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Human Subjects

Level of Review

This page was designed to help you decide what level of review your study needs. All projects that meet the definition of human subjects research require IRB review and approval prior to conduct of the research. IRB review is required only when projects are considered research AND involve human subjects.

Step 1: Is it human subjects research?

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

  • Case studies that 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.

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

  • If the research involves only deceased individuals, the research does not involve human subjects and IRB review is not required.
  • Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.
  • Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. If the investigator does not have access to private, identifiable information or receives only de-identified samples or data, the research does not involve human subjects and IRB review is not required unless the research involves the FDA as described below.

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 the study of 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.), OR
  • study data will be reported to the FDA. These studies may include comparison studies of marketed drugs, clinical trials of new drugs or devices, or studies of in vitro diagnostic devices.

If you believe your research does not meet the definition of human subjects research, please contact an HSO staff member to confirm.

Student projects involving risk to human subjects

Student projects that are intended only for discussion within the classroom 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, IRB review is required. Please submit the 'Application for Non-Research Student Projects' form located on the IRB Forms & Templates page.

Step 2: What level of review?

Is the research eligible for flexibility?
IU has elected to utilize regulatory flexibility for review of some human subjects research. For research that is “flexed,”, equivalent protections that differ from the federal regulations are applied to the research. To be eligible for flexibility, research must meet the following requirements:

  • Not federally funded or supported,
  • Not subject to FDA regulations, and
  • Not subject to VA research regulations.

Depending on the particular flexibility initiative, additional restrictions may also apply as described in the SOPs. For more information, see the Regulatory Flexibility page.

Protocol Decision Tree

This tool was developed to help investigators identify the most likely level of IRB review for their new study submission.

Protocol Decision Tree

Getting Started Submission Review Level of Review
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