Protection of Human Subjects
Participation of human subjects in research is under the jurisdiction of federal regulations (45 CFR 46 and 21 CFR 50 and 56). MUSC investigators are granted the privilege of working with human subjects under normal assurance to the government that such research complies with regulations protecting human subjects. The university has a federal-wide assurance for research with human subjects (FWA 00001888, 02/06/2002-10/06/2008), and is in compliance with federal policy governing use of human subjects. Individuals involved in human subject research at MUSC are required to complete the Collaborative IRB Training Initiative (CITI) offered on-line by the University of Miami. All human subject protocols are reviewed through an academic Institutional Review Board (IRB) process. The MUSC Office of Research Integrity coordinates the activities of three IRB committees, involving faculty members as well as representatives of the business, legal, ethical, religious, and civic communities. These committees are registered at: http://ohrp.cit.nih.gov/search/fasurdtl.asp?ASURIDENT=fwa00001888&Submit=SEARCH. The MUSC IRB serves as the university affiliate for the Ralph H. Johnson VA Medical Center, which is accredited by the National Committee for Quality Assurance.