INSTITUTIONAL REVIEW BOARD (IRB)

“For without responsible and ethical behavior in research, everything else is irrelevant.” –Kelvin K. Droegemeier

Overview

The NSU IRB has 20 current faculty, staff, student, and community members, chosen for their expertise in various academic disciplines and research traditions. The NSU IRB Office has a full-time Director/Chair and a Graduate Assistant available during business hours (see the Office contact information in the left-side menu on this page).

The NSU IRB also maintains a number of publications, videos, and other resources for researchers and IRB members. For more information, see our Resources page (left-side menu).

NOTE: First-time users of the NSU IRB system should FIRST review our “Q & A” page (see the left-side menu on this page).

The IRB mission, as described in federal law, is to protect human beings who participate in research studies. By NSU policy, any study employing human participants (called “human subjects”) must be approved by the NSU IRB before the study may begin—including research using “secondary data,” which is data collected previously from human subjects.

The NSU IRB follows the 2018 revisions to the federal government regulations–called the “Common Rule”–that govern all U.S. IRBs. The complete text of the Common Rule (formally called 45 CFR 46) is located on a webpage at the U.S. Department of Health and Human Services

All NSU researchers who plan studies employing human subjects must complete the NSU IRB-required training certificates. The training is provided by CITIprogram.org. The specific certificates required are detailed in the NSU IRB Training Policy (see the “NSU IRB Researcher Handbook”; a current copy is available on our Resources page).

NOTE: The NSU IRB also has a YouTube channel with instructional videos on various topics in human subjects research. The videos are available on the NSU IRB YouTube Channel homepage.

The application process consists of several steps. NSU researchers are required to follow each step to obtain approval from the IRB to conduct a study. The steps are outlined in the NSU IRB Researcher Handbook (see Resources page).

The NSU IRB has an online IRB application and review system, called Mentor. All IRB applications must be written in and submitted to Mentor (paper and email applications will not be accepted).

Logging in to Mentor: The system uses Single Sign-on (SSO) to manage user access. First, log in to the NSU computer network using your NSU email credentials. Then, use the following link to automatically log in and view your Mentor account homepage.

There are several types of NSU IRB application forms, each tailored for a specific type of study. However, all forms have the same basic parts:

  1. Pre-Protocol Survey: Used to determine the specific application form for a specific study.
  2. Protocol Page: Background information, including the study title, the researcher’s name and university status (student, faculty, or staff), and some basic study details, such as the proposed start and end dates.
  3. Application Sections: Detailed questions about the study design.
  4. Supplemental Documents: Many IRB applications require additional information that is not provided in the Application form. These “supplemental documents” may include recruiting scripts, surveys or other data collection methods, site approval letters/forms, informed consent or child assent forms, and/or other documents, depending on the study design. (See this NSU IRB YouTube video for more information: “What are Supplemental Documents?”)

NOTE: All parts of the application must be completed to qualify for review by the NSU IRB.

The NSU IRB review process requires assigning a “Review Type” to each application. A “review type” is a method for systematically reviewing the specific study design. Review Types are required under the federal rules for IRBs.

The NSU IRB uses five different review types:

  • Not-Human Subjects Research (or “NHSR”)
  • Quality Improvement (or “QI”)
  • Exempt
  • Expedited
  • Full Board

In the Pre-Protocol Survey, the researcher must request one of the five review types. For more information on Review Types, see this NSU IRB YouTube video: “Review Types: First Step to Approval.” Use the video to help determine which Review Type is appropriate for your study.

IMPORTANT: The NSU IRB recommends submitting all NSU IRB research applications, including supplemental documents, at least six weeks before the proposed research start date. The typical timeframe for the NSU IRB to complete a study review–in 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.

See additional topics in the left-side menu of this page: “Q & A” and “Resources.”

We also encourage you to contact the NSU IRB Office if you have questions about policies and procedures. We are also happy to consult on an idea for a research proposal and recommend discussing it with us prior to submitting the IRB application form. See the NSU IRB Office contact information information in the left-side menu on this webpage.