Chapter 2 Understanding the Research Process and Ethical Issues in Nursing Research

Question 1

Anonymity

Answer 1

A condition in which the identity of subjects remains unknown, even to the researcher, to protect subjects participating in a study and to promote objective results.

Question 2

Applied research

Answer 2

1. A type of study designed to gather knowledge that has direct clinical application.
2. Most nursing research falls into this category.

Question 3

Basic research

Answer 3

1. A type of study designed to develop the knowledge base and extend theory without direct focus on clinical application.
2. Closely resembles the work done in laboratories and is associated with scientists.

Question 4

Confidentiality

Answer 4

Protecting data that are gathered or learned from patients by not disclosing information without their permission.

Question 5

Correlational research

Answer 5

A type of nonexperimental study designed to examine the relationship between and among variables.

Question 6

Cross-sectional research

Answer 6

1. A study that collects data at a particular point in time and does not require follow-up.
2. There is no attempt to document changes over time.

Question 7

Descriptive research

Answer 7

1. A type of nonexperimental study designed to provide a knowledge base when little is known about a phenomenon; used to describe variables rather than to test a predicted relationship.
2. A particular situation or event that already exists is described systematically. No attempt is made to examine relationships, make predictions, explain how a situation might be changed, etc.
3. Uses questionnaires, surveys, interviews, or observations to collect data; sample subjects represent the population at large.

Question 8

Experimental research

Answer 8

A study in which the researcher manipulates and controls one or more variables and observes the effect on one or more other variables.

Question 9

Human rights

Answer 9

The protection of subjects participating in a research study; includes (1) the right to freedom from injury, (2) the right to privacy and dignity, and (3) the right to anonymity and confidentiality.

Question 10

Longitudinal research

Answer 10

1. A study that follows a cohort of subjects and collects data over time.
2. Disadvantages: Loss of subjects at different points during the study; threat from testing effects because subjects are tested repeatedly.

Question 11

Nonexperimental research

Answer 11

1. A descriptive study that does not exhibit a great amount of control over variables.
2. Sometimes described as descriptive, correlational, or exploratory research.

Question 12

Prospective research

Answer 12

1. A study that examines data collected in the present.

2. More reliable than retrospective studies because of the potential for greater control of data collection.

Question 13

Retrospective research

Answer 13

1. A study that examines data collected in the past.

2. Typified by a review of medical records.

Question 14

Risk-benefit ratio

Answer 14

1. The relationship between potential harm to subjects and potential positive outcomes gained by participating in a research study.
2. An evaluation used by subjects to make voluntary informed consent.
3. The benefits should exceed the risks - a primary objective standard by which to judge the ethics of certain research procedures.

Question 15

Vulnerable research participant

Answer 15

Those persons who are relatively or absolutely incapable of protecting their own interests and unable to provide meaningful informed consent.

Question 16

Steps of the research process

Answer 16

1. Selecting and defining the problem.
2. Selecting a research design.
3. Collecting data.
4. Analyzing data.
5. Using the research findings.
   The process is circular - researchers may need to go back and forth to rethink and reconceptualize the problem several times.

Question 17

Selecting and defining the problem involves _

Answer 17

1. Identifying the problem (something that provides an opportunity to advance nursing knowledge) and writing the purpose statement.
2. Reviewing related literature.
3. Identifying pertinent variables.
4. Formulating research questions and hypotheses.

Question 18

Selecting a research design involves _

Answer 18

1. Identifying the sample, setting, and testing to be used (based on how the research problem is conceptualized).
2. Defining all measurements.

Question 19

Collecting data involves _

Answer 19

1. Using the data collection methods developed in steps 1 and 2.
2. Recording the data and organizing it into an appropriate form for analysis.

Question 20

Analyzing data involves _

Answer 20

1. Analyzing data (which may involve applying statistical procedures).
2. Interpreting findings and making valid conclusions about the data - including whether the hypotheses were supported or not supported.

Question 21

Using the research findings involves _

Answer 21

Disseminating the findings of the research (through journal articles, abstracts, oral presentations, and poster presentations).

Question 22

Classification of research is based on _

Answer 22

1. The purpose of a study.

2. The amount of control used.

Question 23

Applied research is usually performed _

Answer 23

In actual practice conditions, on subjects who represent the group to which the results will be applied.

Question 24

A high number of research studies in nursing are classified as _

Answer 24

Descriptive correlational designs.

