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Rethinking the Research Ethics Regime: Historical Reflections on Scarcity, Precarity, and Inequity in Clinical Trials
Perspectives in Biology and Medicine
|December 8, 2025
Summary
The post-World War II bioethics system, emphasizing informed consent and review, faces challenges. Emerging trends like precision medicine question its current efficacy and relevance.
Area of Science:
- Bioethics
- Medical Ethics
- Research Ethics
Background:
- Post-WWII bioethics emerged after Nazi atrocities, focusing on human subject protection.
- Key principles include informed consent, autonomy, and rigorous peer/public review.
- This established regime governs the ethical management of research.
Purpose of the Study:
- To examine the historical development of the post-WWII bioethics framework.
- To assess the current challenges and "fit" of this system with modern research.
- To analyze emerging trends impacting bioethical governance.
Main Methods:
- Historical analysis of research ethics regulations and principles.
- Assessment of contemporary bioethical debates and their drivers.
- Review of evolving trends in therapeutics and patient rights.
Main Results:
- The traditional bioethics framework is being questioned in the 21st century.
- Precision therapeutics and "right to try" movements challenge existing protocols.
- The "fit" of historical bioethical foundations with new scientific advancements is debated.
Conclusions:
- The efficacy of the current bioethical management system is under scrutiny.
- Revisions to historical bioethical foundations are being considered.
- Adaptation of bioethics is necessary for emerging medical innovations.
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