Grove & Burns, (1995). "Understanding Nursing Research". Philadelphia: Saunders.
Other goals:
- develop and test nursing theories;
- understand nursing phenomena;
- foster professional commitment & accountability;
- help nurses make informed decisions in patient care;
- validate the effectiveness of particular nursing measures;
- help document nursing's unique role in the health care delivery system;
- improve quality of care and care delivery;
- provide a link between theory & practice;
- advance nursing as a profession.
Nursing research that uses the scientific method is one of the primary sources of generating nursing knowledge.
Scientific Method Characteristics:
- Control of variables and biases
- Use of empirical evidence to generate knowledge
- Produce generalizable results
As researchers, we use the Scientific Method to:
- Describe phenomena
- Explore relationships among phenomena
- Explain phenomena and increase understanding
- Predict the causes of relationships among phenomena
- Control phenomena
In nursing, use of the Scientific Method is limiting because:
- Every research study has flaws
- No one study proves or disproves a hypothesis
- Ethical issues can constrain researchers
- Holistic studies of humans are difficult
- Adequate control is hard to maintain
Tradition
Authority
Intuition
Trial and Error
Personal Experience
Logical Reasoning
Nursing Research may be "Basic" or "Applied":
Basic: Undertaken to advance knowledge in a given area, helps the researcher understand relationships among phenomena
Applied: Undertaken to remedy a particular problem or modify a situation, helps the researcher to make decisions or evaluate techniques. (Clinical nursing problems)
| ADN graduates: | have awareness of the value of nursing research |
|---|---|
| BSN graduates: | understand each step of the research process; interpret, evaluate, determine the credibility of research findings; integrate research into clinical practice; participate in studies |
| MSN graduates: | are active members of the research team, they are clinical experts |
| PhD graduates: | appraise, design and conduct research; they develop theoretical explanations of nursing phenomena; and they disseminate findings (presentations, publications) |
Remember: Nursing research is important to ALL nurses!
| 1850 | Nightingale, first Nurse Researcher |
| 1923 | Goldmark Report proposed reorganization of nursing education into the university setting |
| 1948 | Brown Report: technical ADN, professional BSN |
| 1949 | Ginzberg Report: four year nursing programs, technical nursing programs (ADN) |
| 1952 | Nursing Research published |
| 1950's | clinical research focus from fields of psychiatric & maternal-child health |
| 1960's & 1970's | Nursing archives established; 1st Nursing Research Conference of ANA held, nursing research focused on clinical practice issues. |
| 1970's | increased master's and doctoral programs for nursing |
| 1980's | increased upper level nursing programs, especially doctoral;
Increased interest in qualitative research
|
(LoBiondo-Wood & Haber, 1998, p.6)
Theories have been developed in nursing to explain phenomena that are of importance to clinical practice (Burns & Grove, 1999).Nursing theories guide nursing research by generating hypotheses that can be supported or refuted. Nursing theories also may be generated from nursing research. Theory building approaches that begin with an existing theory and test hypotheses that are "deduced" from that theory are often called "deductive". Theory building approaches that generate hypotheses and explanatory data from observations, interviews and other data are often called "inductive".Research is conducted to either develop or to test theory (Burns & Grove, 1993).
According to Wood & Haber (1998), theoretical formulations supported by research findings may "become the foundations of theory-based practice in nursing" (p. 7).
Research, then, is based on theory. The ideas that lead a researcher to develop a particular study have their roots in theory. As a researcher undertaking a study, you no doubt have a "theory" about what your study outcomes are expected to be, and why. This theory-based "framework" is expressed as the "study framework" or the "theoretical framework". By performing the study, the researcher can answer the question: "Was my theory correct?" So, a study tests the accuracy of theoretical ideas. When the study is completed, the researcher interprets the meaning of the findings in relation to the theoretical framework. Having an understanding of the theory upon which the study is based helps you to determine whether or not it is appropriate to apply the study findings to your clinical practice (Burns & Grove, 1999).
According to Wilson (1992), a theoretical framework for a study is an "essay that places the study in the context of existing related theory based on the literature that has been reviewed" (p. 81).
