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Not Research and Not Human Subjects Projects

Contents

  1. Introduction
  2. Determination Criteria 45 CFR 46.102(e) or 45 CFR 46.102(l)
  3. FDA Determination Criteria 21 CFR 50.3 and 56.102
  4. Projects That Require IRB Submission
  5. Class Projects
  6. Quality or Operational Improvement Projects within UPMC Facilities
  7. Obtaining Not Research and Not Humans Subjects Determinations

Introduction

This guidance is meant to help determine whether your project is research or involves human subjects as defined by the IRB, and when projects that do not meet those definitions may require IRB submission.

Determination Criteria 45 CFR 46.102(e) or 45 CFR 46.102(l)

The Department of Health and Human Services (DHHS) regulations include a very specific definition for what constitutes “research” and for what is meant by a “human subject”.

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 according to DHHS regulations:

  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.
    • Note: Some scholarly and journalistic activities may require IRB oversight, such as ethnography when the information collected from individuals may be generalized to the studied community or group.
  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.

FDA Determination Criteria 21 CFR 50.3 and 56.102

The Food and Drug Administration (FDA) defines “research” and “human subject” differently.

Clinical investigation (which is synonymous with “research”) means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or need not meet the 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 later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.

Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient.

When the test article is a medical device, de-identified specimens (including data) are considered human subjects.

Projects That Require IRB Submission

All human subjects research should be submitted in PittPRO.  In addition, the following types of projects should be submitted in PittPRO even if they do not meet the regulatory definitions of “research” or “human subjects”: 

  • Research involving the collection or analysis of biospecimens 
  • Externally funded research projects, including support from a UPMC entity
  • Coordinating Centers
  • Research that may be FDA-regulated, such as research involving drugs, medical devices, health-related technologies, including health-related artificial intelligence (AI).
  • Research using a certified honest broker

Contact your IRB Coordinator or askirb@pitt.edu if you have questions.  Also see the guidance on Exempt Research and information on Expedited categories.

Note: 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.

Class Projects

Studies conducted solely to fulfill a course, seminar, or practicum requirement are typically considered instructional activities rather than research.

However, they may be considered research and require IRB oversight if one of the following is true:

  • The data or results may be used in the development of a thesis or dissertation or a proposal for a thesis or dissertation; or
  • The data or results may be published or presented to an audience outside of Pitt or UPMC; or
  • The project may meet the FDA definition of a clinical investigation

Also see the guidance on Student Researchers.

Quality or Operational Improvement Projects within UPMC Facilities

Projects that are quality or operational improvement projects within UPMC facilities should first be submitted to the UPMC Quality Review Committee (askQRC@UPMC.edu).  If necessary, the QRC will work with the IRB to determine if IRB submission is required.

Obtaining Not Research and Not Humans Subjects Determinations

You can use HRP’s Human Subjects Research Determination Tool to help you identify if your project should be submitted in PittPRO, if you should contact the IRB for discussion, or if no further action is needed.

Alternatively, you can contact askirb@pitt.edu with questions or for a consult 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.

If the tool is used and a project is determined Not Human Subjects Research based on your responses and doesn't otherwise require IRB submission, the tool will generate an email that you should keep for your records and a study ID that can be used for Vincent payments if needed.

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). 

10/17/2025