Belmont Report was created as part of? Correct Answer: The national Research Act of 1974.
Who was the Belmont Report formulated by? Correct Answer: The National Commission for the protection of human subjects in bio
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Belmont Report was created as part of? Correct Answer: The national Research Act of 1974.
Who was the Belmont Report formulated by? Correct Answer: The National Commission for the protection of human subjects in biomedical and behavioral research.
What year was the publication of the FDA regulations made? Correct Answer: 1980 *1981 for the HHS and revised FDA Regulations.
What year was GCP and HIPAA created? Correct Answer: 1996
What is the National Research Act? Correct Answer: A set of regulations for the protection of human participants in research, mandated by congress in 1974, which lead to the Belmont Report.
What is GCP? Correct Answer: Good Clinical Practice- Guidelines developed by the ICH for global implementation on April 30, 1996
EU, Japan, USA
Australia, Canada, Nordic Countries and WHO.
What is the purpose of ICH? Correct Answer: International Conference of Harmonization- an attempt to streamline the process for developing and marketing new drugs internationally. *Eliminate duplicate research.
What are the ethical standards the ICH documents are based off of? Correct Answer: Declaration of Helsinki
The ICH is concerned with harmonization of what three regions? Correct Answer: European Union, Japan, USA. *Additional countries include: Australia, Canada, Nordic countries and WHO.
Important ethical principals that were the result of experimentations in the concentration camps during WW||? Correct Answer: Nuremberg Code
The organization that developed the Declaration of Helsinki? Correct Answer: World Medical Association.
Who does the Declaration of Helsinki mainly address? Correct Answer: Physicians
Who is Peter Buxton? Correct Answer: The journalist that leaked Tuskegee to the press.
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