At times, nursing uses theories developed in other disciplines, such as psychology, and apply them to nursing situations. Although we use these theories to guide our practice, in many instances, we have not tested them to determine whether or not the nursing actions proposed by the theory actually have the effects claimed Burns & Grove, 1999).
Consider this example, taken from Burns & Grove "Understanding Nursing Research", 1999, p. 130:A theory of mother-infant bonding proposed that bonding between a mother and her newborn child occurred within hours or days of birth (Klaus & Kennell, 1976). The theory proposed that if physical contact between mother and child did not occur during this short time frame, bonding would not occur and the relationship between mother and child would be permanently impaired. Nurses leaped on this idea and focused intensely on ensuring that physical contact between mother and newborn occurred. However, research testing this theoretical notion demonstrated that it was not true (Walker, 1992). Mother and newborn, kept apart because of illness or other circumstances, were able to bond. A theory of attachment, based on long term studies of mothers and infants, emerged. These studies found that development of an attachment between mother and child was indeed critical but that the process occurred over a period of months rather than days. These findings, expressed as the theory of attachment, guide nurses in their care of mothers and their children.
Wilson (1993), in describing the interdependence of nursing theory, research and practice, states: "Developing a body of knowledge about nursing and for nursing practice is critical if we are to move from a dsicipline based on tradition and authority to a discipline based on science. Placing nursing studies within the context of our evolving theoretical base is essential to that goal" (pp. 92-93).
This line of reasoning moves from the particular to the general:
Particular - moves to - General, or, stated another way,
(Specific) - moves to - General
What are some examples of Inductive Reasoning?
A headache is an altered level of health that is stressful.As you can see, this line of reasoning moves from the Specific - to the - General.A fractured bone is an altered level of health that is stressful.
A terminal illness is an altered level of health that is stressful.Therefore, all altered levels of health are stressful.
This line of reasoning moves from the general to the particular,
General - moves to - Particular, or, stated another way,
General - moves to - (Specific)
What are some examples of Deductive Reasoning?
As you can see, this line of reasoning moves from the General - to the Specific.
Premises: All human beings experience loss.
All adolescents are human beings.
Conclusion: All adolescents experience loss.
Remember that the conclusions generated from deductive reasoning are valid only if they are based on valid premises!
Consider this example:
Premises: All health professionals are caring.
All nurses are health professionals.
Conclusion: All nurses are caring. **** Note: * The premise that all health professionals are caring is not valid nor an accurate reflection of reality.
Research is a means to test and confirm or refute a premise, so that valid premises can be used as a basis for reasoning in nursing practice.
Inductive reasoning (particular to general) underlies qualitative research.
If inductive reasoning is used most often in qualitative research, then is deductive reasoning used most often in quantitative research?Yes! Deductive reasoning is most often used in quantitative research.
How is deductive reasoning used in quantitative research?
Deductive reasoning uses two or more variables that form the basis for a concluding assertion of a relationship between the study variables (termed "relational statements"); quantitative research uses data represented as numbers.
Conveys the general meaning of the concept; it reflects the theory used in the study of that concept.
(see box 5-4, pg 142 of textbook)
These definitions are GENERAL and give no indication of how the concepts will be MEASURED!!
Operational Definition
Delineates the procedures or operations required to measure the concept. Supplies the information needed to collect data on the problem being studied.
(see examples in box on pg 143 of textbook)
Remember, all variables or concepts in a study require conceptual and operational definitions. A conceptual definition provides the theoretical meaning of a concept or variable and is derived from a theorist's definition of the concept or is developed through concept analysis. The conceptual definition provides a basis for formulating an operational definition.
