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IRB

Getting Started

How Do I Know if My Project Needs Institutional Review Board (IRB) Approval?

How Do I Determine What Level of Review is Needed for my Study?

Human Subject Tutorial and Certification Test?


How Do I Know if My Project Needs Institutional Review Board (IRB) Approval?

All research that involves human subjects, including some student projects, conducted under the auspices of IU South Bend or on the IU South Bend campus must be reviewed and approved by the IU South Bend Institutional Review Board for the Protection of Human Subjects.


Is it Research?

The Department of Health and Human Services (DHHS) defines research as “a systematic investigation designed to develop or contribute to generalizable knowledge.”


Does it Involve Human Subjects?

Human subject is defined as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”


What About Student Projects?

Some student projects require Institutional Review Board review. However, classroom assignments that do not involve risk and will not lead to generalizable results, may not need to be reviewed.

Student studies that fit ANY of the descriptions below must be reviewed:

  1. Student projects that may place subjects at risk,
  2. Student projects that are undertaken with the intent of adding to generalizable knowledge, including any publication or presentation beyond IUSB.
  3. Student studies that are undertaken involving special populations including pregnant women, fetuses, prisoners, minors, or human in vitro fertilization.
Instructors are responsible for screening individual student research projects and making an initial determination as to whether the project may fall in the category of research. You can use the Student Research Checklist to help in this process. Institutional Review Board approval must be obtained prior to initiation of the research.

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Determining What Level of Review to Apply For:

Exempt Studies: These are studies are exempt from the federal regulations but they still MUST be approved by the Institutional Review Board. The protocol must demonstrate:

  1. The research is minimal risk, and
  2. Fits into one of the exempt categories:
    1. Research on instructional strategies that is conducted in established or commonly accepted educational settings;
    2. Research (except involving minors) including the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless identifiable and sensitive;
    3. Research involving the collection or use of existing data, documents, or records, if publicly available or unidentifiable;
    4. Taste and food quality evaluation and consumer acceptance studies

If you think your study qualifies for Exempt review complete the forms here:


Expedited Studies: These studies may be reviewed by the Institutional Review Board through expedited review procedures. The application form must demonstrate:

  1. No more than minimal risk to subjects, and
  2. Involve only procedures listed in one or more of the following categories:
    1. Research involving materials (data, documents, or records) that have been collected, or will be collected for non-research purposes
    2. Collection of data from voice, video, data, or image recordings made for research purposes
    3. Research on an individual or group characteristics or behavior employing survey, interview, oral history, etc. methodologies

Note: Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research setting is not greater than that ordinarily encountered in daily life or during the performance of routine physical or psychological tests.

If you think your study qualifies for Expedited review complete the forms here:


Full Review Studies: These studies either involve more than minimal risk and/or are being conducted with vulnerable populations.

  1. More than minimal risk to subjects, and/or
  2. Research conducted with certain vulnerable populations
    1. Certain types of research with children, pregnant women, fetuses, and other vulnerable populations
    2. Research involving prisoners
    3. Research that involves experimental drugs or devises
    4. Research that involves invasive procedures
    5. Survey research that involves sensitive questions or is likely to be stressful for the subject.

If you think your study needs Full review complete the forms here