Office of Research Integrity and Assurance

Do I Need IRB Review?

Is IRB Approval Required for My Project?

All projects meeting the regulatory definition of Research with Human Subjects require IRB review and approval. To determine if a project requires submission to the IRB, you must consider two criteria:

If the answer to both questions is “yes”, then the project requires IRB review and approval.

Note: Research projects conducted as part of a course assignment may not require IRB review.  See the Classroom Projects SOP for more information.

Determining whether your project is “research” with “human subjects” under the U.S. regulations

Step 1: Is Your Project Research?

Why this matters

  • If your activity doesn’t fit one of the definitions of research (below), you do not need to obtain Institutional Review Board (IRB) approval or a determination of exempt status.
  • The specific definition (if any) that applies to your activity determines which regulations and requirements govern your research.

Two definitions of “research”

1. FDA-regulated research

Applies to: Activities that are regulated by the Food and Drug Administration (FDA) and that involve the use of a drug, device, or other item regulated by the FDA.

The activity is research if both of the following conditions are met:

    • The intent of the activity is to develop information about a drug, medical device (including diagnostic tests), or biologic substance for submission to the federal Food and Drug Administration (FDA), and
    • The activity involves the prospective physical use of drug, medical device (including diagnostic tests), or biologic substance, in a way that is not completely up to the discretion of a clinical practitioner.
2. Research that is not regulated by the FDA

Applies to: All activities that are not described in Definition 1.

Research is a systematic investigation, including research development, testing, and/or evaluation, designed to develop or contribute to generalizable knowledge.

Systematic investigation: A detailed or careful examination that has or involves a prospectively identified approach to the activity based on a system, method, or plan.

Generalizable knowledge: The information is expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following:

    • Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied
    • Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study.

Program Evaluation, Quality Improvement, and Pilot Studies

Activities can be considered research even if they are also considered to be program evaluation, quality improvement, public health surveillance, preliminary work, or pilot studies. For more information about these and other special situations, consult the IRB ([email protected]).

Step 2: Does Your Project Involve Human Subjects?

Why this matters

  • If your research does not involve human subjects, you do not need to obtain Institutional Review Board (IRB) approval or a determination of exempt status.
  • The specific definition (if any) that applies to your activity determines which regulations and requirements govern your research.

Two definitions of “human subject”

1. FDA-regulated research

Applies to: Research that is regulated by the Food and Drug Administration (FDA) and that involves the use of a drug, device, or other item regulated by the FDA.

Human subject: A living individual who participates in a research investigation, as (a) a recipient of an item regulated by the FDA; (b) as a control; or (c) on whose specimen an investigational device is used.

2. Research that is not regulated by the FDA

Applies to: All research that is not described in Definition 1.

Human subject: A living individual about whom a researcher obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. Review the worksheet, Human Subjects Research Determination for definitions of the bolded words.

Special Considerations

  • Deceased individuals. This refers to individuals who are not alive, as defined by applicable local and national laws. Deceased individuals are not considered to be human subjects.
  • Specimens, records, data (no interaction or contact with living individuals). Private identifiable specimens, records and data about individuals are considered to be human subjects, even if the researcher has no contact or interaction with the individuals.
  • Third party or secondary subjects. This refers to situations in which the researcher obtains information about one individual (“A”) through interaction with another individual (“B”). If the information about A is private and identifiable, then A is a human subject.
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