Term (example) Conceptual Definition Operational Definition TENS "TENS is thought to activate the large diameter, myelinated A-beta fibers which have a low threshold for electrical stimulation. The increased activity in these fibers would serve to decrease the transmission of painful stimuli through the small diameter A-delta and C fibers" (Melzack & Wall, 1984, p. 159 "Piece of equipment with a portable GRASS SD9 stimulator (Grass Instrument Co., Quincy, MA) and two pre-jelled sterile surface electrodes 3 cm in diameter (Myo-Trode II, No. 410)" (p. 160). Benefits "...Benefits are beliefs about the positive aspects that arouse motives to carry out health care activities" (Murdaugh & Hinshaw, 1986, p.19). "Benefit Scales (BES) are used to measure a person's perceived benefits in undertaking preventive behaviors that reduce risk factors in coronary artery disease." (p. 20). Health Care Activities "Health care activities are types of behavior, and behavior is defined as any response to meaningful stimuli that can be measured directly or indirectly." (p. 20). "In the present study, health care activities included participation in a regular exercise program or being a nonsmoker (p. 20)... Health Care Activity Scale is used to elicit smoking and exercise behaviors." (p. 21).
An operational definition is derived from a set of procedures or progressive acts that a researcher performs to receive sensory impressions that indicate the existence or degree of existence of a variable. Operational definitions need to be independent of time and setting, so that variables can be investigated at different times and in different settings using the same definition.
In experimental and quasi-experimental (quantitative) studies, operational definitions are specific and precisely developed.
In qualitative studies, the definitions of concepts are fairly abstract and broad, so the scope of the investigation is not limited. (Burns & Grove, 1993).
- As we have already noted, Nursing Research may be:
** Quantitative Research
- or -
** Qualitative Research
- Quantitative Research may be:
- Descriptive Research
Correlational Research
Quasi-Experimental Research
Experimental Research
- What about qualitative research?
- Qualitative Research uses nonnumerical data, generally collected through interviews, observations, and document analysis
"...in developing a theoretical framework for nursing, knowledge may be acquired from other disciplines or directly from nursing. In either case, that knowledge is used to answer specific nursing questions" (Wood & Haber, 1998)>
Furthermore, a Serendipitous finding:
However,
Critical thinking involves "thinking about your thinking" - to become clearer, more accurate, more defensible
The Problem Statement:
- provides direction to the study
- specifies what the researcher will examine
- helps the user of the research evaluate the study
Generally, the Problem Statement indicates:
- variables to be studied
- relationship between the variables
- specifics about the population studied
- possibility of using empirical testing
The hypothesis is:
- an intelligent "hunch"
- a bridge between theory and the real world
The Problem Statement:
- Identifies the variables under consideration
- Specifies the population being studied
- Implies the probability of empirical testing
- The Final Problem Statement:
- states the relationship between 2 or more variables; it clearly identifies the relationship between the independent variable (IV) and the dependent variable (DV).
However, as you read research, you may find that the problem statement may not be explicitly stated.
Often, you (the reader) must infer the problem statement from the study title, abstract, introduction or purpose!
Major points to remember when developing a research proposal:
Remember,
The research problem is a "situation in need of a solution, improvement or alteration or a discrepancy in the way things are or the way they ought to be" (Burns & Grove, 1993, p. 57).
(Note: 1 = hypothesis; 2 or more = hypotheses)
Research Hypotheses flow from the problem statement, literature review and theoretical framework
The hypothesis is more concise than the problem statement; it provides direction for conducting the study
The hypothesis is a statement about the relationship between 2 or more variables; it provides direction for gathering and interpreting data.
Hypotheses are written before data collection; they are never altered after data analysis; otherwise, the study is invalid!
The researcher formulates as many hypotheses as needed to address all aspects of the research problem.
In order to test the hypothesis, the researcher must be able to define all of the variables theoretically and operationally. Tell me more about hypotheses!
The hypothesis predicts relationships among two or more variables and identifies the population to be studied.
The hypothesis directs the research study, unifies theory and reality and helps extend nursing's knowledge base.
Hypotheses are never proven; they are accepted or rejected, or supported or not supported.
Hypotheses can be classified as simple, complex, directional, non directional, research or null
Each hypothesis is a subset of the research problem.
A hypothesis can be generated for each unit of the research problem.
The hypothesis converts the question posed by the research problem into a declarative statement.
The hypothesis must be testable: the variables must lend themselves to observation, measurement and analysis (Wood & Haber, pp 76-77)
- What is a Directional Hypothesis?
- A directional hypothesis specifies the expected direction of the relationship between the independent and dependent variables (see Table 3-8, p. 79 of textbook).
- What about a Non directional Hypothesis?
