Essay Ten


 Bioterrorism, Informed Consent
and Scientific Method
An Analysis of Common Rule
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).



To Open all Free Reads, enter your email address and click on the Verify Human button….

Agreement Reminder: The essays, letters and brief descriptions that I have written, and published at this web site, are written in the academic standard, which means they all have strong bibliographies.  Therefore, if you should paraphrase, or use direct quotes, or use excerpts, you are required to reference the pertinent essay. Read Full Agreement

Note: AHP does not sell email addresses.


You cannot copy content of this page