In most traditions, the law is founded upon some extralegal view of morality. There are only a handful of cases prior to the 1970s that involved patenting nonhuman organisms. John Moore made several claims, but the one of most interest to us here was a claim for conversion, which means the unlawful use of another person's property for the enrichment of the person using the thing unlawfully. The cell line produced from Moore's spleen cells was eventually patented by the defendants. (...) The potential market for products relating to that patent was estimated to be roughly $3 billion US dollars. The move from patenting hybridized plants, to genetically altered microorganisms, to human tissues and genes reflected the epitome of the fabled slippery slope. There is clearly a gap between our intuitions about the relations between our individual genomes, our identities, perceptions of privacy and personal autonomy, and the law. (shrink)

Human gene patents are patents on human genes that have been removed from human bodies and scientifically isolated and manipulated in a laboratory. The U.S. Patent and Trademark Office (the USPTO) has issued thousands of patents on such genes, and patents have also been granted by the European Patent Office, (the EPO). Legal and moral justification, however, are not identical, and it is possible for a legal decision to be immoral although consistent with legal precedent and (...) procedure. So, it is surprising to learn that some people believe that the legal justification of human gene patents can remove the most serious moral objections to them. Yet, those who are well-versed in patent law often believe that confusion over some quite basic legal and scientific facts accounts for moral objections to such patents and, in particular, for the belief that they justify the ownership of one person by another. Once these confusions are removed, they contend, we will see that there is nothing especially alarming about patents on human genes, and no reason to believe them immoral. -/- Such claims seem especially surprising because the morality of an invention is generally supposed to have little role in decisions about whether or not an invention deserves a patent under U.S. law. Although the European Patent Convention’s article 53 (a) prohibits patenting inventions, the publication or exploitation of which would be contrary to public order or morality, it turns out that this clause rarely justifies withholding a patent from an invention that otherwise meets legal criteria. Thus, although more than 320,000 patents have been granted by the EPO since its creation, this clause has never been used successfully to strike down a claim for a patent. Indeed, Ulrich Schatz explains, “Poisons, explosives, extremely dangerous chemical substances, devices used in nuclear power stations, agro-chemicals, pesticides and many other things which can threaten human life or damage the environment have been patented, despite the existence of the public order and morality bar” in almost all European countries. -/- Indeed, this paper shows, while ethical objections to human gene patents are often controversial, they need not be unreasonable, nor need they depend on mistaken assumptions about patent law. Rather, they may reflect familiar ethical concerns about the dominance of commercial imperatives in modern societies; concerns about the disparities in power and wealth amongst individuals and countries; and concerns about the lack of public discussion, transparency and accountability surrounding significant changes in people’s rights, status and opportunities. Hence, I conclude, ethical concerns cannot be easily dismissed and, indeed, point to the need to think harder about the nature and justification of patent law, itself. (shrink)

In Evangelium vitae, Pope St. John Paul II recognized that scientific progress would bring about new attacks on the dignity of the human person. Since that time, remarkable expansion in our knowledge and understanding of the human genome has brought forth questions of ownership rights via patents on human genes and related technology. This article argues that patenting human genes is incompatible with human dignity as it commodifies that which is priceless. In contrast, granting (...) patents to manipulations of human genes does not violate human dignity so long as it is utilized toward the common good. National Catholic Bioethics Quarterly 15.2 : 265–285. (shrink)

After ten years of debate Directive 98/44/EG on the legal protection of biotechnological inventions was adopted in 1998. This directive takes decisions on some controversial bioethical and legal issues and offers the European biotech industries more space to develop their inventions, but leaves a number of philosophical and moral issues unresolved. This paper distinguishes between different layers in the debate and maps its modes of argumentation. Major philosophical, ethical and conceptual issues are located. It is argued that further analysis of (...) these issues can help resolve further ethical and legal difficulties as regards patenting of human DNA. As the allegedly special status of genetic material remains unclear, the status of (human) DNA and its relation to the human body and personal identity should be further explored. (shrink)