- A non directional hypothesis indicates existence of a relationship between variables, but does not specify the anticipated direction of the relationship.
Both forms of hypotheses statements are acceptable!
What about the Research (or scientific) Hypothesis?
The research hypothesis indicates what the outcome of the study is expected to be; directional or non directional. If statistically significant findings are obtained, then the hypothesis is supported. (see example, p. 81 of text)What is the Null Hypothesis?
The null hypothesis states that there is NO relationship between the Independent variable and the Dependent variable.
If you ACCEPT the Null hypothesis, then you have found NO statistically significant difference in your variables. (Example of Null hypothesis, p. 81, text) If you REJECT the Null hypothesis, then you HAVE found a statistically significant difference in the relationship between the study variables. So,
Rejection of the Null hypothesis = acceptance of the research hypothesis. (You are saying that there IS a difference between the study variables!)
A variable is a concept examined in a research study (examples: gender, age, heart rate, pain perception, skin integrity).
All variables must be concretely defined before they can be studied and measured.
What is the Dependent Variable (DV)?
In research studies, the DV is symbolized as "Y".The dependent variable is the study variable under investigation; it is the one that the researcher examines as a RESULT of conducting the study.
It may be the "effect" or "outcome" of experiment.
With Dependent Variables, the variability presumably DEPENDS on the cause or conditions manipulated by the researcher in the study.
Usually, the Dependent Variables are the ones that the researcher is intending to understand, explain or predict.
Dependent Variables are what the researcher measures about the subjects AFTER they have experienced or been exposed to the independent variable.
Dependent variables may also be referred to as the consequence variables.
Remember:The dependent variable is NOT manipulated! Instead, it is observed and measured (see p. 67, textbook).
What is the Independent Variable (IV)?
In research studies, the IV is symbolized by "X".The Independent Variable is the variable which has the presumed effect on the dependent variable (Y).
The Independent Variable IS manipulated by the researcher in experimental designs.
IVs are the causes or conditions the investigator manipulates or identifies to determine the effects or outcomes. Their values are established independently ahead of time by the investigator.
Independent variables precede measurement of the Dependent Variables.
"In non experimental research, the IV is NOT manipulated and is assumed to have occurred naturally before or during the study" (Wood & Haber, 1998 p. 67).
For example, in a non experimental research design, the investigator is studying the variable "anxiety" in preoperative patients. The patients' anxiety level is the independent variable - it occurs naturally - and the investigator is observing and measuring it only, the investigator is not manipulating it.
An extraneous variable interferes with the operations of the phenomena being studied (For example: age, gender, mental status, etc.). What is an Extraneous (Mediating) Variable?
An extraneous variable can affect the dependent variable and interfere with the results (see text p. 159).
Variables identify the concepts to be studied. What are Characteristics of Variables?
Variables are measurable.
Variables are usually narrow and specific in focus.
A confounding is an extraneous variable that has not been recognized or controlled. What is a Confounding Variable?
When planning a study, it is important to define relevant variables
and
also consider other variables that might have effects on the DV other than, or in addition to, the IV.Otherwise, these "other variables" can confuse interpretation of a study's results, because they confound the effects of the IV.
An Extraneous variable that is not controlled is a confounding variable. Remember,
The researcher always attempts to maximize the degree of control.
Rules used to achieve control are referred to as "design".
Through control, the researcher can reduce the influence or confounding effect of extraneous variables on the research variables.
Experimental studies are designed to have much control.
How does one achieve control?
- By subject selection (i.e., those who have a certain diagnosis)
- By manipulation of the setting (i.e., temperature, noise, ventilation)
- By the timing of data collection (i.e., to avoid factors such as fatigue, hunger)
Note: With Descriptive research, there is no control!
Evaluate your understanding of Independent/Dependent Variables! For the following examples, determine which it is: IV or DV?
- "Parents spend more time teaching their children about water safety after completing a water safety course".
- Completing a water safety course is the ____?
- Time spent teaching is the ____?
- "Oxygen inhalation by nasal cannula of up to 6 LPM does not affect oral temperature taken with an electronic thermometer".
- Oxygen inhalation by nasal cannula is the ____?
- Oral temp is the ____?
