Determination Criteria 45 CFR 46.102(e) or 45 CFR 46.102(l)
The federal regulations include a very specific definition for what constitutes “research” and for what is meant by a “human subject”.
Although the federal regulations do not require official IRB review of studies that do not involve human subjects research, investigators may be required to obtain documentation that their project either is not research and/or does not involve human subjects (e.g., as may be required by a student’s doctoral dissertation committee, a funding agency, or a journal editor). If so, please contact email@example.com to determine how to proceed. This determination will need to be made prior to beginning the project. The IRB will not provide a formal written determination after the project has been initiated.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
The following activities are deemed not to be research:
(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
Guidance based on type of project:
All studies involving specimens require IRB review.
Studies involving specimens or data may meet the “no human subjects” criteria. For these projects, use the form “Secondary Research with Data and/or Specimens”, which will obtain the information that is necessary for review of these types of studies.
Studies involving surveys and interviews may not meet the definition of human subjects' research, (e.g. when no questions are about a human subject). If it is decided in conversation with the IRB that review is needed in order to make this determination, use the exempt form related to Tests, Surveys, Interviews, and Observation of Public Behavior.
If unsure whether your project meets these criteria, contact firstname.lastname@example.org before submitting your application. Be sure to include the PI's name in the email. If a protocol has been started in the electronic system, even if very little information has been entered, include the protocol number in the email.
The form specific to requesting a "no human subjects" or "not research" determination should only be used when no other exempt form applies to the type of research. This is rare.
If the project is NIH-funded, the grant application must explicitly indicate that at least a component of the study does not involve human subjects. Otherwise, the "no human subjects" determination will most likely not be accepted by the NIH.