How would you summarize the historical threats to the protection of human subjects in research
How would you summarize the historical threats to the protection of human subjects in research? What are some things you need to know for your proposed study to meet the seven principles put forth by NIH (see the week two assignment)?
Social and clinical value
Scientific validity
Fair subject selection
Favorable risk-benefit ratio
Independent review
Informed consent Respect for potential and enrolled subjects
What is an informed consent document for a research study; how does it differ from an informed consent for a surgery or a procedure?
How will you determine if a potential participant is fully informed and understands what is expected and how the research study may affect him/her?
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