White Paper

Unique First-in-Human Phase I IRB Considerations you Might not Know About

An institutional review board (IRB) may ask some different questions for first-in-human (FIH) Phase I trials than later phase studies.

Our white paper helps address these questions, explaining why:

  • Informed consent form (ICF) revisions must be implemented quickly
  • IRB experience in Phase I is vital to properly protecting participants
  • FIH studies sometimes feature more robust payments and incentives
  • House rules are important for everyone’s safety
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