The Stanford HRPP Policy Manual (Chapters 3.9, 3.10 and 3.11) and Stanford Prompt Reporting Guidance (GUI-P13) have been updated effective July 2022.
Substantial changes include:
· Updated definition of an Unanticipated Problem (UP) to (underlined text is new):
o Unexpected, and
o Related or Possibly Related and
o Places Subjects or Others at a Greater Risk of Harm (notably, this includes privacy-related risks)
· Expanded definitions for:
o Serious Noncompliance
o Continuing Noncompliance
- Updated Stanford HRPP Policy Manual Chapters 3.9, 3.10, 3.11 at https://researchcompliance.stanford.edu/panels/hs/policies
- Update Stanford Prompt Reporting Guidance (GUI-P13) at https://researchcompliance.stanford.edu/panels/hs/policies/guidances
Action: Please review the updated definition of a UP in the attached guidance or at the link below as this is substantially different from the prior definition. Please also review the updated definitions that will apply to various types of noncompliance.
Additional training and communications will occur in various venues.