IRB Decision-Making with Imperfect Knowledge: A Framework for Evidence-Based Research Ethics Review

Journal of Law, Medicine and Ethics 40 (4):951-969 (2012)
  Copy   BIBTEX


Institutional Review Board decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a chemical ganglionic blocker that was not FDA-approved for use as specified in the experimental protocol. Risks of inhaling hexamethonium, including lung damage, had been reported in the 1950s and ‘60s. An investigation conducted after Roche's death determined that the study's principal investigator had failed to adequately search the medical literature; the protocol submitted for IRB review cited articles indexed in online literature databases that went back only as far as the 1970s.



    Upload a copy of this work     Papers currently archived: 91,164

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

Ethical Decision Making: Special or No Different? [REVIEW]Dawn R. Elm & Tara J. Radin - 2012 - Journal of Business Ethics 107 (3):313-329.


Added to PP

76 (#209,950)

6 months
9 (#242,802)

Historical graph of downloads
How can I increase my downloads?

Author's Profile