Institutional Review Board
IRB UPDATES
Research Compliance Office Hours – Spring-Fall 2022
The ORSP’s Research Compliance Administrator, Dr. Claribel Torres, is available to answer questions related to resuming in-person research activities and give guidance for preparing an IRB or IACUC proposal.
For one-on-one personalized assistance, please contact us to make an appointment during our regular office hours (Monday thru Friday, 8:30 a.m. to 5:00 p.m.)
Send us an appointment request to: juirb@ju.edu
STUDENT RESEARCHERS: Faculty mentors are required to attend the one-on-one sessions.
HUMAN SUBJECTS RESEARCH AND COVID-19 GUIDELINES
A Message from the Jacksonville University IRB Chair
August 3, 2020
Dear Faculty,
In a memo dated March 30, 2020, the Jacksonville University Institutional Review Board (JU IRB) suspended all approvals for both new and ongoing human subjects research that involved face-to-face interactions/interventions with no direct drug or therapeutic benefit.
I am pleased to announce effective August 3, 2020, the JU IRB will resume the review and approval process for all research activities that include direct face-to-face contact with participants (e.g., interventions and interactions). However, to keep our researchers and human participants safe from exposure to COVID-19, the IRB recommends each researcher determine if their project is able to progress with remote data-collection methodologies (for instance, telephone or electronic methods for screening or follow-up).
The new JU IRB guidelines and forms are designed to inform research participants of
the potential risks associated with COVID-19 and their options to join, continue,
or withdraw from a study if there are concerns about possible exposure. These guidelines
are in accordance with the recommendations presented in JU’s Ready to Return guidance, the Centers for Disease Control (CDC), the Office for Human Research Protections (OHRP), the Food and Drug Administration (FDA), and/or local and state agencies and apply to all new project submissions, amendments
and study continuation requests. The JU IRB reserves the right to suspend new and/or existing projects if the COVID-19
pandemic worsens or as new guidelines are issued. The required forms listed below are posted in the Forms and Templates Library in IRBNet.
New COVID-19 Research Guidelines for JU
1. Forms for New Submissions, Amendments, and Study Continuation Requests with Active Enrollment: All review levels (i.e., exempt, expedited, and full board reviews).
The COVID-19 forms listed below are required for all new project submissions, submissions currently under review, amendments and study continuation requests. Be sure to use the project checklist posted in the Forms and Templates Library in IRBNet for other required, non-COVID forms.
- COVID-19 Adult, Minor and Parental Consent Forms for new enrollment/consent.
- IRBNet Reference: Submission Form Numbers: 20, 21, 24, and 25.
- IRBNet Reference: Submission Form Numbers: 20, 21, 24, and 25.
- COVID-19 Adult and Parental Consent Addendum for participants who are actively engaged
via interactions or interventions in an already-approved study. That is, the researcher
continues to collect data from participants.
- IRBNet Reference: Submission Form Number: 19.
- IRBNet Reference: Submission Form Number: 19.
- IRB COVID-19 Assessment Form for New Submissions and Continuation Requests.
- IRBNet Reference: Submission Form Number: 23.
- IRBNet Reference: Submission Form Number: 23.
- COVID-19 Risks Symptoms Pre-Screening Form to assess COVID-19 exposure for new and
existing participants.
- IRBNet Reference: Submission Form Number: 22.
- IRBNet Reference: Submission Form Number: 22.
2. Guidance to Protect Yourself and Others: Basic strategies to mitigate risks of COVID-19 exposure:
- Limit the number of times a participant comes to a research performance site, for
example, the JU campus, an offsite clinic, lab or studio.
- Do not come to the JU campus or a research site if you or someone in your household
has tested positive for COVID-19, have been exposed to a COVID-19 case in the past
14 days or if you are exhibiting symptoms of illness such as fever, cough or shortness
of breath.
- For JU research sites, before coming to campus, visitors/participants must review
a medical disclosure statement, noted below, acknowledging that they have followed
a series of steps to check their health and that they will comply with University
policies, including bringing and wearing a mask on campus. Those unwilling to comply
with policies regarding social distancing and masks will be asked to leave campus.
For other research performance sites, e.g., studios, labs or clinics, please inquire
about site-specific policies. For additional information, please refer to Jacksonville
University’s Ready to Return Guide.
- Jacksonville University’s Medical Disclosure Statement: Visitors with members of their household who have tested positive for COVID-19 in
the past 14 days or who are exhibiting symptoms of illness such as fever, cough or
shortness of breath are not permitted on campus. Please perform a self-health check
and take your temperature prior to arriving on campus to ensure you are not exhibiting
COVID-19 symptoms and your temperature reading is below 100.4 degrees F. Please note
Jacksonville University reserves the right to check visitors’ temperatures upon arrival
to campus.
- Jacksonville University’s Medical Disclosure Statement: Visitors with members of their household who have tested positive for COVID-19 in
the past 14 days or who are exhibiting symptoms of illness such as fever, cough or
shortness of breath are not permitted on campus. Please perform a self-health check
and take your temperature prior to arriving on campus to ensure you are not exhibiting
COVID-19 symptoms and your temperature reading is below 100.4 degrees F. Please note
Jacksonville University reserves the right to check visitors’ temperatures upon arrival
to campus.
- Pre-screen participants for COVID-19 over the phone before they come to the JU campus
or an off-site research site.
- Research participants with possible exposure or symptoms of the illness may be (a.)
rescheduled if medically cleared for COVID-19, that is, they have tested negative
twice for the virus, (b.) excluded or (c.) withdrawn from the study.
- Reduce the time participants are exposed to other people/participants as much as possible.
For example, the researcher may limit the number of study participants at the site
by providing individual appointment times.
- In accordance with institutional policies, the researchers will use personal protective equipment such as masks, gloves and face-shields to minimize exposure. Participants will also wear masks and gloves and clean their hands often while on the research site or the JU campus.
The information related to risks of COVID-19 changes every day. JU continues to monitor the risks and make decisions about how these risks affect our research process. If you have any questions, please feel free to contact the Research Compliance Administrator at juirb@ju.edu.
Sincerely,
Michael Justiss, Ph.D., IRB Chair
Associate Professor of Occupational Therapy
Overview
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.
IRBNet Resources
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 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 in the Forms and Template Library on IRBNet. To access these forms, log into IRBNet or create an account.
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
2022 Meeting Dates
IRB Meetings are held on the 2nd Monday of each month. Paperwork for Full Board review (does not apply for exempt or expedited applications) should be submitted no later than 5:00 p.m. (EST) by the submission deadline. Click here for the IRB timeline.
| Meeting Date | Submission Deadline |
|---|---|
| May 8, 2023 | April 24, 2023 |
| June 12, 2023 | May 29, 2023 |
| July 10, 2023 | June 26, 2023 |
| August 14, 2023 | July 31, 2023 |
| September 11, 2023 |
August 28, 2023 |
| October 9, 2023 | September 25, 2023 |
| November 13, 2023 | October 30, 2023 |
| December 11, 2023 | November 27, 2023 |
Compliance
- 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
Questions?
Email The Jacksonville University Institutional Review Board at juirb@ju.edu.
Contacts
For additional information contact:
Dr. Claribel Torres-Lugo
Research Compliance Coordinator, IRB Administrator
- Email address ctorres3@ju.edu
- Telephone number (904) 256-7151
Dr. Michael Justiss
Chair, Institutional Review Board
- Email address mjustis1@ju.edu
- Telephone number (904) 256-8917