Not Human Subjects

Projects that either do not involve human subjects or fail to meet the definition of research are excluded from IRB review. This is not the same as exempt research.

Is an activity research involving human subjects?

To determine whether or not IRB review is required, the first step is to determine whether or not the study is research.  The next step is to determine whether or not the study involves human subjects.  Some projects that may require careful consideration for this type of determination include: oral histories, case studies, quality improvement studies, etc.  Typically IRB staff will assist the researchers in making this decision; IRB members are usually consulted only in situations that are unclear.

Please see below for the regulatory definitions of research and of human subjects.

Research:  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes.  45 CFR 46.102(d)

Human subject:  a living individual about whom an investigator (whether professional or student) conducting research obtains

  1. Data through intervention or interaction with the individual, OR
  2. Identifiable private information (See List of Possible Identifiers)
  3. 45 CFR 46.102(f)(1),(2)

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. 45 CFR 46.102(f)(1)

Identifiable 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). 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.  45 CFR 46.102(f)(2)

Human Subject Decision Charts

The Office for Human Research Protections (OHRP) provides their Human Subject Regulations Decision Charts as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46.

The Emory IRB has compiled a quick reference chart on IRB review types for researcher use.