What question did this study set out to answer?

To establish a comprehensive, systematic ethical framework for evaluating clinical research studies involving human subjects beyond the standard benchmark of informed consent.

May 24, 2000JAMA

What Makes Clinical Research Ethical?

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Authors

EEEzekiel J. EmanuelUniversity of Pennsylvania

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Implication

Ethical analysis outlines seven universal principles required to conduct human research, indicating that informed consent alone is insufficient to ensure ethical integrity.

Key Points

To establish a comprehensive, systematic ethical framework for evaluating clinical research studies involving human subjects beyond the standard benchmark of informed consent.
Synthesized core ethical principles and historical philosophies from foundational international codes, declarations, and regulatory human-subject protections.
Developed a systematic, seven-part normative model to define the necessary and sufficient conditions for ethical clinical trial design and conduct.
Demonstrated that informed consent is neither necessary nor sufficient alone to ensure that clinical research is ethically sound.
Established seven universal ethical requirements: social or scientific value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, and respect for enrolled subjects.
Concluded that fulfilling all seven requirements simultaneously is both necessary and sufficient for clinical research to be considered ethical across diverse settings.

Cite This Study

Ezekiel J. Emanuel (2000) studied this question.

synapsesocial.com/papers/69d7ca1ff39344339dd184d3 https://doi.org/10.1001/jama.283.20.2701

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Implication

Ethical analysis outlines seven universal principles required to conduct human research, indicating that informed consent alone is insufficient to ensure ethical integrity.

What Makes Clinical Research Ethical?

Discussion

Member takes

Implication

Key Points

Cite This Study

What Makes Clinical Research Ethical?

Discussion

Member takes

Implication

Key Points

Cite This Study

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