Rigorous = strives for more precise measurement tools, a more representative sample, tighter control
Tips on conducting the literature review:
- Use primary sources
- Organize the review write-up according to variables, and chronologically
- Consult a reference librarian and computer CINAHL database
- Use sources no more than 5 years old (unless documenting some historical information)
- What is a "synthesis of the literature"?
- Synthesis of the literature is combining ideas/concepts in the literature to form a conclusion.
Threat: a factor other than the IV which affected the study results.
Threats
- History: another event affected the DV (for example, a mass media campaign going on at the time of the study that was focused on the same issue)
- Maturation: "growing older, wiser, stronger, hungrier, more tired, more experienced" during the course of the study (Burns & Grove, 1993, p. 266)
- Testing: Subject remembers earlier responses and modifies or the pretest changes the subject's posttest response.
- Instrumentation: changes in the measurement device or observation technique may account for changes in the obtained score (i.e., data collectors become more experienced between the pretest and posttest and alter the data they collect)
- Mortality: Subjects drop out of the study before completion (also called "attrition") - this may affect the sample size, and the representativeness of the findings.
- Selection bias: Selection = the process by which the subjects are chosen to take part in a study; how subjects are grouped within a study. This threat is more likely to occur in studies without random selection of subjects. Those in the study may differ from those not in the study.
External validity depends on whether the relationship between the IV and the DV can be applied to other populations or situations.
What is the Hawthorne Effect?
(Same as reactivity)Named after an occurrence at Western Electric's Hawthorne plant. Workers changed their "normal" behavior because they knew they were being studied, not because of the experimental effects. (Wood & Haber, p. 168)
Reliability is concerned with consistency, accuracy, precision, stability, equivalence and homogeneity (Wood & Haber, p. 337).
Reliability asks: "How consistently does the instrument measure the concept of interest?"
Example: Use of a thermometer to measure temperature. Under different environmental conditions and with different techniques, one should always obtain the same results, if the instrument is reliable.
Remember, validity and reliability have to do with the instrument and NOT the study itself!
Example: Ask subjects to respond to an instrument on leadership - also ask them to respond to an instrument on management - to see if a high score on one indicates a high score on the other.
The process of developing construct validity for an instrument often requires years of scientific work (Burns & Grove, 1993, 268).
Random Selection: Each unit of the population has an EQUAL chance of being included in the sample.
Types of Probability Sampling
- Simple random sampling: Allows the researcher to select units randomly from a sampling frame (a list of all units of the population). Involves use of a table of random numbers (see text p. 257). Very time consuming and inefficient (Wood & Haber, p. 258).
- Stratified Random Sampling: Requires the population to be divided into subgroups which are homogeneous. The goal is to achieve representativeness, uses a random selection process for obtaining sample subjects (Wood & Haber, p. 258)
- Cluster Sampling: Successive random sampling of units ("clusters") that progress from large to small and meet sample criteria. One begins with large clusters, or sampling units, then progresses to smaller units. This method is faster and less expensive than other types of probability sampling, but it is associated with more error and is difficult to analyze. (See example in text, p. 260).
- Systematic Sampling: Select every "kth" case drawn from the population (i.e., every 10th member listed...) One must use a starting point that is selected randomly; otherwise, it is not a probability sample. Need to narrowly define the population
- Snowball Sampling: Takes advantage of social networks and the idea that individuals with similar characteristics often group together. Used to locate samples difficult or impossible to locate in other ways. (Example: crack cocaine users)
Remember, a Population may consist of people, objects or events
Eligibility criteria (to be included in the study) are descriptors of the population which provide the basis for selection (for example, five year breast cancer survivors).
Randomization: random assignment to a groupExperimental Designs are used for testing cause-and-effect relationships.Control: Imposing of "rules" to decrease the possibility of error and to increase the probability that the study's findings are an accurate reflection of reality (Burns & Grove, 1993, p. 765).
Manipulation: "doing something" to at least some of the subjects (i.e., medication, therapy, teaching, etc.). (Wood & Haber, p. 178).
Quasi experimental Designs are used when full experimental control is not possible.
With a quasi experimental design, a "treatment" occurs but some characteristic of a true experiment is missing, often randomization, or perhaps, the presence of a control group.
