Guidance for Industry. IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations: Final Guidance
Rockville, MD: Food and Drug Administration 2003 October 21: 10 p. [Online]. Available: http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0204-gdl0001.pdf
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Guidance for Industry: Institutional Review Board Review of Stand-Alone Health Insurance Portability and Accountability Act Authorizations; Availability Unknown creator (United States. Food and Drug Administration [FDA], 2003-11-07)