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Articles 1 - 3 of 3
Full-Text Articles in Law
Informed Consent And Patients' Rights In Japan: 2001 Epilogue, Robert B. Leflar
Informed Consent And Patients' Rights In Japan: 2001 Epilogue, Robert B. Leflar
Robert B Leflar
Japan is on a steeper trajectory toward the incorporation of informed consent principles into medical practice than the “gradual transformation” observed in a 1996 article, Informed Consent and Patients’ Rights in Japan. Among the most significant recent developments from 1996 to 2001 have been these seven: (1) the 1997 enactment of the Organ Transplantation Law permitting the use of brain death criteria in limited circumstances in which informed consent is present; (2) the strengthening of patients’ rights in clinical drug trials; (3) the continued trend toward increasing disclosure to patients of cancer diagnoses; (4) initiatives by the health ministry toward …
Informed Consent And Patients' Rights In Japan, Robert B. Leflar
Informed Consent And Patients' Rights In Japan, Robert B. Leflar
Robert B Leflar
This article analyzes the development of the concept of informed consent in the context of the culture and economics of Japanese medicine, and locates that development within the framework of the nation's civil law system. Part II sketches the cultural foundations of medical paternalism in Japan; explores the economic incentives (many of them administratively directed) that have sustained physicians' traditional dominant roles; and describes the judiciary's hesitancy to challenge physicians' professional discretion. Part III delineates the forces testing the paternalist model: the undermining of the physicians' personal knowledge of their patients that accompanies the shift from neighborhood clinic to high-tech …
Public Accountability And Medical Device Regulation, Robert B. Leflar
Public Accountability And Medical Device Regulation, Robert B. Leflar
Robert B Leflar
In enacting the Medical Device Amendments of 1976, Congress instituted a flexible system of regulatory controls over a vast array of health care products. Analyzing the complex statute and its legislative history, Professor Leflar finds at the law's core a structure designed to ensure the Food and Drug Administration's accountability to the public for its regulatory actions. Reviewing the history of FDA's implementation of the medical device law, however, the author demonstrates that FDA has strayed widely and, he contends, illegally from the congressionally mandated structure of public accountability. In particular, in its review of new-model medical devices in the …