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16 Cards in this Set
- Front
- Back
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Tuskegee Syphilis Study:
who? when? why? what did it result in? |
1932-1972
U.S. Public Health Services conducted studies on 600 low-income African Americans. They wanted to study the natural disease progression of untreated syphilis. They did not get informed consent or treat the patients with penicillin after the 1940s validation that it was an effective drug. It resulted in the Belmont Report |
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Belmont Report
3 main guiding principles of research? |
Respect for persons
Beneficence Justice |
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Guatemala STD experiments:
when? who? why unethical? |
STD research in Guatemala that was unethical in the U.S. The NIH funded for soldiers, prostitutes, and mental patients to be intentionally infected with STD.
They were given treatment, but it resulted in more than 80 deaths. |
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Nazi Experiments, lead to?
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Nuremburg code of medical ethics - most importantly informed consent
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Jewish Chronic Disease Study
who? where? what? |
22 elderly patients in a hospital in Brooklyn, NY were injected with live cancer cells in order to "discover the secret of the invasion of malignant cancer"
oral consent was not documented |
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Dr. Frances Kelsey
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Part of the FDA, did not allow thalidomide to be approved in the US - concerned of lack of scientific evidence of safety.
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Kefauver Amendments - what are they, and why were they passed?
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They were passed as part of the Food, Drug, and Cosmetic Act, to ensure drug efficacy and greater drug safety.
Result of the Thalidomide scare in the 1950s |
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Declaration of Helsinki
-what is it? who created it? enforceable? |
Basis for "Good Clinical Practices" used today
Created by the World Medical Association Moral but not legal |
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NIH OPRR - what does it do?
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Office for protection of research risks
created IRBs |
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National Research Act - NCPHS
What are they? and what did they do? |
national comission for the protection of human subjects of biomedical and behavioral research
they created the Belmont Report |
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Belmont Report
-created by who? -critique by who? and why? -3 tenants? |
created by NCPHS
operates at individual level and fails to address the needs of communities (environmental justice, etc) critique by Nancy Shore respect for persons, beneficence, justice |
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Nancy Shore
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critic of the Belmont Report - need more community-based participatory researchers, taking into account cultural, gender, ethnic, and geographic considerations. community interpretations.
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Common Rule
-when? -what? |
1991 - defines the current IRB system
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Human Dosing Studies
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Adds a safety factor for children (modifying factor) in the RfD
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CHAMACOS - what are the ethics surrounding the study?
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culturally sensitive study, with community advisory board (CAB) and has an ethical obligation to the participants
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Lockwood - Ethics in PH research & PESTICIDES
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6-human pesticide dosing studies submitted to the EPA all had serious ethical or scientific deficiencies --- financial conflicts of interest, lack of informed consent --- the US EPA should not rely on this type of study
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