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~ Hi ~ ~ Hi ~ Hi Large-Scale Biology It is important that we, as a society, continue to have access to such Wealth services] research in order to inform policy making in both private and governmental arenas. At the same time, it is important that we, as a society, protect the privacy of individuals and of vulnerable groups, and the confidentiality of information that patients share with health care providers. Protecting Data Privacy ir' Health Services Research, 2000 Mapping the human genome, the cell's complete set of genetic instructions that guides each person's basic life processes, will revolutionize disease diagnosis arid treatment. At the same time, the convergence of genomics, structural biology, arid in- formatics, coupled with related charges in the research environment, is transforming biomedical research and public health. The scale, com- plexity, and costs of research are si- multaneously increasing There are Predictably, science is developing other challenges as well. ~ virtually much faster than the ethical and every scientific area, privately funded legal structures to guide its research and development is increas- application. ing as fast as publicly funded re- search. These trends create a series of problems In managing a public- private interface that does not yet have a well-articulated set of rules to match the new science. Problems involving conflict of interest, control of the research agenda, and the free flow of information are increas- ingly important. Predictably, science is developing much faster than the ethical and legal structures to guide its application. 69
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Informing the Future: Critical Issues in Health Clinical research, a multifaceted area that focuses on assessing po- tential health improvements and moving them into everyday use, is under particular pressure. Stress on the existing systems for regulating, financing, and managing clinical re- The framework of regulatory search is growing. The explosion in controls and ethical guidelines covering clinical research must be updated to more adequately protect patient interests and to rebuild public trust. privately funded clinical research has introduced complex issues of conflict of interest regarding investigators who also have a financial stake in their proj- ects. Public trust and confidence In clinical research has eroded, compli- cahug the challenges of holding clinical trials and finding sufficient subjects to participate In them. The Damework of regulatory controls and ethical guidelines covering coccal research must be updated to more adequately protect patient interests and to rebuild public trust. The Institute of Medicine conducts numerous studies at the inter- face where "big biology'' meets public policy and clinical applications. CHALLENGES IN RESEARCH A number of TOM reports and other activities address important pol- icy issues in research management and neglected areas of scientific opportunity. Setting Priorities for Biomedical Research in the Public Sector The federal government is the single largest sponsor of medical re- search in the United States, principally through the National Institutes of Health (NDI). Understandably, both the constituencies concerned with specific diseases and those focused on particular fields of re- search want to ensure that their interests are given fair consideration in establishing funding priorities. ~ the mid-199Os, concerns about the allocation of Nut research funds came to a head, with extensive de- bate about congressional eannarking of funds for particular diseases, 70
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Large-Scale Biology about N]H's ability to properly balance the social burden of disease with scientific and technical opportunity, and about the adequacy and fairness of public input into the appropriations process and N~'s allocation processes. Scientific Opportunities and Public Needs: Improving Priority Setting and Public Input at the National Ir~sti- tutes of Health (~1998) recommended criteria for Ending allocation, the internal NIH decision-making process, arid mechanisms for public participation in that process. A single theme ran throughout He recommendations: that NIH should revamp its approach to public participation and outreach, at every level and without delay. In publicly fi~nded research, openness is as important to the process as such other valued qualities as expertise, innovation, and objectivity. NIH has filthy implemented the report's recommendations, one of which was to establish a Director's Council of Public Relations ax advisory group made up of citizens who are patients, family members of patients, or advocates of patients—that meets regularly and facili- tates interactions between N]H and the general public. Addressing the Crisis in Clinical Research Translating the flood of new discovenes in basic research into effec- tive treatment requires a robust clinical research system. Clinical re- search is the funnel through which basic research must travel on its way into clinical application. Increas- ingly, the funnel threatens to become a Conical research is the funnel bottleneck. Among the other forces at through which basic research work, reimbursement changes by marl- . must travel on Its way Into conical aged care arid federal Insurance pro- application. Increasingly, the grams have significantly reduced funds funnel threatens to become a available to conduct cI~mcal research. At bottleneck. the same time, the costs of conducting clinical trails in emerging fields, such as genomics, are much higher and entail complex ethical issues that add to their difficulty. in this era of remarkable scientific opportunity, fewer young physicians are electing to train for clinical research. 71
