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Philosophy 2 - Safeguards = voluntary informed consent and...

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Philosophy 2 February 18, 2008 5 objectives = 1. Expand prisoner definition to anyone on parole or anyone whose liberties are criminally restricted by the judicial system 2. Ensure universal, consistent ethical protection Recommend = central data base 3. Shift from category-based to a Risk-Benefit based approach Recommend = R – B analysis similar to children – Only benefits to prisoners calculated @ Phase 3 – prisoners less then or equal to 50% No phase 1 or Phase 2 research 4. Collaborative Responsibility Recommend = incorporate as part of principle of justice 5. Enhance systematic oversight
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Unformatted text preview: - Safeguards = voluntary informed consent and privacy- The riskier research, the more stringent safeguards- universalize- Prisoner research advocate- expand the OHRP jurisprudence Phase 1 – first testing on humans after animal testing Phase 2 – larger study on effectiveness, study risks and short term side effects, gather information about dosages Phase 3 – several hundred to several thousand people in study, monitor long term effects Phase 4 – after FDA approval, gather additional information about risks and benefits in real life conditions...
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