Kuali Research Protocols (KRP): No Transcription Study Team Amendments


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Institutional Review Board

Human Research Protections (HRP)

 

Kuali Research Protocols (KRP):

No Transcription Study Team Amendments

 

Version October 7, 2021

To ensure timely review of amendments, we are providing a new option in KRP.Study Team changes can now be made via amendment without requesting an ERA transcriptionThis will allow immediate placement of the amendment in IRB review queue.  Please remember that not all Study Team changes require an IRB amendment, and should follow guidelines below:

Role ofStudy Team

             MinimalRiskProtocol

GreaterThan

MinimalRiskProtocol

Access to subject identifiable data includingProtectedHealthInformation(PHI)forscreening/

determining eligibility

 

 

 

 

 

List only the Lead Researcher (LR) and Co-Researcher(s) in the KRP “Study Team” Section.

For Research Personnel (RP), the LR is required to retain a Study Team Log or List RP’s on the “Permissions” Tab in KRP.

Recruiting subjectsdirectlyviaphone,emailorin

person

Accesstosubjectidentifiabledatawhichmay

include PHIfordatacollectionpurposes

Involvement intheinformedconsentprocess (i.e.,explainingthestudytoprospectivesubject)

Performing researchproceduresthatinvolve greaterthanminimalrisk

 

 

List the LR, Co-Researcher(s) andResearch Personnelin the KRP “Study Team” Section.

Involvement intheinterpretationofstudydata

Finalization of the informed consent process(i.e., able to sign off as the individual obtainingconsent)

Hasadisclosablefinancialconflictofinterest

 

For more information on KRP, see the original announcement.

Any questions? Please contact HRP Stafffor questions related to IRB submissions. Contact ERAfor technical questions related to the use of KRP.