The legal status of the human body is hotly contested, yet the law of the body remains in a state of confusion and chaos. Sometimes the body is treated as an object of property, sometimes it is dealt with under the rubric of contract, and sometimes it is not conceived as property at all, but rather as the subject of privacy rights. Which body of law should become the law of the body? This question is even more pressing in (...) the context of current biomedical research, which permits commodification and commercialization of the body by everyone except the person who provides the “raw materials.” The lack of property protection for tangible parts of the human body is in stark contrast to the extensive protection granted to intellectual property in the body in the form of patents upon human genes and cell lines. Moreover, even courts that reject ownership claims on the part of those who supply body parts appear willing to grant property rights to scientists, universities, and others who use those body parts to conduct research and create products. (shrink)

The decade-long debate over ownership of living human materials has recently intensified with the ability of biomedical research to isolate, purify, and use human genes and gene products as therapeutics, factories for the production of therapeutics, and targets for the identification of therapeutic pharmaceuticals. Indeed, advances in genomic research have resulted in the identification of hundreds of thousands of DNA fragments and hundreds of genes. Many within the scientific and business communities believe genes and gene (...) fragments have commercial value and have filed patent applications on the nucleic acid sequences. This commercialization has amplified the discussion surrounding the ethics of patenting genes and the ownership of the human genome. (shrink)

Questions concerning the moral status of embryos, the validity of new technologies for human reproduction, ownership of one's own genes, gene patenting, privacy and discrimination have all been raised and debated. Although debate is healthy, it is only useful if all participants understand the fundamental biological principles underlying human life, human genes and human parenthood. Many people believe that science can play no role in determining when human life begins. I argue that this (...) false assumption is based on a failure to separate different contradictory meanings of the term 'human life'. In actuality, science has provided great insight into when and how human life and human beings come into existence. I argue as well that, contrary to our intuitive feelings, there is no physical connection between any father and his son; shared genes represent shared information and nothing more. Nevertheless, the feeling of a physical connection between parent and child is very real and instinctive, no matter how false it may be. These new understandings have profound ramifications for the way we treat issues surrounding human reproduction, including both abortion and assisted reproductive technologies. (shrink)

Gene patenting was enabled by strained interpretations of legal precedent and with very little consideration of its ultimate ethical implications. The sciences of justice, ethics, and morals remain in their dark ages, with their practitioners all ascribing to differing values and modes of inquiry, besieged in their various camps of deontological, or consequentialist, or emotive or theistic dogmas. Ownership and property rights in moveables are good candidates for grounded relations as opposed to intellectual property. The groundedness of a (...) valid possession rests on the intentional state of the possessor and other external and objective facts of the possession. The ontology of the social and legal institution of ownership reveals that it is grounded in certain states of affairs, such as brute‐worldly facts and intentional states, as well as social acts revealing intentions of the parties. (shrink)

Questions concerning the moral status of embryos, the validity of new technologies for human reproduction, ownership of one's own genes, gene patenting, privacy and discrimination have all been raised and debated. Although debate is healthy, it is only useful if all participants understand the fundamental biological principles underlying human life, human genes and human parenthood. Many people believe that science can play no role in determining when human life begins. I argue that this (...) false assumption is based on a failure to separate different contradictory meanings of the term ‘human life’. In actuality, science has provided great insight into when and how human life and human beings come into existence. I argue as well that, contrary to our intuitive feelings, there is no physical connection between any father and his son; shared genes represent shared information and nothing more. Nevertheless, the feeling of a physical connection between parent and child is very real and instinctive, no matter how false it may be. These new understandings have profound ramifications for the way we treat issues surrounding human reproduction, including both abortion and assisted reproductive technologies. (shrink)

Glenn McGee argues that the time is now for debating the morality of patenting human genes. In one sense he is surely right. While thousands of patents have been issued or are pending on many gene sequences, public policy with respect to ownership of the human genome is still far from settled. So a debate about the ethics of patenting genes is, if nothing else, timely. In another sense however, Professor McGee is wrong.

