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How should adverse events be reported in US clinical trials?: ethical considerations

A E Shamoo1, L I Katzel

  • 1Department of Biochemistry and Molecular Biology, University of Maryland School of Medicine, Baltimore, Maryland, USA. ashamoo@umaryland.edu

Clinical Pharmacology and Therapeutics
|February 29, 2008
PubMed

Insights

Accurate reporting of adverse events in human subject research, including clinical trials, is vital. This ensures ethical conduct and proper risk assessment for drug and device development.

Area of Science:

  • Medical research ethics
  • Clinical trial safety

Background:

  • Human subject research, including clinical trials, is essential for evaluating drug and device safety and efficacy.
  • Adverse events in clinical trials can range from minor side effects to severe complications, including death.

Purpose of the Study:

  • To emphasize the critical role of adverse event reporting in ethical research.
  • To highlight the importance of risk assessment and minimization in human subject research.

Main Methods:

  • Review of regulatory criteria for research approval (45 Code of Federal Regulations 46.111).
  • Focus on risk assessment and minimization principles.

Main Results:

  • Regulatory criteria mandate a focus on risk assessment and minimization.
  • Accurate and complete reporting of adverse events is a key ethical requirement.

Conclusions:

  • Thorough adverse event reporting and risk assessment are fundamental to the ethical conduct of research involving human subjects.
  • Ensuring participant safety is paramount in all stages of clinical trials and research.

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