Glossary

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Case Law

The LawSeqSM database collects reported judicial decisions that were issued in litigated cases.

CDC

"The Centers for Disease Control and Prevention (CDC) serves as the national focus for developing and applying disease prevention and control, environmental health, and health promotion and health education activities designed to improve the health of the people of the United States." (Centers for Disease Control and Prevention. Accessed April 13, 2018).

CLIA

The federal Clinical Laboratory Improvement Amendments. "The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the US through the CLIA rules." (Centers for Medicare & Medicaid Services. Accessed April 30, 2018).

Clinical Trials

"A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." ("NIH's Definition of a Clinical Trial." Office of Extramural Research, National Institutes of Health. Accessed May 10, 2018). 

Clinical Validity/Clinical Utility

"Clinical validity refers to how well a genetic variant being analyzed is related to the presence, absence, or risk of a specific disease. Clinical utility refers to whether a test can provide information about diagnosis, treatment, management, or prevention of a disease that will be helpful to a consumer." ("How Can Consumers Be Sure a Genetic Test is Valid and Useful?" Genetics Home Reference, US National Library of Medicine. Accessed April 18, 2018).

CMS

The Centers for Medicare & Medicaid Services "is the federal agency that runs the Medicare program. In addition, CMS works with the States to run the Medicaid program. CMS works to make sure that the beneficiaries in these programs are able to get high quality health care." (Glossary, Centers for Medicare & Medicaid Services. Accessed May 7, 2018).

Common Rule

The "Common Rule" refers to the section of HHS regulations governing research with human participants that is followed by multiple federal agencies. ("Federal Policy for the Protection of Human Subjects ('Common Rule')," Office for Human Research Protections, US Department of Health & Human Services. Accessed June 13, 2018). 

Confidentiality

Researchers who work with human participants are required to maintain confidentiality, which means that "with limited exceptions, researchers may not disclose names or any information, documents or biospecimens containing identifiable, sensitive information. . . . [This refers to] information about an individual, gathered or used during the course of biomedical, behavioral, clinical or other research, through which the individual is identified, or there is at least a very small risk that some combination of the information, a request for the information, and other available data sources could be used to determine the identity of an individual. . . . Identifiable, sensitive information includes but is not limited to name, address, social security or other identifying number; and fingerprints, voiceprints, photographs, genetic information, tissue samples, or data fields that when used in combination with other information may lead to identification of an individual." ("General Information on Certificates." Certificates of Confidentiality Kiosk, National Institutes of Health. Accessed May 7, 2018). 

Contract

"An agreement between private parties creating mutual obligations enforceable by law. The basic elements required for the agreement to be a legally enforceable contract are: mutual assent, expressed by a valid offer and acceptance; adequate consideration; capacity; and legality." (Legal Information Institute, Cornell Law School. Accessed May 7, 2018).