SODM research projects involving human subjects are required to obtain IRB approval from a "home" institution (CWRU or UH) before the start of any research activities. Use the information below to learn about the purpose of IRBs and how to get started on your submission.
It is vital that IRB policies are followed, as violations may have serious consequences, including termination of research and disciplinary actions.
**NEW** In early 2021, the SODM has implemented a new process for DMD students, graduate students, residents, and interns who submit protocols to the IRB for projects. These submissions will go through a pre-submission review by Dr. Catherine Demko to help identify any common mistakes or omissions in the submission which can prolong the review process. Details can be found here. Please contact Dr. Demko with any questions.
**NEW** Please review the Timeline document from the CWRU IRB office to get a better understanding of the flow of an IRB submission and also information on the time required for a review.
A general overview of the IRB process and requirements has been prepared for the SODM community. Additionally, more information about the CWRU IRB can be found in a recent presentation to the SODM DMD students by Colleen Karlo of the CWRU IRB office.
Important information regarding the policies associated with protected health information used in research.
Submissions for IRB approval are completed in Sparta IRB. Click here to access SpartaIRB!
SpartaIRB requires that the majority of information be submission on an approved template. The type of project you propose to do will determine which template you should use for the protocol. Templates, instructions, and other useful information is housed in the SpartaIRB Library. Log into SpartaIRB and access the Library from the main page. UH has created an Investigator Manual that can be used as a submission guide. Though it is specific to applications being submitted to the UH IRB, the underlying processes are generally the same for the CWRU IRB. However, please be sure to consult the instructions for the IRB to which you are submitting.
Institutional Review Boards are committees of scientific experts, employees, faculty members, and community representatives who are responsible for reviewing human subjects research conducted at a given institution.
Research - A systematic investigation that is designed to develop or contribute to generalizable knowledge (45 CFR 46.102)
Human Subject - A living individual about whom an investigator is conducting research obtains data through (1) intervention or interaction with the individual OR (2) identifiable private information (45 CFR 46.102). Note that retrospective chart review research studies are still considered "human subject research" and require IRB approval.
An exemption is a determination that the human subject research in question meets the federal requirements to waive IRB review. Investigators are generally prohibited from making exemption determinations themselves. Rather, all research involving human subjects must be submitted to an IRB for a determination of exemption.
Expedited review means that the research in question meets the criteria listed in 45 CFR 46, and as such, can be reviewed and approved by one or more of the members of the IRB.
3. Full Board
A full board review means that the research in question must be discussed and voted on by a quorum of IRB members in order to obtain IRB approval. All research that the IRB does not exempt of expedite requires full board review. Full board meetings generally occur at least once a month. A full board review may increase the time a study takes to get approved. It is important to submit all required documents by meeting deadline dates in order to avoid unnecessary delays. If an investigator does not submit a protocol requiring full board review before the meeting deadline date, the review will automatically take more time, as it will not be reviewed until the next full board meeting. Some projects require multiple full board review due to poorly written initial protocols/documents that require substantial revision. IRBs will not approve projects lacking required information or that are unclear.
Submitting to the IRB
Investigators are responsible for submitting their studies to the appropriate IRBs for approval, as well as monitoring the progress of submissions and responding to IRB inquiries. Approval timeframes vary based upon IRB, type of submission, and nature of the research. Approval for an Initial Review Submission can expected to take at least 4 weeks, with more accurate averages around 8-12 weeks.
While some research projects may not require IRB oversight, that decision can only be determined by the IRB.
The majority of human subjects research in the SODM will be submitted to the CWRU IRB. However, CWRU has agreements to allow approval from five different local IRBs through the Cleveland Area Reliant Review Process. Choosing the right IRB for submission depends on multiple factors, including type of research, location of data collection, and home institution of investigator. Research involving cancer studies may be required to be reviewed by the Case Comprehensive Cancer Center's Protocol Review and Monitoring Committee. Please contact the SODM Research Administration office if you have questions on which IRB to use.
1. CWRU IRB
Submit to the CWRU for all research conducted by CWRU faculty, staff, and students that involve CWRU facilities, data, and/or resources.
