Addressing the Ethical Challenges of First-inHuman Trials

  title={Addressing the Ethical Challenges of First-inHuman Trials},
  author={Audrey R. Chapman},
Phase I clinical trials raise ethical challenges, particularly the Phase I trials that involve a novel therapy being tested in humans for the first time, usually termed first-in-human (FIH) trials. The ethical appropriateness of clinical research requires having a favorable risk-to-benefit ratio and protecting patients from excessive risk, but both of these standards may be difficult to assess and to achieve in Phase I trials. There are no widely accepted standards for judgments concerning risk… CONTINUE READING


Publications citing this paper.
Showing 1-10 of 13 extracted citations

Rethinking risk assessment for emerging technology first-in-human trials.

Medicine, health care, and philosophy • 2016
View 12 Excerpts
Highly Influenced

The ethics of HIV "cure" research: what can we learn from consent forms?

AIDS research and human retroviruses • 2015
View 1 Excerpt


Publications referenced by this paper.
Showing 1-10 of 38 references

Similar Papers

Loading similar papers…