Environmental Health and Safety

Research with Human or Animal Subjects

Involving FDA Regulated Products

The U.S. Food and Drug Administration (FDA) considers a clinical investigation to be research involving a test article and one or more human subjects that will be used to support an application for an FDA research or marketing permit. FDA regulated products include food and color additives, drugs for human use, biological products for human use, and electronic products. FDA regulations apply to research regardless of funding source. FDA regulated biomedical research is subject to their Bioresearch Monitoring (BIMO) inspection program which includes investigators, sponsors,and the Institutional Review Board. The inspections are performed to ensure compliance with FDA's Good Clinical Practices required of all regulated research.

All Research Involving Human Subjects

All research projects with human participants conducted by faculty, staff,and students associated with The University of Texas at Austin must receive ethical approval before research starts. All researchers using human subjects must be familiar with the policies and procedures regarding proposal review by the Institutional Review Board.

All Research Involving Animal Subjects

The U.S. Animal Welfare Act and the Public Health Service (PHS) "Policy on Humane Care and Use of Laboratory Animals" require institutional review and approval of all proposals prior to conduct of any research actively involving vertebrate animals. Research involving animals falls under USDA and NIH/PHS jurisdiction and all projects at The University of Texas at Austin must be reviewed for approval by the Institutional Animal Care and Use Committee.