Policies For Biomedical Research

Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

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.

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.

This volume brings together the views of authors involved in many aspects of biomedicine-from research on basic biology to clinical invest igation of the causes and treatment of human disease to hospital adminis tration ·to health care planning on the state and Federal levels to Con gressionallegislation covering biomedical research, medical education, the development of medical technology, and the delivery of health care. The purpose is not to present a "party line" representing a consensus of these often divergent viewpoints, and we do not suggest that we have found solutions to the many problems encountered in the interaction of scientists, administrators, legislators, and the recipients of health care. These articles are intended primarily to communicate to both biomedical scientists and intelligent laymen the processes, social and political as well as scientific, whereby biomedical science advances, and the need for biomedical scientists to take an interest and initiative not only in scientific research but also in research on health care delivery and in related public issues before the legislative and administrative branches of government.

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.