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.3 (2000) 265-281 [Access article in PDF] Scope Note 39 Genes, Patents, and Bioethics-Will History Repeat Itself? Susan Cartier Poland Gene patenting--the very notion sounds absurd! How can anyone claim to have invented the genes with which one is born? To make matters worse, genetic makeup precedes birth, meaning the existence of the invention predates the existence of the inventor. So, do we (...) really own our genes, or do they belong to our parents, or our governments, or a Supreme Being? Ownership is only one bioethical issue involved in gene patenting. But before looking at the issues, some essential and basic terms must be understood, namely genes and patents. Genes In his book On the Origin of Species, published in 1859, the biologist Charles Darwin proposed a theory called "natural selection," whereby living things changed over time or evolved through generations due to competition and variation. By experimenting with the garden pea in the 1860s, Gregor Mendel, a monk and accomplished horticulturalist, provided the mechanism of inheritance supporting the natural selection theory of his contemporary Darwin. That mechanism is the gene, or, as Mendel described it, a discrete "factor." The gene has also been defined as "the fundamental unit of heredity" (United States 1987, p. 157). Each individual has two copies of a gene, one from each parent, but that individual passes down to offspring only one of the two copies. Because of Mendel, the gene has become a scientific concept and the basis of a new scientific field: genetics.David C. Page (2000) of the Whitehead Institute for Biomedical Research at the Massachusetts Institute of Technology explained today's terms for genetics structures using an analogy taken from the home. In his view, the cell is a kitchen, the genome is a shelf in the kitchen, the chromosome is a cookbook on the shelf, the gene is a recipe in the cookbook, and a base-pair (either adenine with thymine or guanine with cytosine) is a single letter in the recipe. A protein, the [End Page 265] working molecule blueprinted by a gene, is a dish ready to eat, and an ingredient in the dish is an amino acid, which is a building block of the protein as specified by a string of base-pairs.Colin Tudge (1993), a British science journalist, would disagree with Page's description of the gene as a recipe. A recipe is like a blueprint: both are directions that precede the work. But a gene is not passive according to Tudge; it actively administers the cell's work, and it also responds to cellular events (Aldridge 1996).The current focus of scientific research and funding is on the gene and the completion of the sequencing of all the genes that comprise the human genome, portrayed in the press as a race between the U.S. government's Human Genome Project and the private corporation Celera Genomics. The real action, however, is at the protein level. The gene only holds the information to produce a protein; it is the three-dimensional shaped protein that does the work. In order to produce energy, eliminate waste, and perform other functions specific to a cell or tissue, proteins must bind, thus creating "biological pathways." Proteins bind (or not) and detach as a function of their shapes, which are determined by their precise chemical composition as spelled out in their genetic code. IBM will spend the next five years making one computer, Blue Gene, that will then take an entire year to come up with the chemical map for only one protein (Gillis 2000). It is estimated that there are about 40,000 proteins in the human body.Despite these overwhelming numbers, modern biology has been able to achieve significant results within the Human Genome Project's 15-year time frame, from 1990 to 2005. The genetic map was completed in 1993; the physical map was completed in 1995; and the genetic sequence is expected to be completed in 2002, with 97 to 99 percent completed as of 26 June 2000. This... (shrink)

Genes are functional cell segments of DNA within an organism, as well as basic physical units of biological inheritance, which have consequences for human dignity and public interest. Genes and genetic material (DNA strands of nucleotides, genetically altered plants and animals e.g., see Appendix B) are patentable. In the US and around the globe, governments grant genetic patents for new, non-obvious, and useful gene inventions. A wide range of interest groups such as religious leaders, scientists, biotech pharmaceuticals, medical (...) practitioners, health care providers, venture capitalists, medical patients and persons have interests in defining what is subject to patents. Yet, it is at least questionable that genetic inventions, and the ownership of discoveries of gene mutations leading to possible diseases, should be subject to influence by interest groups. Although some genes (cDNA) are currently legally patentable, the question in this examination is whether gene patents should be legally and morally justified. In this work I examine whether gene patents should legally and morally be justified, given the principles of biomedical ethics such as human Beneficence /Autonomy and Justice. I argue that gene patenting is not justifiable, and I consider what can be done to create a system that delivers access to genetic information in the current genetic Intellectual Patent system. This interdisciplinary work is more complex than whether bio-science researchers and corporate entities should hold gene patents, or differentiating the legal question of whether genes are an invention or a discovery in the human genome. Mere responses to these questions would not ultimately solve the genetic justice problem. The justification for genetic appropriation is more complexity, since it is grounded in axiological claims about human dignity and public interest set in an ever changing biomedical/biogenetic technology. To address this complexity, I will draw upon the ideas of “the capability approach” to genetic justice found in the work of Nussbaum and Sen. This work is an interdisciplinary examination of the proper appropriation of natural genetic material and its impact on human dignity. It is argued that genetic material and information should be accessible to all, via heath care, for example. We must look to new ways to achieve genetic justice that promote human flourishing as a public good. (shrink)

