Moral decisions concerning what ought to be done always assume metaphysical presuppositions concerning the way the world is. In the field of biomedical ethics, some of the metaphysical presuppositions underlying many current discussions of issues of life and death seem particularly implausible. These include our assumption of the reality of social atomism and our beliefs relating to the possibility of autonomy. Given the implausibility of these two assumptions, many discussions have focused our attention on the wrong issues by reducing (...) questions of alternative social practices to questions of individual preferences. Far from facilitating intelligent solutions to our problems, this merely clouds the issues involved. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Women and Health Research:A Report from the Institute of MedicineAnna C. Mastroianni (bio), Ruth Faden (bio), and Daniel Federman (bio)In recent years, claims have been made by segments of the research community and by women's health advocacy groups that clinical research practices and policies have not benefitted women's health to the same extent as men's health. Central to these claims has been an assertion that women have been inadequately (...) represented as subjects of clinical studies and that as a result neither health conditions unique to women—e.g., menopause—nor women's manifestations of health problems affecting both sexes—e.g., heart disease—have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of women's participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Women's Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committee's charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects [End Page 55] and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences.1 Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committee's deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.Deliberations of the CommitteeA number of issues arose at the outset as the Committee considered its charge. A few members initially believed that verification of the underrepresentation of women relative to men in clinical studies as a whole was a prerequisite to providing policy recommendations. Others believed that such an examination would be an important contribution to the knowledge base, but that it was not necessary for addressing the Committee's charge. As summarized in the Committee's report, the Committee's research indicated that firm conclusions about the relative underrepresentation of women could not be drawn from the available data because of the lack of systematic information... (shrink)

In much the same way that genomic technologies are changing the complexion of biomedical research, the issues they generate are changing the agenda of IRBs and research ethics. Many of the biggest challenges facing traditional research ethics today — privacy and confidentiality of research subjects; ownership, control, and sharing of research data; return of results and incidental findings; the relevance of group interests and harms; the scope of informed consent; and the relative importance of the therapeutic misconception — have become (...) important policy issues over the last 20 years because of the ways they have been magnified by genomic research efforts. Research that examines the ethical, legal, and social implications of human genomics research has become a burgeoning international field of scholarship over the last 20 years, thanks in part to its support first by the genome research funding bodies in the U.S. and then by national science agencies in other countries. (shrink)

This paper describes the present resource allocation problems in the Danish tax-based public health care system and presents an analysis of the two policy options put forward as a solution to these problems: (1) explicit rationing of services, and (2) the introduction of two-tiered health care. It is argued that a two-tiered system with a private second tier is unlikely to be acceptable and viable in Denmark, whereas an introduction of a second tier within the public system may be more (...) acceptable. It is further argued that present implicit rationing methods may be unethical and ought to be replaced by explicit rationing. Keywords: justice, resource allocation, two-tiered health care CiteULike Connotea Del.icio.us What's this? (shrink)

: An analysis of traditional Jewish texts yields neither the capitalist notion of medicine nor the socialist one. Neither alternative is sufficient to ground the respect for the sanctity of the human person as a being created in the image of God that is so rationally appealing. That is why the Jewish ethical tradition, which is based on this respect for the sanctity of human personhood, both individual and collective, is so attractive—if only for its insights, rather than its (...) authority; its guidance, rather than its governance. (shrink)

This volume, honoring the renowned historian of science, Allen G Debus, explores ideas of science - `experiences of nature' - from within a historiographical tradition that Debus has done much to define. As his work shows, the sciences do not develop exclusively as a result of a progressive and inexorable logic of discovery. A wide variety of extra-scientific factors, deriving from changing intellectual contexts and differing social millieus, play crucial roles in the overall development of scientific thought. These essays (...) represent case studies in a broad range of scientific settings - from sixteenth-century astronomy and medicine, through nineteenth-century biology and mathematics, to the social sciences in the twentieth-century - that show the impact of both social settings and the cross-fertilization of ideas on the formation of science. Aimed at a general audience interested in the history of science, this book closes with Debus's personal perspective on the development of the field. Audience: This book will appeal especially to historians of science, of chemistry, and of medicine. (shrink)

