Chapter 20 - Biomedical And Research Support

Question 1

Attributable risk (AR)

Answer 1

A measure of the impact of a disease on a population (for example, measuring additional risk of illness as a result of exposure to a risk factor

Question 2

Beneficence

Answer 2

A legal term that means promoting good for others or providing services that benefit others, such as releasing health information that will help a patient receive care or will ensure payment for services rendered

Question 3

Biomedical Research

Answer 3

The process of systematically investigating subjects related to the functioning of the human body

Question 4

Case-control study

Answer 4

A study that investigates the development of disease by amassing volumes of data about factors in the lives of persons with the disease (cases) and person without the disease

Question 5

Clinical trial

Answer 5

The final stages of a long and careful research process that tests new types of medical care to see if they are safe. 2. Experimental study in which an intervention or treatment is given to one group in a clinical setting and the outcomes compared with a control group that did not have the intervention or treatment or that had a different intervention or treatment

Question 6

Cohort study

Answer 6

A study, followed over time, in which a group of subjects is identified as having one or more characteristics in common

Question 7

Cross-sectional study

Answer 7

A biomedical research study in which both the exposure and the disease outcome are determined at the same time in each subject

Question 8

Double-blind study

Answer 8

A type of clinical trial conducted with strict procedures for randomization in which neither researcher nor subject knows whether the subject is in the control group or the experimental group

Question 9

Epidemiological study

Answer 9

Study concerned with finding the causes and effects of diseases and conditions

Question 10

Experimental study

Answer 10

The exposure status for each individual in the study is determined and the individuals are then followed to determine the effects of the exposure

Question 11

Health Research Extension Act

Answer 11

Federal legislation that established guidelines for the proper care of animals used in biomedical and behavioral research

Question 12

Health services research

Answer 12

Research conducted on the subject of healthcare delivery that examines organizational structures and systems as well as the effectiveness and efficiency of healthcare services

Question 13

Human subjects

Answer 13

Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research program

Question 14

Incidence

Answer 14

Refers to the number of new cases of a disease

Question 15

Informed consent

Answer 15

A legal term referring to a patient’s right to make his or her own treatment decisions based on the knowledge of the treatment to be administered or the procedure to be performed 2. An individual’s voluntary agreement to participate in research or to undergo a diagnostic, therapeutic, or preventive medical procedure

Question 16

Institutional Review Board (IRB)

Answer 16

An administrative body that provides review, oversight, guidance, and approval for research projects carried out by employees serving as researchers, regardless of the location of the research (such as a university or private research agency); responsible for protecting the rights and welfare of the human subjects involved in the research. IRB oversight is mandatory for federally funded research projects

Question 17

Justice

Answer 17

Requires that people be treated fairly and that benefits and risks be shared equitably among the population

Question 18

Morality

Answer 18

A composite of the personal values concerning what is considered right or wrong in a specific cultural group

Question 19

National Committee for Quality Assurance (NCQA)

Answer 19

A private not-for-profit organization dedicated to improving healthcare quality. Since its founding in 1990, NCQA has been a central figure in driving improvement throughout the healthcare system, helping to elevate the issue of healthcare quality to the top of the national agenda

Question 20

Observational study

Answer 20

Study where the exposure and outcome for each individual in the study is studied (observed)

Question 21

Odds ratio

Answer 21

A relative measure of occurrence of an illness; the odds of exposure in a diseased group divided by the odds of exposure in a non-diseased group

Question 22

Office for Human Research Protections (OHRP)

Answer 22

Provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the US Department of Health and Human Services (HHS). OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and socialbehavioral research

Question 23

Office Research Integrity (ORI)

Answer 23

Promotes integrity in biomedical and behavioral research supported by the US Public Health Service (PHS) at about 4,000 institutions worldwide. ORI monitors institutional investigations of research misconduct and facilitates the responsible conduct of research (RCR) through educational, preventive, and regulatory activities

Question 24

Prevalence

Answer 24

The proportion of people in a population who have a particular disease at a specific point in time or over a specified period of time; also known as prevalence rate

Question 25

Principal

Answer 25

The individual with primary responsibility for the design and conduct of

Question 26

investigator

Answer 26

a research project

Question 27

Privacy Rule

Answer 27

The federal regulations created to implement the privacy requirements of the simplification subtitle of the Health Insurance Portability and Accountability Act of 1996; effective in 2002; afforded patients certain rights to and about their protected health information

Question 28

Prospective study

Answer 28

A study designed to observe outcomes or events that occur after the identification of a group of subjects to be studied