Examples of Activities that May or May Not be Human Subjects Research
Classroom activities include instructing students in research methodologies and techniques. If the sole purpose of the activity is to teach students research techniques or methodology with no intention to develop or contribute to generalizable knowledge, it is not considered research. If students will practice research methodologies on human beings, however, they should be instructed in the ethical conduct of such activities and advised to obtain informed consent from their practice subjects.
Service surveys issued or completed by University personnel for the intent and purposes of improving University services/programs or for developing new services or programs for students, employees, or alumni, may not meet the definition of human subject research as long as the privacy of the subjects is protected, the confidentiality of individual responses are maintained, and survey participation is voluntary. If the survey is being conducted to produce generalizable knowledge or survey data is used in the future for a new study producing generalizable knowledge, IRB review may be required. Contact an IRB Program Coordinator in the ORS to determine if IRB review is needed.
Information-gathering interviews where questions focus on things, products, or policies rather than people or their thoughts regarding themselves may not meet the definition of human subjects research. Examples include interviewing librarians about inter-library loan policies or rising journal costs. Contact an IRB Program Coordinator in the ORS to determine if IRB review is needed.
Biography or oral history research involving a living individual is not generalizable beyond that individual. Therefore, it does not meet the definition of research and does not require IRB review and approval.
Case reports do not involve systematic investigation and, therefore, do not meet the definition of research involving human subjects and do not require prior IRB review and approval. However, a report of a series of cases may qualify as human subjects research and should be submitted for review and approval by IRB prior to initiation. Contact an IRB Program Coordinator in the ORS to determine if IRB review is needed.
Research involving publicly available data does not require IRB review. Examples of publicly available data include census data and labor statistics.
Research involving secondary use of data may not meet the definition of human subjects research and therefore may not require IRB review, provided that the data set contains no identifiers (either direct or linked code numbers). If the data set contains identifiers but does not contain private information, the project may not meet the definition of human subjects research. Private information is defined as information about behavior that occurred in a context in which the individual could reasonably expect that no observation was taking place or involved no information which had been provided for specific purposes for which the individual could reasonably expect would not be made public. Contact an IRB Program Coordinator in the ORS to determine if IRB review is needed.
Educational tests, surveys, interviews, or observations – research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior meets the definition of human subjects research and requires IRB review.
Operation of data warehouses or research database centers are subject to oversight by IRB. Protocols reviewed by the IRB must specify the conditions under which data may be accepted and shared, and ensure adequate provisions to protect the privacy of subjects and maintain the confidentiality of data. IRB will also review and approve a sample collection protocol and consent document.
Leftover biological materials is the material that was originally collected for clinical or diagnostic purposes but some of the material is leftover after the original purpose has been met. Research involving leftover biological materials is human subjects research and needs IRB review. Leftover material that is anonymous may not meet the definition of human subjects research. Contact an IRB Program Coordinator in the ORS to determine if IRB review is needed.
Extra biological materials is biological material that is collected above and beyond what is needed for a clinical or diagnostic procedure, i.e., collecting a few extra mls of blood during a blood draw for diagnostic purpose. Research involving collection and use of extra biological material is human subjects research and needs IRB review.
Quality assurance (QA) projects are activities designed to determine if aspects of any practice are in line with established standards. Quality improvement (QI) projects are designed to improve the performance of any practice in relation to an established standard. Both QA and QI projects may involve systematic investigation and contribute to generalizable knowledge and, therefore, may meet the definition of human subjects research. Contact an IRB Program Coordinator in the ORS to determine if IRB review is needed.
Investigational use of marketed drugs, biologics, and medical devices, or use of a product that is not indicated in the approved labeling, requires prior IRB review and approval. Application submissions for either an Investigational New Drug (IND) or Investigational Device Exemption (IDE) to the FDA may be required when the principal intent is to develop information about the product’s safety or efficacy.
NOTE: The above information was adapted from The University of Texas System “IRB Task Force Report,” April 2009.