Research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge.

• Case studies which involve only one subject are not considered to be systematic investigations, and do not require IRB approval.
• If the investigator does not intend to use the information for publication or presentation outside of the investigator’s department or organization, the research will not contribute to generalizable knowledge and IRB review is not required.

Does it involve Human Subjects?

Human subjects are living individuals about whom an investigator obtains identifiable private information OR data through an intervention or interaction.

• If the investigator does not have access to private, identifiable information or receives only deidentified samples for use in research, the research does not involve human subjects and IRB review is not required.
• If the research involves only deceased individuals, the research does not involve human subjects and IRB review is not required.

In addition, IRB review may be required in the following situations:

Research involving the FDA:

If your research is subject to FDA regulations, it must be submitted to the IRB. Research is subject to FDA regulations when it involves a drug, biologic, or device for which at least some aspect of the administration is dictated by the protocol (e.g. randomization to determine use or administration, protocol dictates route or dose, etc). These studies may include comparison studies of marketed drugs, clinical trials of new drugs or devices, or studies of in vitro diagnostic devices.

Student projects involving risk to human subjects

• Student projects which are intended for discussion within the classroom only do not contribute to generalizable knowledge and IRB review is not required.
• If the activity is a student project that may place individuals at risk and involves a vulnerable population, please submit the 'Application for Non-Research Student Projects' form located on the IRB Forms & Checklists page.

Research involving IRB review may fall into several levels of review, including the following. See the Research Decision Trees below for help determining which level of review is required.

• Exempt Review: Research which falls into one of the six defined exempt categories is considered exempt from many research requirements. A submission must be made to the IRB and designated staff members may approve the application.
• Expedited Review: Research which is considered minimal risk and falls into one of nine expedited categories defined by the federal regulations may be reviewed via an expedited procedure.  Expedited research may be reviewed by a single IRB member and does not require review by the full committee.  Research is considered minimal risk if the probability and magnitude of harm presented by the research are not greater than encountered in ordinary life or during the performance of routine physical or psychological exams.
• Full Board Review: Research which does not meet the criteria for exempt or expedited research, or is considered greater than minimal risk, must be reviewed by a full committee.  IU has six IRBs which meet monthly.

Use the following decision trees to help you decide whether IRB review is required and what level of review is necessary.

• Exempt Decision Tree
• Non-Human Subjects Decision Tree
• Research with Existing Data

For guidance on determining the appropriate area of research for IRB review click here.

2013 Meeting Dates & Locations

Calendar of all IRB meeting dates

IUB-IRB – Social/Behavioral Sciences
Reviews: Psychology, Informatics, Marketing, Survey/Oral History, Arts & Sciences, Public Health

Click to view IUB IRB Meeting Dates list

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IRB-01 – Social/Behavioral Sciences
Reviews: Biostatistics, Nursing, Psychiatry, Psychology, Social Work, Sociology

Click to view IRB-01 Meeting Dates list

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IRB-02 - Biomedical
Reviews: Dentistry, Endocrinology, Genetics, Hematology/Oncology, Infectious Disease, Internal Medicine, Nursing, Pediatrics, and Pharmacy.

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IRB-03 — Biomedical
Reviews: Cardiology, Dentistry, Emergency Medicine, Gastroenterology, Hematology/Oncology, Infectious Disease, Internal Medicine, Neurology, Nursing, Ophthalmology, Optometry, Pediatrics, and Pharmacy.

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IRB-04 - Biomedical
Reviews: Cardiology, Dentistry, Gastroenterology, Genetics, Hematology/Oncology, Internal Medicine, Pediatrics, Pharmacy, and Radiation Oncology

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IRB-05 - Biomedical
Reviews: Endocrinology, Hematology/Oncology, Optometry, Pediatrics, Pharmacy, Psychiatry, Radiation Oncology, and Radiology.

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Effective April 1, 2010, the fee schedule for Institutional Review Board review is as follows:

The fee applies to for-profit sponsored projects involving human subjects. Contracts that were negotiated prior to April 1, 2010, will be subject to the previous IRB Fee Policy (effective January 1, 2005). Indirect costs will not be calculated on the IRB Review Fee. The fee does not apply if the project recovers full indirect costs at the federally negotiated rate. Investigators and/or departments are responsible for payment of the IRB Review Fee if the sponsor does not ultimately reimburse this fee. There are not anticipated exceptions to the applicability of this fee; however, in rare occasions and under exceptional circumstances, a request for a fee waiver/reduction may be made in writing directly to the Executive Director, Human Research Protection Program.