With support from the National Institutes of Health, a Case Western Reserve University law professor will study ethical differences between therapeutic and enhancement genetic research that involves human subjects and suggest guidelines to fill public policy gaps.
Maxwell Mehlman, Arthur E. Petersilge Professor of Law, received a two-year $773,000 NIH grant to lead a team of researchers in identifying these relevant ethical differences and then determining whether current rules and regulations adequately protect human subjects in genetic enhancement research.
"If policies are found to be inadequate, then changes will be proposed to existing rules and regulations in order to enable society to respond effectively to possible future attempts to conduct genetic enhancement research using human subjects," said Mehlman, who is director of the Case's Law-Medicine Center at the Case School of Law and professor of bioethics at the Case School of Medicine.
Over the past half-century, elaborate rules have been developed to protect human subjects in medical testing.
"The problem is that the rules were designed with therapeutic goals in mind," stated Mehlman. "The question is, are these safeguards appropriate to govern testing for non-therapeutic enhancements, where the measurement and valuation of the benefits is different from therapeutic testing?"
If guidelines do not exist for enhancement research, Mehlman said it exposes research subjects to risks that would be unacceptable for enhancement research but acceptable in the case of advancing therapeutic research. Moreover, without guidelines to govern enhancement research, the possibility exists that enhancement research could be driven "into the realm of 'underground' illicit or off-label use and self-experimentation, which could cause serious harm," explained Mehlman.
Examples might be abuse of growth hormones to increase stature or studies of genetic mutations to acquire desired non-disease traits.
The project is the first major research grant received in connection with the Center for Genetic Research Ethics and Law (CGREAL) at Case, which is one of four university centers recognized by the NIH for excellence in work on the ethical, legal, and social implications of the Human Genome Project. Mehlman is a research coordinator and director of public policy for CGREAL.
"We are very pleased and proud that the NIH has chosen to award this grant to Professor Mehlman and the Law-Medicine Center to begin exploring new issues in health law and bioethics," said Gerald Korngold, dean and McCurdy Professor of Law. "Among the reasons that the Law-Medicine Center is so highly regarded is that it undertakes important new research like this."
Mehlman said the need for, and importance of, developing individual and societal protections to restrict enhancement research is growing rapidly, thanks to the ever-increasing use of gene-based diagnostic and therapeutic technology.
"It's obvious that many of the genetic-based techniques used for diagnosis and treatment can also be used for enhancements," he said.
He noted that substances such as human growth hormone and erythropoietin (a substance which controls the body's production of red blood cells and can be used to enhance athletic performance) are already available.
Other members of the research team include: Jessica Berg, professor of law and bioethics; Jennifer Fishman, assistant professor of bioethics and sociology; Mary Quinn Griffin, assistant professor of nursing; Eric Juengst, associate professor of bioethics; and Eric Kodish, MD, the F.J. O'Neill professor and chairman of the Department of Bioethics at the Cleveland Clinic Foundation.
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