The UHCMC IRB must review any studies that involve UH patients, data, and/or resources.
3. Cleveland Clinic IRB
4. Veterans Affairs IRB
1. Initial Review
First submission to the IRB for initial approval.
Requests for revisions or changes to currently approved, active protocols.
Requests must include a description of the proposed change(s) and rationale, a copy of the new or revised materials (e.g. protocol, consent document, questionnaires, scripts), and other relevant documents (e.g. letters of cooperation).
3. Personnel Change Requests
Requests to change, add, or remove personnel involved in the study.
4. Continuing Review
Mandatory reviews of approved, active protocols at least once per year.
5. Protocol Deviations/Unanticipated Problems
Any event or problem occurring that was not sanctioned by the submitted protocol or IRB approval.
6. Adverse Events
Any social, psychological, legal, or physical problems that occur as a result of the research.
Investigators generally must report adverse events within a given number of days of discovery of the event.
7. Study Close-out
Termination of a study, ending its IRB approval.
Research involving cancer studies may be required to be reviewed by the Case Comprehensive Cancer Center's Protocol Review and Monitoring Committee.
Research involving the Department of Medicine at University Hospitals Case Medical Center may require additional approval from the Department of Medicine Clinical Research Review Committee.
IRB Frequently Asked Questions
Q: How do I submit to the IRB?
A: Submissions may be completed electronically or in paper form, depending on the IRB. The most common IRBs used by the School of Dental Medicine, CWRU IRB and the UHCMC IRB, use an electronic program called SpartaIRB. While the two IRB offices are separate, they can be accessed through the same portal - SpartaIRB.
Q: How do I obtain access to SpartaIRB?
A: If you previously had access to iRIS, you should already have access to SpartaIRB. At the SpartaIRB site, you will be asked which institution's IRB you will be using. Click the appropriate button and use that institution's login to gain access to the system. For example, if you are submitting to the Case IRB office, use your CWRUnet ID (e.g. abc123) and password.
If you do not have access already, you will need to request to be added to the system. There is a link on the SpartaIRB page to request a new user. Keep in mind that it may take 24-48 hours for the process to complete.
Q: Do chart reviews need IRB approval?
A: For most cases, yes. Most Chart Review studies can fall under Expedited Review, and some may even be Exempt if they are not using any identifiable information. However, Chart Review applications still have to be submitted to the IRB, even when requesting exemption.
Q: I am doing a chart review. Why is the application asking for subjects enrollment numbers? I am not seeing any subjects.
A: for the purposes of the IRB review, each chart is considered a subject. Therefore, in your application and continuing reviews, each chart you will review or have reviewed counts as one subject.
Q: Can Research Assistants and Students work on the IRB application and/or other submission forms?
A: Yes and no. SpartaIRB collects the majority of the study details in specific templates which are uploaded to the SpartaIRB application once they are completed. These are downloadable from the SpartaIRB Library. Anyone with access to SpartaIRB can download these forms and complete the required information for the type of study being done.
The initial data entry into SpartaIRB can be done by anyone with access to SpartaIRB. The Principal Investigator (PI) must be a fulltime faculty member. Students, residents, and staff can be added as part of the study team. The initial submission of the study to the IRB Office must be done by the faculty PI. Once the initial submission has been completed by the PI, s/he can then delegate responsibility to someone on the project team for future SpartaIRB submissions of that protocol, known as a Proxy PI.
Q: How long does it take to get IRB approval?
A: It depends on the study. Unfortunately, there are no guaranteed approval timeframes for the IRB process. Approval time generally depends on completeness of your application and the type of study. The best way to speed up the review process is to start early! To avoid delays during the review process, make sure the entire submission form has been completed and all required documents are attached. Provide timely responses to IRB correspondence and ask for assistance when needed.
Q: My IRB review seems to be taking a really long time. What's going on?
A: Due to the changing workload, it may take some time to complete a review. SpartaIRB has two areas that can help you determine where your application is in the process. First is the flowchart shown on the application dashboard. As your application moves through the process, you can monitor progress through the flowchart. Also, below the flowchart is the History detail which will tell you who has touched the application and will note any comments.