Chapter 20 - Biomedical And Research Support Flashcards
Attributable risk (AR)
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
Beneficence
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
Biomedical Research
The process of systematically investigating subjects related to the functioning of the human body
Case-control study
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
Clinical trial
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
Cohort study
A study, followed over time, in which a group of subjects is identified as having one or more characteristics in common
Cross-sectional study
A biomedical research study in which both the exposure and the disease outcome are determined at the same time in each subject
Double-blind study
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
Epidemiological study
Study concerned with finding the causes and effects of diseases and conditions
Experimental study
The exposure status for each individual in the study is determined and the individuals are then followed to determine the effects of the exposure
Health Research Extension Act
Federal legislation that established guidelines for the proper care of animals used in biomedical and behavioral research
Health services research
Research conducted on the subject of healthcare delivery that examines organizational structures and systems as well as the effectiveness and efficiency of healthcare services
Human subjects
Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research program
Incidence
Refers to the number of new cases of a disease
Informed consent
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
Institutional Review Board (IRB)
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
Justice
Requires that people be treated fairly and that benefits and risks be shared equitably among the population
Morality
A composite of the personal values concerning what is considered right or wrong in a specific cultural group
National Committee for Quality Assurance (NCQA)
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
Observational study
Study where the exposure and outcome for each individual in the study is studied (observed)
Odds ratio
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
Office for Human Research Protections (OHRP)
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
Office Research Integrity (ORI)
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
Prevalence
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
Principal
The individual with primary responsibility for the design and conduct of
investigator
a research project
Privacy Rule
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
Prospective study
A study designed to observe outcomes or events that occur after the identification of a group of subjects to be studied