Much qualitative research is "Ethnographic": It focuses on "scientific descriptions of cultural groups" (W & H, p. 229).
Ethnonursing research is described by Leininger from her theory of transcultural nursing.
A Cohort is a group of people who have something in common; who have been followed over time (Example: identify a cohort of 45 year old twins; follow them over the years to study their aging patterns).
Ex: An RN manager is assigned an honors graduate from what the manager considers to be a prestigious university; subsequently, the manager's evaluation of the honors graduate is biased.
Physiological toolsObservational tools
Interviews
Questionnaires
Likert Scale A Likert Scale uses a close-ended, "fixed response" format, such as: "strongly agree"; "agree"; "disagree"; "strongly disagree"
- Advantage: Easy to answer, easy to analyze
- Disadvantage: Forces answers from subjects (Wood & Haber, pp.316-318)
Types of Scales
(W & H, pp 352-354)
- Nominal:
- Classifies objects/events into categories
Example: 1 = Male; 2 = Female- Ordinal:
- Uses rank order
Example: Low - Medium - HighNo information is provided regarding the distance between low-medium-highOrdinal Scale (Likert)
Example: 5 = extremely depressed; 4 = very depressed; 3 = moderately depressed; 2 = slightly depressed; 1 = not depressed
Responses 5>4>3>2>>1 but there is no guarantee that the intervals between the numbers are equidistant.
- Interval:
- Equal intervals between the numbers
Example: BP reading: 150/90 > 140/90An interval scale has no absolute zero point; instead, zero is arbitrary.Example: Fahrenheit thermometer uses a zero point of "0"; Celsius thermometer uses a zero point of "32"
- Ratio Scale:
- Has rank order
Has equal intervals
Has an absolute zero point
A ratio scale is the highest level of measurement scale for statistical analysis
A ratio scale is used with physical/biological measures, not with psychosocial qualities
Review the Normal Curve (p. 360 of textbook)
- Skewness:
- non symmetry of the curve; if the longer "tail" is to the right, it is positively skewed; if the longer "tail" is to the left, it is negatively skewed (p. 361, 362 of textbook)
- Kurtosis:
- related to the peakness or flatness of a distribution (see figure, p. 362 of textbook)
Cross Tabulation Allows for visual comparison of data(example: sad by seasons)
| Type I: | Committed if you reject the null hypothesis when it is actually TRUE. (see figure 15-2, p. 374 of textbook) |
| Type II: | Committed if you accept the null hypothesis when it is actually FALSE. (see figure 15-2, p. 374 of textbook) |
In practice, a Type I error is more serious because if you say that differences do exist (and they do not), the potential is there for patient care to be adversely affected. (see example in textbook found on page 374).
Minimum alpha level for nursing research = 0.05With an alpha level of 0.05, if you conduct the study 100 times, the decision to reject the null hypothesis would be wrong 5 times out of those 100 trials. (textbook, page 375). This is what you are willing to accept (with an alpha level set at 0.05).
Examples:
- -0.76 is as strong a correlation as +0.76.
- 0.52 is "stronger" than 0.34. A positive (direct) relationship indicates that as the values of one variable become larger or smaller, so do the values of the other variable. A negative (inverse) relationship indicates that as the values of one variable tend to become large, the values of the other variable tend to become small.
- Values are displayed on a "scatter plot"
What is a research critique? According to Leininger (1968), a research critique is a "critical estimate of a piece of research which has been carefully and systematically studied by a critic who has used specific criteria to appraise...the general features..." The challenge is to determine what the researcher has tried to do and to evaluate the strategies selected, in light of the overall constraints of the study. The purpose of the critique is to help research investigators refine and improve their programs of inquiry, and to help research consumers decide how to use findings from a study, based on the judicious appraisal of its strengths and limitations (Wilson,1993, p. 269).
It is important that any study proposal include a plan for dissemination of findings - and money and time should be allotted for this purpose.
Conclusions should address implications for nursing: practice, education, and research
Findings must be communicated in order to have an impact on nursing practice
Communicate findings through a research report: written, oral, poster (be sure it is legible!)
