Essay Ten


 

 Bioterrorism, Informed Consent
and Scientific Method
An Analysis of Common Rule
by   
Anthony N. Lalli
 March 18, 2002
copyrights 2002 (c) Anthony N. Lalli All Rights Reserved


Efficacy Studies in Animals and Safety Testing in humans

The Public Health Security and Bioterrorism Response Act of 2001 (Act) (8) is still being debated in the U. S. Congress.  However, two sections, which deal with human subject research needs more thought; Section 123 is one of those sections and it so states:

  “Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall complete the process of rulemaking that was commenced with the issuance of the proposed rule entitled `New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot be Conducted’ published in the Federal Register on October 5, 1999 (64 Federal Register 53960).” 

While perhaps this may be the only way to do this type of R&D, however, if a decision is made to go ahead in this manner, then it does emphasize the need for an informed consent that is guaranteed by law (1).
 

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