Nursing Research Chapters 3 & 4

Front 1

A priori

Back 1

Conceived or formulated before an investigation

Front 2

Beneficence

Back 2

A basic principle of ethics that states that persons should have their decisions respected, be protected from harm, and have steps taken to ensure their well-being.

Front 3

Ethics

Back 3

Concerned with researcher values, individual rights, personal beliefs, and societal norms. Tells us how we should conduct research. Guided by the researcher’s integrity. Applied though personal decision making. Legal guidelines tell us how are required to conduct research. Founded in laws and regulations.

Front 4

Exempt Review

Back 4

A review of study proposals that pose no risk to subjects; the full IRB is not required to participate.
ex: surveys, noninvasive procedures, secondary data or documents, methods where identification of subject is impossible

Front 5

Expedited Review

Back 5

A review of study proposals that pose minimal risk to subjects; one or two IRB members participate; probability/magnitude of discomfort not greater than what is encountered in daily life.

Front 6

Full Disclosure

Back 6

Reporting as much information about the research as is known at the time without threatening the validity of the study. This practice allows the subject to make an informed decision as to whether to participate.

Front 7

HIPAA

Back 7

Health Insurance Portability and Accountability Act passed by congress in 1996 that protects the privacy of personal health information.

Front 8

Informed Consent

Back 8

A process of information exchange in which participants are provided with understandable information needed to make a participation decision, full disclosure of the risks and benefits, and the assurance that withdrawal is possible at any time without consequences. This process begins with recruitment and ends with a signed agreement document.

Front 9

Institutional Review Board (IRB)

Back 9

The board required in research institutions that reviews and oversees all research involving human subjects and ensures studies meet all federal regulation criteria, including ethical standards; established by US department of health and human services; membership includes at least 5 diverse members.

Front 10

Justice

Back 10

A basic principle of ethics that incorporates a participant's right to fair treatment and fairness in distribution of benefit and burden.

Front 11

Nontherapeutic research

Back 11

Studies that are carried out for the purpose of generating knowledge. They are not expected to benefit the research subject, but may lead to improved treatment in the future.

Front 12

Respect for persons

Back 12

A basic principle of ethics stating that individuals should be treated as autonomous beings who are capable of making their own decisions. Persons who have limited autonomy or who are not capable of making their own decisions should be protected.

Front 13

Right of Privacy

Back 13

A persons right to have his or her health information kept confidential and released only to authorized individuals and to have his or her body shielded from public view.

Front 14

Therapeutic research

Back 14

Studies in which the subject can be expected to receive a potentially beneficial treatment

Front 15

Vulnerable populations

Back 15

Groups of people with diminished autonomy who cannot participate fully in the consent process. Such groups may include children, individuals with cognitive disorders, prisoners, and pregnant women.

Front 16

Human Rights in Research

Back 16

Subjects have the right to: Be informed about the study
;Expect fair treatment; Withdraw from the study at any time.

Front 17

International Guides for the Researcher

Back 17

The Nuremburg Code
The Declaration of Helsinki

Front 18

The Nuremburg Code

Back 18

Developed in response to the atrocities inflicted during WWII. Requires voluntary informed consent to participate in medical experimentation. Research must serve a worthy purpose. The anticipated result must justify the performance of the experiment. Human subjects must be protected from even a remote possibility of harm. This is when animal research began.

Front 19

The Declaration of Helsinki

Back 19

Differentiates research.

Therapeutic research: The subject has an opportunity to receive beneficial treatment.

Nontherapeutic research: Generating knowledge that might lead to improve treatments

Further protection of physically or mentally incapable of providing consent.

Front 20

National Guidelines for the Researcher

Back 20

National Research Act
The Belmont Report

Front 21

National Research Act

Back 21

National Commission for the Protection of human subjects of Biomedical and Behavioral Research.

Front 22

The Belmont Report

Back 22

Statement of ethical principles in which the regulation for the protection of human subjects are based.

Front 23

Ethical Principles

Back 23

Respect for persons: individuals are autonomous human beings capable of making their own decisions

Beneficience: do no harm

Justice: Subjects right to fair tx; fairness in distribution of benefits

Front 24

Ethical Researcher Responsibilities

Back 24

Respect the person’s autonomy, Use the principle of justice in subject selection, Minimize potential harm, maximize possible benefits for all subjects in the study, Assure that benefits and burdens associated with the research is distributed equally for subjects of the study, Protect privacy and confidentiality, anonymity

Front 25

Maintaining Research Integrity

Back 25

Ensure that research data is not manipulated or changed to seem more significant

Front 26

Full review

Back 26

A review of study proposals that pose more than minimal risk to subjects, that do not qualify for exempt status, and in which the full IRB committee participates. Direct access to subjects is needed, protected health information is required, federal funds are received, and publication is anticipated.

Front 27

Common Law

Back 27

Judicial decisions; medical malpractice

Front 28

Administrative Law

Back 28

Governmental regulation; HIPPA

Front 29

Statutory Law

Back 29

Statutes; affect clinical researchers

Front 30

Tort Law

Back 30

Civil law; negligence, assault, invasion of privacy

Front 31

Who can provide consent?