You quite rightly need not fear being owned in the most traditional and reprehensible sense by which humans ... New and more subtle forms of ownership have emerged in the past hundred years that now impact on essential qualities and ...

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)

The essays in this book discuss human behavior and the institutions of capitalism. The essays are non-technical and are written so as to be accessible to students of all disciplines and to all other persons interested in capitalism and in economic behavior. They often present unconventional views of the topics they discuss. Those containing unconventional views discuss self-interested behavior, selfish gene theory, the meaning and social function of private ownership, the externality problem, the nature of the firm (...) and the rise of capitalism. The essays are not meant to be a textbook, but they offer a useful supplementary reading source for courses in business, economics and law that deal with human behavior in the marketplace and with capitalism, ownership, markets and firms. (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)

The strength of a slippery slope argument is a matter of some dispute. Some see it as a reasonable argument pointing out what probably or inevitably follows from adopting some practice, others see it as essentially a fallacious argument. However, there seems to be a tendency emerging to say that in many cases, the argument is not actually fallacious, although it may be unsubstantiated. I shall not try to settle this general discussion, but merely seek to assess the strength of (...) the slippery slope argument applied to human gene therapy. The structure of my argument will be the following. First, I shall distinguish between three different versions of the slippery slope argument; two logical versions and an empirical one. Next, I will address human gene therapy in terms of each of the three versions, partly relying on slippery slope arguments against this practice that have already surfaced in the literature. I shall argue that neither version pulls through. The logical versions fail primarily because relevant distinctions can be made between different uses of gene therapy, contrary to what the proponents of the arguments claim. The empirical version fails because there seems to be no evidence supporting the claim that we shall in fact slide down the slope if we engage in gene therapy, and because if we accepted the conclusion that we should not allow gene therapy on the basis of the empirical argument, we should have to make very far-reaching and undesirable modifications in health care in general, in order to be consistent. Or at least so I shall argue. (shrink)

Is it defensible to use the concept of a right? Can we justify this concept's central place in modern moral and legal thinking, or does it unjustifiably side-line those who do not qualify as right-holders? Rowan Cruft brings together a new account of the concept of a right. Moving beyond the traditional 'interest theory' and 'will theory', he defends a distinctive role for the concept: it is appropriate to our thinking about fundamental moral duties springing from the good of the (...) right-holder. This has important implications for the idea of 'natural' moral rights-that is, rights that exist independently of anyone's recognising that they do. Cruft argues that only rights that exist primarily for the sake of the right-holder can qualify as natural in this sense.In its relation to property, however, matters are far more complicated because much property is groundable only by common or collective goods beyond the right-holder's own good. For such property, Cruft argues that a non-rights property system-that resembles modern markets but is not conceived in terms of rights-would be preferable. The result of this study is a partial vindication of the rights concept that is more supportive of human rights than many of their critics might expect, and is surprisingly doubtful about property as an individual right. (shrink)

