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Clinical Trials and Ethics
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Flashcards
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Risk-Benefit Analysis
The potential benefits of a study must be weighed against the risks to the participants.
Post-Trial Access
Participants should have access to the best proven intervention identified by the trial, post-study.
Protection of Vulnerable Populations
Special considerations must be taken when the subjects are vulnerable or unable to consent.
Privacy and Confidentiality
Participants' data must be kept secure and private, with access limited to personnel with a need to know.
Placebo Use
The use of placebo in trials must be ethically justified, especially when effective treatments exist.
Informed Consent
Process by which a subject voluntarily confirms his or her willingness to participate in a particular trial.
Data Integrity and Reporting
Accurate and thorough reporting of clinical trial data is necessary to maintain integrity of research.
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