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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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