Back 31

Directly from subject; from legal guardian if incompetent, minor

Front 32

Assent

Back 32

Person should still agree to be in study even though formal consent is from another party.

Front 33

Incomplete Disclosure

Back 33

is only allowable when the following conditions are met:
No other non-deceptive method exists to study the phenomenon of interest

The study will make substantial contribution to the body of knowledge

The deception is not expected to cause significant harm or emotional distress, and participants are debriefed about the deception as soon as possible

Front 34

Elements of the IRB

Back 34

Research project description
Description of sample and selection process
Risks and benefits for subjects
Protection of confidentiality / anonymity
Contact information
Explanation of compensation
Statement about voluntary participation

Front 35

Research Misconduct

Back 35

Fabrication
Falsification
Plagiarism

Front 36

Fabrication

Back 36

Making up data
Intentional misrepresentation of data

Front 37

Falsification

Back 37

Manipulates the data
Omits, adds data

Front 38

Plagiarism

Back 38

Ideas, written account is not the researcher’s

Front 39

Challenges of Internet Research

Back 39

Assure subjects have a safe, private space to respond. Support the ethical acquisition of web addresses; assure that the list owner has endorsed the study. Assess potential risk of harm to participants and the intrusiveness of the study.
Evaluate the vulnerability of the subjects. Implement a process to assure subjects are of legal age to participate (Williams, 2012)

Front 40

Concepts

Back 40

Abstract ideas or topics of interest that must be narrowed to researchable questions to be investigated

Front 41

Deductive

Back 41

A process of reasoning from a general theory to a specific and well-articulated question.

Front 42

Directional Hypothesis

Back 42

a one-sided statement of the research question that is interested in only one direction of change. Gives teh direction of the researcher's expectations for the study results.

Front 43

Hypothesis

Back 43

A restatement of the research question in a form that can be analyzed statistically for significance. Determines which tests should be run, which outcome is expected. A statement of an expected relationship (or lack thereof) and an identified direction of interest.

Front 44

Inductive

Back 44

A process of reasoning from specific observations to broader generalizations and theories.

Front 45

Non-directional hypothesis

Back 45

a two-sided statement of the research question that is interested in change in any direction.

Front 46

null hypothesis

Back 46

a statement of the research question that declares there is no difference between groups. Predicts no relationship between variables. In statistical analysis will accept or reject the null hypothesis.

Front 47

problem statements

Back 47

Statements of the disparity between what is known and what needs to be known and addressed by the research. Statements of the gap between what is known and unknown. Articulate the area of concern and provide support for the extent of the problem. Focus the research process on a known nursing practice problem

Front 48

purpose statements

Back 48

Declarative and objective statements that indicate the general goal of the study and often describe the direction of the inquiry. Objective statement indicating the general goal of the study. Describe the direction of the inquiry. Contain the key variables to be studied, their possible relationships, and the nature of the population of interest.

Front 49

replication study

Back 49

A study generated from previous research studies in which the research is reproduced to validate findings, increase generalizability, or eliminate or minimize limitations.

Front 50

research question

Back 50

A question that outlines the primary components to be studied and that guides the design and methodology of the study. Carefully constructed and refined.

Front 51

Feasibility of the study

Back 51

Appraised prior to developing the study design:
Evaluate:
requires resources, ethical considerations, specific variables to be studied, availability of the population, potential access to the setting

Front 52

The PICO approach

Back 52

Population: Who is the patient or what is the population of interest?

Intervention: What is the planned nursing intervention?

Comparison: What is the comparison intervention?

Outcome: What is the outcome of interest?

Front 53

FINER criteria

Back 53

Used for evaluating the desirability of a research question:
Feasible: adequate subjects, time, money
Interesting: Interesting to the researcher
Novel: confirms or refutes previous findings
Ethical: no unacceptable risk to subjects
Relevant: Knowledge, clinical, future study

Front 54

Descriptive study

Back 54

Studies a subject of interest in a defined population or setting

Front 55

Analytic study

Back 55

Studies that compare interventions and outcomes

Front 56

Prospective study

Back 56

Studies that are planned and carried out in the future under control of the researcher

Front 57

Retrospective

Back 57

Studies that use existing secondary data to answer a research question

Front 58

Simple Hypothesis

Back 58

Predicts the relationship between a single independent variable and a single dependent variable.
Ex:
Lower levels of exercise postpartum will be associated with greater weight retention

Front 59

Complex Hypothesis

Back 59

Predicts the relationship between two or more independent variables and two or more dependent variables.
Ex:
Low risk pregnant women who value health highly; believe that engaging in health promoting behaviors will result in positive outcomes are more likely than other women to attend pregnancy related education programs

Front 60

Statistical Hypothesis

Back 60

A statement about the way a random variable is distributed. An assumption about a population parameter.
Ex:
Suppose we want to determine whether a coin is fair and balanced. The null hypothesis might be half the flips would be heads etc.
We flip the coin 50 times resulting in 40 heads and 10 tails. We would reject the null hypothesis.