IRB Application Checklist
Before you get started on your IRB application, review this checklist! Using this checklist will ensure that you have created all of the required supplemental documents. Incomplete IRB submissions will be immediately returned.
Submit an IRB Application using Cayuse IRB (Human Ethics)
IRB applications must be submitted to the IRB using Cayuse. Submissions will not be accepted via email. You can access Cayuse IRB with your Liberty University username and password. Please only log in to Cayuse when you are sure you are ready to apply for IRB approval. After you have received IRB approval, any modifications, incident reports, or renewal applications must be submitted using Cayuse.
Having trouble with Cayuse? Review our Cayuse How-Tos and Cayuse FAQs for additional guidance!
- If you are unable to log in to Cayuse, please review the login instructions.
- If you are still unable to access Cayuse IRB, please email firstname.lastname@example.org with your name, email address, and department name.
- We will add you to Cayuse and your profile should be active the following day.
Supporting Document Templates
Cayuse IRB will require you to attach various supporting documents to your application. We offer templates for most of these documents* below and encourage you to make use of them:
*Please note, the IRB does not provide templates for study instruments (e.g., survey questions, interview prompts, or session outlines). Study instruments must be created by the researcher and attached to the IRB application in Cayuse.
Human subjects research is governed by numerous guidelines, regulations, and policies:
- IRB Assurance
- FWA#: 00016439; Expires 3/14/2024
- IORG#: 0006023; Expires 10/15/2023
Liberty University fosters an environment focused on academic achievement and excellence in research. Explore the below opportunities:
The IRB strives to review applications adequately and in a timely manner while providing positive feedback for researchers. Certain processes have been put in place to help us meet this goal:
To ensure that researchers remain compliant with federal regulations, the IRB has developed the below policies:
Human subjects research is regulated by the federal government through the Department of Health and Human Services’ Office for Human Research Protections. The IRB committee consists of faculty members from various Liberty departments and one non-university member.
The IRB is required to review all research involving human participants to ensure the privacy, confidentiality, and safety of participants. The IRB is part of Liberty University’s Research Ethics Office, which is responsible for ensuring that all research conducted by Liberty University faculty, staff, and students are done in accordance with federal regulations and university policy.
Case Report Publication Guidance: IRB Review and HIPAA Compliance
Many journals require a letter, or other acknowledgement, from an IRB before they will publish a case report. Specifically, journals wish to know whether IRB approval was obtained or not required for the described case. LU’s IRB has adopted a policy to address the following questions and answers.
Q: What is a “case report”?
A case report is a retrospective analysis of one, two, or three clinical cases. If more than three cases are involved in the analytical activity, the activity will constitute “research”. Case reports should not be confused with qualitative case studies.
Q: How do I get IRB approval for my case report?
Please submit a case report application to the IRB through email, or Cayuse (if applicable). This application can be found here.
Q: Are there HIPAA implications associated with publication of case reports?
Yes. Under HIPAA, a case report is an activity to develop information to be shared for medical/educational purposes. Although the use of protected health information to prepare the paper does not require IRB review, the author of a case report must comply with HIPAA. Ideally, the author of the article will obtain the signed authorization of the subject, or the subject’s legally authorized representative if the subject is deceased, to use the subject’s information in the article. If it is not possible to obtain authorization, the author should be aware that one of the identifiers described by HIPAA as requiring written authorization is, “Any other unique identifying number, characteristic, or code….” Moreover, HIPAA requires that, at the time of publication, “[t]he covered entity does not have actual knowledge that the information could be used alone or in combination with other information to identify an individual who is a subject of the information.” (See: Definition of De-Identified Data.)
- Authors who remove HIPAA identifiers (including unique patient characteristics) from the data prior to submission and publication of the article do not need to obtain a signed privacy authorization.
- Investigators who wish to publish case report data with HIPAA identifiers will need to obtain from the patient a signed HIPAA compliant authorization. This authorization does not need to be submitted to the IRB for review. The appropriate authorization form for use with a single case report may be found on the HIPAA web site HERE.
- If the author strips off all HIPAA identifiers, but the information associated with the subject of the article includes a “unique characteristic” which would make it identifiable to the subject, or the author has actual knowledge that the information about the subject could be used alone or in combination with other information to identify the subject, the author must contact the HIPAA Privacy Officer to discuss the required steps to take prior to publication.