"Evidence of a flight from reason is as old as human record-keeping: the fact of it certainly goes back an even longer way. Flight from science specifically, among the forms of rational inquiry, goes back as far as science itself... But rejection of reason is now a pattern to be found in most branches of scholarship and in all the learned professions."--from the introduction In the widely acclaimed Higher Superstition: The Academic Left and Its Quarrels with Science, Paul R. Gross (...) and Norman Levitt offered a spirited response to the "science bashers," raising serious questions about the growing criticism of scientific practice from humanists and social scientists on the academic left. Now, in The Flight from Science and Reason, Gross and Levitt are joined by Martin W. Lewis to bring together a diverse and distinguished group of scholars, scientists, and experts to engage these questions from a wide variety of perspectives. The authors take on critics of science whose views range from moderate to extreme, from social constructivists to deconstructionists, from creationists and feminists to Afro-centrists. They discuss the rise of "alternative medicine" and radical environmentalism (here skewered as "ecosentimentalism"). They explain why the "uncertainty principle" does not work as a metaphor for ambiguity, and why "chaos theory" cannot be invoked without an understanding of mathematics. Throughout, they grapple with the paradox inherent in arguing with opponents who contend that reason itself, and thus logic, is suspect. Distributed for the New York Academy of Sciences. (shrink)

Resumo Em 1747, John Wesley, spiritus rector do movimento metodista, publicou a primeira edição do seu guia medicinal Primitive Physic[k] . Qual era o seu propósito num mundo onde a academia real, herbalistas, curandeiros/as, exorcistas e charlatães competiam pela atenção da população? O artigo apresenta os diferentes grupos que atuaram, ou pretendiam atuar, em prol da saúde na Inglaterra do século 18, e compara o conteúdo do guia Primitive Physic[k] com suas propostas e estratégias terapêuticas. Conclua-se que uma parte significativa (...) do guia é composta por orientações da academia real de medicina, mas que sempre se favorecem remédios caseiros, com ingredientes acessíveis para as classes mais humildes. Quanto à chamada Spiritual Physick , menciona-se a oração como medida complementar, mas ignora-se plenamente a prática do exorcismo. Palavras-chave: John Wesley; saúde; Guia medicinal popular; Primitive Physic[k]; academia real de medicina; herbalismo; curandeirismo.In 1747, John Wesley, spiritus rector of the Methodist movement, published the first edition of his medical guide Primitive Physic[k] . What was its purpose in a world where the Royal Academy, herbalists, healers, exorcists and quacks competed for the attention of the population? The article introduces the different groups who promoted or pretended to promote health in 18th century England and compares the contents of the guide Primitive Physic[k] with their proposals and therapeutic strategies. The conclusion is that a significant portion of the guide consists of guidelines of the Royal Academy of Medicine, but that it always favors homemade remedies with ingredients available to humbler classes. In relation to the so called Spiritual Physick, prayer is mentioned as a complementary measure, but the practice of exorcism is totally ignored. Keywords: John Wesley; health; Popular Medicinal Guide; Primitive Physic[k]; Royal Academy of Medicine; herbalism; healers. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and informed (...) consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

Doctoring the genitals is compatible with a recognizable conception of social medicine. This commentary critically examines the distinction between medical and nonmedical procedures; presents an alternative account of Sohaila Bastami’s personal reaction to the anonymous caller’s request for referral information concerning hymen reconstruction surgery; and makes use of Yelp to simulate the caller’s procedure for locating a helpful practitioner. Yelp is a very useful informational search engine that does not subject its users to a moral examination.

