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.