Part 3: Legal Requirements
Department of Health and Human Services. Code of Federal Regulations, Title 45, Public Welfare. Part 46, Protection of Human Subjects. 2005. Accessed 14 August 2006. Available from
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
U.S. Food and Drug Administration. Guidance for Institutional Review Boards and Clinical Investigators
1998 Update. 1998. Accessed 14 August 2006. http://www.fda.gov/oc/ohrt/irbs/appendixc.html.
U.S. Food and Drug Administration. Guidance for Institutional Review Boards and Clinical Investigators
1998 Update. 1998. Accessed 14 August 2006. Available from http://www.fda.gov/oc/ohrt/irbs/appendixc.html.
U.S. Food and Drug Administration. Part 312 - Investigational New Drug Application. 1 April 2003. Accessed 14 August 2006. Available from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=312.
U.S. Food and Drug Administration. Part 600 – Biological Parts: General. 1 April 2003. Accessed 14 August 2006. Available from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=600.
U.S. Food and Drug Administration. Part 182 - Investigational Devise Exemptions. 1 April 2005. Accessed 14 August 2006. Available from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812.
U.S. Department of Health and Human Services. Policy Guidance. 15 October 2003. Accessed 14 August 2006. Available from http://www.hhs.gov/ohrp/policy/index.html.
University of Wisconsin-Madison. Health Insurance Portability and Accountability Act (HIPAA). 10 March 2003. Accessed 14 August 2006. Available from http://www.wisc.edu/hipaa/.
U.S. Department of Health and Human Services. Federalwide Assurance (FWA) for the Protection of Human Subjects for Domestic (U.S.) Institutions, by Janice Ferrar Walden. 29 April 2004. Accessed 14 August 2006. Available from http://info.gradsch.wisc.edu/research/compliance/humansubjects/FWA.pdf.