Questions & Answers (“Q & A”)

Contact the NSU IRB Office. See our contact information on the left side of this page.

Yes–if you are doing research with human beings. NOTE: This type of study is called “Human subject research” and includes using data from people collected previously (called “secondary data”).

The number of human subjects does not matter; even a study (called a “protocol”) with one human subject must be approved by the NSU IRB.

Yes. Under NSU and NSU IRB policy, all human subject protocols must be pre-approved by the NSU IRB. The study cannot begin until you receive the official IRB approval letter.

No. The recruiting procedures and any recruiting information that you plan to share with potential research participants must be approved before study recruiting may begin.

There are several steps that must be taken before the protocol application is submitted to the NSU IRB:

–Read the NSU IRB Researcher Handbook (available on the Resources page).

–Watch the NSU IRB YouTube playlist, “Step 1:Before You Begin Your IRB Application.” NOTE: Includes information on NSU IRB-required training for researchers.

–Design the study using the information gained from the Researcher Handbook, the researcher training, and the requirements of your NSU academic department or administrative unit.

The NSU IRB uses an online system called “Mentor” for writing, submitting, and reviewing human subject research protocol applications.

As an NSU student, faculty, or staff member, your Mentor account homepage is already prepared for you–click the link to view it. (NOTE: To see your Mentor page, you must already be logged into the NSU computer network; for example, log in to MyNSU first and then click the link above to view your personal Mentor homepage.)

Your Mentor homepage is where you select an application form, fill it out, and submit it for review. You will also receive communication in Mentor from the NSU IRB, including the official approval letter. On the NSU IRB YouTube channel, there is a playlist, “Step 2: The IRB Application in Mentor,” that provides instructions on how to use Mentor to write and submit the IRB application.

Yes. An application that is not yet submitted for review can be withdrawn at any time. See the NSU IRB YouTube video, “Withdrawing A Protocol” for more information.

The “Review Type” is used to help the IRB Office staff determine how to conduct the application review; the Review Type can affect the amount of information needed for the review and how long the review will take before am approval decision can be made. The NSU IRB recommends that the researcher choose either NHSR or QI Review for a study unless the researcher is certain that the study requires another review type. For more information on review types, see the NSU IRB YouTube video, “Review Types: The First Step to Approval.”

The NSU IRB does not have protocol application deadlines. However, we recommend submitting any NSU IRB research applications, including supplemental documents, at least six weeks before the proposed research start date, to provide adequate time to complete the application review.

The typical timeframe for the NSU IRB to complete a review–for each “Review Type”–is as follows (in business days; does not include weekends or official university holidays):

–NHSR or QI = 3-5 days;
–Exempt = 6-10 days;
–Expedited = 11-20 days;
–Full Board = 21-40 days.

Not right away. After submitting the form, the application is “locked” until the NSU IRB reviews it. (NOTE: For student researchers, the assigned Research Advisor must also review it before it will be sent to the NSU IRB).

After the review, the NSU IRB (and/or your Research Advisor) may require revisions or updates to the form. The application will then be “unlocked” so that you can provide the revisions. Once the revisions are done, the application is again locked for another review.

Additional files, called “supplemental documents,” may be required to support the application form. These documents can include Informed Consent forms, surveys/tests given to human subjects, permission letters, recruitment plans, and/or other documents. See the NSU IRB YouTube playlist, “Step 3: Application Attachments,” for more information this topic.

Any change to an approved study is called an “Amendment.” An Amendment Request must be made and approved by the NSU IRB before the change can be implemented in the study. In some cases, the study activity must be suspended until the approval is granted officially. For more information, see the NSU IRB YouTube video, “Requesting an Amendment.”

Yes, there are two things to be done:

–“Close” the study; see the NSU IRB YouTube video, “Closing a Protocol” for details.

–Protect the collected study data: All data collected from human subjects must be stored and maintained securely for three years. The data can only be accessible to the Principal Investigator (PI).