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Informing the Future: Critical Issues in Health At the request of the leading scientific and professional organiza- tions concerned with clinical research, the lOM has established a Clinical Research Rour~dtable that meets quarterly to discuss these and other challenges facing clinical research. The Roundtable ex- plores ways to create a more hospitable environment for the conduct of high-quality clinical research. It does so by serving as a forlorn for leaders from the academic health community, federal agencies, pri- vate organizations that sponsor clinical research, health plans and in- surance companies, corporate purchasers of health care, foundations, arid patient advocacy groups to explore approaches for resolving both acute arid long-term issues affecting clinical research. Specific topics addressed thus far include health and professional education and training and public confidence and participation. Addressing Concerns About Privacy and the Protection of Human Subjects While anxious to receive the benefits of medical breakthroughs, the public is increasingly uneasy about a range of issues touching upon medical records privacy and the adequacy of protections for human 72
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Large-Scale Biology subjects in research. Protecting the privacy of personal health infor- mation while enabling improvements in clinical care and research has been intensely debated and is still far from resolved. There is no com- prehensive federal statute protecting the privacy of health-related in- formation. Limited federal and state statutes and regulations protect certain types of information under spe- cific circumstances. Finding ap- There is no comprehensive federal proaches that can adequately protect statute protecting the privacy of privacy without cnppling legitimate hea'th-related information. research and public health practice will be one of the most important policy issues of the next few years. Protecting Data Privacy ir' Health Serv- ices Research (2000) examines the procedures followed by Institu- tional Review Boards (IRBs) and identifies those practices and princi- ples that best protect the privacy, confidentiality, and security of personally identifiable health information. Institutional Review Boards are at the heart of the current system for protection of human research subjects. Each institution that con- ducts research has its own IRB (or group of TRBs) that reviews proto- cols proposing clinical research and determines whether the risks to human subjects are reasonable in the light of expected benefits to the subjects and the knowledge to be gained. Consensus is strong that the IRBs as currently constituted are ill equipped to perform their mission. The lOM is conducting a two-phase study of the framework for pro- teeing the interests of those involved In research. Phase ~ is a fast-track study (release expected In Apn} 2001) that will provide recommenda- tions for accreditation standards to regulate the performance of IRBs. The second phase of the study will examine the entire role of TRBs and consider alternative means of protecting human subjects in research. Identifying Research Opportunities The TOM is occasionally asked to look intensely at a specific field of research and to offer recommendations to guide grants arid other in- vestments. A report requested by the NTH, Lesbian Health: Current Assessment anal Directions for the Future (1999), provided research 73
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Informing the Future: Critical Issues in Health recommendations for the NTH Office of Women's Health. Multiple Sclerosis: Current Status ant! Strategies for the Future (2000) pro- vides an agenda for basic and clinical research to accelerate scientific discovery and improve clinical treatment of this disease. Sponsored by the National Multiple Sclerosis Society, the report offers a strate- gic vision for research and training, suggesting ways to engage scien- tific fields that may not previously have focused on the disease. Also of increasing importance in the design and conduct of basic, applied, and clinical research is understanding the biological basis of sex and gender differences and their determinants. Research in these areas is of particular interest due to a renewed focus on women's health issues and to the histoncal lack of research on conditions that are more prevalent in women or that manifest themselves differently in males and females. To further advance the field, the TOM is re- viewing the current state of knowledge pertaining to the science base of sex and gender differences and determinants. The report, authored by the Committee on Understanding