Nursing Research Review
SOURCES OF DATA
Primary Sources (Preferred)
In research, primary sources are preferred. They are the original research from which the data came. Primary sources are factual and not subjected to interpretation by others.
Secondary sources are created when the original data (primary data) are interpreted or analyzed by another person (not the original researcher). These are “second-hand” accounts.
ETHICAL ISSUES IN NURSING RESEARCH
Institutional Review Boards (IRBs)
An important duty of the IRB is to ensure the rights, safety, and welfare of human research subjects who are participating in research studies in their institution, hospital, or clinic. According to U.S. Food and Drug Administration (FDA) guidelines, IRBs have the authority to approve or reject research proposals that are submitted to their institution or hospital. If an IRB member has a conflict of interest, “they must absent themselves from deliberation and abstain from voting” (FDA, 2014).
IRB Committee Members
The members of the IRB committee are formally designated to review and monitor research that involves human subjects at their institution. The IRB members are individuals who are affiliated with the institution. Therefore physicians, clinicians, or retail pharmacists who are not affiliated with the institution are generally not included in an IRB committee (unless they are hired as consultants). In addition, experienced staff members, not recent graduates, are preferred. The size of the IRB and the number of members depend on the type of institution.
Almost all types of biomedical and behavioral research in the United States require informed consent. Groups considered “vulnerable populations” require additional paperwork and consent requirements. The following groups have special protections and have additional informed consent requirements:
Infants and children younger than 18 years of age
Pregnant women, fetuses
Persons with mental disabilities
Persons who are economically disadvantaged
A report that outlines the important ethical principles that should be followed when performing research involving human subjects. The Belmont Report was issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979).
Tuskegee Syphilis Experiment
The Tuskegee experiment was an infamous study of 600 African American sharecroppers (1932–1972) in Alabama. The men were all tested for syphilis infection, and those who had positive results were never informed or treated. Because of this study, laws were passed that protect human subjects’ rights and mandate informed consent.
Informed Consent of Human Subjects
Research subjects must be informed that they have the right to withdraw from the research study at any time without adverse consequences or penalty. There are additional requirements for minors and vulnerable subjects.
Describe the study. Inform the subject of what he or she is expected to do (e.g., questionnaires, labs).
Describe the risk or the discomforts of participating in the study in the present and the future (if applicable).
Describe the benefits of participating in the study in the present and the future (if applicable).
Discuss the alternatives to the study. Allow enough time for the subject to ask questions.
Discuss whether there is any compensation or reward for participation.
Discuss how confidentiality and data will be secured to protect the subject’s identity.
Give the number and/or email address of the contact for the study so that the subject can contact that person if he or she has any concerns or problems with the study.
Any persons who are younger than 18 years of age.
Emancipated Minor Criteria
Legal court document declaring that the minor is an “emancipated minor”
Active duty in the U.S. military
Legally binding marriage (or divorced from a legally binding marriage)
Consent Versus Assent
Consent may only be given by individuals who are aged 18 years or older. A minor (who is not emancipated) as young as the age of 7 years up to age 17 years can give assent to participate in a research study but cannot give consent legally. The child should be assured that he or she can withdraw from the study after discussing it with his or her parents.
The parent or legal guardian must first consent to the minor’s participation in the study. In addition, the researcher needs parental permission to speak with the minor in order to obtain assent (the child signs a separate assent form).
α: Also known as the significance level or the “p-value.” It is usually set as either p <.05 or p <.01.
• A significance level of p <.05 means that there is a 5% probability that study results are due to chance.
• A significance level of p <.01 means that there is only a 1% probability that the study results are due to chance. Therefore, a α of p <.01 is “better” than an α of p <.05.
Control group: These are subjects in an experiment who do not receive treatment.
N: This letter indicates the total size of the sample.
n: This letter indicates the number of subjects in the group.
Significance level: Also known as the “α” or a “p-value.” The p-value is usually set at either p <.05 or p <.01. See additional explanation under “α.”
Any attribute or characteristic that varies and is measurable.
Independent variable: Variable that is being manipulated and is used to influence the dependent variable. In experimental studies, the researcher has control over the independent variable.
Dependent variable: This is the result of the manipulation of the independent variable.
• Example: Manipulation by researcher (independent variable) allows a response to manipulation that can be observed and measured (dependent variable).
An idea (or supposition) that can be tested and refuted. When conducting research, an examiner tests a hypothesis (or several hypotheses). He or she can either accept or refute the hypothesis.
Null hypothesis: Null hypothesis (H0): This is the opposite of the hypothesis being studied.
• Example: If the hypothesis is “corn plants grow faster when expose to sunlight; the null hypotheses is “corn plants will not grow faster when exposed to sunlight.” If the research data meets the set p value (p <.01), the results are considered significant (not due to random chance) and the null hypothesis can be rejected. But if the null hypotheses cannot be rejected, it means that there is no relationship between the variables and the results are due to chance.
A bell-shaped curve
Measures of Distribution
Also known as the average. Calculated by adding all of the scores together and dividing it by the total number.
Example: 5, 5, 5, 10, 10 (35 ÷ 5 = 7, average is “7”)
The number that is in the middle when values are arranged from lowest to highest (chronological order)
Example: 1, 3, 4, 5, 7, 10, 14 (median value is “5”)
The most common value or frequently occurring value in a set of scores
Example: 3, 5, 7, 7, 7, 8, 9, 10, 10 (mode is “7”)
The difference between the largest and smallest values in a distribution
Example: 2, 3, 5, 7, 10, 15 (15 – 2= 13, range is “13”)
Types of Studies
Studies done in the present (to the future). Longitudinal studies are a type of prospective study. Data are obtained in the present, and then periodically measured in the future.
Studies done on events that have already occurred (e.g., chart reviews, recall of events). Another name for this study design is “ex post facto.”
Long-term studies that follow the same group of subjects (or cohort) over many years to observe, measure, and compare the same variables over time. These are observational studies (there is no manipulation or intervention). For example, the Framingham Heart Study has tracked the same research subjects (N = 5,029) from the town of Framingham, Massachusetts. The goal is to study the development and identify the risk factors that are associated with the development of cerebrovascular disease.
Cohorts are simply groups of individuals that share some common characteristic such as gender, age, job, ethnicity, and so on. Cohort studies are useful for studying the causative factors or risk factors of a disease(s). For example, the Nurses Health Study is a longitudinal cohort study that examined the effects of oral contraceptive use in nurses over the long term. It has been expanded to study the effect of lifestyle choices on health.
A cross-sectional study compares differences and similarities between two or more groups of people or phenomena and collects data at one point in time.
An in-depth investigation of a single person, group, or phenomena.
Descriptive Versus Experimental Studies (Table 28.1)
In these studies researchers observe and collect pertinent information but do not manipulate or change the environment. Also known as observational studies.
A type of observational study in which the relationship (interrelationships) between at least two variables is evaluated. There are three types of correlations:
Positive correlation: Two variables change together in the same direction. For example, when variable A increases, then variable B also increases.