research

Ethical studies protect subjects and are carried out using scientific principles.

Unethical research includes:Scientific misconductFraud, research protocol violationsFabrication, falsification, forging of dataPlagiarismPutting subjects at risk without consent

Ethical Theories

•Principles •Value of life, goodness, or rightness• Justice or fairness•Truth-telling or honesty• Individual freedom•Normative or descriptive

Code of Ethics Underpinnings

• Teleology (consequentialism or utilitarianism)• Deontology (non-consequentialism)• Values Theories• Principles of Ethics• Respect• Autonomy• Justice• Beneficence• Non-maleficence

Historical Overview

•Edward Jenner – England, 1789•Moses Maimonides – Western Europe, 1135-1204•Claude Bernard – France, 1865•Nazi - Europe, 1943-1946•Tuskegee Syphilis – US, 1930’s•Thalidomide – England, 1950’s•Hexamethonium – US

Codifying Research ethics

• Nuremberg Code of 1846• National Commission for the Protection of

Human Subjects of Biomedical and Behavioral Research – 1973• International Council of Nurses • American Nurses Association

National Commission for the Protection of Human Subjects

Ethical principles:Principle of respect for personsPrinciples of beneficencePrinciple of justice

These may be seen in the DHHS Belmont Report

(1978).

Principle of Respect for Persons

Self-determination (participation and withdrawing)

No coercion Full disclosure, no deception Voluntary consent Persons with diminished autonomy

have special protections

Principles of Beneficence

Freedom from harmFreedom from exploitationRisk/benefit ratios

High anticipated benefit may balance high risks

Principle of Jutice

Fair treatment(even if choose not to participate)

Right to privacyAnonymityConfidentiality

Institutional Review Board (IRB)

•Offers protection to the institution, the researcher, and the human subjects•Code of Federal Regulations which

govern• Five members of different

backgrounds at minimum•Research must be honest

Developing a Researchable Topic

• Critical factor – protection of the vulnerable subject

• Certificate of confidentiality

• Real interest to researcher

Participant Recruitment and Informed Consent

•Vulnerable Populations•Very young•Frail elder•Prisoners•Mentally incompetent•Women•Freedom of Choice

Data Collection and Data Analysis

•Protection of vulnerable human subjects remain critical issue•Privacy•Confidentiality•Honesty and trustworthiness•Scientific misconduct

EPB and Ethical Implications

•Quality Improvement issues•Patient autonomy•Quality of life• End of life• Internal Pressures

Other Issues

•Publication• Issues in Quantitative and Qualitative Research•External Pressures•Emerging Issues in Research and EBP

Summary Points• History has many lessons • Lessons results in development of national and

international ethical codes of conduct• ICN and ANA acknowledge obligations of the

nursing profession• Ethical theories guide the standards• Vulnerable populations do exist• Each step of research process involves ethics• Privacy and confidentiality must be guaranteed• Informed consent a must• Honesty and trustworthiness are crucial

Parts of Lit. Review

•Purpose of the study• Sample size and selection•Design of the study•Data collection procedures•Analysis of the data•Conclusion

Overview of the Research Process

• Abstract• Introduction• Identification of a research problem• Purpose• Literature review• Theoretical Framework• Hypothesis/research question

Research Process Contd.

•Research design•Sampling•Data collection methods•Results•Discussion•Summary

Types of Research

•The two main research paradigms in nursing are quantitative and qualitative.

Research Designs and Methods

•Quantitative Research Design•Draws conclusions about some procedure.•Uses statistical methods.•Uses deductive reasoning, logic, and measurable aspects of experience.

Quantitative Research Design

•Descriptive • Exploratory • Survey•Historical review•Cross-sectional• Longitudinal

Quantitative Research Design

•Retrospective•Prospective•Correlational•Quasi-experimental• experimental

Quantitative Research

•Descriptive Studies •Describe a phenomenon of interest

(clinical observation).


• Exploratory Studies •Describe in detail the phenomena

and try to identify contributing factors.


• Survey Method • Surveying a group of individuals for

responses to certain questions.


•Historical Research •Systematic data collection relating to past events.•Places concepts in perspective.•Establishes parameters for continued research in a specialized area.


•Cross-Section Studies •Data collected at one specific

measurement point about a single event.•A relatively large number of

individuals is sampled in a short period of time.


• Longitudinal Studies •Data collection on the same subjects

studied over time. •Data is collected on a number of

variables.


•Retrospective Studies •Review existing data from medical

records/hospital charts.•A carefully conducted retrospective

study can provide the research questions for a prospective study.


•Prospective Studies •Actively follow subjects over the

period of the study.• The researcher is able to control all

information collected.


• Correlational Designs – Investigate the correlation (relationship) of one

variable to another.– Useful for studying the relationships among large

numbers of variables associated with “human research.”


•Quasi-Experimental Design •A modified experiment exposing all

subjects to the independent variable.• Less robust than a true

experimental design.


Experimental design • Tests an “independent variable”

against a “dependent variable.”• Subjects are randomized to a

treatment group or a control group.• “Gold standard” in research design.

Qualitative Research Design

•Qualitative Research Design• The systematic collection and

consideration of data relating to humans’ interactions in and with the world.• Frequently involves interview data.•Provides a more holistic approach

that is conducted in natural settings.

•Biographical•Case Study Method• Ethnography• Ethnomethodology•Grounded Theory•Phenomenology

•Biographical Method• Involves writing about people’s

lives.• Sources of data include historical

documents: artifacts, diaries, letters, personal stories, related historical facts.•Data analysis involves sorting and

relating all the information gathered.

•Case Study Method •May refer to a single case, subject,

group, or institution.•Multidimensional approach using a

variety of data-collection strategies.

• Ethnography• Longitudinal, descriptive research

approach used by anthropologists to describe behaviors of a culture. •Data sources include observation of

participant behavior, interviews, artifacts.

• Ethnomethodology• Interpretive descriptions of how

people make sense of their social world.

•Grounded Theory• Field research used in hospitals,

nursing homes, clinics.• Investigates social and decision-

making processes of clients.• Involves theoretical sampling until

data saturation is reached.

• Phenomenology• Approach uses a variety of distinctive,

yet related, philosophical approaches.• Begins in profound reflection on the

phenomenon to be studied.•Multiple sources of data collection.• Requires intense reflection to

understand its meaning.

Homework

Go to the NIH website and complete online course and print certificate

Week 3

Documents

Transcript of Week 3