Emerging Policies For Biomedical Research

The book abstracts & excerpts significant articles about science issues that influence the development of national policy. Commentaries by CEOs of academic health centers explore a myriad of topics including societal goals, priority setting, allocation of the funds for biomedical research, biotech, & global competition, integrity in scientific research, public perceptions, & ethical challenges in the use of genetic information. The book provides a unique reference for policy makers, analysts, & those interested in health care policy.

On February 26, 2020, the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine hosted a 1-day public workshop in Washington, DC, to examine current and emerging bioethical issues that might arise in the context of biomedical research and to consider research topics in bioethics that could benefit from further attention. The scope of bioethical issues in research is broad, but this workshop focused on issues related to the development and use of digital technologies, artificial intelligence, and machine learning in research and clinical practice; issues emerging as nontraditional approaches to health research become more widespread; the role of bioethics in addressing racial and structural inequalities in health; and enhancing the capacity and diversity of the bioethics workforce. This publication summarizes the presentations and discussions from the workshop.

The report says that important organizational changes are needed at the National Institutes of Health to ensure the agency meets future challenges effectively. In particular, the report advises NIH to devote additional resources to innovative interdisciplinary research that reflects its strategic objectives and cuts across all agency's institutes and centers. The report recommends that Congress should establish a formal process for determining how specific proposals for changes in the number of NIH agencies and centers should be addressed.

In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Biomedical scientists' concern about the future of funding of health science research prompted this volume's exploration of the financing of the entire health research enterprise and the complex reasons underlying these increasing concerns. The committee presents clear-cut recommendations for improving allocation policies to ensure a balanced distribution of resources that will allow the biomedical research community to build on exciting recent discoveries in many areas. Funding Health Sciences Research also provides the first-ever comprehensive reports on the 1980s policies that have affected the research landscape, including stabilization, downward negotiation, and extended grant duration.

This report is the twelfth assessment of the National Institutes of Health National Research Service Awards program. The research training needs of the country in basic biomedical, clinical, and behavioral and social sciences are considered. Also included are the training needs of oral health, nursing, and health services research. The report has been broadly constructed to take into account the rapidly evolving national and international health care needs. The past and present are analyzed, and predictions with regard to future needs are presented.

Drawing on the work of the Roundtable on Evidence-Based Medicine, the 2007 IOM Annual Meeting assessed some of the rapidly occurring changes in health care related to new diagnostic and treatment tools, emerging genetic insights, the developments in information technology, and healthcare costs, and discussed the need for a stronger focus on evidence to ensure that the promise of scientific discovery and technological innovation is efficiently captured to provide the right care for the right patient at the right time. As new discoveries continue to expand the universe of medical interventions, treatments, and methods of care, the need for a more systematic approach to evidence development and application becomes increasingly critical. Without better information about the effectiveness of different treatment options, the resulting uncertainty can lead to the delivery of services that may be unnecessary, unproven, or even harmful. Improving the evidence-base for medicine holds great potential to increase the quality and efficiency of medical care. The Annual Meeting, held on October 8, 2007, brought together many of the nation's leading authorities on various aspects of the issues - both challenges and opportunities - to present their perspectives and engage in discussion with the IOM membership.