Agenda 21 of United Nations demands better situation of ecology, economy, health, etc. in all countries. An evaluation of scientific contributions in international congresses of fundamental anthropological sciences (philosophy, psychology, psychosomatics, physiology, genito-urology, radio-oncology, etc.) demonstratesevidence of large discrepancies in the participation not only of developing and industrial countries, but also between the last ones themselves. Low degree of research and education leads to low degree of economy, health, ecology, etc. [Lit.: Neu, Michailov et al.: Physiology in Agenda 21. (...) Proc. Int. Un. Physiol. Sci. San Francisco, Faseb J. 19/5, A1355, 2005; Agenda 21 in Psychol. 28th Int. Congr. Psychol. Beijing, 1028.62/3028.96, 2004]. CONCEPTION: The science is leading in the social and economic development of humanity, but the misuse of science causes disastrous repercussions (ecological and self-destruction). New models for scientific education, beginning with philosophy, followed by philosophical, pedagogical, medical, theological anthropology, and research are necessary tosupport Agenda 21 and prevent misuse of science. According to proposals on foundation of experimental schools (Immanuel Kant) and international universities (Bertrand Russell) the International Academy of Science/ICSD supports these ideas and initiated the creation of first (interdisciplinary) International Faculties forAnthropology as paradigm for humanization, higher effectiveness and pluralistic internationalization of science, leading to better education ("Erziehung und Ausbildung") and research in all countries, i.e. decrease of the gap between industrial and developing countries. CONCLUSION: Foundation of international institutes for general (philosophy, pedagogy, medicine) as well as for special anthropology (theology, informatics-logic-mathematics, culture, biology, (bio-) physics/chemistry) in context of an integralanthropology via networks of national ones from selected countries of Africa, America, Asia, Australia, Europe can permit the necessary implication of philosophy in education of anthropological sciences as well as research and education (post graduate) by common international research and educational programmes, lecturers, students, etc. in one country. This project needs political and financial support by UNO, European Union, governments, banks, industries to support the education of a homo sanus, humanus et spiritualis for the future humanity. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and informed (...) consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

Society has historically not taken a benign view of genetic disease. The laws permitting sterilization of the mentally re tarded~ and those proscribing consanguineous marriages are but two examples. Indeed as far back as the 5th-10th centuries, B.C.E., consanguineous unions were outlawed (Leviticus XVIII, 6). Case law has traditionally tended toward the conservative. It is reactive rather than directive, exerting its influence only after an individual or group has sustained injury and brought suit. In contrast, state legislatures have not been (...) inhibited in enacting statutes. Many of their products can be characterized as hasty, unnecessary, ill-conceived, and based on the heart rather than the head. Moreover the lack of expert consultation sought has also been remarkable. One state legislature, for example, has advocated immunization for sickle cell anemia! Many others have enacted laws for the screening of inborn errors of metabolism, e.g., phenylketon uria, but have poorly defined the lines of responsibility to secure compliance. A spate of specific disease-related bills has emerged in the u.S. Congress, each seeking recognition and appropriations. Sickle cell anemia, hemophilia, Cooley's anemia and Tay-Sachs disease have been among the front-runners for support. Finally, in 1975, Congress has begun to examine an omnibus bill concerning all forms of genetic disease. The bill, termed the National Genetic Diseases Act is, however, still far from being enacted. (shrink)

The success of precision medicine depends on obtaining large amounts of information about at-risk populations. However, getting consent is often difficult. Why? In this commentary I point to the differentials in social status involved. These differentials are inevitable once personal information is surrendered, but are particularly intense when the studied populations are socioeconomically or socioculturally disadvantaged and/or ethnically stigmatized groups. I suggest how the deep distrust of the latter groups can be partially justified as a lack of confidence (...) that their core values or interests will sufficiently be taken into account. Hence, the ethical challenge here lies not in avoiding status differentials, but in dealing with them appropriately. Scientists should not assume trust from others but adopt a norm of “demonstrating trustworthiness”. (shrink)