The article investigates the validity of two different versions of the slippery slope argument construed in relation to human gene therapy: the empirical and the conceptual argument. The empirical version holds that our accepting somatic cell therapy will eventually cause our accepting eugenic medical goals. The conceptual version holds that we are logically committed to accepting such goals once we have accepted somatic cell therapy. It is argued that neither the empirical nor the conceptual version of the argument (...) can provide a conclusive moral reason for banning somatic cell therapy. According to a third interpretation, referred to as the arbitrary result argument, the many apparent similarities between somatic cell therapy and eugenic-based human genetic engineering drive us to make principled choices concerning what differences and similarities between the two practices should be regarded as morally (ir)relevant. Decisions of this kind are likely to have unpredictable moral consequences. Thus formulated, the slippery slope argument has much plausibility. One objects to somatic cell therapy not so much because of what is at the bottom of the slope on which it lies, but because it is on a slope of which one does not know what is at the bottom. While the arbitrary result argument does not provide a conclusive reason for prohibiting human gene therapy, it reminds of a very important thing: when making bioethical decisions, we should be as specific and as consistent as possible about our basic moral and medical concepts. (shrink)

: The medical and clinical promise of stem cell research is widely heralded, but moral judgments about it collide. This article takes general stock of such judgments and offers one specific resolution. It canvasses a spectrum of value judgments on sources, complicity, adult stem cells, and public and private contexts. It then examines how debates about abortion and stem cell research converge and diverge. Finally, it proposes to extend the principle of "nothing is lost" to current debates. This extension links (...) historic discussions of the ethics of direct killing with unprecedented possibilities that in vitro fertilization procedures yield. A definite normative region to inhabit is located, within a larger range of rival value judgments. The creation of embryos for research purposes only should be resisted, yet research on "excess" embryos is permissible by virtue of an appeal to the "nothing is lost" principle. (shrink)

The patenting of human genes has been the subject of debate for decades. While China has gradually come to play an important role in the global genomics-based testing and treatment market, little is known about Chinese scholars’ perspectives on patent protection for human genes. A content analysis of academic literature was conducted to identify Chinese scholars’ concerns regarding gene patents, including benefits and risks of patenting human genes, attitudes that researchers hold towards gene patenting, and (...) any legal and policy recommendations offered for the gene patent regime in China. 57.2% of articles were written by law professors, but scholars from health sciences, liberal arts, and ethics also participated in discussions on gene patent issues. While discussions of benefits and risks were relatively balanced in the articles, 63.5% of the articles favored gene patenting in general and, of the articles that explored gene patents in the Chinese context, 90.2% supported patent protections for human genes in China. The patentability of human genes was discussed in 33 articles, and 75.8% of these articles reached the conclusion that human genes are patentable. Chinese scholars view the patent regime as an important legal tool to protect the interests of inventors and inventions as well as the genetic resources of China. As such, many scholars support a gene patent system in China. These attitudes towards gene patents remain unchanged following the court ruling in the Myriad case in 2013, but arguments have been raised about the scope of gene patents, in particular that the increasing numbers of gene patents may negatively impact public health in China. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Human Gene TherapyMary Carrington Coutts (bio)On September 14, 1990, researchers at the U.S. National Institutes of Health (NIH) performed the first approved gene therapy procedure on a four-year-old girl named Ashanti DeSilva. Born with a rare genetic disease, severe combined immune deficiency (SCID), Ashanti lacked a healthy immune system and was extremely vulnerable to infection. Children with SCID usually develop overwhelming infections and rarely survive to (...) adulthood; even a common childhood illness like chicken pox is life-threatening. Ashanti led a cloistered existence, avoiding contact with people outside her family, remaining in the sterile environment of her home, and battling frequent illnesses with massive amounts of antibiotics.In Ashanti's gene therapy procedure, her own white blood cells were genetically modified and then infused back into her bloodstream. Laboratory tests show that the therapy has strengthened Ashanti's immune system. She no longer has recurrent colds, has been allowed to attend school, and has been immunized against whooping cough. This gene therapy procedure is not a cure, however. The genetically-treated white blood cells only survive for a few months and must then be replaced, but Ashanti's future is much brighter because of the new therapy (VI, Thompson [The First] 1993).Although this simplified description of Ashanti's gene therapy procedure sounds like a happy ending, it is little more than an optimistic chapter in a long story. The road to the first approved gene therapy procedure was rocky and fraught with controversy. The biology of human gene therapy is very complex, and there are still many techniques that need to be developed and diseases that need to be understood more fully before gene therapy is well established. The public policy debate surrounding the possible use of genetically engineered material in human subjects is equally complex. Major participants in the debate come from the fields of biology, government, law, medicine, philosophy, politics, and religion, each bringing different views to the discussion.In studying the ethics of gene therapy, one should draw a distinction between [End Page 63] therapy on somatic (non-reproductive) cells and germ (reproductive) cells. Only the germ cells carry the genes that will be passed on to the next generation. Reactions to gene therapy have varied widely. Some commentators on gene therapy object to any form of genetic manipulation, no matter how well-intentioned (VI, Rifkin 1983). Another reaction is to allow the use of somatic-cell therapy, but not to approve the use of germ-line therapy, which could have unforeseeable effects on future generations. A different stance is that, with proper regulation and safeguards, germ-line gene therapy is a logical extension of the progress made to date and that it is an ethically acceptable procedure.TechniquesTo date, 43 research protocols have been approved for somatic-cell gene therapy in the United States. The techniques employed in each protocol vary, but in general a virus is used as a "vector" to insert the desired gene into the DNA of the patient's cells, in order to compensate for a defective gene. For Ashanti's gene therapy, this technique involved obtaining white blood cells and introducing properly functioning genes into as many of the cells as possible. The normal genes were delivered through the use of a specially-engineered virus.Although similar techniques are used in germ-line gene therapy, the procedure is more difficult. There are two basic ways to perform germ-line gene therapy: (1) to treat a preimplantation embryo that carries a serious genetic defect before its implantation in the mother, which necessitates the use of in vitro fertilization techniques; or (2) to treat the germ cells (sperm or egg cells) of afflicted adults so that the genetic defects would not be passed on to their offspring, which requires the technical expertise to delete the defective gene and insert a properly functioning replacement. Because of the complexity of the procedures involved and the attendant ethical controversy, germ-line therapy is not currently performed.Candidate Diseases for Gene TherapyAt present, gene therapy is likely to be most successful in treating diseases that are caused by single-gene defects and has been approved for treating diseases such... (shrink)

