Human gene therapy, consent, and the realities of clinical research: is it time for a research subject advocate?
Silber, Tomas Jose
Human Gene Therapy 2008 January; 19(1): 11-13
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Protection of Children in Research: Beyond Pediatric Risk Levels: The Emergence of the Research Subject Advocate Silber, Tomas J (2010-09)The author describes the role of the research subject advocate (RSA), inaugurated in 2001, which adds a fourth level of protection for human research subjects.