Nursing Research Chapter 4

Front 1

Anonymity

Back 1

Condition in which the subject's identity cannot be linked, even by the researcher, with his or her individual responses.

Front 2

Assent to participate in research

Back 2

Affirmative agreement to participate in research by a child or adult with diminished responsibilities.

Front 3

Autonomous Agents

Back 3

Prospective subjects who are informed about a proposed study and who can voluntarily choose whether to participate.

Front 4

Benefit-risk ratio

Back 4

Ratio considered by researchers and reviewers of research as they weigh potential benefits (positive outcomes) and risks (negative outcomes) of a study; used to promote the conduct of ethical research.

Front 5

Breach of confidentiality

Back 5

accidental or direct action that allows an unauthorized person to have access to raw study data.

Front 6

Coercion

Back 6

Overt threat of harm or excessive reward intentionally presented by one person to another to obtain compliance- for example, offering prospective subjects a large sum of money to participate in a dangerous research project.

Front 7

Confidentiality

Back 7

Management of private data in research in such a way that only the research knows the subjects' identities and can link them with their performance.

Front 8

Consent form

Back 8

written form, tape recording, or video recording used to document a subject's agreement to participate in a study.

Front 9

Covered Entities

Back 9

Public or private entity that processes or facilitates the processing of health information.

Front 10

Covert Data Collection

Back 10

Data collection that occurs without subjects' knowledge or awareness

Front 11

Data use agreement

Back 11

Agreement that limits how the data set with health information may be used and how it will be protected in research

Front 12

Deception

Back 12

Misinforming subjects for research purposes.

Front 13

Diminished autonomy

Back 13

Condition of subjects whose ability to give informed consent voluntarily is decreased because of legal or mental incompetence, terminal illness, or confinement to an institution.

Front 14

Discomfort or harm

Back 14

Phrase used to describe the degree of risk for a subject participating in a study. These levels of risk include no anticipated effects, temporary discomfort, unusual levels of temporary discomfort, risk of permanent damage, or certainty of permanent damage.

Front 15

Ethical Principles

Back 15

Principles of respect for persons, beneficence, and justice relevant to the conduct of research.

Front 16

Principles of beneficence

Back 16

Ethical principle that encourages researchers to do good and, "above all, do no harm".

Front 17

Principle of justice

Back 17

Ethical principle that states that human subjects should be treated fairly in terms of the benefits and risks of research.

Front 18

Principle of respect for person

Back 18

Ethical principle indicating that people should be treated as autonomous agents with the right to self-determination and the freedom to participate or not participate in research

Front 19

Fabrication in research

Back 19

A form of scientific misconduct in research that involves making up results and recording or reporting them

Front 20

Falsification of research

Back 20

A type of scientific misconduct that involves manipulating research materials, equipment, or processes, or changing or omitting data or results, so that the research is not accurately represented in the research record.

Front 21

HIPAA

Back 21

Federal regulations implemented in 2003 to protect an individual's health info. This privacy rule affects not only the healthcare environment but also the research conducted in this environment.

Front 22

Human Rights

Back 22

Claims and demands that have been justified in the eyes of an individual or by the consensus of a group of people and are protected in research.

Front 23

Individually identifiable health information

Back 23

"...any information, including demographic information collected from an individual that is created or received by healthcare provider, health plan, or healthcare clearinghouse; and related to past, present, or future physical or mental health condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual, and identifies the individual; or with respect to which there is a reasonable basis to believe that the information can be used to identify the individual.

Front 24

Informed Consent

Back 24

Agreement by a prospective subject to participate voluntarily in a study after he or she has assimilated essential information about the study.

Front 25

Institutional Review

Back 25

Process of examining studies for ethical concerns by a committee of peers

Front 26

Complete Review

Back 26

Type of institutional review process for studies with risks that are greater than minimal. The review of a study is extensive or complete by an institutional review board.

Front 27

Exempt from review

Back 27

Designation given to studies that have no apparent risks for the research subjects and thus are designated as exempt by by an institutional review board.

Front 28

Institutional Review Board (IRB)

Back 28

A committee that review research to ensure that the investigator is conducting the research ethically.

Front 29

Invasion of Privacy

Back 29

Sharing private information with others without a person's knowledge or against his or her will.

Front 30

Minimal Risk

Back 30

Research subject's risk of harm anticipated in the proposed study that is not greater, considering probability and magnitude, than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations.

Front 31

Nontherapeutic Research

Back 31

Research conducted to generate knowledge for a discipline; the results might benefit future patients but will probably not benefit the research subjects.

Front 32

Permission to participate in research

Back 32

The agreement of parents or guardian to the participation of their child or ward in research.

Front 33

Plagerism

Back 33

A type of scientific misconduct that appropriates another person's ideas, processes, results, or words without giving appropriate credit, including those obtained through confidential review of others' research proposals and manuscripts.

Front 34

Privacy

Back 34

Freedom to determine the time, extent, and general circumstances under which private information will be shared with or witheld from others.

Front 35

Research misconduct

Back 35

Intentional deviation from practices commonly accepted within the scientific community for proposing, conduction, or reporting research; may include fabrication, falsification, or plagiarism; does not include honest errors or honest difference in interpretation or judgment of data.

Front 36

Therapeutic research

Back 36

Research that provides a patient with a patient with an opportunity to receive an experimental treatment that might have beneficial results.

Front 37

Voluntary consent

Back 37

Decision made by a prospective subject, of his or her own volition, without coercion or any undue influence, to participate in a study.