Health and Human Services Homepage

  U.S. Department of Health and Human Services | National Institutes of Health

Versions Compared

Old Version 44

changes.mady.by.user Pauly, Kelly (NIH/OD) [E]

Saved on

compared with

New Version 45

changes.mady.by.user Pauly, Kelly (NIH/OD) [E]

Saved on

Key

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

Reportable Events

Div
classpanel-top sans-heading


Federal regulations for the Protection of Human Subjects require that investigators notify the IRB when specific research-related events occur.  These regulations also require that IRBs have written processes for notifying federal agencies (OHRP and, as applicable, FDA) of NIH IRB or RCRC  (IRB) determinations including unanticipated problems, serious and/or continuing noncompliance, and any suspension or termination of IRB approval. NIH investigators are expected to know which events require expedited reporting via submission of a Reportable New Information (RNI) form in PROTECT.

...