Do I Need IRB Approval?

Federal regulations define research as a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.  For example, some demonstration and service programs may include research activities.

Key components of this definition:

• Systematic investigation – data are collected in a systematic manner, in accordance with a plan or method.
• Including development, testing and evaluation – this means that a pilot study or a small project that is part of a larger study could be research if it involves a systematic investigation designed to contribute to generalizable knowledge.
• Designed to develop or contribute to generalizable knowledge – those conducting the project will draw conclusions or make generalizations based on the information gathered and apply them to a broader population or setting (beyond the specific persons or setting from which data are gathered). The intent or purpose of research is to further scientific knowledge in a particular field of study.  Publication is often viewed as a defining factor, however many publications are based on non-research activities (e.g., medical case reports, reports of program evaluations, etc.).

Federal regulations define a human subject as A living individual about whom an investigator (whether professional or student) conducting research:

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

The regulations further define:

• Intervention includes both physical procedures by which information or biospecimens are gathered (e.g. 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 includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g. medical record)
• Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
• Identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

The FDA defines a Clinical Investigation as any experiment that involves a test article and one or more human subjects that is either subject to requirements for prior submission to the Food and Drug Administration under section 505(i), or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted to, or held for inspection by the Food and Drug Administration as part of an application for a research or marketing permit.   A test article means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug and Cosmetic Act (21 CFR 50.3(j)).

Complete the online self-test in OneAegis (IRBManager) – Does My Study Require IRB Oversight

Decision Tree 1:  Does Your Project Require IRB Approval? (updated 1-8-2019)

Decision Tree 2:  Research Use of Secondary Data (updated 1-8-2019)

Student Projects Involving Human Subjects

Oral History Projects