Advertisement

Institutional Review Boards and Standards

  • Claire O. Burns
  • Esther Hong
  • Dennis R. DixonEmail author
Chapter
Part of the Autism and Child Psychopathology Series book series (ACPS)

Abstract

Establishing evidence-based paradigms requires approval and oversight of treatment research. This review covers the history and status of these methods and procedures beginning with the Declaration of Helsinki. Key elements of ethical guidelines with respect to how participants are protected and cost/benefits are weighted are discussed. Methods and procedures used by universities, states, and federal review boards are also covered.

Keywords

IRB Ethics IRB review 

References

  1. American Psychological Association. (2002). Ethical principles of psychologists and code of conduct. American Psychologist, 57(12), 1060–1073.CrossRefGoogle Scholar
  2. Centers for Disease Control and Prevention (CDC). (2016). U.S. Public Health Service Syphilis Study at Tuskegee. Retrieved from http://www.cdc.gov/tuskegee/timeline.htm
  3. Clarke, P. (2012). 50 Years: The Kefauver-Harris Amendments. Retrieved from http://www.fda.gov/Drugs/NewsEvents/ucm320924.htm
  4. Freeze, S. (2014). Jewish chronic disease hospital [Prezi presentation]. Retrieved from https://prezi.com/3datqmxu0gms/jewish-chronic-disease-hospital/
  5. Hornblum, A. M. (2013, December 28). NYC’s forgotten cancer scandal. New York Post. Retrieved from http://nypost.com/2013/12/28/nycs-forgotten-cancer-scandal/
  6. Kim, J. H., & Scialli, A. R. (2011). Thalidomide: The tragedy of birth defects and the effective treatment of disease. Toxicological Sciences, 122(1), 1–6.CrossRefPubMedGoogle Scholar
  7. Matson, J. L., Adams, H. L., Williams, L. W., & Rieske, R. D. (2013). Why are there so many unsubstantiated treatments in autism? Research in Autism Spectrum Disorders, 7(3), 466–474.CrossRefGoogle Scholar
  8. National Institutes of Health (NIH). (2009). Willowbrook hepatitis experiments. In Exploring bioethics (pp. 294–297). Retrieved from https://science.education.nih.gov/supplements/nih9/bioethics/guide/pdf/teachers_guide.pdf
  9. Nürnberg trials. (2015). In Encyclopedia Britannica online. Retrieved from http://www.brittanica.com/event//Nurnberg-trials
  10. Office for Human Research Protections (OHRP). (1993). Institutional Review Board Guidebook. Retrieved from http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm
  11. Office for Human Rights Protection (OHRP). (1998). Federal Register, Volume 63, Number 216. Retrieved from http://www.hhs.gov/ohrp/policy/63fr60364.html#Google Scholar
  12. Robinson, W. M., & Unruh, B. T. (2008). The hepatitis experiments at the Willowbrook state school. In E. J. Emanuel, R. A. Crouch, C. Grady, R. K. Lie, F. G. Miller, & D. Wendler (Eds.), The Oxford textbook of clinical research ethics (pp. 80–85). New York, NY: Oxford University Press.Google Scholar
  13. U.S. Department of Health and Human Services (DHHS). (1979). The Belmont Report. Retrieved from http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
  14. U.S. Department of Health and Human Services (DHHS). (2005). The Nuremberg code. Retrieved from http://www.hhs.gov/ohrp/archive/nurcode.html
  15. U.S. Department of Health and Human Services (DHHS). (2009). Code of Federal Regulations, Title 45 Part 46. Retrieved from http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101
  16. World Medical Association (WMA). (1964). Deklaration von Helsinki 1964. Retrieved from https://www.aix-scientifics.com/en/_helsinki64.html
  17. World Medical Association (WMA). (2013). World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA, 310(2), 2191–2194.Google Scholar

Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  • Claire O. Burns
    • 1
    • 2
  • Esther Hong
    • 1
  • Dennis R. Dixon
    • 1
    Email author
  1. 1.Center for Autism and Related DisordersWoodland HillsUSA
  2. 2.Department of PsychologyLouisiana State UniversityBaton RougeUSA

Personalised recommendations