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Emergency medicine and the development of the Food and Drug Administration's final rule on informed consent and waiver of informed consent in emergency research circumstances.

This article reviews the federal regulations for emergency and acute resuscitation research in effect prior to October 1996, the historical issues that contributed to the development of these regulations, the controversies that arose surrounding the application of these regulations to emergency research circumstances, and the methods by which the regulations were changed. The new regulations introduced by the U.S. Food and Drug Administration (FDA) also are reviewed.

Disclosure↗

Australia needs an office of academic integrity.

Institutions investigating allegations of research misconduct are vulnerable to claims that their processes are inadequate or that they have an institutional conflict of interest. The Office of Research Integrity in the United States sets down standards for and reviews the adequacy of investigations of research misconduct by institutions; recognises that internal politics and the involvement of non-experts can lead to honest mistakes being regarded as serious misconduct; requires complainants and investigators to act "in good faith"; and reduces damaging publicity when complaints are misconceived or false. Australia needs an office of academic integrity to ensure that all complaints are thoroughly investigated; the investigative procedures meet international standards; fair processes are provided for complainants and respondents; and institutions are protected from claims of "cover-up" and institutional conflict of interest.

Australia↗

Collaboration and importance of federally sponsored Superfund research programs.

Numerous studies have shown that the release of hazardous substances in the environment impact the environment and human health. Communities want to know if they have been exposed, if their health is affected, and how they can protect themselves. For environmental impacts the concerns include how best to clean up and manage the contamination, and protect the environment. The answers to these questions are complex and many times unknown. Three federal agencies conduct Superfund-related research to answer a wide range of questions from identifying contaminants of concern and health risks to determining effective cleanup and prevention strategies. This article discusses the research programs for the Agency for Toxic Substances and Disease Registry, U.S. Environmental Protection Agency (Office of Research and Development), and National Institute of Environmental Health Sciences (Superfund Basic Research Program). The three agencies collaborate on their research programs and research agenda setting activities. This introduction to Superfund-related research provides a foundation and context for the scientific articles in this special edition of the journal. Because of the magnitude of environmental and human health concerns, there is a critical need for additional research to address many challenging questions involving exposures, biological responses, and environmental technologies.

Environmental Pollution↗