Defining Human Research

Is This Human Subjects Research?

Pursuant to the National Research Act in 1974, the Belmont Report was published and federal regulations to protect human subjects (45 C.F.R. Part 46 aka "Common Rule") established requirements for the registration of IRBs. Every IRB is concerned with ethics as they apply to research with human subjects, so the first part of the IRB process is determining if the proposed activity is human subjects research.

  • Research - An activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge, which is typically expressed in theories, principles, and statements of relationships.
  • Human Participants - A study has human participants when a researcher does any of the following with a living individual for the purpose of conducting research:
    • interacts with them
    • or asks them to take part in an intervention
    • or manipulates their environment
    • or collects identifiable materials about them
Non human subjects research must be officially determined by the IRB office. If your project is not human research, look for a form on your school's IRB website.
Non-Human Subjects Research: If you believe your project does not constitute human subjects research, per BLANK University Institutional Review Board (IRB) guidelines, please review and complete the Non-Human Subjects Notification Form and submit to the Interim IRB manager.
The IRB officially determines if a study is human subjects research, not the researcher.

What About the Animals?

In case you are concerned, institutional committees for the protection of animals also exist. Here is a link to the Guide for the Care and Use of Laboratory Animals that supports animal protection. Ironically, animal testing is frequently more controversial than testing on human subjects. For their protection, a university near me does not even publish the names of members of its animal research protections committee. The members of the IRB are on the website!

Based on material produced by the Office for Human Research Protections, including the Belmont Report (1974) and Human Research Protection Foundational Training.