How to make PI involved in Clinical Trials

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What Happened in 1999? 1999 may have been a watershed year for public awareness of chinks in clinical research !!May 1999: Duke University failed to respond to requests

for proper monitoring of human volunteer subjects – FDA temporarily suspended all research.

!!Sept. 1999: Univ. of Pennsylvania; an 18 year old died

from drugs given as part of gene vector therapy study; Understated risks, protocol not followed and Conflict of Interest not disclosed

!!June 2001: Johns Hopkins Univ.; a 24 year old died after receiving inhaled hexamethonium. OHRP Suspended all federally funded research.

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