History
1966 Dr. Henry K Beecher (anesthesiologist) wrote an article in NEJM describing 22 studies with controversial ethics that had been conducted by reputable researchers and published in major journals.
Beecher Article
45 CFR 46 Additional protections for research involving children.
Subpart D
Quorum
A medical device, cleared by the FDA, that is substantially equivalent to a predicate device.
510(k) Device
Requires written permission from a parent or a student who is 18 or older before releasing any identifiable information from a student's record.
FERPA
40 Year Public Health Service study designed to document the natural history of syphilis in African-American men.
Public Health System Syphilis Study
The probability of harm or discomfort...not greater...than those ordinarily encountered in daily life or during the performance of routing physical or psychological examinations.
Minimal Risk
Data set including only dates and/or zipcodes as identifiers
Limited Data Set
1963 liver cancer cells were injected into senile patients without their knowledge as part of a study of immunity to cancer.
Jewish Chronic Disease Study
Review conducted by the IRB Chair or designated IRB member.
Expedited review
Highest ranking IRB administrative authority
Instiutional/Organizational Official
Document describing deficiencies found during an FDA audit.
Form 483
PPRA
1956 An institution for mentally retarded children initiated a study to determine the natural history of viral hepatitis, and to test the effectiveness of gamma globulin as an agent for innoculating against hepatitis.
Willowbrook Hepatitis Study
A medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the US per year
Humanitarian Use Device (HUD)
1971 Mexican-American women seeking contraceptives from a clinic participated in a study that involved taking oral birth control then crossover to placebo.
San Antonio Contraception Study