What is an Institutional Review Board (IRB)?

An Institutional Review Board (IRB) is a group of people formally designated to review and monitor research involving human subjects. The purpose of the IRB is to protect the rights and welfare of individuals who are participating as subjects in the research. The IRB has the authority to approve, disapprove, and require modifications to research projects involving human subjects. Once a project is approved, the IRB must monitor the progress of the ongoing research, prospectively approve modifications, and, if necessary to protect subjects, suspend a research project.

How often does the IRB meet?

The IRB meets on the 3rd Tuesday of each month at 7:00 am.

When is the deadline for IRB submissions?

Seven business days prior to the IRB meetings at 3:00 pm.

What is the turnaround time for IRB review and approval?

Turnaround time depends on a number of factors, including but not limited to: completeness of submission; meeting dates; type of review; and the investigator’s responsiveness to an IRB request.

Full Board reviews are placed on the next available agenda. Notification of the outcome of the review occurs approximately seven business days after the date of the meeting.

Expedited/Exemption reviews occur approximately five business days after submission to the IRB.

What is Exempt Determination?

Exemption means that the project is not subject to the requirements of the federal regulations (45 CFR 46). A protocol may be determined to be exempt from IRB review if all procedures fall into 1 or more of 6 specific categories of research described in 45 CRF 46.10(b). A designated IRB reviewer makes this decision.

What is Full Board Review?

Full Board review is required for all protocols that are not eligible for exemption or expedited review.

What is Expedited Review?

Expedited review means that the convened IRB need not review the proposed research. Expedited review is appropriate for a protocol that presents not more than minimal risk to subjects. The IRB Chair or designated reviewer makes this decision.

How do I submit a study to the IRB?

Electronically, via www.irbnet.org. Contact the IRB office for further instruction.

NEBH maintains and supports the Institutional Review Board (IRB) utilizing the industry-leading IRBNet suite of tools, bringing electronic on-line IRB submissions to the NEBH research community.

Some helpful tips may be found here:

New Registration Tips
How to Submit a New Study
How to Submit for an Existing Study

I am just reviewing medical records; do I need IRB approval?

Yes, if the project meets the criteria for research with human subjects (your IRB office can help you determine this).

I’m just administering surveys/questionnaires; do I need IRB approval? Even if I am only interviewing a few people?

Yes. Any activity conducted by an individual who is affiliated with NEBH that involves research on human subjects must be prospectively reviewed by the IRB.

What adverse events need to be reported to the IRB?

Adverse events that are also unanticipated problems must be reported to the IRB. Unanticipated problems are any incident, experience, or outcome that meets all of the following criteria (the IRB office can give a more detailed definition):

• Unexpected (in terms of nature, severity, or frequency)
• Related or possibly related to participation in the research
• Suggests that the research places subjects or others at greater risk of harm than was previously known or recognized

What changes require approval by the IRB after the protocol is approved?

Any proposed change to the protocol procedures (including subject selection, consent process), personnel, documents (including recruitment ads, study instruments) must be submitted to the IRB for review and approval prior to implementation. Any other changes that may affect a participant’s willingness to participate in the study must also be submitted for prospective IRB review.

Do I need to let the IRB know when I have completed a study?

Yes, an investigator needs to inform the IRB that a study is being terminated or closed and complete a termination report. A study should not be terminated until all subjects have completed the study and research-related activity has ceased, including subject follow-up, data collection, and/or data analysis.

What is CITI and why do I need it?

Collaborative IRB Training Initiative (CITI) is an educational program to support the protection of human subjects in research. CITI was developed by experts in the IRB community and is focused on different aspects of bioethics and human subject research.  The core courses are Biomedical Research and Good Clinical Practice (for those conducting clinical trials). Each module includes educational materials that can either be read on the screen or printed out.  A brief quiz follows each module. CITI Certifications need to be up to date and submitted to the IRB before beginning human subjects research.