What is NOT Human Subject Research?

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The Office for Human Research Protections has established regulations at Randolph-Macon College.

When there is any doubt as to whether or not a study could qualify as human subject research, you should submit an abstract to the IRB Chair (April Marchetti) to review and make a determination.

Classroom Data

Classroom Research Projects that Do NOT require IRB Approval. Class projects are projects that will not leave the classroom. Classroom data collection does not require IRB review if all of the following is true:

  • The project is limited to observations of public behavior directly related to topics being studied in the course;
  • The data collected contains no personal questions or other personal information that could stigmatize an individual;
  • No identifying information is recorded to link a person with the data;
  • The participants in the project are not from a vulnerable population;
  • The data does not leave the classroom setting;
  • No employee or student is receiving financial compensation for collecting, organizing, analyzing, or reporting the data.

Types of Data and Data Collection Procedures that Do NOT require IRB Approval

Data collection for internal departmental, school, or other institutional administrative purposes (i.e., teaching evaluations, customer service surveys).

Information-gathering interviews where questions focus on things, products, or policies rather than about people or their thoughts (i.e., canvassing librarians about inter-library loan policies or rising journal costs) and the information will not be published or presented outside Randolph-Macon community.

Publicly available data does not require IRB approval (i.e., for internal departmental, school or other institutional administrative purposes such as teaching evaluations and customer service surveys).

Coded data that were not collected for the currently proposed projects as long as the investigator receiving the data cannot link the data back to the individual.

Case Studies which are published and/or presented at national or regional meetings are often not considered human subject 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 (For example, the comparison of case studies would qualify as human subject research).