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COLLOQUIA & CONFERENCES
Jacqueline Fox USC School of Law March 31, 2006 Friday, 4:00pm-6:00pm Nursing, Room 127 There is a clash of value systems between those that govern drug companies and those that govern the use of human beings as research subjects. Drug companies are driven primarily by a fiduciary obligation to maximize profit for their shareholders. The ethical and regulatory scheme that allows human beings to volunteer to be research subjects is driven by a commitment to expanding the knowledge base of human kind. Drug companies need to use human research subjects to assess safety and efficacy of their products in two primary contexts: (1) to test whether their products work and (2) to provide adequate data to regulatory agencies so that the products will be approved for marketing to the public. The problem arises when publicizing the data generated by this research is not useful for furthering the profit motives of the corporation. The risk is that this data will be suppressed or distorted and not utilized in a manner calculated to further the ethical justification for testing on human beings in the first place. The requirement that research conducted on human subjects be done to increase knowledge for human kind is what I would call a foundational element of research. The failure to adhere to this, to allow data derived from human beings to be suppressed, has resulted in a broad systemic problem with ramifications for the thousands of human research subjects who volunteer each year as well as for the general public, which is not benefiting as it should from the sacrifices made by these people. These and related issues will be explored in this talk.  |
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Last updated 4/8/08 10:32 PM
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burke@sc.edu
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