IRB FAQs

General Questions

Does my project require review?

Please see the section of the IRB website: Need IRB Review? This section contains a decision tree with definitions and a Research with Human Subjects Determination form to assist you. Please also consult with the Compliance Manager via phone or e-mail.

 

How long does the review take? 

The review time, regardless of type of review, depends on completeness of the application; response time from the Principal Investigator addressing the pre-review or IRB review concerns and need for additional review or information due to the subject matter. A pre-review process will identify any necessary revisions or missing documentation at the time of initial submission. The following turnaround times are approximate. High volume and office closure could effect.

Exempt Review: 10-15 days after the pre-review process

Expedited Review:  15-20 days after the pre-review process

Full Review:  Please see the submission deadline dates. Please note, projects may be tabled at the meeting if not enough information is included for the members to grant an approval. Review would occur again at the next meeting.

 

When should I submit my project to the IRB?

IRB review is the last part in your research study development process. Please create a time line and ensure you provide adequate time for the review process. For students, first, you will decide on a topic and choose a mentor. If you need guidance on review, please see Need IRB Review?  and Submission Instructions. Then you may contact the Compliance Manager to consult on the type of review your project may go through. Detailed information is required. If you have surveys, measures, tests, etc. all must be final to determine the review type. Dissertations, theses and protocols should be final and approved by all involved.

Please note:  if you are completing your project for a dissertation, thesis or University Honors Thesis, your project must come to the IRB at LEAST 2-3 months before you plan to begin study implementation. The Compliance Manager cannot guarantee a review timeframe.

Amendments may be necessary however; all documents should be in a state where once you receive approval, you are ready to start your study.

 

When can I begin my study?

You can begin your study AFTER you have received an exempt determination or IRB approval letter via e-mail. Please note, any research with human subjects completed before the exempt determination or IRB approval process completion is non-compliance. The IRB cannot complete a retrospective review. Data collected outside of the IRB review process, may be unusable and requested for destruction. The IRB Chair and/or IRB, as needed complete this determination.

 

How long is my approval valid?

New project submissions: Full/Expedited review:  365 days from day of approval. The project must undergo a review for re-approval prior to the expiration date. Please see your approval letter for more details. If the IRB requires, your project may receive a shorter approval time or a re-evaluation must occur after completion of a certain amount of procedures. This occurs when the project is greater than minimal risk or a vulnerable population. Please ensure to review your approval e-mail and keep for your records and informational purposes.

Exempt projects undergo a determination of exemption and are not granted an approval period. For additional information, please see the Exempt Application.

 

What if my study involves other sites and multiple IRBs?

 First, identify the primary IRB. Usually, this is where recruitment is to be done, procedures completed or where the Primary Investigator resides. If you have a sub award or contract from another institution, which is the primary reward recipient, FDU will serve as the secondary IRB. You will submit to the FDU IRB at the same time you submit to the Primary IRB. You will then forward the IRB approval and all approved documents once the Primary IRB completes the process.

Please also contact the Compliance Manager to see if an Institutional Authorization Agreement is necessary for the Primary IRB to become the IRB of jurisdiction over the study.

If FDU IRB is to be the primary site, submit the proposal in accordance with all directions. Please be sure to include a site agreement letter/letter of permission/IRB approval (if completed) for the project. After IRB approval, the PI is responsible for sharing approved documents with any collaborating investigators and/or IRBs as required by that Institution.

 

I received a complaint from a participant or participant’s parent/guardian. What do I do?

Please contact the Compliance Manager as soon as the complaint comes in. The Compliance Manager will provide you with information.

 

What happens if data was entered or used in analysis while the protocol was expired and I did not submit for Continuing Review?

This type of activity is a deviation from the study and is considered non-compliant to IRB requirements. Please contact the Compliance Manager as soon as this is discovered. A decision will be made by the IRB Chair if the data may be used.

If the project is not completed, data collected and analysis is ongoing, you may submit for a continuation. The following additional information is also required:

  • Continuation review form;
  • New Application for IRB review;
  • Consent Form, if still in use only;
  • Additional Consent and Assent Forms, if still in use only;
  • Recruitment Efforts, if still in use only;
  • Corrective Action plan detailing how the lapse occurred and how it will be avoided in the future.

 

I am a faculty member leaving FDU and I have an active research study. What do I have to do with the FDU IRB before I leave?

First, please consult with the head of the school/department regarding the data collected and retention at FDU.  All internal school/departmental as well as FDU policies regarding intellectual property, data management and security must be followed. Second, once the conversation is completed, please contact the Compliance Manager to go over the full process. Third, all activity must stop on your project and a Final Closure form completed with the FDU IRB. Please contact the Compliance Manager for information and specific questions.

 

Where I may find instructions for all types of submissions to the IRB?

Each type of submission will have its own application. All instructions are included directly in the application. Please see the section IRB Forms, Templates and Guidance Documents and download a copy of the submission application you require. Please ensure you directly download all documents when you are ready to prepare the application to ensure you have the most recent document. If you have any questions while completing the applications, please contact the Compliance Manager.

 

What are some common mistakes that I should avoid when submitting a new study?

Not enough detail in your application.

  • The IRB needs the details to ensure subjects are protected and to make the 45 CFR 46.111 findings to approve the research according to Federal Regulations. This information is also needed to ensure your review type is correct.

Research Population not defined.

  • Number of subjects.
  • No information provided on the statistical analysis completed explaining why this is the right number of subjects to be enrolled.

Inclusion/Exclusion criteria not included however, specific population described.

  • No information on screening or how permission is obtained for the screen to occur.
  • No justification or details included why there is an inclusion/exclusion.

Recruitment Plan and Description

  • Scripts not submitted of in-person recruitment
  • No details
  • Recruitment materials not submitted. Types of material missing: solicitation letters/e-mails, flyers, SONA system solicitations, etc.

Methods and Procedures

  • No details on the randomization procedure.
  • No specific information on data storage and confidentiality.
  • No information on how staff will be educated regarding the project or have access to the protocol if being completed off site.

Consent Process not described. Assent Process not described.

Information differs from IRB application and dissertation/thesis. All documentation should match each other. Example, if your application states that a subject will complete a survey at 3, 6 and 9 months but your consent states at 3, 6, 9 and 12 months, that is an issue. Revisions plus more information will be required.