Human subjects research is defined by its methods, aims, and materials. The core methodological notion is that research involves the systematic collection or accumulation of data, that is, numbers or texts subject to later analysis. The definition of human subjects research is more a practical matter than a philosophical, linguistic, or scientific matter because defining research as human subjects research means that it can be subject to special regulatory protections and review by institutional review boards. The need for a clear definition of human subjects research grows from a history of degrading, harmful experimental and observational studies that the lead researchers and their sponsors may have seen as justified by the pursuit of medical knowledge, national security, or insight into the human condition.

Although the nature ...