The Case Western Reserve University Institutional Review Board reviews social science/behavioral studies, and low-risk biomedical research not conducted in a hospital setting for all faculty, staff, and students of the University.
Guidance for Researchers - COVID-19
The Case Western Reserve University (CWRU) Institutional Review Board (IRB) has been working diligently to answer questions and process modifications for researchers whose studies have been affected by mandates surrounding the COVID-19 crisis. You can check out the guidance page or FAQs for additional information. We look forward to helping you.
Processing and Timeline Information
The CWRU IRB's portfolio includes over 1200 active protocols and averages 110 protocol submissions each month. 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 the reliant review process of studies that have multiple sites and are required to rely on one IRB of record (either the CWRU IRB or an external IRB). We are committed to performing a thorough and timely review of submitted protocols.
The current guidelines to submit IRB submissions are posted below as a general guide only. Submissions that are incomplete or do not adhere to IRB submission guidelines will require additional time for review and approval. Additional information can be found in the IRB Timeline document.
- It is strongly recommended to submit at least 8-12 weeks in advance of the proposed start date of the study whenever practicable to avoid delays in the onset of human subjects’ research.
- 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 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 in which 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 subjects research of your colleague.
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, Kim Volarcik (firstname.lastname@example.org) and provide justification and a description of the specific circumstances.
The Office of Research Administration has implemented SpartaIRB, which processes electronic protocol submissions efficiently and improves business process.
- About the CWRU IRB and Its Members
- Meeting Information and Types of Review
- Forms & Templates
- Local Policies and Federal Regulations
- CWRU Guidance
- Resources & Links
- Human Subjects Research Education
- Frequently Asked Questions
- Quality Improvement Program (IRB Auditing)
Questions or feedback for the IRB? Contact any of the following individuals:
CWRU IRB Office (email@example.com):
- Colleen Karlo: 216.368.0838, firstname.lastname@example.org
- Adelaide Lang: 216.368.6925, email@example.com
- Ginger Pomiecko: 216.368.4514, firstname.lastname@example.org
Kim Volarcik - CWRU IRB Director
Sana Loue, JD, PhD, MPH - IRB Chairman
Barbara Lewis, PhD - IRB Vice-Chair