National regulatory agencies and local institutional committees involved in the oversight of gene therapy trials.

Abbreviations: DHHS, Department of Health and Human Services; OHRP, Office for Human Research Protection; OPRR, Office for Protection of Research Risks; FDA, Federal Drug Administration; CBER, Office for Biologics Evaluation and Research; NIH, National Institute of Health; OBA, Office of Biotechnology Activities; ORDA, Office of Recombinant DNA Activities; RAC, Recombinant DNA Advisory Committee; IBC, Institutional Biosafety Committee.