Institutional Review Board
Jacksonville University recognizes that an Institutional Review Board is an indispensable body regarding oversight of research activities undertaken by its faculty, staff, and students. As research activities often involve the potential for abuse of a subject's autonomy and / or privacy rights, Jacksonville University has developed this board to ensure that the rights of all research subjects are protected. All research that involves human subjects, tissues/specimens, data/records, or surveys requires review and approval from the IRB. Researchers may not collect data from human subjects until after IRB approval has been obtained.
JU's IRB is maintained according to its Standard Operating Procedures, and in compliance with 45 CFR 46 ("The Common Rule") and the Belmont Report. The Office of Research & Sponsored Programs provides administrative support to the JU IRB, and helps to facilitate the review process for submissions.
For instructions on how to submit a research proposal to the JU IRB, please see the resources below.
Please Note: For industry-sponsored clinical trials, the JU IRB requires investigators to use an external IRB for all protocol reviews, amendments and continuing reviews. JU has partnered with Western IRB for all externally funded clinical trials, and WIRB submissions may be made directly through IRBNet. The study sponsor is responsible for the cost of the WIRB services, and these costs may be built into in the sponsored research agreement with the University. In the event a sponsor will not pay for the WIRB services, the college will be responsible for the cost.
The JU IRB is only accepting online submission through the platform IRBNet. In order to submit, you will have to build a User Profile using the New User Registration Guide. Additional training guides can be found below.
- New Project Submission Guide
- Post-Submission Advanced Topics Guide
- Designer Enhancements Guide
- Linking NIH Training Credentials Guide
IRBNet also has a database of research training resources. This is a free resource available to all JU faculty, staff and students. The username is jacksonville and the password is training1; you must be logged into IRBNet to access the training and education tools.
Forms and Guidance
Each IRB submission must have certain forms and documents included in the submission in order to meet the requirements for approval. The goal of these forms is to gather all the necessary information for the IRB to make an informed decision about the level of risk of the project. The forms also seek to anticipate the questions of the IRB reviewers looking at the project. Even if the answers to the forms can be found in a larger research proposal document, the JU IRB requires that all investigators use the prescribed forms in order to streamline the review process.
The required forms for each project will vary based on the project design, though most every project will require a Protocol-Application (called the "Pro-App"), an Informed Consent Template, the Investigator Assurances page, and a data table outlining all the data points that will be collected. Any submissions with more than one investigator will require a Research Team Attachment. Student Investigators must have their faculty mentor complete the required forms and sign off on them. If you have any questions about which forms need to be included in your submission, please contact the IRB Administrator.
The most current versions of the forms are available below, as well as in the Forms Library on IRBNet.
- Protocol Application Expedited and Full (PRO APP)
- Exempt Application
- Research Team Attachment Form
- Informed Consent - Adult
- Informed Consent - Exempt Review
- Minor Assent Letter Template
- Minor Parental Consent Letter Template
- Research Equipment Attachment
- Investigator Assurances
- Human Subjects Research Checklist
- Event Report Form
- Drug, Biological, Chemical Attachment Form
- Device Attachment Form
- Mentor Agreement Letter
- Site Authorization Letter
- PI Transfer Form
- Continuation Form
- Amendment Request
- Closure Request
Policy and Procedures
- Standard Operating Procedures
- IRB Definitions - June 2018
- Internet Research Consent Guidelines
- Human Subject Recruitment Guidelines
- Training Requirements
- Review Categories
- Unanticipated Problems and Adverse Events Involving Risks to Subjects
- Requirements for Recruitment by External Researchers
2018 Meeting Dates
IRB Meetings are held on the 2nd Monday of each month. Paperwork for Full Board review should be submitted no later than 5:00 p.m. (EST) by the submission deadline.
|Month||Meeting Date||Submission Deadline|
- Code of Federal Regulations - Protection of Human Subjects
- HIPAA Privacy Rule Information for Researchers
- The Belmont Report
- HHS Human Subject Regulations Decision Charts
JU's Federalwide Assurance: FWA00020200
JU's IRB Registration number: IRB00009290
JU's IORG Registration number: IORG0007742
Email The Jacksonville University Institutional Review Board at email@example.com.
For additional information, contact:
Dr. Claribel Torres-Lugo
Research Compliance Coordinator, IRB Administrator
- Email address firstname.lastname@example.org
- Telephone number (904) 256-7151
Dr. Michael Justiss
Chair, Institutional Review Board
- Email address email@example.com
- Telephone number (904) 256-8917