What is Human Subjects Research?

What is Human Subjects Research?

Human Subject Research - Image

Researchers sometimes have difficulty deciding if their study qualifies as human subjects research. Sometimes, humans are involved in research but they are not considered subjects.

Studies that are not considered human subjects research typically include:

  • Internal studies not made public, including data collections for internal departmental, school, or other institutional administrative purpose (e.g., office procedure evaluations, teaching evaluations, or customer service surveys).
  • Information-gathering interviews where questions focus on items, products, procedures, or policies and are not about people, their perceptions, or thoughts regarding themselves. Information-gathering interview are typically not human subjects research (e.g., when individuals ask professionals product description questions, conduct office policy inquiries, or gain information from teacher-trainers about their upcoming workshop plans).
  • Course-related activities designed specifically for educational or teaching purposes where data is collected from and about human subjects as part of a class exercise or assignment but is not intended for use outside of the classroom (e.g., instruction on research methods and techniques).
  • Biography or oral history research involving a living individual that is not generalizable beyond that individual’s experiences. An oral history may include an individual's description of events earlier in their life. Interviews are designed to document events and lives that might otherwise be lost or forgotten.
  • Case histories that are published and/or presented at national or regional meetings are often not considered research if the case is limited to a description of the clinical features and/or outcome of a single patient and do not contribute to generalizable knowledge. A case history is designed to record the past, an environment, or relevant details of a case and used as an example, analysis, or illustration of the event (e.g., a 38-year-old adult female complained of chronic left ankle pain which led to a new joint stress-relieving physical therapy method).
  • Publicly available data does not require IRB review (e.g., census data, labor statistics).

The IRB reviews each study on a case-by-case basis. The Institutional Review Board at Teachers College will make the final determination of whether a study requires review. If you have questions about your potential study, email IRB@tc.edu, or call 212-678-4105.

Studies that are considered human research typically include:

  • Studies involving human subjects to test or design devices, products, or materials developed through research for human use (e.g., testing if interactive virtual reality (VR) experiences using biometric information contribute to individual mindfulness and relaxation).
  • Interventions or interactions with individuals to collect data for research purposes (e.g., evaluation of teaching methods and programs, internet surveys about sugar consumption, research involving risky behaviors or attitudes, and open-ended interviews with minors about family values in a foreign country that contribute to generalizable knowledge). 
    Studies using private information that can be readily identified with individuals, even if the information was not collected specifically for the study in question.
  • Studies that use bodily materials, such as cells, blood, urine, tissues, organs, hair, or nail clippings, even if these were not originally collected for research purposes.
  • Studies that intend to produce generalizable knowledge about categories or classes of subjects from individually identifiable information.
  • Studies that involve analysis of existing individually-identifiable private information.
  • Studies that use human subjects to evaluate environmental alterations (i.e., weatherization options, travel patterns, or habitat modifications).

Research belonging to any of the above categories must comply with the Federal Regulations and the institution's policies for the protection of human subjects. Research is reviewed on a case-by-case basis. The Institutional Review Board at Teachers College will make the final determination of whether a study requires review. Researchers should email IRB@tc.edu if they have questions or concerns about their study design, and whether it should be IRB reviewed.

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