Institutional Review Board
Institutional Review Board (IRB) are independent institutions aimed at approving, monitoring and reviewing human experimentations in order to protect research subjects’ rights from the necessity to increase the current medical knowledge.
After a brief historical introduction of humans experimentation, this section presents American and European regulation of this specific institution, as well the main related issues in Law and Economics.
- American regulation: title 45 of the Code of Federal Regulations – part 46 (2009) Title 21 of the Code of Federal Regulations– part 56 (revised 2013)Google Scholar
- Calabresi G (1969) Reflection on medical experimentation in human. Daedalus 98(2):387–405Google Scholar
- Coleman CH (2004) Rationalizing risk assessment in human subject research. Arizona Law Rev 46(1):1–51Google Scholar
- Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects (1964)Google Scholar
- European Union regulation: Directive 2001/20/EC (2001)Google Scholar
- Gustafsson BE, Quensel CE, Lanke LS, Lundqvist C, Grahnen H, Bonow BE, Krasse B (1954) The Vipeholm dental caries study; the effect of different levels of carbohydrate intake on caries activity in 436 individuals observed for five years. Acta Odontol Scand 11(3–4):232–264Google Scholar
- Hoffman S (2001) Continued concern: human subject protection, the institutional review board, and continuing review. Tenn Law Rev. 2001 Summer 68(4):725–70Google Scholar
- ICH Topic E 6 (R1) Guideline for Good Clinical Practice (2002)Google Scholar
- The Nuremberg Code of Ethical Human Subjects Research Conduct (1947)Google Scholar
- Thomas SB, Quinn SC (1991) The Tuskegee syphilis study, 1932–1972: implications for HIV education and AIDS risk programs in the black community. Am J Public Health 81:1503Google Scholar