Issues of race have traditionally been addressed in medical school curricula in a didactic manner. However, medical school curricula often lack adequate opportunity for the application of learning material relating to race and culture. When confronted with acts of racism in clinical settings, students are left unprepared to respond appropriately and effectively. Forum Theatre offers a dynamic platform by which participants are empowered to actively engage with and become part of the performance. When used in an educational context, Forum Theatre (...) can be a powerful tool for students to interact with a wide variety of social issues. This paper describes the process by which one medical school designed a workshop in the Forum Theatre style to equip students to respond to racism observed in clinical settings. Based on real student experiences, the Responding to Racism in the Clinical Setting workshop was designed to give students an opportunity to combine cultural humility, communication theory and conflict resolution skills in order to prepare for interactions in clinical stages of medical education. As a result of workshop evaluations, surveys, and written reflections, the authors propose that Forum Theatre is a novel teaching modality for incorporating issues of race and culture into medical curriculum. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 13.1 (2003) 53-64 [Access article in PDF] Incentives for Providing Organs Patricia Milmoe McCarrick and Martina Darragh After a contentious debate at its 2002 annual meeting, the American Medical Association's House of Delegates voted to endorse the opinion of its Council on Ethical and Judicial Affairs that the impact of financial incentives on organ donation should be studied (Josefson 2002). The shortage of organs (...) for transplantation has been an ongoing problem for more than 20 years. In June1981, Representative Philip Crane (R-IL) introduced legislation in the U.S. House of Representatives proposing a $25,000 income tax deduction and a $25,000 estate tax exclusion for donating an organ (Tax Incentives 1981). Still the National Organ Transplant Act enacted in October 1984 prohibited the offering of any "valuable consideration" in return for organs (United States 1984).The developments of a legal market for tissues in the United States and a black market for organs around the world have raised the question of whether donation without compensation is the only ethically viable option. Some critics of the current system claim reliance on donation actually promotes a black market in organs (Kaserman and Barnett 2002, p. 38; Palmer 1999, p. 36). In addition, a new set of compensation issues has arisen as living kidney donor transplantations begin to rival those performed with cadaveric organs (United States 2001).As a result, current suggestions for incentives go far beyond the traditional death benefit payment to include such ideas as medals of honor for donors, reimbursement for funeral expenses, exchange programs for organ donation, and special medical insurance for living organ donors. Numerous bills introduced into the 107th Congress have proposed such incentives (Delmonico et al. 2002.) In October 2002, the U.S. Department of Health and Human Services awarded $5.2 million in grants to study both clinical and behavioral interventions for increasing organ donations that do not involve incentives. The inspiration for some of the funded proposals comes from the successes of Spain's social services and the United Kingdom's clinical administration of organ procurement programs (Robeznieks 2002). [End Page 53]With a nod to evidence-based medicine, the underlying concern expressed in much of the current literature is that no idea for increasing the supply of organs should be discounted before it is studied. This bibliography provides a short introduction to the range of opinions expressed on the issue of incentives for providing organs.al-Mousawi, M.; Samhan, M.; al-Mezairee I.; Razzak, M.A.; and Khawari, F. Cadaver Organ Procurement in Kuwait. Transplantation Proceedings 31 (8): 3375-76, 1999.The authors describe a protocol that significantly increased cadaveric organ donation and credit it with fostering the expansion of an organ sharing program among the Arab Gulf states. Developed by Kuwaiti neurologists and anesthetists after a continuing education course on transplantation, the protocol places a special emphasis on the role of local transplant coordinators who facilitate the investigation of brain death cases by neurologists.Arnold, Robert; Bartlett, Steven; Bernat, James; et al. [Ethics Committee of the American Society of Transplant Surgeons] Financial Incentives for Cadaver Organ Donation: an Ethical Reappraisal. Transplantation 73 (8): 1361-67, 27 April 2002.To prepare for proposed studies of financial incentives for organ donation, the American Society of Transplant Surgeons convened a panel to develop a methodology for evaluating the ethics of such research. Comprised of organ procurement organization executives, physicians, surgeons, and ethicists, the panel generated a list of nine criteria for use in judging any incentives proposal. While opposed to direct payment or tax incentives for organ donation, a majority of the members support funeral expense reimbursement or charitable contributions as incentives that would not violate or undermine the ideal of altruism.Cameron, J. Stewart, and Hoffenberg, Raymond. The Ethics of Organ Transplantation Reconsidered: Paid Organ Donation and the Use of Executed Prisoners as Donors. Kidney International 55 (2): 724-32, February 1999.After reviewing arguments for and against payment for organ procurement, the authors apply these arguments to the specific case of obtaining organs from executed... (shrink)

