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Optimizing Informed Consent in Cancer Clinical Trials.

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Informed consent is a cornerstone of US biomedical research ethics. Challenges in obtaining informed consent persist due to systemic, clinician, and patient factors, necessitating ongoing interventions.

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Area of Science:

  • Biomedical Ethics
  • Clinical Trials
  • Health Policy

Background:

  • Informed consent evolved into a foundational ethical principle for US biomedical research throughout the 20th century.
  • Despite regulation, obtaining informed consent in cancer research faces significant systemic, clinician, and patient-related barriers.

Purpose of the Study:

  • To review the historical development, policy landscape, and practical challenges of informed consent in clinical trials.
  • To examine the evolving role of informed consent in light of emerging technologies and research methodologies.

Main Methods:

  • Literature review of historical documents, policy statements, and contemporary research on informed consent.
  • Analysis of factors impeding informed consent processes in clinical research.
  • Discussion of new challenges posed by genomic sequencing, editing, and artificial intelligence.

Main Results:

  • Informed consent is a critical ethical tenet in clinical trials, yet its implementation is frequently hindered.
  • Innovations in trial design, genomics, and AI introduce novel complexities to the informed consent process.
  • Systemic, clinician, and patient-level factors require multifaceted interventions to improve consent acquisition.

Conclusions:

  • The ethical principle of informed consent in clinical trials requires continuous adaptation to address evolving research practices and technological advancements.
  • Addressing pragmatic challenges in informed consent is crucial for ethical and effective biomedical research.
  • Future research and policy should focus on mitigating barriers and ensuring robust informed consent in the era of precision medicine and AI.