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I recognize that the scientific rationale for the inclusion of LEP participants in clinical research is, as of this writing, only a prima facie imperative. That is, it is certainly conceivable that alleleic frequencies get effectively “washed out” as we move upward along the axis I described of ancestral genetic group ethnicity LEP participant, or that any alleleic frequency profiles along this axis have no impact on pharmacokinetic profiles (though already there is ample evidence to suggest otherwise), or that any possible pharmacokinetic profiles that may be more prevalent in a particular sub-population are already sufficiently represented in today's relatively homogenous clinical trial populations. My point here is that while any of these possibilities may invalidate my proposed scientific necessity for the inclusion of LEP participants in clinical trials, there remains a prima facie imperative until that time when we can disprove it by any of the aforementioned empirically determined possibilities.Google Scholar

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Lamentably, even after several reminder letters from the Assistant Attorney General's office and formal deadline extensions, many federally funded agencies have not complied with the requirement to submit LEP guidance per Executive Order 13166. For updates on agency LEP guidance, see <http://www.usdoj.gov/crt/cor/13166.htm> (last visited November 18, 2008). (last visited November 18, 2008).' href=https://scholar.google.com/scholar?q=Lamentably,+even+after+several+reminder+letters+from+the+Assistant+Attorney+General's+office+and+formal+deadline+extensions,+many+federally+funded+agencies+have+not+complied+with+the+requirement+to+submit+LEP+guidance+per+Executive+Order+13166.+For+updates+on+agency+LEP+guidance,+see++(last+visited+November+18,+2008).>Google Scholar

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