Phase 1 studies are designed to:
A. evaluate the pharmacokinetics and pharmacodynamics of new treatments
B. evaluate the risks of the treatment
C. evaluate how the drug influences the human body andhow the human body influences the drug
D. identify an appropriate dose to be used in subsequent phase 2 studies
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Analysis of the ethics of clinical research requires evaluation of three related risk-benefit profiles:
A. the risk-benefit profile of the interventions(s) under study
B. the risk-benefit profile of the included research procedures
C. the risk-benefit profile of the study as a whole
D. the risk-benefit profile of the investigator
The Nazi experiments are among the worst ever performed on human subjects. Some of these included:
A. Exposing research subjects to freezing cold temperatures, extremely low pressures, and high levels of electricity and radiation to study their effects on the human body
B. Inflicting wounds on human subjects to study wound healing (subjects were shot, stabbed, or injected with metal or glass)
C. Intentionally exposing human subjects to malaria, staphylococcus, tetanus, & other infectious diseases to study the effectiveness of vaccines
D. Injecting dye into human eyes to try to change eye color (many subjects went blind)
The Declaration of Helsinki (2013, Article 10) declares that, "Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for __________________."
TheDeclarationofHelsinki(2013, Article 9)declaresthat,"itisthedutyofphysicianswhoareinvolvedinmedicalresearchtoprotectthelife,health,dignity,integrity,righttoself-determination,privacy,andconfidentialityofpersonalinformationof_______________."
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