Page 270 - CHST Research Administration eBook 2 of 2 (Q4 2021)

U n a n t i c i p a t e d P r o b l e m s I n v o l v i n g R i s k s t o Su b j e c t s o r O t h e r s ( U P I R SO ) D e c i s i o n T r e e : What and When to Report to the UTSW HRPP/ IRB*
An event, experience, incident, or outcome occurs
No
Yes
Yes
Yes
No
No
No
Was it caused by or did it result in possible noncompliance (e.g., a deviation)?
Conduct noncompliance reviewusingthe Noncompliance Decision Tree
Co n t i n u e
UPIRSOCriteria#1:Isit unexpectedinnature, severity, or frequency?
Track & summarize at continuing review or notice of study closure, whichever comes
first
UPIRSO Criteria #2: Is it probably1 or definitely relatedtotheresearch?
UPIRSOCriteria#3:Doesit suggest theresearch placessubjectsor othersat agreater risk2 of harm (physical, psychological, social, financial, or legal) than was previously known or recognized?
Yes
If yes to ALL 3 UPIRSO criteria, report via RE within5workingdaysof discovery
* See section 9.0 in the HRPPpolicy and procedure manual and the REFAQsfor more information on UPIRSOs.
1 Probablymeanshavingmoreevidenceforthanagainst;morelikelythannot;over50%chance.Possiblymeansnotsure;don’t
know; lesslikely; could/might/maybe.
2 IsitNEWinformationthatindicatesparticipatingintheRESEARCHposesneworincreasedriskstosubjectsorothers?
NOTE: UPIRSOsrequire changesto research documents/investigational plans(e.g., protocol, IB, ICF, consent process) or other corrective actionsto protect theintegrity of the research or the rights, safety, or welfare of subjectsor others. Therefore, if no changesarebeingmadeasaresult of theevent,it isprobablynot aUPIRSO.
Version 3.0 Effective: November 18, 2019