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Does your project meet the federal definitions of research described below? If not, it may not need to be reviewed by the IRB. See our page regarding projects that are usually not human subjects research for examples.

Definition 1. This definition is for all projects that are not regulated by the FDA.

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

Systematic investigation: An activity that involves a prospective plan that incorporates data collection (quantitative or qualitative) and data analysis to answer a question or address a hypothesis.
Designed: The activity has a predetermined purpose and intent.
Generalizable: The results may be applied more broadly beyond the individuals studied or beyond a specific time and/or location, such as to other settings, circumstances, or categories. Publishing or presenting does not necessarily make a project generalizable.

Definition 2. This definition is for all projects involving the use of a drug, device, or other item that is regulated by the Food and Drug Administration (FDA).

Research is any clinical investigation that involves an item regulated by the FDA, and involves one or more humans subjects and:

• Must meet the federal requirements for prior submission (of the planned investigation) to the FDA, or
• The results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit.

Items Regulated by the FDA include: Any drug (including biological products) for human use, medical device for human use, human food additives, color additives, and electronic products intended for clinical use by or with humans.
Prior submission: This refers to the FDA requirement for obtaining the FDA's approval prior to doing research with investigational items or for doing research on already-approved items for a new use, dose, route of administration, or population.
Application for a research or marketing permit: This refers to whether the researchers (or the research sponsor) intend to eventually use the data from the project to obtain approval, or a research or marketing permit, from the FDA.

Other Resources

• Case Report Research Self-Determination Form. If your study involves a Case Report you may not need IRB review. Complete this simple form to self-determine.
• Case Report - IRB and HIPAA Requirements. Use this flow chart to determine if your Case Report falls under any IRB or HIPAA requirements.

Next Steps

Now that you know your project is research, what do you do? Continue on...