the Biology of Sex and Gender Differences, will make recommendations on how to facilitate scien- tific endeavors, take advantage of new opportunities in basic and ap- plied research, and fill identified research gaps to improve the under- standing of sex and gender differences and determinar~ts. VACCINES AND IMMUNIZATION Immunization represents one of the world's primary public health and medical triumphs. However, several advocacy organizations in the United States have raised concerns about the possibility that some vaccines can cause adverse long-tenn Immunization represents one of health consequences, especially on the the worId's primary public health immune system and the central nerv- and medical triumphs. ous system, arid have pushed for a halt to mandated vaccinations dunng childhood. Since the mid-1970s, the TOM has addressed a variety of issues regarding immunization, with several reports focused specifi- cally on vaccine safety. Their conclusion: There is little evidence linking vaccines to many of the purported untoward health events. 74
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Large-Scale Biology However, public concern remains high, and media coverage of sus- pected adverse events has resulted in growing numbers of individuals who reuse vaccination. As the biotechnology revolution develops a new generation of vaccines, public confidence in the safety of these products cannot be assumed. The lOM plays an important role in providing objective scientific advice about the safety and efficacy of vaccines. Our Immunization Safety Review Project meets quarterly to assess emerging informa- tion and to recommend appropriate responses including research re- garding putative adverse events involving vaccines. We also study vaccine development, as many diseases, even cancer, may be prom- ising targets for immunization. Vaccines for the 21st Century: A Tool for Decisionmaking (2000) provides an analytic Damework and quantitative mode! for comparing potential new vaccines. The report outlines a cost-effectiveness approach for assessing vaccine candi- dates on the basis of their anticipated impact on morbidity and mor- tality, as well as on their anticipated costs in terms of development, use, and related health care requirements. Such analysis can help cianfy trade-offs in decisions to invest in the development of one vaccine as compared to another, thus simplifying a complicated pic- ture in which vastly different forms of illness and health benefits must be balanced against a variety of costs. The results of such compan- sons, of course, will have to be incorporated with other value judg- ments in targeting particular vaccines for development. 75
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Selected Recommendations Related to Military Personnel and Veterans ~ . . Health of Deployed Forces: The Department of Defense should include immunization data, ambulatory care data, and exposure data with immedi- ate medical implications in the individual medical records, and link those records to other information about deployment exposures. Implement a joint system for recording and retrieving information on the locations of service members units during operations. (Protecting Those Who Serve: Strategies to Protect the Health of Deployed U.S. Forces) DoD should clarify the leadership authority and accountability for coordina- tion of preventive medicine and environmental and health surveillance. The efforts of environmental surveillance, preventive medicine, clinical, and in- formation technology personnel should be integrated. (Strategies to Protect the Health of Deployed U.S. Forces: Medical Surveillance. Record KeeD- ing, and Risk Reduction) , DoD should implement, as quickly as possible, a deployment disease and non-battle injury surveillance system. A lifetime computer-based patient re- cord for service members should be a high priority for development. (Pro- tecting Those Who Sen/e) Military Deployment Research: Establish a National Center for Military Deployment Health Research that will focus on the health of active, re- serve, and guard forces, and veterans and their families. (National Center for Military Deployment Health Research) Radiation Exposure in Military Operations: Whenever possible, soldiers should be accorded the same level of protection as civilians. Military person- nel should receive appropriate training in both radiation effects and protec- tion. A program of measurement, recording, maintenance, and use of do- simetry and exposure information is essential. (Potential Radiation Exposure in Military Operations: Protecting the Soldier Before, During, and After3 VA Formulary: VA should examine drugs newly approved by FDA in a timely manner. Drugs providing significant improvement in treatment options should be given priority review and serious consideration for the National Formulary. (Description and Analysis of the VA National Formulary) Gulf War and Health: Further research is needed on the long-term health effects of biological and chemical agents including depleted uranium, sarin, pyridostigmine brominde and anthrax and botulinum toxoid vaccines. (Gulf War and Health: Volume1. Depleted Uranium, Pyridostigmine Bromide, Sa- rin, and Vaccines)
Representative terms from entire chapter: