Institutional Review Board

 

IRB UPDATES

Research Compliance Office Hours – Summer and Fall 2021

 

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.

  • 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.

  • IRB COVID-19 Assessment Form for New Submissions and Continuation Requests.
    • 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.

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.

  • 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.

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.

Click Here for IRBNet

Policy and Procedures​

2021 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. Click here for the IRB timeline

2018 Meeting Dates
Meeting Date Submission Deadline
Monday- August 9, 2021 Monday-July 26, 2021
Monday- September 13, 2021 Monday- August, 23. 2021
Monday- October 11, 2021 Monday- September 27, 2021
Monday- November 8. 2021 Monday- October 25, 2021
Monday- December 13, 2021 Monday- November 29, 2021

Compliance

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

Dr. Michael Justiss

Chair, Institutional Review Board