Words & Phrases
An individual who participates in research as either a recipient of the test article or as a control.
Human Subject
Legally responsible for the conduct and oversight of a clinical trial at a site.
Principal Investigator?
Principle of doing no harm, maximizing benefits while minimizing risks.
Beneficence
In the Tuskegee Syphilis Study, this information was not provided to subjects participating in the study.
Purpose of study (syphilis) and availability of penicillin.
Statement of ethical principles put forth by the World Medical Association in 1964 that defined rules for research.
Declaration of Helsinki
The belief that the purpose of a clinical trial is to benefit the individual patient rather than to gather data for the purpose of contributing to scientific knowledge,
Therapeutic Misconception
Organization or individual who funds, designs, collects and analyzes data and reports updates to regulatory authorities.
Sponsor
Codification of the rules and regulations governing clinical research published in the Federal Register by agencies of the federal government of the United States.
Code of Federal Regulations
The ethical basis for medical research that involves assigning patients to different treatment arms of a clinical trial.
Clinical Equipoise
A standard for design, conduct, performance, monitoring, recording, analysis and reporting of clinical trials.
Good Clinical Practice (GCP)
Three categories of IRB review of research based upon risks to subjects.
Full Board, Expedited, Exempt
Group formally designated to review biomedical research to protect human subjects.
Institutional Review Board
Portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA)
Title 21
Withholding or omitting of information; the researcher intentionally does not tell participants some information about the study.
Passive deception
Provides leadership in the protection of the rights, welfare, and well being of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS)
Office of Human Research Protections (OHRP)
The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life, or during the performance of routine physical or psychological examinations or tests
Minimal Risk
An independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.
Data Monitoring Committee
Concept that information necessary to make a decision must be presented to a subject and that their participation must be voluntary.
Respect for Persons
Response to the thalidomide disaster in Europe manding drug efficacy be established through a clinical trial. Also instituted stricter control over drug trial manufacturing.
1962 Kefauver-Harris Amendments
Landmark document of 10 guidelines for the ethical treatment of human participants in research.
Nuremberg Code
A systematic investigation, including research development, testing and evaluation involving living individuals designed to develop or contribute to generalizable knowledge.
Human Subject Research
Through this agreement, an institution commits to comply with the requirements of 45 CFR part 46.
Federalwide Assurance
Risks and benefits should be equitably distributed among different populations.
Principle of Justice
Refused to authorize thalidomide for market because she had concerns about the drug's safety.
Frances Kelsey
Protects individually identifiable health information held or transmitted by a covered entity.
Health Insurance Portability & Accountability Act