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 CWRU 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 affiliate hospital (CC, Metro, UH, and VA) with research funding managed by CWRU
- CWRU Board appt Faculty/Clinical Faculty CWRU Board appt Faculty/ Clinical Faculty at affiliate hospital (CC, Metro, UH, and VA) conducting research to benefit CWRU Students
*Some exceptions can be made for individuals who meet the following criteria:
- Post-Doctoral Scholar/Fellow with independent funding
- Research Scientist/ Senior Research Associate/ 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
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 you aren’t sure if your research activity requires IRB Review, please contact the IRB Office to consult if IRB approval is required: firstname.lastname@example.org
Request a SpartaIRB account here and make sure that the PI and all study team members have an active Continuing Research Education Credit (CREC) Certificate and applicable training required by CWRU (GCP).
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:
- Social, Educational, Behavioral
- Chart Review
When creating the protocol submission please follow the following Submission Standards and Study Preparation Tips:
- 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.
- Informed Consent Document
- Recruitment materials
- Letters of Cooperation
- Approval letters from other committees/departments that are required to support the research activities in your 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 Offive to answer any clarifications/modifications required to secure approval.
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.
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 (email@example.com) and provide justification and a description of the specific circumstances.