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15 Va. J. Soc. Pol'y & L. 51 (2007-2008)
Ethical Reforms in Biotechnology Research Regulations

handle is hein.journals/vajsplw15 and id is 57 raw text is: ETHICAL REFORMS IN BIOTECHNOLOGY RESEARCH REGULATIONS Gerald R. Prettyman, Jr.* ABSTRACT Federal regulations for the ethical practice of biotechnology research focus primarily on the health, welfare and safety of the research subject. The regulations rely on the informed consent and voluntary participation of the research subject for ongoing research. One complication to the field has been that federal regulations do not apply to state or privately funded research, and state regulations are inconsistent from state to state. Furthermore, biotechnology research has greatly evolved since promulgation of the federal regulations. Research subjects are less prevalent, especially for living-cell research. Another complication questions the point at which a researcher's commercial interest in the outcome is a conflict of interest in what will soon be an $80 billion dollar a year business. Many of the regulations do not define when a financial interest becomes a conflict of interest while the motivation of commercial success has become an important factor in violations of the federal regulations, as recorded in FDA records. Some research subjects and regulators see the regulations as lacking enough disclosure requirements. This view is supported when the capitalization of research motivates unethical acts. On the other hand, some researchers view disclosure and privacy regulations as already too strict, hampering the ability of research and the business of healthcare to move quickly on new discoveries. In the balance are the donors who want to know in advance how the personal interests of the researcher influence their decision to participate. * LL.M. (Intellectual Property), J.D., B.S.M.E. Contact information is available from the U.S. Patent and Trademark Office's attorney listings. Mr. Prettyman started his career as a medical technician before working as a regulatory compliance engineer in, among other areas, medical applications, and is now an Intellectual Property and Patent Attorney. The author extends his sincere appreciation to his mentors, Professors Virginia Meyer and Marc Greenberg.

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