A well-organized report needs to include the logical development of ideas and lead to a scholarly conclusion (Burns & Grove, 1993).
Always provide major conclusions and findings - and recommendations for further research.
Illustrations provide a picture of the results and often include diagrams and graphs which are discussed in the narrative of the report.
For journals, send query letters to editors to assess their interest in your topic (it is important to choose journals that are peer reviewed).
Keep your query letter limited to one page
Submit the manuscript to only ONE journal at a time.
Include: research problem; brief discussion; significant findings; author contact information
When writing the article, consider your journal audience:
The Nuremberg Code (1949) was the first international effort to create formal ethical standards
International standard adopted in 1964 by World Medical Assembly; revised in 1975
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created in 1974. It was charged with identification of the basic principles that should underlie the conduct of biomedical and behavioral research involving human subjects.
Three Basic Ethical Principles for research were identified:(see W & H, pp. 277, 280; course document)
- respect for persons
- beneficence
- justice
ANA "Human Rights Guidelines for Nursing in Clinical and Other Research"- nursing's code of ethics for research (see p. 283 of textbook)
- Deontology:
- a theory in which rules/principles are right in themselves (irregardless of consequences)
- Nonmaleficience:
- one ought not inflict harm/evil
- Formalism:
- the doctrine that acts are right/wrong regardless of consequences
- Paternalism:
- an attitude that another needs to be protected from consequences of own actions
- Justice:
- fair treatment; equal right of basic liberties for all
See additional Ethics terms for further information.
Protection of Human Rights (ANA, 1985): Five rights outlined are:
- Self determination
- Privacy and dignity
- Anonymity and confidentiality
- Fair treatment
- Protection from discomfort, harm (see textbook, p. 284-289)
Professional Codes of Ethics:
Informed ConsentInformed consent is the legal principle that "governs a patient's ability to accept or reject medical interventions designed to diagnose or treat an illness" (Wood & Haber, p. 285)
Informed consent "determines and regulates participation in research" (Wood & Haber, p. 285).
A researcher may NOT involve a human being as a research subject before obtaining the (legal) informed consent from the subject or a legally authorized representative (W & H, p. 285).
Subjects must be given time to decide to participate.
Subjects must never be coerced; they may withdraw from the study at any time without any penalty.
No data may be collected on subjects who refuse to participate.
Language of the consent form must be understandable (no > 8th grade reading level, no technical language).
Obtaining informed consent:
- Most often, the researcher engages in a personal discussion with potential subjects prior to obtaining informed consent.
- Always use written consent forms that assure anonymity and confidentiality; always signed and dated by the subject (minors, mentally incapable - legal guardian or representative signs). Subject gets original informed consent; researcher keeps a copy.
- If minimal risk is involved, information sheet & verbal explanation may suffice; in a volunteer convenience sample, completion and return of the completed instruments suffices as informed consent. (see textbook, pp. 285 - 293)
National Research Act (1974): mandates that all agencies (universities, hospitals, etc.) MUST submit with funding requests that they have an IRB (AKA "human subjects committee") which reviews research projects and protects the rights of human subjects (see textbook, p. 293).
IRB Requirements
- Minimum 5 members
- Various backgrounds
Qualified by virtue of expertise and experience - Diversity of members (gender, racial, professional, cultural)
- At least one member with nonscientific concerns (e.g., clergy, lawyer, ethicist)
- At least one member from outside the agency (see textbook, p. 293)
IRB Roles Determines if the study has minimal level of risk to the subject; protects subjects from undue risk and loss of personal rights and dignity
Provides guidelines to researchers to enhance approval
IRB may approve, require modifications or disapprove a study
IRB approval MUST be received before beginning research
IRB may suspend or terminate approval if research is not conducted in accordance with the IRB requirements
IRB may conduct an expedited review:
usually shortens the length of the review process if project involves minimal risk - but - the IRB makes the FINAL determination and research cannot begin until that time! (categories for expedited review - see textbook, pp. 293-294)
Obtaining permission - write to the publisher
Copyright duration - depends upon original copyright date [?more detail]
U.S. Gov. documents - are in the public domain and are not protected by the Copyright Law
????(See additional information located in the Course document)????