IRB's & Johns Hopkins

In June, 2001, Ellen Roche, a healthy 24 year old volunteer in a clinical trial at Johns Hopkins, died. Her death was attributable to adverse effects of hexamethonium, the drug being administered in the trial. Reports of the adverse effect that led to her death had been published in the medical literature. They were missed by the physician doing the literature search.

The document, "Actions Taken to Strengthen Research Oversight at Johns Hopkins" www.hopkinsmedicine.org/press/2001/AUGUST/actionplan.htm calls for investigators to work with a pharmacist and a librarian for all literature searches related to clinical trials.

JHU's "Guidelines for determining an adequate and comprehensive literature search" are at http://irb.jhmi.edu/Forms/LiteratureSearch.doc

The article, "Johns Hopkins’ Tragedy: Could Librarians Have Prevented a Death?" by Eva Perkins is available at http://www.infotoday.com/newsbreaks/nb010806-1.htm

This information helps to make the point that the skills of a medical librarian must be brought to bear on critically important searches.