Effective May 1, HRP is streamlining the study team information collected for IRB review so that only the Lead Researcher (LR), Co-Researchers*, and Research Personnel (as indicated on the below Research Personnel Heat Map) should be listed in the IRB Application & Protocol Narrative.
How will remaining study personnel be tracked? LR’s are responsible for tracking changes to other study personnel who are not required to be listed in the IRB Application & Protocol Narrative. LRs may use the UCI Study Team Log template or something comparable. This log may be requested by the IRB or its partners at any time, such as School of Medicine Compliance and Privacy and the Conflict of Interest Oversight Committee so please be sure to keep it up-to-date. Administrative Contacts (AC) will continue to be listed in the IRB Application.
Please note that non-UCI LRs are not listed in the IRB Application or Protocol Narrative; instead they are listed in Appendix U (when UCI serves as the IRB of record) or Appendix R (when the UCI IRB relies on another IRB) following the Single IRB Reliance (sIRB) process. For more information on the sIRB process, see HRP News & Announcement: When UCI Serves as the IRB of Record for Cooperative Research: A Streamlined Process.
Because we still need to update IRB Applications, Protocol Narratives, website documentation and HRP policies, we are soft launchingthis change so that researchers may immediately benefit from it. A soft launch also give us the opportunity to collect feedback regarding this change prior to updating all associated documents. Please send your feedback and comments to or .
*Co-Researchers are faculty, staff, students and other academic appointees who the LR considers to be key personnel for conducting the research study. These individuals work closely with the LR to design, conduct, and/or report on the research.
| Role of Research Personnel | 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 LR and Co-Researcher(s) in the UCI IRB Application & Protocol Narrative. The LR is required to maintain a Study Team log or something similar to track Research Personnel independently. |
|
| Recruiting subjects directly via phone, email or in person | ||
| Access to subject identifiable data which may include PHI for data collection purposes |
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| Involvement in the informed consent process (i.e., explaining the study to prospective subject) |
||
| Interacting with subjects as part of study procedures; for greater than minimal risk research this may include more invasive procedures |
List the LR, Co-Researcher(s) and Research Personnel in the UCI IRB Application & Protocol Narrative. | |
| Involvement in the interpretation of study data | ||
| Finalization of the informed consent process (i.e., able to sign off as the individual obtaining consent) |
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| Has a disclosable financial conflict of interest | ||