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

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 transcription.  This 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 of Study Team

Minimal Risk Protocol

Greater Than Minimal Risk Protocol

Access to subject identifiable data including Protected Health Information (PHI) for screening/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 subjects directly via phone, email or in person
Access to subject identifiable data which may

include PHI for data collection purposes

Involvement in the informed consent process (i.e., explaining the study to prospective subject)
Performing research procedures that involve greater than minimal risk  

List the LR, Co-Researcher(s) and Research Personnel in the KRP “Study Team” Section.

Involvement in the interpretation of study data
Finalization of the informed consent process (i.e., able to sign off as the individual obtaining consent)
Has a disclosable financial conflict of interest

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.