Federal regulations require that grant applications or proposals that support human subjects research be reviewed and approved by an IRB. Sponsors, including NIH and NSF, will accept new grant proposals with the understanding that the researcher will proceed with the IRB review process upon receiving notification of a score in the fundable range. This is called the Just-in-Time procedure.
The NIH may issue awards with restrictions; the NSF may follow the same process, with the caveat that institutions provide documentation to make an award when proposals involve human subjects. In these cases, the principal investigator may ask the IRB to specifically and separately review and approve “planning phase” activities.
To initiate the process, please access the Kuali Protocols Portal to create a planning phase administrative request. The Kuali Protocol User Guide has a searchable table of contents to the specific sections of Guide to assist you in creating a protocol.
The request must include the objectives of the planning and development activities including:
- the planned participants
- the planned design of the study, and
- the potential benefits and/or risks participants may experience from participating in the research.
As part of its review, IRBs are required to ensure that the activities described in the grant are consistent with the proposed or IRB-approved protocol. At times principal investigators will plan research projects that will eventually lead to the submission of grant applications where human subjects use are either planned in future but have not been finalized, or when a PI received a “just-in-time” notice from a granting agency and is requesting documentation of IRB approval.
Please submit this request in Kuali IRB at least one (1) business day before you need approval for the determination. The ORPC staff will review the request, in conjunction with the IRB Chair, to make sure that there are no activities described in the planning and development involves human subjects. If this is the case, the ORPC will assign an IRB protocol number and administratively approve the planning and development project activities for up to 12 months.
Note that approval of this request is NOT actual IRB approval. PIs must submit an protocol application to before conducting begin the actual human subjects research.. The PI is responsible for notifying the Office of Sponsored Program of the of planning and development activities approval if such approval is associated with submission of a grant application.
Have a Kuali technical issue or problems with access? Contact the ORPC on this online form and we’ll send your issue to VPR Research Administrative Systems
IRB Application and Pre-review Consultation
The ORPC staff is available to answer any questions regarding the IRB submission process and IRB review of research studies. We also provide pre-review consultation to discuss all aspects of IRB review, from preparing the submission to completion of the study. The ORPC will send comments to investigators within one week if there are revisions required. Final versions are then forwarded to the IRB for review. If you have any questions, please contact us at compliance@umbc.edu.