ࡱ> y{x~b Ʒjbjb Ʊ8::::$$:t8T:L:::::::SSSSSSS,URWS:::::S;::S;;;:::S; ::S;;QlS: .:; 1S(S S0TYS(Y;YPS;88.6886Incorporation of Biomedical Ethics in Institute of Medicine Studies 1970-2000: An Assessment of Content and Evidence Table of Contents Abstract Introduction Brief summary of the incorporation of biomedical ethics in IOM studies Terminological distinctions: ethics, bioethics, biomedical ethics Why biomedical ethics is important for health sciences policy Considerations in determining the role of bioethics in a report Review of the ethical content of past IOM reports 2.1 Identification of reports with ethical analysis or consideration of ethical issues. Discussion of levels of ethical analysis used in past reports. A consideration of overarching ethical themes or issues present in reports Does biomedical ethics have an evidence base? Conclusions and Recommendations Bibliography Appendices Appendix A: Graphs of the relative incorporation of ethics in IOM publications Appendix B: IOM publications listed by amount of ethics content Abstract This background paper identifies, reviews, and assesses the incorporation of biomedical ethics in Institute of Medicine (IOM) studies, with particular emphasis on contributions from the Board on Health Sciences Policy (HSP). The paper consists of three main sections: 1) an introduction to some issues relevant to the incorporation of biomedical ethics analysis in IOM reports; 2) a review and assessment of the incorporation of biomedical ethics issues in past IOM studies; and 3) a consideration of the relevant evidence base for biomedical ethics. Introduction A brief summary of the incorporation of biomedical ethics in IOM studies Ethical considerations have been a component of Institute of Medicine studies, papers, and reports since the Institute was chartered in 1970. Among the first studies produced by the IOM, Ethics of Health Care (1974), examined such issues as the preciousness of life, the consumers perception of health as a value, ethical problems in treating the chronically ill and aged, and the origin of professional values (Societys Choices, p. 128). In 1977, with the development of the first formal division structure, a Division on Legal, Ethical, and Educational Aspects of Health (LEEAH) was established at the IOM along with five other program divisions (For the Public Good, p. 15). However, apparently due to funding difficulties, LEEAH was eliminated after just a year of operation (SC, p. 128) leaving behind a legacy of several reports and commissioned papers (see Appendix B). After the elimination of LEEAH, the considerations of ethical and legal issues in medicine were incorporated into other division areas. Currently, there are nine boards into which IOM program activities are organized. The Board on Health Sciences Policy (HSP) has taken the lead in the incorporation of ethical issues into studies and reports (see Appendix A). Indeed, the HSP mission statement specifies inclusion of ethical issues in its consideration of the impact of scientific advances on society (IOM Staff Orientation Handbook, p. 13). Other boards that have been concerned with ethical issues include the Board on Health Promotion and Disease Prevention and the Board on Health Care Services (see Appendix B). The Board on Global Health specifies recognition and guidance on ethical issues in public health (Staff Orientation Handbook, 11) as among its areas of concern and has included discussion of ethical issues in some of its reports (see Appendix B). Terminological distinctions: ethics, bioethics, biomedical ethics Generally speaking the term ethics refers to the study of moral right and wrong, good and bad, and virtue and vice. Ethics as such is a broad discipline covering issues from how one relates to oneself to how one relates to the environment. Originally the term bioethics was coined (by Van Rensselaer Potter) to describe the proposal that we need an ethic that can incorporate our obligations, not just to other humans, but to the biosphere as a whole (Bioethics: An Anthology, p. 1). In current usage, however, the term is most often used in reference to ethical issues relating to biological or medical science (Bioethics: An Anthology, p. 1). Under this use, bioethics and biomedical ethics are nearly synonymous, as biomedical ethics is the more specific term for ethics relating to biological and medical science and health care. Why biomedical ethics is important for health sciences policy With the dramatic progress achieved in the health sciences in the past several decades, issues in biomedical ethics have come to the foreground in many questions of public policy. Specific examples include the establishment of a moratorium on cloning humans through somatic cell nuclear transfer and prohibitive policies on fetal experimentation. Policies guiding organ donation, retrieval, and transplantation, xenotransplantation, limits to the use of medical technology in extending life, genetic therapies, medically assisted reproduction, and experimentation on humans and animals generally have all been undertaken with the explicit incorporation of ethical considerations. Moreover, ethical considerations are also at stake in the perennial issues facing health sciences policy, such as the role of the health professional in society and the responsible conduct of health sciences research. For these reasons, the consideration of the ethical issues impacting the deployment of health sciences policy is clearly of paramount importance. Considerations in determining the role of bioethics in a report Despite the clear importance of a consideration of biomedical ethical issues generally in questions surrounding health sciences policy, there are a number