ÐÇ¿Õ´«Ã½

Research Study Compliance

For your convenience, below is information about the IRB. Forms and processes for IRB submission are online. An overview on regulatory binder preparation and maintenance can be found in a presentation delivered by Drs. Sara Douglas and Amy Lipson. 

Learn More‌‌ about IRB

IRB Submission

Frances Payne Bolton School of Nursing research Projects Involving Human Subjects are required to obtain IRB approval from a "home" institution (in most cases, ÐÇ¿Õ´«Ã½ 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 for IRB approval. 

It is vital that IRB policies are followed, as violations may have serious consequences, including termination of research and disciplinary actions. 

ÐÇ¿Õ´«Ã½ IRB (iRIS)            Case Cancer Center PRMC 

IRB Overview

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.  For students, please note that while a student may serve as the primary researcher, the IRB requires that a faculty advisor sign as the responsible/principle investigator with ultimate responsibility for human subject projection.

Definitions

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.

Types of Review

1. Exempt
   • 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. 
2. Expedited
   • 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 be 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.

Which IRB Should I use?

ÐÇ¿Õ´«Ã½ 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.  

1. • The ÐÇ¿Õ´«Ã½ IRB currently accepts studies involving only social or behavioral research.
2. • The UHCMC IRB generally receives the majority of ÐÇ¿Õ´«Ã½ projects involving biomedical research or clinical interventions.
3. • Available to Cleveland Clinic employees.

Types of Submissions

1. Initial Review
   • First submission to the IRB for initial approval.
2. Amendments
   • 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.

Departmental Review

Cancer 

Research involving cancer studies requires review and approval by the Case Comprehensive Cancer Center's Protocol Review and Monitoring Committee.  

University Hospitals

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 are completed electronically. The most common IRBs used by the School of Nursing, ÐÇ¿Õ´«Ã½ IRB and the UHCMC IRB, use an electronic program called iRIS. The programs are housed at different website, but contain similar processes.

Q: How do I obtain access to iRIS?

A: Both ÐÇ¿Õ´«Ã½ and UH iRIS programs are accessed with your ÐÇ¿Õ´«Ã½ username (e.g. abc123) and password.

ÐÇ¿Õ´«Ã½ iRIS - Access is activated by contacting the ÐÇ¿Õ´«Ã½ IRB directly via email or phone. 

UH iRIS - Access is activated by an initial log-in to iRIS using your ÐÇ¿Õ´«Ã½ username and password. Once you have logged in, you must complete the "My Account Information" section on the left side under "My Assistant". Make sure the "Email Address" field is completed so you are able to receive any IRB correspondence.

Q: Do chart reviews need IRB approval?

A: Probably, 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: Can Research Assistants and Students work on the IRB application and/or other submission forms?

A: Yes! While Research Assistants and Students should not submit forms for approval, they can help prepare applications and documents for submission.

Q: How long does it take to get IRB approval?

A: It depends on the study. Unfortunately, there are no guaranteed approval timeframes for IRB submission. 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.