November 2000
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Public health & preventive medicineFebruary 1995Society's Choices
Social and Ethical Decision Making in Biomedicine
by Ruth Ellen Bulger, Elizabeth Meyer Bobby, and Harvey V. Fineberg, Editors; Committee on the Social and Ethical Impacts of Developments in Biomedicine, Institute of Medicine
Breakthroughs in biomedicine often lead to new life-giving treatments but may also raise troubling, even life-and-death, quandaries. Society's Choices discusses ways for people to handle today's bioethics issues in the context of America's unique history and culture--and from the perspectives of various interest groups. The book explores how Americans have grappled with specific aspects of bioethics through commission deliberations, programs by organizations, and other mechanisms and identifies criteria for evaluating the outcomes of these efforts. The committee offers recommendations on the role of government and professional societies, the function of commissions and institutional review boards, and bioethics in health professional education and research. The volume includes a series of 12 superb background papers on public moral discourse, mechanisms for handling social and ethical dilemmas, and other specific areas of controversy by well-known experts Ronald Bayer, Martin Benjamin, Dan W. Brock, Baruch A. Brody, H. Alta Charo, Lawrence Gostin, Bradford H. Gray, Kathi E. Hanna, Elizabeth Heitman, Thomas Nagel, Steven Shapin, and Charles M. Swezey.
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MedicineFebruary 1991Biomedical Politics
by Kathi E. Hanna, Editor; Committee to Study Decision Making, Division of Health Sciences Policy
The abortifacient RU-486 was born in the laboratory, but its history has been shaped by legislators, corporate marketing executives, and protesters on both sides of the abortion debate. This volume explores how society decides what to do when discoveries such as RU-486 raise complex and emotional policy issues. Six case studies with insightful commentary offer a revealing look at the interplay of scientists, interest groups, the U.S. Congress, federal agencies, and the public in determining biomedical public policy--and suggest how decision making might become more reasoned and productive in the future. The studies are fascinating and highly readable accounts of the personal interactions behind the headlines. They cover dideoxyinosine (ddI), RU-486, Medicare coverage for victims of chronic kidney failure, the human genome project, fetal tissue transplantation, and the 1975 Asilomar conference on recombinant DNA.
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Pollution & threats to the environmentSeptember 2002
Cancer and the Environment
Gene-Environment Interactions
by Samuel Wilson, Lovell Jones, Christine Couseens, and Kathi Hanna, Editors, Roundtable on Environment Health Sciences, Research, and Medicine.
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MedicineOctober 2004Strategies to Leverage Research Funding
Guiding DOD's Peer Reviewed Medical Research Programs
by Michael McGeary and Kathi E. Hanna, Editors, Committee on Alternative Funding Strategies for DOD's Peer Reviewed Medical Research Programs
Since 1992 the Department of Defense (DOD), through the U.S. Army Medical Research and Material Command, has received congressionally earmarked appropriations for programs of biomedical research on prostate, breast, and ovarian cancer; neurofibromatosis; tuberous sclerosis; and other health problems. Appropriations for these Congressionally Directed Medical Research Programs are used to support peer reviewed extramural research project, training, and infrastructure grants. Congress has become concerned about funding increases for these programs given current demands on the military budget. At the request of Congress, the Institute of Medicine (IOM) examined possibilities of augmenting program funding from alternative sources. The resulting IOM book, Strategies to Leverage Research Funding: Guiding DOD’s Peer Reviewed Medical Research Programs, focuses on nonfederal and private sector contributions that could extend the appropriated funds without biasing the peer review project selection process.
