Submission Guidelines for Full Board, Expedited, Exempt and Limited Review
All submissions must be completed through IRBManager and should include the following items:
- IRB Application - https://up.my.irbmanager.com
- Informed Consent or a Request for a Waiver of Consent
- Protocol (the who, what, when, why, where & how of the study)
- All handouts that will be given to the study subjects, including any scripts for verbal surveys
- All other pertinent study documents (data collection forms, tools to be used, etc.)
- Completed Conflict of Interest forms for all study team members (must be completed annually)
- Certificate of completion of Conflict of Interest training (CITI training) for all study team members (must be updated every four years)
- Certificate of completion of Human Subject training (CITI training) for all study team members (must be updated every three years)
All applications are to be completed through the IRBManager website where you can attach the necessary forms to the application submission. Form templates can be found on our website under the Forms tab. The link to the CITI Conflict of Interest Training and CITI Human Subjects Training course can be found under the Education tab. If your CITI account is affiliated with UnityPoint Health - Des Moines, your researcher training and your Conflict of Interest training will automatically be updated within IRBManager.
Full Board Review - It is expected that either the principal investigator or a co-investigator will present a new protocol at a regularly scheduled meeting of the IRB. Amendments requiring full board review can be presented by the PI, Co-I or the study coordinator. Please review the Guidelines for Oral Presentation of a Protocol to the IRB prior to your presentation to the board.
The submission deadline for materials being reviewed by the full board is the 3rd Friday the month before the scheduled board meeting. Submissions received after this deadline will be put on the agenda for the following month's meeting. The UnityPoint Health-Des Moines IRB meets the 2nd Thursday of each month at 7am on the Iowa Methodist Hospital campus.
Expedited Review - Protocols may be submitted at any time. The investigator is not required to present the protocol to the full board. Federal regulations (45CFR46.110) define the types of research eligible for review by expedited procedures. Only the IRB Chair or his designee is authorized to make the determination whether a protocol qualifies for expedited review. The average turnaround time for expedited reviews is 10-14 business days once all required materials have been received and confirmed as complete. Submissions are processed on a first come-first served basis.
Exempt Review - Certain research activities are exempt from review and institutional oversight under 45CFR46.104. However, authority to classify research as exempt rests with the Chair of the Institutional Review Board and not with an investigator. Please refer to the UPHDM IRB Exemption Categories Tool for information on updated exempt categories.
Limited Review - Research which satisfies the criteria for exemption under 45 CFR 46.104(d) (2iii or 3C) undergo limited IRB review if information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects.
Applications may be submitted at any time. For exempt or limited review please select "exempt" as the study type on the application. The investigator is not required to present the protocol to the full board. Only the IRB Chair or his designee is authorized to make the determination whether a protocol qualifies for exempt or limited review. The average turnaround time for exempt and limited reviews is 10-14 business days once all required materials have been received and confirmed as complete. Submissions are processed on a first come-first served basis.
For more detailed information on Exempt Research Activities, please review our IRB Procedures, Section IV.A(3).