IRB Submissions

When is IRB Approval Required? 

If your project involves "research" and "human subjects" as defined by 45 CFR 46, you must submit an application to the Case Western Reserve University Institutional Review Board (IRB) for approval prior to the recruitment of study participants and the collection of data. Human research for student theses and dissertations always requires prior IRB approval. Data collected before approval is obtained cannot be used for research.

Who can be the Principal Investigator of an IRB Protocol submission? 

The principal investigator (PI) of all protocol submissions submitted to the IRB must be a CWRU faculty member. 

The definition of a CWRU faculty member includes: 

• CWRU Board of Trustees appointed faculty, who is eligible for benefits 
• CWRU Board of Trustees appointed faculty at an affiliate hospital* with research funding managed by the university 
• CWRU board appointed faculty or clinical faculty at an affiliate hospital* conducting research to benefit CWRU students 

Some exceptions can be made for individuals who meet the following criteria: 

• postdoctoral scholar or fellow with independent funding 
• research scientist, senior research associate or research associate; CWRU benefits eligible, with approval from department dean/chair or vice president of unit 
• other staff positions, with approval from department dean/chair or vice president of unit

* Affiliate hospitals are: Cleveland Clinic, The MetroHealth System, University Hospitals, Louis Stokes Cleveland Veterans Affairs Medical Center

When to submit a protocol submission to the CWRU IRB versus an affiliate hospital IRB?

Some CWRU faculty members also have an appointment at one of CWRU’s hospital affiliates. 

• If the faculty member is conducting research that will involve hospital patients, their data, and/or a hospital facility or equipment, the affiliated hospital IRB will be the IRB of record.
• If the CWRU faculty member is conducting research under their role as a CWRU faculty member and not recruiting hospital patients or using their data, then the CWRU IRB can be the IRB of record.

For questions or a consultation: Please contact the CWRU IRB at cwru-irb@case.edu or one of the hospital-affiliated IRBs:

• Cleveland Clinic IRB
• VA Northeast Ohio Healthcare System IRB
• University Hospitals IRB
• MetroHealth IRB

Getting Started

If you aren’t sure if your research activity requires IRB review, please contact cwru-irb@case.edu to learn whether IRB approval is required.

Request a SpartaIRB account

If you do not have one already, request a SpartaIRB account and make sure that the PI and all study team members have an active Continuing Research Education Credit (CREC) certificate. Additional training, such as Good Clinical Practices (GCP), may be required for certain research.

Access SpartaIRB to create a study

In SpartaIRB, prepare a protocol application by creating a new study and complete the information in the SmartForm.

Select the correct protocol template by determining the type of research you would like to conduct:

• Biomedical
• Social, educational, behavioral
• Chart review
• Biospecimens

Keep in mind:

• IRB submissions must be complete and review-ready when they are first submitted to the IRB.  Poorly prepared submissions negatively impact the review and approval times of well-prepared submissions by diverting significant time and resources to a small fraction of submissions that do not meet our basic standards for review.

Upload the required documents

The following documents are required to support your research study and must be uploaded in SpartaIRB:

• Informed Consent Document
• Questionnaires
• Recruitment materials
• Letters of Cooperation
• Approval letters from other committees/departments that are required to support the research activities in your protocol submission

Complete and submit the protocol 

In SpartaIRB, complete the protocol submission

• Submit it for Department Scientific Review.
• Once this review is approved, the PI is required to submit the application to the CWRU IRB.
• Respond to the CWRU IRB Office to answer any pre-review clarifications requested.
• Respond to the CWRU IRB Office to answer any clarifications/modifications required to secure approval.

Processing and Timeline Information

The CWRU IRB Committee and Office are committed to performing a thorough and timely review of submitted protocols. They are also dedicated to helping faculty members, staff and students move their research forward expeditiously in an ethical manner.

2024 CWRU IRB Initial Study Submission Turnaround

Average days from initial review to approval between Jan. 1, 2024 and April 1, 2024. The portfolio includes over 1,300 active protocols.

*Includes Request for Clarification and Modifications to Secure Approval processes

The review categories outlined in the table include:

• Non-committee Review
  • Exempt Review Determination: Research activities that present no more than minimal risk to human subjects and meet categories of Exemption from IRB review. Review is conducted by experienced IRB or HRPP administrators.
  • Expedited Review Approval: Research activities that present no more than minimal risk to human subjects and meet categories for Expedited Review. Review is conducted by at least one IRB committee member.
• Committee Review
  • Full Board Committee Review: Greater than minimal risk study, where review is conducted by the full board at a convened IRB meeting.

In addition to the review and approval of new studies, the IRB is responsible for review and approval of modifications, continuing reviews, study closures, and determining whether research falls under the Not Human Research or Not Engaged in Research category.

The IRB Office also works collectively with the Reliant Review Agreement Office to review federally funded studies that have multiple sites and are required to rely on one IRB of record (either the CWRU IRB or an external IRB). 

Submission Support and Recommendations

The IRB Office provides consultations to researchers via Zoom

• Office hours are conducted weekly via Zoom on Mondays from 10-11:30 a.m. and Wednesdays from 2:30-4 p.m. Please contact the IRB Office at cwru-irb@case.edu to schedule an appointment and obtain the Zoom link.
• In order to ensure a protocol submission is complete and adheres to the submission guidelines, consultations with an IRB administrator can be scheduled by emailing the CWRU IRB Office at cwru-irb@case.edu and requesting a Zoom meeting. 

It is strongly recommended to submit at least 4-6 weeks in advance of the proposed start date of the study whenever practicable to avoid delays in the onset of human research. The review process of IRB protocol submissions are contingent upon making sure all of the requirements are met within the IRB review and other departments which comprise the HRPP:

• IRB approval is dependent on meeting the regulatory criteria, institutional policies and procedures, and the cooperation of the investigator(s) in responding to the IRB's requests for clarifications and modifications promptly.
• IRB approval will be delayed if all study team members are not CREC certified and do not have a Conflict of Interests disclosure form on file.
• Completion of Ancillary Committee Reviews and meeting additional FDA requirements, if applicable, can delay IRB approval.
• NIH grants or submissions requiring Just-In-Time (JIT) Review. 
  • To ensure that the NIH's timelines are met, the IRB Office encourages investigators to start working on the study submission in the SpartaIRB system as soon as a fundable score is received.

Studies are reviewed in the order they are received. When investigators request that the IRB prioritize a review, it affects our ability to perform a timely review of those protocols already in the queue. This may cause a delay in the start of human research for your colleagues.

Investigators who believe that their submission requires immediate processing due to delays, which adversely affect study subjects, should contact the executive director for research compliance, and provide justification and a description of the specific circumstances.

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