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.
PLEASE NOTE: This is not an NSU-dedicated system so your NSU email and password will not work with IRBManager. You must first create a new user account. Please follow the directions below in order to create your new user account for IRBManager.
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.
You will be prompted to complete the Researchers Qualification Form upon registering for IRBManager. This form is where researchers document their qualifications to conduct research with human participants and provide proof of current Human Subjects Protection Training, such CITI. This form needs to be completed by all study team members prior to submitting your Initial Submission Form.
Please refer to the IRBManager Electronic Submission System section of our website for more information regarding the completion of this form.
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 the IRB Office via email at email@example.com or via office phone at 954-262-5369 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***
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.
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.
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 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
Once a xForm has been submitted, it must be approved by the Faculty Advisor or Thesis/Dissertation Chair (in the case of students) before it is reviewed by the College Representative to determine its Level of Review.
The College Representative Review process takes 7-12 business days for feedback. The College Representative will review the submission and may request revisions from the PI before determining the Level of IRB Review as either Exempt, Expedited, or Full.
For Expedited studies, the IRB Office and Chair review takes approximately 7-12 business days. The IRB Office may request revisions from the PI or the submission may be approved at that time.
For Full studies, the IRB Office will review the submission and work with the PI to prepare the submission for review at the next monthly IRB Board meeting. The schedule of meetings can be found on our website at http://www.nova.edu/irb/meetings.html.
NOTE TO PI: Each time revisions are requested and submitted is another 7-12 business days for review. The entire IRB review process takes between 2-8 weeks for approval depending on how responsive PI is to requests for revisions.
Yes. NSU has determined that all individuals involved in research with human subjects, including investigators (principal and co-) as well as members of the research team (i.e. research assistants) must complete the CITI: Course in the Protection of Human Subjects.
Each CITI Learner Group is comprised of certain modules. Each college at NSU selected the modules that their respective investigators would have to complete. Members of the research team who are not affiliated with another college at NSU must complete the modules within the same learner group as the Principal Investigator on the study.
No. The CITI Program is a free training service offered to all researchers conducting human subjects research in affiliation with NSU.
If you are prompted to pay for the training, please see our CITI Training page for guidance on how to correctly register for the free CITI Training Program for human subjects research.
Only 'Human Subject Research' training courses will be accepted for the human participants protection training requirement. The following courses DO NOT meet the requirement for human participants protection training for IRB purposes:
Please visit our CITI Training page at http://www.nova.edu/irb/training.html for help with registering for the correct training modules in CITI.
Please visit our CITI Training page at http://www.nova.edu/irb/training.html for help with the CITI Training Program such as:
Everyone using IRBManager needs to complete the Researchers Qualification Form.
The CITI expiration date pulls automatically from the CITI server based on the email address provided in your IRBManager profile. If you used another email address other than your official NSU email address then this field will have "MISSING" instead of your CITI expiration date.
If "MISSING" appears in the CITI expiration field then please enter the email address you used when registering for CITI in the "CITI Alternate Emails" field located in the Researcher information block. It may take a few hours for this information to update in the system and update both your Researchers Qualification Form and New Protocol Submission Form.
In order for IRBManager to populate these fields, the study team member must have a registered account with IRBManager and have completed the Researchers Qualifications Form. If their email address does not pull up their contact information, then they do not have an account with IRBManager with that email address. Please note: All NSU students and employees must use their official NSU email address when registering with IRBManager.
Please contact the study team member and instruct them to our website for information regarding creating an IRBManager account and completing the Researchers Qualifications Form.
Yes, before posting recruitment materials permission must be given by that location.
In the case of studies being conducted at other universities, schools, clinical facilities, etc. a letter needs to be submitted with your IRB applicaiton showing that you have permission from the site to conduct your study there. Please contact the IRB Office if you have further question regarding this question.
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.
Once you have submitted the New Protocol Submission Form it is locked from editing until it has been reviewed (depending on the stage) by either the:
If you need to make edits prior to review, please contact the IRB Office so that we may reopen your submission form. Otherwise wait until the reviewer has sent it back to you for revisions.
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. This can be done two ways.
First, you may click the link provided in your email notification and it will take you directly to your submission. OR you can follow the instructions below:
Either of these methods will take you to your research submission where you can then edit the form or add notes to address the revisions requested by the reviewer. All requested revisions will appear in green text boxes. DO NOT DELETE THESE BOXES AFTER MAKING REVISIONS!!!
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.
Yes. There are a few things to remember:
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).
If you completed your Initial Submission Form via the old paper format, please refer to the Paper Submission Forms section of our website.
If you completed your Initial Submission Form via the new IRBManager electronic submission system, please refer to the IRBManager Electronic Submission System section of our website.
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 new IRBManager electronic submission system, please follow the directions listed in the IRBManager Electronic Submission System section of our website.
If you completed your Initial Submission Form via the paper format, please refer to the Paper Submission Forms section of our website and complete the paper Amendment Form and mail the signed hard copy to our office at:
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.
If you completed your Initial Submission Form via the paper format, please refer to the Paper Submission Forms section of our website and complete the paper Continuing Review Form and mail the signed hard copy to our office at:
If you completed your Initial Submission Form via the new IRBManager electronic submission system, please refer to the IRBManager Electronic Submission System section of our website for more information regarding the completion of this form.
Studies are randomly selected for evaluations by the IRB Post-Approval Monitor.
Certain factors may increase the odds of a study being selected for evaluation, these include but are not limited to, the following criteria:
The Not-for-Cause Pre-Evaluation Questions were designed by the IRB Office to assist Principal Investigators with preparing their study documents for their Not-for-Cause Evaluation. They will be sent to the Principal Investigator with their selection packet.
The Principal Invesitigator should be able to answer these questions and having study materials organized will help expedite the evaluation process.
Please review our website for more information about the evaluation process at http://www.nova.edu/irb/post-approval-monitoring.html.