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Protecting Human Research Subjects

Address correspondence to Roger L. Bertholf, Ph.D., Department of Pathology, University of Florida Health Science Center/Jacksonville, 655 West 8th Street, Jacksonville, FL 32209 USA; tel 904 244 5076, fax 904 244 4290, e-mail roger.bertholf{at}jax.ufl.edu.

Respect for persons, beneficence, and justice are the cardinal principles that guide the ethical conduct of research on humans. Past abuses of human research subjects prompted medical organizations and governmental agencies to develop guidelines that ensure the protection of human research subjects. Human research funded by the U.S. government is strictly regulated, and Institutional Review Board approval of the experimental protocol is required prior to the award. Under limited circumstances, human research may be exempted from review, or review may be expedited. Research involving specimens submitted for pathological examination or diagnostic studies sometimes qualifies for these special categories of limited review. Academic pathologists and laboratorians should be aware of the regulations that apply to research on human subjects.

Keywords: Human research, Nuremberg Code, Belmont Report, Declaration of Helsinki