Question 25

The basic documents that have been used to develop ethical guidelines in nursing research are based on _

Answer 25

1. The Nuremberg Code (1947) - protection of human subjects from risk or harm, the right to withdraw from experimentation, and adequate qualifications of those conducting research.
2. The Declaration of Helsinki (1964) - informing subjects of direct benefits/potential harms associated with the study before consenting to participate in the research, obtaining informed consent in writing.

Question 26

Tuskegee Syphilis Study (1932-1972)

Answer 26

The U.S. Public Health Service wanted to compare black men who had been diagnosed with syphilis with those who did not have syphilis. Due to a difficulty recruiting subjects, the experimenters told men that they needed to receive treatment for “bad blood”. They were not told they were participating in a research study. The experimenters further treated syphilis patients with a drug that they knew would not help the disease, resulting in progression of the disease and death.

Question 27

Willowbrook Study (1950-1970)

Answer 27

The subjects were mentally handicapped children who were intentionally given the hepatitis B virus for the purposes of studying the period of infectivity. Parents were required to consent for their children to participate in the study in order to admit their child to the school. They were not told about the serious consequences of infection with the hepatitis B virus, which has no cure.

Question 28

Two factors involved in attempting to ensure the right to freedom from injury

Answer 28

1. Ability of the benefit to justify participants’ exposure to involved risks.
2. The participants’ vulnerability.

Question 29

The use of subjects with limited civil freedom can usually only be justified when _

Answer 29

There is a predicted benefit to them or others in similar circumstances.

Question 30

Categories of vulnerable research subjects

Answer 30

Children; the cognitively impaired; the elderly (some); human fetuses; the mentally incapacitated; neonates; prisoners; sedated or unconscious (comatose) patients; students and employees; terminally ill patients.

Question 31

Informed consent requires _

Answer 31

1. A person has the mental capacity to (1) understand the information provided; (2) appreciate how it is relevant to their particular circumstance; (3) make a reasonable decision about participation in the study.
2. Providing potential subjects with sufficient information about participating in a research study.
3. Assuring subjects that participation is voluntary and can be withdrawn at any time without negative consequences.
4. Freedom from coercion.

Question 32

Office for Human Research Protections (OHRP)

Answer 32

The agency responsible for setting policies and regulations regarding the protection of the rights, welfare, and well-being of subjects participating in research.

Question 33

Self-determination

Answer 33

The idea that individuals have the right to decide for themselves whether they want to participate in a research study.

Question 34

Assent of a child

Answer 34

Refers to a child’s affirmative agreement (not failure to object) to participate in a research study - obtained in addition to informed consent from the parent or guardian.

Question 35

Institutional review board (IRB)

Answer 35

1. A review group responsible for ensuring that researchers do not engage in unethical behavior or conduct poorly designed research studies.
2. Feasibility of conducting a study is outside the realm of the IRB.
3. Most institutions and funding agencies have an IRB; lawyers, lay persons, and clergy often serve on IRBs to deal with nonscientific issues.

Question 36

Responsibilities of the nurse

Answer 36

1. As patient advocates, nurses must make an effort to verify the nature of a study and whether the study has been reviewed by an IRB.
2. The nurse must report ethical concerns about the study to both the researcher and the IRB.
3. The nurse should not assume that the rights of subjects have been adequately addressed unless the exact nature of protection has been specified.

Question 37

The research process is a _ process.

Answer 37

Decision-making.

Question 38

Nonexperimental research is often said to be weaker than experimental research in terms of _

Answer 38

Documenting a causal relationship.

Question 39

A researcher designs an experiment to test how variables interact to influence how well children learn. The main purpose of this study is _

Answer 39

Explanation.

Question 40

Abstract

Answer 40

A brief, succinct summary of an article or a research study; allows readers to determine whether or not they are interested in reading the entire manuscript. Usually 50 to 300 words.

Question 41

Qualitative research seeks to describe _ while quantitative research seeks to describe _

Answer 41

Experiences; phenomena.

Question 42

Basic ethical principles relevant to the conduct of research

Answer 42

Identified by the National Research Act of 1974:

1. Beneficence.
2. Respect for persons.
3. Justice.

Question 43

Informed consent

Answer 43

Knowing consent of individual or legal authorized representative, under circumstances that provide the prospective subject or representative sufficient opportunity to consider whether or not to participate without undue inducement or any element of force, fraud, deceit, duress or other forms of constraint or coercion.

Question 44

Expedited review by an IRB

Answer 44

Appropriate when there is minimal risk (no substantive increase beyond risks of ordinary life); when the study involves nonvulnerable participants, a nonsensitive topic, or noninvasive procedures; surveys, interviews.