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MedicineOctober 2005Cord Blood
Establishing a National Hematopoietic Stem Cell Bank Program
by Committee on Establishing a National Cord Blood Stem Cell Bank Program, Emily Ann Meyer, Kathi Hanna, and Kristine Gebbie, Editors
With the potential for self-renewal and differentiation, the possibilities for stem cells are enormous. One specific type of stem cell, the hematopoietic progenitor cell (HPC), which is derived from umbilical cord blood (as well as adult bone marrow and mobilized peripheral blood), holds particular promise. To make the most of these HPCs, the Institute of Medicine was asked to consider the optimal structure for a national cord blood program and to address pertinent issues related to maximizing the potential of stem cell technology. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program examines: The role of cord blood in stem cell transplantation The current status of blood banks already in existence The optimal structure for the cord blood program The current use and utility of cord blood for stem cell transplants The best way to advance the use of cord blood units and make them available for research Expert advice from leaders in the fields of economics, public health, medicine, and biostatistics combine to make this very timely and topical book useful to a number of stakeholders.
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MedicineJanuary 2003Responsible Research
A Systems Approach to Protecting Research Participants
by Daniel D. Federman, Kathi E. Hanna, and Laura Lyman Rodriguez, Editors, Committee on Assessing the System for Protecting Human Research Participants
When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants’ safety and their capacity to safeguard the well-being of those who volunteer for research studies. Responsible Research outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes: Improved research review processes, Recognition and integration of research participants’ contributions to the system, and Vigilant maintenance of HRPPP performance. Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards. Responsible Research will be important to anyone interested in the issues that are relevant to the practice of using human subjects as research participants, but especially so to policy makers, research administrators, investigators, and research sponsors â€" but also including volunteers who may agree to serve as research participants.
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Pollution & threats to the environmentFebruary 2001
Rebuilding the Unity of Health and the Environment
A New Vision of Environmental Health for the 21st Century
by Kathi Hanna and Christine Coussens, A Workshop Summary for the Roundtable on Environmental Health Sciences, Research, and Medicine, Division of Health Sciences Policy
This is a summary of the workshop Rebuilding the Unity of Health and the Environment: A New Vision of Environmental Health for the 21st Century. The goal of this workshop was to emphasize the connection between human health and the natural, built, and social environments. This workshop integrated talks from many fields and created a dialogue among various environmental health stakeholders. The language presented in this respect should not be viewed as an endorsement by the Environmental Health Sciences Roundtable or the Institute of Medicine of what action is needed for the future, but rather as an effort to synthesize the various perspectives presented.
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Science funding & policyJuly 2006Discussions of the Committee on Daubert Standards
Summary of Meetings
by Kathi E. Hanna and Anne-Marie Mazza, Rapporteurs; Committee on Daubert Standards; Committee on Science, Technology, and Law; Policy and Global Affairs; National Research Council
In 1993, the U.S. Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc., laid out a new test for federal trial judges to use when determining the admissibility of expert testimony. In Daubert, the Court ruled that judges should act as gatekeepers, assessing the reliability of the scientific methodology and reasoning that supports expert testimony. The resulting judicial screening of expert testimony has been particularly consequential. While the Supreme Court sought to bring better science into the courtroom, questions remain about whether the lower courts’ application of Daubert accords with scientific practices. This report summarizes discussions held by an ad hoc committee of the The National Academies to consider the impact of Daubert and subsequent Supreme Court opinions and to identify questions for future study.
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PharmacologyOctober 2001Innovation and Invention in Medical Devices
Workshop Summary
by Kathi E. Hanna, Frederick J. Manning, Peter Bouxsein, and Andrew Pope, Editors, Based on a Workshop of the Roundtable on Research and Development of Drugs, Biologics, and Medical Devices, Board on Health Sciences Policy
The objective of the workshop that is the subject of this summary report was to present the challenges and opportunities for medical devices as perceived by the key stakeholders in the field. The agenda, and hence the summaries of the presentations that were made in the workshop and which are presented in this summary report, was organized to first examine the nature of innovation in the field and the social and economic infrastructure that supports such innovation. The next objective was to identify and discuss the greatest unmet clinical needs, with a futuristic view of technologies that might meet those needs. And finally, consideration was given to the barriers to the application of new technologies to meet clinical needs.
