Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

The regulations at 45 CFR 46.408 and 21 CFR 50.55 include the requirements for obtaining or waiving parental permission and assent of child participants.

The regulations define when assent of children will be required and when it can be waived. The IRB can waive the requirement for assent if either:

...