Encyclopedia of Law and Economics

2019 Edition
| Editors: Alain Marciano, Giovanni Battista Ramello

Institutional Review Board

  • Roberto IppolitiEmail author
Reference work entry
DOI: https://doi.org/10.1007/978-1-4614-7753-2_197


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.

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  1. 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
  2. Calabresi G (1969) Reflection on medical experimentation in human. Daedalus 98(2):387–405Google Scholar
  3. Campbell EG, Weissman JS, Vogeli C, Clarridge BR, Abraham M, Marder JE, Koski G (2006) Financial relationships between institutional review board members and industry. N Engl J Med 355:2321–2329.  https://doi.org/10.1056/NEJMsa061457CrossRefGoogle Scholar
  4. Coleman CH (2004) Rationalizing risk assessment in human subject research. Arizona Law Rev 46(1):1–51Google Scholar
  5. Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects (1964)Google Scholar
  6. European Union regulation: Directive 2001/20/EC (2001)Google Scholar
  7. Emanuel EJ, Lemmens T, Elliot C (2006) Should society allow research ethics boards to be run as for-profit enterprises? PLoS Med 3(7):e309.  https://doi.org/10.1371/journal.pmed.0030309CrossRefGoogle Scholar
  8. 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
  9. 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
  10. ICH Topic E 6 (R1) Guideline for Good Clinical Practice (2002)Google Scholar
  11. Ippoliti R (2013a) Economic efficiency of countries’ clinical review processes and competitiveness on the market of human experimentation. Value Health 16:148–154CrossRefGoogle Scholar
  12. Ippoliti R (2013b) The market of human experimentation. Eur J Law Econ 35(1):61–85CrossRefGoogle Scholar
  13. The Nuremberg Code of Ethical Human Subjects Research Conduct (1947)Google Scholar
  14. 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

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Department of ManagementUniversity of TurinTurinItaly
  2. 2.Scientific PromotionHospital of Alessandria – “SS. Antonio e Biagio e Cesare Arrigo”AlessandriaItaly