Los estudios de ciencia, tecnología y sociedad revelan las interrelaciones entre la ciencia y la tecnología como procesos sociales. Este artículo persigue como objetivo: valorar la significación social de un entorno virtual en la enseñanza aprendizaje de la Estadística descriptiva en la carrera de Medicina. El diagnóstico preliminar mediante de la observación, la encuesta y el análisis documental, mostró que existen insuficiencias en el uso de las tecnologías de la información y las comunicaciones en el proceso de enseñanza aprendizaje (...) de la Estadística. Se diseñó un entorno virtual constituido por cinco módulos que incluyen contenidos de Estadística descriptiva, ejercicios, bibliografía y ayuda. Con la validación a partir del criterio de especialistas y la sistematización con la introducción en la práctica, se evaluó el mismo como muy adecuado, fue considerado útil, necesario y aplicable al contexto objeto de estudio, lo que contribuye a la formación científica de los estudiantes desde una posición materialista. Science, technology and society studies reveal the interrelations between science and technology as social processes. This article pursues the following objectives: to assess the social significance of a virtual environment in the teaching and learning of descriptive Statistics in Medicine degree course. The preliminary diagnosis through the observation, opinion poll and documentary analysis, showed that there are insufficiencies in the use of Information and Communication technologies in teaching and learning Statistics. It was designed a virtual environment with five modules that include contents of descriptive Statistics, exercises, bibliography and help. With the validation of specialists and the systematization after putting it in practice, the virtual environment was assessed as adequate, useful, necessary and applicable to the context being studied, which contributes to the scientific training of students from a materialistic position. (shrink)

Se realizó una revisión bibliográfica de materiales disponibles en revistas electrónicas de la base SciELO con el objetivo de fundamentar la contribución de la Medicina Tradicional y Natural a la Salud Pública cubana y las interrelaciones ciencia-tecnología-sociedad. La perspectiva Ciencia, Tecnología y Sociedad contribuye a construir una cultura científica para que la población en general pueda llegar a sentirla como propia, lo cual requiere priorizar la aplicación de la Medicina Tradicional y Natural socialmente útil y culturalmente relevante con el compromiso (...) social basado en la erradicación de la pobreza, la armonía con la naturaleza y el desarrollo sustentable. Se enfatizó en la importancia de la medicina preventiva, además de poner en evidencia la necesidad de reconceptualizar la investigación en las ciencias médicas sobre la base de una visión interdisciplinaria que permita revelar fenómenos no explicados hasta el momento, aspecto que necesita del enfoque desde la perspectiva de la ciencia, tecnología y sociedad como complemento esencial. We conducted a bibliographic review of materials available in electronic journals in SciELO base aiming to substantiate the contribution of Natural and traditional medicine to the Cuban public health and the interrelationships of science-technology - society. Science, technology and society perspective contributes to build a scientific culture so the population can in general get to feel it as their own, which requires to prioritize the application of traditional medicine and Natural, socially useful and culturally relevant social commitment based on the eradication of poverty, the harmony with nature and sustainable development. Emphasized the importance of preventive medicine, as well as highlight the need to reconceptualize the research in the medical sciences on the basis of an interdisciplinary view that reveal phenomena not explained so far, issue that needs the approach from the perspective of science, technology and society as essential complement. (shrink)

The social ethics of medicine is the study and ethical analysis of social structures which impact on the provision of health care by physicians. There are many such social structures. Not all these structures are responsive to the influence of physicians as health professionals. But some social structures which impact on health care are prompted by or supported by important preconceptions of medical practice. In this article, three such elements of the philosophy of medicine (...) are examined in terms of the negative impact on health care of the social structures to which they contribute. The responsibilities of the medical profession and of individual physicians to work to change these social structures are then examined in the light of a theory of profession. (shrink)

Because medicine can preserve and restore health and function, it is widely acknowledged as a basic good that a just society owes its members. Yet there is controversy over the scope of what should be provided, to whom, how, when and why. This comprehensive and authoritative book - by well-known philosophers, doctors, lawyers, political scientists, and economists - lays a theoretical foundation for understanding the debate, assesses how health care is distributed in different countries and to various social (...) groups, and analyzes practical issues in constructing a socially just health care system. (shrink)