of factors that have affected the incorporation of these issues in any IOM given report. Of primary significance is whether consideration of these issues is reasonably construed as being consistent with the mandate guiding the scope of the study. Also important is the topic or subject of the report. Clearly a report on cloning or medically assisted reproduction will have more to do with ethics than a report on dietary reference intakes. Importantly, however, neither of these conditions (mandate or topic) alone has determined whether a discussion of ethics will be incorporated into an IOM report. In particular, it is interesting to note that each consideration may be modified by the other. Two examples will help to illuminate this interaction. In May of 1975, the IOM published a report titled Legalized Abortion and the Public Health. Obviously, in the context of the social environment of the time, abortion was the most ethically significant of the health-related issues under public debate. Interestingly, however, it was in precisely this context that the IOM published a report on abortion that explicitly ignored the ethical issues at stake. On page 1 of the report the following statement appears: Ethical issues of abortion are not discussed in this analysis, nor are questions concerning the fetus in abortion. One may surmise that it was precisely the heated nature of the ethical debate about abortion, and in particular the moral status of the fetus, that caused the study group to put these issues aside and focus solely on the mandate to study the medical risks to women who obtained legal abortions, and to document changes in the risks as legal abortion became more available (p. 1). Despite the explicit exclusion of ethical considerations in the report, the conclusion that legislation and practices that permit women to obtain abortions in proper medical surroundings will lead to fewer deaths and a lower rate of medical complications than restrictive legislation and practices(p 8), offered a significant contribution to the ethical case for legalized abortion. The second example is of a report titled Veterans at Risk: The Health Effects of Mustard Gas and Lewisite (1993) with a mandate to survey the medical and scientific literature on mustard agents and Lewisite, assess the strength of association between exposure to these agents and the development of specific diseases, identify gaps in the literature, and recommend strategies and approaches to deal with any gaps found (p. vi). It seems fairly clear that a consideration of ethical issues at stake in the experimental testing of mustard gas and Lewisite on WWII soldiers is not part of the studys mandate. Nevertheless, during the course of the study, the committee members were so overwhelmed by the ethical significance of the issue under study that the, picture of abuse and neglect was impossible for the committee to ignore(p vii) and gave them cause to include (in the introduction to the report) a discussion of the appalling ethical discrepancies in the human subject experiments involving mustard gas and Lewisite. The committee concluded, Although the human subjects were called volunteers, it was clear from the official reports that recruitment of the WWII human subjects, as well as many of those in later experiments, was accomplished through lies and half-truths. Most appalling was the fact that no formal long-term follow-up medical care or monitoring was provided for any of the WWII human subjects, other exposed military personnel, or chemical warfare production workers, despite knowledge available by 1933 that mustard agents and Lewisite could produce long-term debilitating health problems(p vii) Review of the ethical content of past IOM reports 2.1 Identification of reports with ethical analysis or consideration of ethical issues Although a relatively high percentage of IOM reports have some passing mention of ethics, the number of reports with significant ethics content is relatively small (see Appendix A). A search of the National Academy Press web site and report archives at the IOM as well as a review of relevant published histories of the IOM and interviews with staff members suggests that the total number of publications with significant ethics content (defined as dedication of a significant portion of a chapter or more to ethical issues) is thirty (see Appendix B). Of these thirty publications, seventeen stand out as having particularly substantial ethical content (see Appendix B). These publications include five having to do with the responsible conduct of scientific research (Responsible Science, vol. 1 and 2 [1992 and 1993 respectively], On Being a Scientist, first and second editions [1988 and 1995 respectively], and Responsible Conduct of Research in the Health Sciences[1989]), two volumes of Women and Health Research (1994), two studies on organ transplants (Xenotransplantation [1996] and Non-Heart Beating Organ Transplantation: Medical and Ethical Issues in Procurement [1997]), two studies on political and social decisionmaking about biomedical ethical issues (Biomedical Politics [1991] and Societys Choices[1995]), a study on Assessing Genetic Risks (1994), four publications from LEEAH (1977-1978), and an early study on the Ethics of Health Care (1974). In what follows, a representative study from each of the first five categories will receive brief summary. The early publications from LEEAH and the Ethics of Health Care, while mentioned for the sake of completeness, will not be described in further detail in this section. Responsible Science: Ensuring the Integrity of the Research Process, Vol. 1 1992: This report stems out of concern for protecting the integrity of the research process in the context of changes in the research environment such as the faster pace and growing complexity of research as well as an emphasis on commercialization (p 2). While it is supposed that potential problems with ensuring the integrity of the research process are not themselves new, the internal checks and balances that have been relied upon to ensure this integrity have been strained by changes in the research environment and have come under close scrutiny. The challenge of the report is to foster responsible research conduct in a period of increasing diversification of funding sources, growing demands on limited research resources, and greater incentives for financial gain in the research environment and at the same time to ensure fairness and balance in efforts to establish individual and institutional accountability in scientific research activities(p 3). While the committee concludes that cases of misconduct are relatively rare (at least as reported), it notes that any such cases are highly problematic because of their significant negative impact on the field and the public. The committee differentiates three categories relevant to the discussion of irresponsible science: misconduct in science, questionable research practices, and other misconduct (p. 4) and advises that these categories should be incorporated into all formal policies dealing with misconduct in science. Moreover, it emphasizes the importance of dealing with each category as a distinct type of problem. Misconduct in science is defined by the committee as fabrication, falsification, or plagiarism, in proposing, performing, or reporting research (p. 5). Questionable research practices are those that violate traditional values of the research enterprise and may be detrimental to the research process. Other misconduct includes activities that are unethical or illegal, but not directly related to misconduct in science. Examples given are harassment, misuse of funds, and violations of government research regulations. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies Vol. 1, 1994 This study takes as its starting point that the state of concern over womens participation in clinical research stems from a conflict between two somewhat contradictory public policy positions: protectionism and access.(2) The principle of justice as it applies to clinical research was initially construed as means of protecting vulnerable populations from undue burdens. With recognition of the benefits of clinical research for women as a group, the principle of justice has been reconstrued as demanding inclusion. Since women as a group and womens health issues in general have traditionally been marginalized in clinical research, the principle of justice is seen to demand focus on women and womens health issues in clinical research. Recommendations offered throughout the report are tailored according to a principle of justice, which is defined according to three types: distributive, procedural, and compensatory. Distributive justice is the requirement that the goods and harms of research be allocated fairly. Procedural justice is relevant when the achievement of an unbiased result depends on adherence to a set of well-ordered procedures (p 76). Compensatory justice is relevant when a history of wrongs done to individuals or groups has led to an unfair playing ground. According to each requirement of justice, different actions may be necessary with regard to inclusion of women in clinical trials. These requirements are determined in context as no single abstract principle of justice can be produced to guide action in all clinical trials (76). Xenotransplantation: Science, Ethics, and Public Policy, 1996 This report is based on a workshop and additional deliberations by a committee convened to consider the scientific and medical feasibility of xenotransplantation and to explore the ethical and public policy issues applicable to the possibility of renewed clinical trials of xenotransplantation as well as respond to concern about the risk posed by xenotransplantation of animal-to-human disease transmission (p 1). Ethical discussion focuses on patients perspectives of xenotransplantation, issues of informed consent, justice and fairness in organ allocation and access to research, the use of animals for human purposes, and resource allocation The committee recommends that the ethical issues raised by xenotransplantation receive more study. In particular, there are concerns about informed consent in light of the risks to patients and the need for continuing patient surveillance. In addition, issues of fairness and justice in organ allocation are highlighted as needing further investigation. Finally, research into the psychological and social impact of receiving animal organs on recipients, their families, and members of society as a whole is recommended (p 95). Despite real concerns about the risk of animal-human disease transmission, the committee concludes, that the potential of xenotransplantation is great enough to justify funding (p 96). Societys Choices: Social and Ethical Decisionmaking in Biomedicine, 1995 The aim of this report is to advance a systematic study of the various social processes through which we subject the ethical and social issues in medicine and biotechnology to debate and analysis (p.1) These processes are termed public ethics bodies. Areas of particular interest for the report include biomedical research involving human subjects, health care decision making, delivery, and financing, advances in medical diagnostics and therapeutics, and academic-industry relationships in biotechnology (p. 2). The study delineates three types of mechanisms for deliberation and decision making in the areas of biomedical ethics. These include political and legal bodies, professional and institutional bodies, and individual and community groups. Examples of each type include the National Commission, Institutional Review Boards, and ACT-UP. Criteria for judging the success of particular ethics bodies and their products are also delineated. These include intellectual integrity (logic, scholarship, and sound judgement), democratic values (respect, representation, openness), and effectiveness (communication and authority) (p, 9-13). Two noteworthy goals and measures of success of a public ethics body include achieving consensus and results (p. 13). Assessing Genetic Risks: Implications for Health and Social Policy, 1994 This report on genetic risks aims at the study of the scientific, ethical, legal, and social issues implicit in the field of genetic diagnosis, testing, and screening (p 2). The committee proposes several general principles to guide and evaluate practices of genetic testing, diagnosis, and screening (p 3). These principles include ethical principles of voluntariness, informed consent, and confidentiality, which in turn derive from respect for autonomy, equity, and privacy. (P 3) In addition the committee insists on the importance of ensuring the highest level of quality in genetic tests, diagnosis, and screening. Based on appeals to the guiding principles and substantive analysis of the issues at play in genetic testing, diagnosis and screening, the committee offers a number of recommendations to guide these practices. Among these recommendations are the following: Nondirectiveness should remain the standard of care for reproductive planning, confidentiality should be honored in all but those rare circumstances where serious harm can only be averted by breaching confidentiality, the offering of genetic tests for newborn treatable disorders should be mandatory but screening itself should not be mandatory, and legislation should be adopted to prevent medical risks, including genetic risks, from being taken into account in decisions on whether to issue or how to price health care insurance. (P 24) Discussion of levels of ethical analysis used in past reports Ethical analysis in IOM reports has followed a number of distinct patterns. In reports with only a small sub-section on ethics, the discussion tends to be limited to the acknowledgement of some of the ethical issues raised by the report and/or a brief summary of applicable ethical considerations (see Appendix B for a listing of these reports and sub-sections). Occasionally, a report with only a small section on ethics will also contribute a substantive ethical conclusion or argument to the issue under consideration. Three examples of reports with small sections on ethics will be considered, then several reports with substantial ethics content will be examined in light of the level of ethical analysis that is employed. In Confronting Aids: Directions for Public Health, Health Care, and Research (1986), the ethics discussion (p 153-155) is essentially a reminder that health professionals are ethically obligated not to avoid infected persons or to discriminate against them in providing care (p. 153); that individuals with HIV are ethically obligated to minimize the risk of transmission to others; and that AIDS sufferers should be provided with appropriate terminal care according to their wishes (p 154). In the case of this report, there is also a positive contribution to the content of ethical claims relevant to AIDS patients as the study proposes that part of societys obligation to provide care for patients with AIDS is the provision of a variety of settings in which AIDS patients can spend their final days (p155). Unfortunately, in the context of such a short consideration of relevant ethical obligations, there is no substantive argument offered to support this claim. In Lesbian Health: Current Assessment and Directions for the Future (1999) a subsection on Ethical Considerations (p.150-154) reviews some of the ethical issues related to the conduct of research on lesbians. In particular, risks such as the undesired disclosure of sexual orientation, discriminatory use of research information, and violating the privacy of sexual partners are highlighted. The committee concludes that research is needed on whether lesbians will answer sensitive questions about their sexual orientation and health-related practices on confidential government surveys that have personal identifiers. Potential Radiation Exposure in Military Operations: Protecting the Soldier Before, During, and After (1999) offers an Ethical Framework (p 7-9) for the consideration of acceptable risks of radiation exposure. The committee notes that, There is a general ethical principle that one should not put individuals at risk of harm. Exceptions to this principle require justification (p 7). Ways of justifying exposure to risk include consent and role related responsibilities. Other requirements of ethics include an analysis that supports the conclusion that no more risk is imposed than is necessary to achieve the goal, a duty to treat persons placed at risk with respect, and a consideration of issues of justice in exposure to risk. Reports with either significant or substantial ethics content (see Appendix B for a listing) conform to several different patterns in the levels of ethical analysis employed. One pattern is the reliance on established ethical norms as a background assumption and a consideration of which practices and policies will cohere with and protect these norms. A second pattern is the presentation of several competing ethical points of view with or without the acceptance of one particular ethical conclusion. Finally, a report may argue for the adoption of some substantive ethical point of view and use this conclusion to structure its recommendations. As a caveat, it is important to note that this list of patterns is not meant to be exhaustive and that each pattern may be combined with any of the others in any given report. To illustrate these patterns of ethical analysis, three examples will be considered. In the reports considering the responsible conduct of science, there is a general assumption that the ethical norms governing science research are established. Although there may be some need to remind scientists of these norms (and much need to ensure that these norms are protected and upheld), there is no need for the study committee itself to establish such norms. It is under these background assumptions that the report on Responsible Science can, in its very first sentence, establish that The community of scientists is bound by a set of values, traditions, and standards that embody honesty, integrity, objectivity, and collegiality (vol. I, 1992). An example of the second pattern of ethical analysis is offered by the section on the human use of animals in the report on Xenotransplantation. While several competing ethical theories relevant to animal use are reviewed (including utilitarianism, rights-based approaches, and deep ecology), the committee notes that no one ethical theory has gained consensus as to the use of animals (p 72). The committee tends towards acceptance of a moderate ethical perspective that recognizes the value of beings in terms of their proximity or likeness to persons (p 77) but the ethical reasons for this choice remain unexplored. In general, an underlying acceptance of established norms governing the human use of animals tends to guide the committees conclusions. So, for example, the committee notes that It almost goes without saying that if pigs could be developed as a source of organs, most people would not object because these animals are traditionally used as a source of food, are distant from humans phylogenetically, and fall much lower on the personhood scale(p. 78). In the context of this statement, the committee seems to be concluding that the fact that most people would not object to using pigs in this way, offers some ethical justification for this usage. The report on Women and Health Research (Vol. I) offers an example of the third pattern of ethical analysis. This report is structured around claims about the requirements of justice in clinical research. As stated in the report, Throughout the course of our deliberations, several distinct appeals to justice in the context of clinical studies took shape. These appealsguided the composition of each of our arguments and recommendations (p vii) In this sense, committee recommendations were open to radical discontinuity from established social and clinical norms. Indeed, the recommendation that the attitude toward pregnant women in clinical trials ought to be one of inclusion (p 18) evidences just such a break with established norms. 2.3 A consideration of overarching ethical themes and issues present in reports Two recurring themes present themselves when reviewing the IOM reports with bioethical content. These are a principles-based analysis of ethical requirements and a focus on issues related to clinical research and in particular informed consent. While the reports cover a broad range of topics and issues, some general areas of focus can be delineated. These are scientific integrity, justice in clinical research, medical professionalism, reproductive issues, organ replacement technologies, and advances in genetic medicine. Generally speaking, the language of principles is the dominant mode of discussion about ethics in IOM reports. By language of principles I refer to the practice of thinking and writing about ethical obligations in medicine as stemming from underlying ethical principles such as respect for autonomy, beneficence, non-maleficence, and justice. It is not surprising that principles play such a predominant role in ethics discussions in IOM reports since they also play a predominant role in both the medical and bioethical communities discussions of ethical requirements. The appeal of the principles based approach can be traced back to the publication of the National Commissions Belmont Report (1978) and the first edition of Beauchamp and Childress Principles of Biomedical Ethics (1979). Both of these publications established a new focus for medical ethics by appealing to basic shared principles that do and ought to guide action in the realm of clinical medicine, research, and health care delivery. Although the principles-based approach does offer a comprehensive and consistent method of thinking about biomedical ethics, it seems important to point out that this is just one of several useful approaches to ethics and biomedical ethics in particular. Other methods include case-based reasoning, narrative approaches, communitarian views, the ethics of care, and virtue-based approaches. In particular, it is important to keep in mind that different methods of approaching biomedical ethical issues can bring different nuances of our ethical obligations to the forefront. A number of reports with ethical content deal with the issues surrounding clinical research and in particular with the requirement of informed consent. The focus on informed consent as the central requirement for the conduct of ethical research stems in part from considerations of what went wrong in historical examples of unethical experiments like those performed by the Nazis in WWII and on black males in this country in the Tuskegee studies. Moreover, a focus on informed consent goes hand in hand with the principle of respect for autonomy, which became a central concern of biomedical ethicists responding to a history of medical paternalism. Despite the clear importance of informed consent to the ethical conduct of clinical research, it is interesting to note that focus on this requirement as paramount is itself somewhat arbitrary. After all, one might reasonably conclude that the primary problem in the Nazi experiments and Tuskegee was not a lack of consent per se, but a lack of humanity on the part of the scientists. Objectifying racial stereotypes no doubt encouraged this lack of humanity. So, one might conclude, were the subjects treated with the respect due all humanity, such horrible breaches of research ethics would never have taken place. Does biomedical ethics have an evidence base? The IOM is dedicated to an evidence-based analysis of issues in health and health science. It is useful in this context to ask about the appropriateness of incorporating biomedical ethical concerns into these analyses. After all, one might think that ethical concerns, as essentially value-based, could never conform to the standards of evidence that are the key to maintaining the objectivity that is a hallmark of IOM reports. As with most things, there are grains of truth in this concern and a lot of gray area in between. Of paramount importance to sorting out this difficult issue is a distinction between objectivity and value-neutrality. While value neutrality almost never obtains in any area of human concern (including science) this does not mean that objectivity in human endeavors is unobtainable. The value-ladenness of ethical concerns does not obviate the possibility of ethical objectivity just as the goal of objectivity in science is not obscured by the incorporation of values. But does the possibility of objectivity in ethics rely on obtaining empirical evidence for our ethical conclusions? In a sense the answer to this question is clearly no. That sense is just recognition of what has been termed the naturalistic fallacy in ethics. This fallacy basically consists in mistaking what is the case for what ought to be the case. Since ethics is concerned primarily with what ought to be the case, it will not serve as an answer to an ethical problem to point out what happens to be the case. Thus it seems that evidence in the traditional sense is of no use in ethics. Yet, again, this conclusion was too quick. Two considerations modify the conclusion: the logical base of ethics and arguments against the naturalistic fallacy. As with any good argument, ethical arguments generally must rely on logical consistency and coherence in establishing their claims. Logical analysis is therefore a kind of evidence base for bioethics and scientific theories alike. After all, it is not the empirical data that establishes the validity of a scientific theory, but rather the logical relationship between that data and the hypothesis under consideration (at least on one theory of scientific evidence). Yet, since it seemed that the naturalistic fallacy ruled out the incorporation of empirical data as a foundation in our ethical analysis, it seems that we are back at square one in looking for an evidence base for ethics. Despite the appeal of the naturalistic fallacy, it seems to overstate the case against an appeal to empirical evidence in ethics. While it is certainly true, for instance, that social norms and values cannot determine the answer to the question of what we ought to value ethically, they do necessarily play some role in answering that question. Under this interpretation, societal values themselves might be considered a kind of ethical evidence or data. Indeed, in many of the IOM reports dealing with ethics, such evidence does inform the conclusions and recommendations offered. Conclusions and Recommendations A review of the incorporation of biomedical ethical concerns in IOM reports leads this reader to two main conclusions and three recommendations. First the conclusions. It is clear that an interest in and focus on issues in biomedical ethics has always been a significant part of work at the IOM. Although the purview of a specific division for only a year, issues in biomedical ethics have since been incorporated into a wide variety of reports and other IOM publications. While HSP clearly leads in numbers of reports with a biomedical ethical focus, other boards have also published in this area. Secondly, although a relatively large percentage of IOM reports contain some mention of ethics, the percentage with an extended discussion of ethical concerns is relatively small. Moreover, within this percentage a wide array of levels of ethical analysis can be found. Finally, the recommendations: 1. Where appropriate, the discussion of bioethical issues should occupy a chapter, section or sub-section of a study. This type of organization helps to draw attention to the issues as ethical issues (rather than public policy or legal considerations, for example). 2. An explicit approach to ethical considerations should be established and background ethical assumptions should be identified where applicable. 3. A focus on biomedical ethics as essentially principle-based should not go unquestioned. Appendix A: This appendix consists of three data graphs relating to IOM publications with ethics content. The data for Graph 1 was gathered from a survey of the National Academy Press web site  HYPERLINK http://www.nap.edu www.nap.edu, which maintains a searchable archive of IOM and other National Academy publications. Only IOM publications with searchable texts are represented on this graph. Some publications listed on the NAP site are not searchable while other IOM publications (older publications in particular) are not listed at all. This graph shows that, despite the fact that ethics is mentioned in a high percentage of IOM publications, the number of publications with significant ethical content is relatively limited. Graphs 2 and 3 represent the distribution of IOM publications with ethics content by board. Graph 2 focuses on reports with some ethics content, while Graph 3 is limited to reports with significant ethics content. The discrepancy between total numbers of publications listed and numbers of publications attributable to specific boards is accounted for by publications produced in concert with other National Academy institutions as well as publications authored by a specific individual or by LEEAH (1977-1978). Data for these graphs was gathered by four methods: 1) A Search of the NAP web-site, 2) An on-site archive search of early IOM publications, 3) A survey of IOM publications including Societys Choices: Social and Ethical Decision Making in Biomedicine (1995), For the Public Good: Highlights from the Institute of Medicine, 1970-1995, and To Improve Human Health: A History of the Institute of Medicine (1998), and 4) Interviews with IOM staff members. It is clear from these graphs that the Board on Health Sciences Policy has contributed most significantly to the reports with substantial ethical content. Graph 1  EMBED MSGraph.Chart.8 \s  Graph 2  EMBED MSGraph.Chart.8 \s  Graph 3  EMBED MSGraph.Chart.8 \s  Appendix B Category 1: Studies with substantial ethics content Responsible Science, Volume I: Ensuring the Integrity of the Research Process, 1992 National Academy of Sciences National Academy of Engineering Institute of Medicine Responsible Science, Volume II: Background Papers and Resource Documents, 1993 National Academy of Sciences National Academy of Engineering Institute of Medicine On Being a Scientist: Responsible Conduct in Research, Second Edition, 1995 National Academy of Sciences National Academy of Engineering Institute of Medicine On Being a Scientist: Responsible Conduct in Research, First Edition, 1988 National Academy of Sciences National Academy of Engineering Institute of Medicine Societys Choices: Social and Ethical Decision Making in Biomedicine, 1995 Division of Health Sciences Policy Ruth Ellen Bulger, Elizabeth Meyer Bobby, and Harvey V. Fineberg, Eds. Assessing Genetic Risks: Implications for Health and Social Policy, 1994 Division of Health Sciences Policy Lori Andrews, Jane Fullarton, Neil Holtzman, and Arno Motulsky, Eds. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Vol. I, 1994 Division of Health Sciences Policy Anna Mastroianni, Ruth Faden, and Daniel Federman, Eds. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Vol. II (Workshop and Commissioned Papers), 1994 Division of Health Sciences Policy Anna Mastroianni, Ruth Faden, and Daniel Federman, Eds. Xenotransplantation: Science, Ethics, and Public Policy, 1996 Division of Health Sciences Policy Division of Health Care Services Non-Heart Beating Organ Transplantation: Medical and Ethical Issues in Procurement, 1997 Division of Health Care Services John T. Potts, Principal Investigator Roger Herdman, Study Director Biomedical Politics, 1991 Kathi E. Hanna, Ed. Committee to Study Decision Making Ethics of Health Care, 1974 Result of a 1973 conference on Health Care and Changing Values Division of Legal, Ethical, and Educational Aspects of Health, 1977-1978 Ethical Issues in Governmental Efforts to Promote Health, 1978 By Daniel I. Wikler (An Andrew W. Mellon Foundation Paper) The Right of Physicians: A Philosophical Essay, 1978 By Albert R. Jonsen The Elderly and Functional Dependency, 1977 (Report) Beyond Malpractice: Compensation for Medical Injuries, 1978 (Report) Category 2: Studies with a chapter or significant portion of a chapter dealing directly with ethics Fetal Research and Applications: A Conference Summary, 1994 Division of Health Promotion and Disease Prevention Session I: Ethical and Legal Issues of Fetal Research: History and Background, pgs. 10-14 The Artificial Heart: Prototypes, Policies, and Patients, 1991 Division of Health Care Services John R. Hogness and Malin VanAntwerp, Eds. Ch. 8: Ethical and Societal Issues, pgs. 135-150 Human Gene Therapy, 1988 Eve K. Nichols Based on presentations at the annual meeting of the IOM and a workshop Ch 7: Ethical and Economic Issues, pgs. 162-173 Science and Babies: Private Decisions, Public Dilemmas, 1990 Book by Suzanne Wymelenberg drawing on a IOM symposium Ch. 7: New Technologies: The Ethical and Social Issues, pgs. 147-157 Patient Outcomes Research Teams: Managing Conflict of Interest, 1991 Division of Health Care Services Molla S. Dobaldson and Alexander M. Capron, Eds. Ch. 3: Conflict of Interest, pgs. 27-46 The New Health Care for Profit: Doctors and Hospitals in a Competitive Environment, 1983 Collection of Papers- preliminary to study Division of Health Care Services Ethical Dilemmas of For-Profit Enterprise in Health Care by Robert M. Veatch, pgs. 125-152 For-Profit Enterprise in Health Care, 1986 Division of Health Care Services Bradford H. Gray, Ed. Part II, Papers: Ethical Issues in For-Profit Health Care by Dan Brock and Allen Buchanan pgs. 224-249 Rational Therapeutics for Infants and Children: Workshop Summary, 2000 Division of Health Sciences Policy Sumner Yaffee, Ed. Ch. 5, Raising Awareness of Regulatory, Legal and Ethical Issues pgs. 71-91 Guidelines for Clinical Practice: From Development to Use, 1992 Division of Health Care Services Marilyn J. Field and Kathleen N. Lohr, Eds. Ch. 6, The Inescapable Complexity of Decision-Making Ethics, Cost, and Informed Choices, pgs. 135-162 Blood and Blood Products: Safety and Risk, 1996 Division of Health Sciences Policy Henrik Bendixen, Frederick Manning and Linette Sparacino, Eds. Part V: Risk Communication: Attitudes Toward Risk: The Right to Know and the Right to Give Informed Consent by Jonathan D. Moreno, pgs. 127-142 Patients, Informed Consent, and the Health Care Team by David J. Rothman, pgs. 143-147 Food and Drug Administration Advisory Committees Division of Health Care Policy, IOM Rettig, Earley, Merrill, eds. NAP, 1996 Ch. 6: Ensuring Committee Integrity pgs. 127-162, Extending Life, Enhancing Life: A National Research Agenda on Aging, 1991 Ch. Research in Biomedical Ethics Vaccines for the 21st Century: A Tool for Decisionmaking, 2000 Kathleen R. Stratton, Jane S. Durch, and Robert S. Lawrence, Eds. Division of Health Promotion and Disease Prevention Ch. 6 Ethical Considerations and Caveats Category 3: Reports with a sub-section devoted to the discussion of ethical issues Confronting Aids: Directions for Public Health, Health Care, and Research, 1986 IOM National Academy of Sciences Ch. Care of Persons Infected with HIV, Section, Ethical Aspects of Providing Care, pgs.153-155 Potential Radiation Exposure in Military Operations: Protecting the Soldier Before, During, and After, 1999 Medical Follow-up Agency, IOM Thaul and OMaonaigh, Eds. Ch. Summary, Section: Ethical Framework, pgs. 7-9 Health Data in the Information Age, 1994 Division of Health Care Services Donaldson and Lohr, eds. Ch. Confidentiality and Privacy of Personal Data Review of the FIAU Clinical Trials, 1995 Division of Health Sciences Policy Manning and Swartz, eds. Ch. 2: Clinical Trials, Section, Ethical Considerations pgs. 28-32 Nursing, Health, and the Environment, 1995 Division of Health Promotion and Disease Prevention Andrew Pope, Meta Snyder, Lillian Mood, eds. Section. Factors that Influence Nursing Practice, Sub-Part, Ethical Dilemmas pgs. 51-53 Lesbian Health, 1999 Neuroscience and Behavioral Health Program Health Sciences Policy Program Health Sciences Section IOM Andrea L. Solarz, Ed. Ch. Contextual Barriers to Conducting Research on Lesbian Health Subsection: Ethical Considerations, pgs. 150-154 An Assessment of the NIH Womens Health Initiative, 1993 Food and Nutrition Board and Board on Health Sciences Policy Susan Thaul and Dana Hotra, eds. Section, Ethics: Consent and Stopping Rules, pgs. 35-38 Approaching Death: Improving Care at the End of Life, 1997 Division of Health Care Services Marilyn J. Field and Christine K. Cassel, eds. Ch. Directions for Research, part 3, Ethical Issues in Research Kidney Failure and the Federal Government, 1991 Richard A. Rettig and Norman G. Levinsky, eds. Ch. 2, part 2, Ethical Issues Medically Assisted Conception: An Agenda for Research, 1989 IOM National Research Council Ch. Barriers to Progress in IVF and Embryo Transfer section ethical and Social Issues, pgs. 67-77 Science and Technology Leadership in American Government: Ensuring the Best Presidential Appointment, 1992 National Academy of Sciences, National Academy of Engineering, IOM Ch. 2 Reducing the Hurdles and Disincentives Setting Priorities for Health Technologies Assessment: A Model Process, 1992 Ch. Recommendations for a Priority-Setting Process Reducing Risks for Mental Disorders: Frontiers for Preventive Intervention Research, 1994 Ch. 10 Designing, Conducting, and Analyzing Programs, Section: Ethical Issues, pgs. 397-405 Managing Managed Care: Quality Improvement in Behavioral Health, 1997 Ch. Trends in Managed Care, Section: Ethical Issues in Managed Behavioral Care pgs. 67-71 Preventing HIV Transmission: The Role of Needles and Bleach, Ch. 4 Community Views, Section Moral/Ethical Arguments, pgs. 105 Global Health in Transition: A Synthesis: Perspectives from International Organizations, 1996 Section, Ethics and Human Rights, Ethical and Value Judgements Built into the Model, pgs. 69-70 Risk Communication and Vaccination: Workshop Summary, 1997 Section: Ethical and Policy Issues, pgs. 11-14 Gulf War Veterans: Measuring Health Pgs. 78-79 Summarizing Population Health: Directions for the Development and Application of Population Metrics, 1998 Recommendations, pgs. 17-20 QALYs, DALYs, pgs. 5-16 Medical Professional Liability an the Delivery of Obstetrical Care: Vol. II, An Interdisciplinary Review, 1989 Sub-part Ethical Considerations, pgs. 4-5 Consensus Development at the NIH: Improving the Program, 1990 Recommendations for Program Structure, pgs. 10-12 Ending Neglect: The Elimination of Tuberculosis in the United States, Section: The Ethics of Tuberculosis Elimination, pgs. 46-48 Policy Implications of Greenhouse Warming: Mitigation, Adaptation, and the Science Base, 1992 Ch. 33 Issues, Assumptions and Values, sub-part Economics and Ethical Values, pgs. 521-4 tu& '  O &d{$$..../R/j///// 0}000000&1<111Y22:J;X;AA GcGjG_LL:RyRXUU'Y*YjY[[cce-eiillqqqruĿ h1>* h16>* h15CJh156CJ h16h1OJQJh1 h1>* h15>* h15CJKuv*i5v & ' 2 d`d & F dd^ & F ddƷ  O M%&dz{O$(***.++^ d`gd1d` & Fdd+X2Y22P7::X;C>AAAAODG GjGkGqI^L_LLO9R:RzR & F d$a$dd`zRTU'Y[u^bdgilllnr(uw%z&z'z^zo|L~IGHhd$`a$d`uu%zTz̄Մ֌׌،ّ+1qQRlmnoǓȓɓʓΓϓړ_ ]Žx h15>*h1OJQJj/ h1U%jE> h1CJOJPJQJUVjh1U%jE> h1CJOJPJQJUVjh1U%j;E> h1CJOJPJQJUV h10Jjh1Ujh1U h15h1 h16/h׉܎?@ACEFGHIQpqrstuvwxdd`d˓͓̓Γϓړۓf &F\]ƕddHe QRmȘɘVy45AR^ɘ#5F[%hל-/0˝a1y9;_EϣŤ3^qs>ۨcȩϩ_h16B*ph h15>*h1B*ph h16H* h1>*CJh15>*CJh15>*OJQJ h15 h156h1 h16E՚"EFb,gh-./0ҝ$a$ҝ`a8G3xyߠ89ߡ:;ffLoΣϣ0]ĤŤW>?p;]^^=>bcϩ:;dЪѪ6y^^_dmt3gn)0^ٯ>aV4{ҳ;oʴٴ<yKɶ_ŷƷh1OJQJh1OJQJh16B*phh1B*phh1 h16:yz٫^_t֬ڬbc٭23n0`~^`~ۯ=>iTUV7yz{ڳ:;ww̴شٴD`xyg·÷ķŷƷd/ =!"#$%DyK  www.nap.eduyK (http://www.nap.edu/Dd*%B  S A? 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Courier New"h S4& 'K8!~4dE 1jIncorporation of Biomedical Ethics in Institute of Medicine Studies: An Assessment of Content and EvidenceRRebecca WalkerP