Frequently Asked Questions

Creating and Accessing IRBManager Account

IRBManager is the electronic submission system used here at NSU to submit IRB protocols for review.

You must have an IRBManager account if you are the Principal Investigator, a co-investigator, or an academic advisor/dissertation chair to a student investigator who is involved in human subjects research here at NSU.

  1. Go to the IRBManager home page at https://nova.my.irbmanager.com.
  2. Enter:
    • Username: newuser (enter this exactly as it appears to the left, all lowercase)
    • Password: newuser (enter this exactly as it appears to the left, all lowercase)
    • Client: Nova
  3. Click “Log-in” and further information will be asked.

NOTE: You must use your official NSU email address for accessing IRBManager; no personal email addresses will be accepted.

No. The Principal Investigator and all other researchers involved with the study that are affiliated with NSU must use their official NSU email address as their primary contact email.

NSU requires that all official communications between students, faculty, and staff be made using their official NSU email address.

If a researcher, that is not the Principal Investigator, is not affiliated with NSU then they may use a primary email address of their choosing.

If you used an email address other than your official NSU email account when you created your CITI account, you will need to provide that email address here. This allows IRBManager to automatically load your CITI completion date into your online protocol submission.

  1. Go to https://nova.my.irbmanager.com/Login.aspx
  2. Click on “Forgot Password”
  3. When prompted, enter your NSU email address and Client ID (Nova) in order to retrieve your password.
  4. Within a few minutes, an email will be sent to you containing your new (reset/temporary) password.
  5. Once logged in, you will be asked to change (personalized) your password.

If locked out of the system due to several failed login attempts (i.e. entering an incorrect password), please follow the instructions listed in the question regarding “Forgot my IRBManager password”.

Please contact William Smith via email at wsmith2@nova.edu or via office phone at 954-262-5311 with any questions or issues you have regarding the IRBManager electronic submission system.

***Please do not contact NSU OIT or IRBManager for assistance with IRBManager***

General Information

Investigators should contact their College Representative.

Please visit our website to determine your College Representative.

Your College Representative will be listed below the heading for the College or Center you are enrolled in.

The Procedure Manual for Research with Human Subjects is a document that outlines the responsibilities of investigators conducting human subjects research at NSU. This document is currently being updated and will be published on our website when completed.
All NSU IRB Policies and Procedures can be found on our website under IRB Process in the navigation menu to the left. Periodically these documents are updated, but the latest versions are always available on our website.

College Representatives are responsible for determining and recommending the level of IRB review for a submission. In no instance is an investigator permitted to make that determination.

College Level Review (Exempt Review)

This level of review is conducted by the College Representative and is reserved for research that involves no more than minimal risks to participants and does not involve participants who are vulnerable to coercion or undue influence. This level of review may not be used for research involving prisoners.

Expedited Review

This category is reserved for studies that do not qualify as exempted research, but also do not represent more than minimal risk to the participants involved as determined by the College Representative. Review of Expedited studies is conducted by the IRB Chair or their designee.

Full Review

Full review by the entire IRB Board is intended for research that does not meet he College (Exempt) or Expedited levels of review, studies that have more than minimal potential risk to human participants, and/or involve certain vulnerable populations including, but not limed to, prisoners.

Please visit our website for more information regarding the different Levels of IRB Review.

In order to better explain the Review Process the IRB Office has created following document outlining the Review Process, from the time of your initial submission to final approval.

IRB Review Process Map

IRB New Protocol Submission

Yes, the first page of all consent and assent forms needs to be on the offical NSU letterhead for your College or Center. The NSU logo at the top may not be altered in any manner and the contact information for your College or Center must be in the footer.

Contact your IRB College Representative

You must log in to your IRBManager account to view the status of your IRB submission.

If the College Representative determines that that a protocol meets the Exemption categories under 45 CFR 46.101(b)(2) and no more revisions are necessary, an Exempt approval memo will be generated and sent to the Principal Investigator via either IRBManager for electronic submissions or email for paper-based submissions.

After the Principal Investigator has received this memo research activity may begin.

If you received an email from IRBManager requesting revisions to your xForm, this means that your Academic Advisor/Dissertation Chair, College Representative, or the IRB Office/Board has reviewed your protocol and is requesting that some clarifications or revisions be made to your xForm.

Please make the requested revisions and resubmit your protocol to send it back for review.

In the case of Faculty Advisor/Dissertation Chair Reviewer: Once they have determined that no more revisions are necessary, the protocol is submitted for review by your College Representative.

In the case of College Representative Reviewer: Once they have determined that no more revisions are necessary, they will make a Level of Review determination. If your study is determined to be Exempt, an approval document will be generated and sent to you either via IRBManager for electronic submissions or email for paper submissions. If your study is deteremiend to be Expedited or Full, it will be submitted for review by the IRB Office.

In the case of IRB Chair or their designee Reviewer: The IRB Chair or their designee will review the revisions that were requested by our office. Once the IRB Chair or their designee have determined that no more revisions are necessary, an approval memo will be generated and sent to the Principal Investigator either via IRBManager for electronic submissions or email for paper submissions. This will include all stamped materials such as recruitment materials, assent/consent forms, etc. After the Principal Investigator has received these documents, research activity may begin.

All approval documents including Approval Memo and stamped documents are located in IRBManager.

  1. Log into your IRBManager account.
  2. Click on “Dashboard” located on the left-hand side of your screen.
  3. Select the IRB Protocol Number for this study.
  4. Click on “Attachments “ and all your approval documentation will be there for your use and download.

Yes. There are a few things to remember:

  • Approval is only good for the period of time stipulated on the approval letter you receive from the IRB office.
  • Federal regulations require that approved studies be reviewed on a continuing basis as defined by the approval granted by the IRB.
  • The IRB office asks that you submit a Continuing Review Form via paper form with the necessary documents at least three months before your study's approval will expire so that your study may be reviewed and approved by the expiration date.
  • The IRB office asks that you submit an Amendment Form if you need to make an modifications to your study design, add/subtract personnel, etc.
  • If your study has been approved at the expedited or full review levels, you must submit a final Closing Report Form when your study is complete notifying the IRB that no further activities with human subjects will occur.

Yes, if your research has concluded, please complete a Closing Report Form and submit it to the IRB Office so taht we may officially close out your study. This form must be submitted within 30 days of the conclusion of research activities (intervention/interaction with human subjects AND data analysis have ended).

Please complete the paper Closing Report Form and mail the signed hard copy to our office at:
3301 College Avenue
Fort Lauderdale, FL 33314
ATTN:  IRB

Please do not put a person’s name on the mailing envelope.

Amendment or Modification to an Approved Study

You will need to fill out an Amendment Form and submit the completed form to the IRB Office.

If you completed your Initial Submission Form via the old paper format, please follow the directions listed for the paper form.

If you completed your Initial Submission Form via the new IRBManager electronic submission system, please follow the directions listed for the electronic submission form.

If your Initial Submission Form was completed in the old paper format:

Please complete the paper Amendment Form and mail the signed hard copy to our office at:

IRB office at NSU
3301 College Avenue, Fort Lauderdale, FL 33314
ATTN:  IRB

If your Initial Submission Form was completed in the new IRBManager electronic submission system:

  1. Log into your IRBManager account.
  2. Select "Dashboard" located on the upper left-hand side of screen.
  3. Click on the Protocol Code (IRB Number) for the study you wish to file an amendment for.
  4. Click on "xForm" on the left side of the screen.
  5. Select the icon for "Copy for Amendment".
  6. Follow instructions to complete the electronic Amendment Form

Continuing Review and Approval Duration

It is the responsibility of the IRB Office to ensure that research is conducted in accordance with governmental guidelines and regulations and with IRB requirements. In order to effectively do this, the IRB Office must conduct continuing review of approved research not less than once a year.  Continuing review is required for any active protocol including those where the only activity that remains is data analysis.

We kindly ask that you submit your Continuation/Renewal at least one month in advance to allow for review if you will be seeking a continuation.

No, at the moment the Continuing Review Form is not live in IRBManager. It is currently under development and will be available for use with studies orginally submitted via the IRBManager electronic submission system shortly. Principal Investigators will still need to complete the Continuing Review Form in the paper format and mail it to the IRB Office. This form should be sent directly to the IRB office at NSU:

Please complete the paper Closing Report Form and mail the signed hard copy to our office at:
3301 College Avenue
Fort Lauderdale, FL 33314
ATTN:  IRB

Please do not put a person’s name on the mailing envelope.

Yes, if your research has concluded, please complete a Closing Report Form.  This form must be submitted within 30 days of the conclusion of research activities (intervention/interaction with human subjects AND data analysis have ended). 

3301 College Avenue
Fort Lauderdale, FL 33314
ATTN:  IRB
Please do not put a person’s name on the mailing envelope.

Still have questions?

If after reviewing our Frequently Asked Questions section you still have questions regarding the IRB process, please contact our office by email at irb@nova.edu or call us at 954-262-5369.