SummaryThis article analyses the viewpoints of doctors, patients and the state of the phenomenon of unconventional methods of treatment/alternative medicine in Slovenia. The doctors’ viewpoints are taken from the official documents of the Medical Chamber of Slovenia and the Slovene Medical Association. The patients’ viewpoints are established on the basis of public opinion and epidemiological research, carried out in 1994 and 1996 on two representative samples of the Slovene population from the Celje area. The estimation of the attitude of (...) the state is based on legislation and other regulations connected with alternative medicine. The findings of our analysis show a strongly negative attitude of doctors to any form of alternative medicine. In contrast, as many as half the patients express a favourable opinion on alternative methods of treatment, and more than a third of them actually make use of them. From existing laws it is evident that the state in general does not deal with alternative medicine, except for possibilities in such cases when a doctor or some other healthcare professional uses alternative methods of treatment. Alternative medicine is, from the point of view of social medicine, a phenomenon that should be followed, analysed and controlled. Dangerous as well as protective factors which accompany the exceution of alternative methods should be recognised so as to be able to inform the public of the results in a timely and accurate manner. Because of the need for the legal and healthcare security of Slovene citizens, the state should regulate existing unconventional treatments. (shrink)

This article deals with the public debates on the genealogy of Polish social sciences after the Second World War. The author shows how the changes in political conditions in the period between the end of the war (1945) and the ‘Stalinisation’ of Polish science at the First Congress of Polish Science (1951) influenced the ‘limits of the permissible’ in public discussions about the scientific identity of sociology. The article describes the stages in the development of public discourse on the (...) genealogy of the social sciences and thematises the increasing influence of the political agenda on the public practices of academics. When, immediately after the war, continuity with inter-war tradition, and the limited character of the Marxist approach, were particularly emphasised in the public discourse on the genealogy of social sciences, the beginning of the ‘Stalinisation’ of public space in 1948 forced the scholars to put emphasis on the political role of sociology, which, according to them, belonged to the ‘progressive camp’ together with Marxism. The closing of the sociological departments, and a journal, between 1950 and 1951 started a new stage of the debates within the preparatory meetings for the scientific congress. At this congress, the task of the social scientists was to construct, together with philosophers, a ‘progressive scientific tradition’ in Poland. For the Polish social scientists, the congress was a task to write a ‘mathematical equation’ with a known result and several mandatory elements such as ‘the progressive national tradition,’ ‘Marxism-Leninism,’ and ‘six-year plan.’ However, even under strong political pressure, the participants in the discussions did not come to a compromise concerning the progressive tradition of the Polish social sciences, and did not achieve the necessary ‘unity.’. (shrink)

Bengt Brülde in his article ``The Goals of Medicine. Towards a Unified Theory'' has proposed a normative theory of the goals of medicine within which the concept of quality of life plays a crucial role. In Brülde's analysis, however, the very concept of medicine is deliberately left quite vague and it is therefore difficult to see how the goals of medicine are related to the goals of closely allied enterprises such as health promotion and social (...) welfare. In this reply I therefore propose an analysis of these related conceptual areas. I do this mainly in two respects. Following the nomenclature in a previously published article I propose a systematic conceptual framework for all varieties of health enhancement and distinguish different notions of medicine within this framework. A consequence of this analysis is, for instance, that the means and also the immediate goals of medicine in its broadest sense are more diversified than the means and immediate goals of medicine in its narrowest sense. From this position I expand the topic further by comparing medicine and health enhancement with social welfare and try to trace the basic features between – as well as the common properties of – these different enterprises. (shrink)

The problem of harmful, unnecessary and neglected pain has been studied extensively in many health care settings over the past decade. Research has documented the incidence of untreated pain, and scholars and advocates have given the problem several names: “public health crisis,” “oligoanalgesia, and “moral failing,” among them. Articles have identified a litany of now familiar “obstacles” or “barriers” to effective pain relief. Each of these individual obstacles or barriers has been the subject of targeted remedial action in at least (...) some context.The checklist approach to improving care for patients in pain, however, is likely to have only limited effect. What really appears to be operating is a complex ecosystem that supports ambivalence, denial, and even suspicion of the circumstance of patients in pain and efforts to treat them. Pain relief in emergency medicine, a relatively new setting for the study of challenges to treating pain, provides a revealing context for viewing discrete obstacles to effective pain management in medicine as part of an integrated environment into which patients with pain enter for treatment. (shrink)

