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A Word from the Editor

By Michael E. Clark
July 06, 2005

It is my pleasure to welcome you to LJN's Bioethics Legal Review on behalf of the publisher and the Board of Editors. Few areas are as controversial, far-reaching, and important as the broad field of bioethics. Dramatic advances in scientific knowledge and technology have led to some of the most provocative and difficult issues encountered in law, science, and ethics. Questions about genetic research, AIDS research, and whether federal funding for stem cell research should be increased (or even provided) are just of few of the issues being debated by the nation's leading commentators, bureaucrats, and politicians. Some of the recent events that have presented tough bioethical issues and captured widespread public interest have included the saga of the brain-damaged Terri Shiavo – and her death after the final round of court orders from state courts in Florida to cease providing her with nutrition and water (followed by legislation passed in Congress, and failed appeals by her parents to federal courts); the cloning of human embryos in foreign countries – and the ethical and moral issues that are possible from such activities; and, the (denied) request by a death row inmate for a stay of execution long enough so that he could donate a body organ to his chronically ill sister.

Members of Congress are rapidly becoming more focused on (and polarized about) bioethical issues. On June 8, 2005, for example, Sen. Chuck Grassley (R-IA), Chairman of the powerful Senate Committee on Finance, announced that he had sent a letter to the Acting Commissioner of the U.S. Food and Drug Administration, Lester M. Crawford, questioning the make-up of the new drug and safety board set up by the Food and Drug Administration to provide independent review of FDA-approved medicines.

We have assembled an illustrious editorial board that can offer insights to readers from differing perspectives — industry, medical practice, academia, and private legal practice — on these and other issues. Bioethical concerns present difficult compliance and risk management issues for health care professionals involved in private and public clinical research, drug and medical device manufacturers, and academic institutions involved in research, among others – and the litigation risks can be substantial. In tandem with these financial costs are the reputational costs involved when researchers are alleged to have acted improperly, unethically, or without adequate oversight.

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