IRB Process and Schedule

Human Subjects Protections (HSP) Certification

The UHCMC IRB requires all Principal Investigators, individuals obtaining informed consent, and Key Study Personnel (KSP) on federally funded research obtain CITI certification prior to conducting research. See IRB Policy – Certification in Human Subjects’ Protections. Questions regarding this certification can be directed to .

https://about.citiprogram.org/en/homepage

Once certified, investigators must maintain valid certification by participating in ongoing continuing research education credit (CREC) programs. The UH IRB follows the Case Western Reserve University requirements for re-certification.

Investigator Training

UH Investigator Training serves as an introduction and detailed overview of the research process here at University Hospitals and highlights the essential information needed to be successful. Completion of this course is required for all investigators and is strongly recommended for all staff conducting research at University Hospitals.

UH Investigator Training can be accessed through the UH GPS Learning Management System.

Research Credentialing

For all non-UH personnel that will have access to UH PHI, UH systems, or will be conducting research on UH facilities, credentialing is required. See UH Research SOP GA-103.

Additional credentialing information can be obtained on the UH Research Credentialing webpage.

IRB Process Flow (flowchart)
1. Submission

Study team submits to the IRB via the electronic system. You can login at https://spartairb.case.edu using your UH or CWRU username and password.

2. Pre-Review with IRB Specialist

The submission is assigned to an IRB specialist who reviews the entire submission. If clarifications are needed, the IRB specialist will send stipulations back to the study team that should be addressed (this back-and-forth may happen more than once).

3. Formal Review

Once the study team has sufficiently addressed all stipulations from the pre-review stage, the study will either be:

  1. Electronically expedited to an IRB chair or vice chair – for not greater than minimal risk studies (with exceptions)
  2. Assigned to the next full board meeting with an open agenda (meeting agendas are closed and sent out ~six days prior to the meeting date) – for greater than minimal risk studies (with exceptions)
4. Post-Review Results

The formal review may yield one of five results:

  1. Approved: No changes are needed and the IRB specialist may send an approval letter immediately.
  2. Approved with administrative confirmation: The submission is approved pending minor changes. Stipulations will be sent back to the study team and must be addressed before an approval letter may be sent.
  3. Approved with modifications: The submission is approved pending minor clarifications. Stipulations will be sent back to the study team and must be addressed before an approval letter may be sent.
  4. Deferred: Not enough information was available for the board to make a determination and the study must be brought back to a subsequent full board meeting. Stipulations will be sent back to the study team and must be addressed before the study is assigned to the next full board meeting for re-review.
  5. Disapproved: If a study is lacking in scientific merit, if it raises ethical questions that cannot be resolved, or if the risks outweigh the benefits.
5. Review Complete:

After the study is approved it is the responsibility of the PI and the study team to ensure communication with the IRB is maintained.

  1. Submit a continuing review six to eight weeks before study’s expiration date.
  2. Submit an addendum if there is any change in the study including (but not limited to): PI changes, protocol changes, informed consent form changes, and application changes.
  3. Submit personnel change forms to add or remove study personnel.
  4. Report deviations and adverse events to the IRB.
  5. Submit a file form when you have new information to present to the IRB. This can include, but is not limited to, updating the drug information sheet, updating the investigator brochure, reports from the data and safety monitoring committee, and reports from sponsors.
  6. Submit a closure when you are ready to close the study.

In order for a study to make the agenda for a Full Board meeting, the study must be completed with the Pre-Review stage six calendar days prior to the meeting date.