Purpose: This review identifies the prominent topics in the literature pertaining to the ethical, legal, and social issues raised by research investigating personalized genomic medicine. Methods: The abstracts of 953 articles extracted from scholarly databases and published during a 5-year period were reviewed. A total of 299 articles met our research criteria and were organized thematically to assess the representation of ELSI issues for stakeholders, health specialties, journals, and empirical studies. Results: ELSI analyses were published in both scientific (...) and ethics journals. Investigational research comprised 45% of the literature reviewed and the remaining 55% comprised normative analyses. Traditional ELSI concerns dominated the discourse including discussions about disclosure of research results. In fact, there was a dramatic increase in the number of articles focused on the disclosure of research results and incidental findings to research participants. Few papers focused on particular disorders, the use of racial categories in research, international communities, or special populations. Conclusion: Considering that strategies in personalized medicine increasingly target individuals’ unique health conditions, environments, and ancestries, further analysis is needed on how ELSI scholarship can better serve the increasingly global, interdisciplinary, and diverse PGM research community. (shrink)

This paper considers the question of whether the explanation of homosexual orientation offered by Sigmund Freud qualifies as a genuine explanation, judged by the criteria of the social sciences. It is argued that the explanation, namely that homosexual orientation is a function of atypical parental influences, is indeed an explanation of the kind found in the social sciences. Nevertheless, it is concluded that to date Freud's hypotheses about homosexuality are no more than unproven speculations. Also considered is the (...) question of whether the very topic of homosexuality falls or ought to fall within the domain of medical inquiry. CiteULike Connotea Del.icio.us What's this? (shrink)

The theme of consent is, without question, associated with the origins of bioethics and is one of its most significant paradigms that has remained controversial to the present, as is confirmed by the proposal for its debate during the last World Congress of Bioethics. Seen broadly as a compulsory minimum procedure in the field of biomedical ethics, even today it keeps open the issues that it has raised from the start: whether it is really necessary and whether it can be (...) proven to be effective. My goal will be to attempt to determine the most genuine and relevant meaning of consent, going back from its present dominant normative meaning and, from there, identifying or simply sketching other possible forms of its expression in the world we live in, so as to justify its pertinence and validity. This objective will involve three stages: (1) ‘Consent’ as a privileged paradigm of bioethics (the ethical-juridical sense), (2) The symbolic value of ‘consent’ (the social-cultural sense), and (3) ‘Consent’ as promotion of the human (the humanistic-personal sense) .It is concluded that the common notion of normative consent is not the only one, nor does it hold universal validity; that, from a historical-cultural perspective, new expressions of consent appear, adapted to different social contexts and to possibly be implemented in developing countries; and, finally, that consent is strictly indispensable in situations of extreme dependence, in its symbolic relational character, in as much as it promotes ethical relationships among strangers and ensures that they remain so. (shrink)

The branch of clinical medicine most likely to qualify as a social science is family medicine. Whether family medicine is a social science is addressed in four steps. First, the nature of family medicine is outlined. Second, the extent to which social science knowledge is used in family practice is discussed. Third, the extent to which family medicine can qualify as a social science is considered with respect to an orthodox model (...) of the social sciences, that is, one that emphasizes affinities between the natural and social sciences. Finally, the same question is addressed with respect to an unorthodox model of the social sciences, that is, one that stresses the evaluative nature of the social sciences. CiteULike Connotea Del.icio.us What's this? (shrink)

Technologies for enhancement of the human body historically have taken the form of an apparatus: a technological device inserted in, or appended to, the human body. The margins of these devices were clearly discernible and materially circumscribed, allowing the distinction between the corporeality of the human body and the “machine” to remain both ontologically and materially secure. This dualism has performed some important work for human rights theorists, regulators, and policy makers, enabling each to imagine they can establish where the (...) human ends and the other begins. New regenerative products such as Infuse™ and Amplify™ subsist, as animal-derived scaffolds seeded with growth hormone implanted within a prosthetic device. They are much more materially complex, and their identities thus remain open to contestation. Following Lochlann Jain’s 2006 work, I thus attend closely to their social lives, particularly the stories that are told about them and how these are employed to construct understandings of what kind of a phenomenon they are: systemic drug, biologic, or combinatorial medical device. The significance of this classificatory project is revealed in the final section of this paper, which explores how these stories shape understandings of “product failure,” liability, and causation when such products overflow their material and ontological categorization and their recipients become disturbingly “more than human.”. (shrink)