Institutional Review Board
Human Research Protections (HRP)
– Feb 28, 2022 –
Kuali Research Protocols (KRP):
Department Chair (DC) or Organized Lead Unit Director (OLUD) Sign Off
Effective March 1, 2022, the IRB will require DC or OLUD sign off before releasing final protocol approval. This is the same requirement the IRB had before migrating to KRP.
Why is Department/OLU Review Needed?
Per HRP policy, the IRB relies on the DC /OLUD to help assess and provide an assurance to the following points:
- The Lead Researcher (and Faculty Sponsor) is competent to perform (and supervise) the study.
- All study team members are aware of their responsibility to disclose to the Conflict-of-Interest Oversight Committee (COIOC) any disclosable financial interests in the research. There is no (other) known disclosable conflict of interest related to this research than what is already specified.
- The research is appropriate in design (i.e., the research uses procedures consistent with sound research design, the study design can be reasonably expected to answer the proposed question, and the importance of the knowledge expected to result from the research is known).
- There are adequate resources and funds available to support the performance of this research.
What will the Review Process Look Like in KRP?
KRP will send an email to the DC or OLUD (or their designee) to alert them about each new protocol under their auspices, with a link to the protocol. DC or OLUD’s will communicate with their colleagues to request changes or ask for clarifications outside of KRP. When ready, the DC or OLUD will sign off on the protocol via the Ancillary Committee tab by marking ‘Approved.’
For a video of this process, step-by-step, click here.
For more information about KRP, please see the original announcement and/or refer to our IRB Listservs. Please contact HRP Stafffor questions related to IRB submissions, and please contact ERAfor technical questions related to KRP.