Subject, Human Research

The federal regulations define two ways in which an individual becomes a human research subject. The first involves having a researcher obtain data about the individual via actual intervention or interaction with the individual. Once the person agrees to participate in the research study, he or she becomes a human research subject. The second circumstance does not require the individual to be present in the research setting in order to be considered a human subject. Once an individual's identifiable private information (for example, from a medical record, or obtained from investigation of biological specimens, and so on) is proposed for research use, that individual becomes a human research subject as well.

Human research subjects are afforded important rights that must be protected. One of the most important rights a subject has is the ability to choose whether or not to participate in the research; that is, participation must be voluntary. Further, even if a subject agrees to participate, the subject must retain the right to withdraw from the research at any time, without any effect on his or her status with the investigator (this is particularly important when the investigator is also the treating physician).

The protection of human subjects occurs at many levels. The Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA; for research involving drugs, biologics, and devices) at the federal level, and the institutional review boards (IRBs) and research investigators at the local level, must all maintain levels of communication, education, and monitoring to ensure that the rights and welfare of human subjects are protected.