Maxwell Mehlman, Arthur E. Petersilge Professor of Law, director of the Law-Medicine Center at the Case Western Reserve University School of Law, and professor of bioethics in the Case School of Medicine, will lead a team of law professors, physicians, and bioethicists in a two-year project to develop standards for tests on human subjects in research that involves the use of genetic technologies to enhance "normal" individuals - to make them smarter, stronger, or better-looking.
"Over the past half-century or so we have developed elaborate rules protecting human subjects in medical testing," Mehlman said. "The problem is that the rules were all designed with therapeutic goals in mind. 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?"
The project's specific aims are to:
- Identify the differences between genetic research performed for therapeutic purposes and research performed for enhancement purposes.
- Determine the conditions under which it would be ethical to conduct genetic enhancement research using human subjects.
- Determine whether existing rules meet the ethical conditions for performing genetic enhancement research, and if they don't, recommend changes to the existing rules.
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 rules for 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. "Given that these technologies are already being developed, if we don't have legitimate, approved ways of conducting research it will just go underground, like steroid use in baseball, where players are essentially acting as their own guinea pigs," Mehlman said.
An additional reason for developing guidelines governing genetic enhancement is that their absence may discourage institutions from conducting formal research.
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
- Eric Kodish, MD, the F.J. O'Neill professor and chairman of the Department of Bioethics at the Cleveland Clinic Foundation.