Since the establishment of the Human Genome Project and the identification of genes in human DNA that play a role in human diseases and disorders, a long, moral and political, battle has began over the extension of IPRs to information contained in human genetic material. According to the Nuffield Council on Bioethics, over the past 20 years, large numbers of human genes have been the subject of thousands of patent applications. This paper examines whether (...) class='Hi'>human gene patents can be justified in terms of liberal theories of morality such as natural law, personality development, just reward and social utility. It is argued that human gene patents are in conflict with fundamental principles of liberal morality and justice because they result in "genetic information feudalism". (shrink)

Despite widespread agreement that it would be ethical to use somatic cell gene therapy to correct serious diseases, there is still uneasiness on the part of the public about this procedure. The basis for this concern lies less with the procedure's clinical risks than with fear that genetic engineering could lead to changes in human nature. Legitimate concerns about the potential for misuse of gene transfer technology justify drawing a moral line that includes corrective germline therapy but (...) excludes enhancement interventions in both somatic and germline contexts. Keywords: somatic cell, germ line, genetic diseases, genetic engineering, humanness, enhancement, eugenics CiteULike Connotea Del.icio.us What's this? (shrink)

The production of genetic knowledge -- Scientific and economic strength of genetic reductionism -- Policy implications : discourses of genetic enlightenment as new disciplinary devices -- Genetic conceptualizations of normality and the idea of genetic justice -- Beyond genetic universality and authenticity, the lure of the genetic underclass -- Previews of the future as background -- Economic and actuarial perspective on genetics and insurance -- Practical and normative arguments against genetic exceptionalist legislation -- The changing social role of private insurance (...) : risk as a new representational regime. (shrink)

types of application of genetic engineering for the insertion of genes into humans. The scientific requirements and the ethical issues associated with each type are discussed. Somatic cell gene therapy is technically the simplest and ethically the least controversial. The first clinical trials will probably be undertaken within the next year. Germ line gene therapy will require major advances in our present knowledge and it raises ethical issues that are now being debated. In order to provide guidelines for (...) determining when germ line gene therapy would be ethical, the author presents three criteria which should be satisfied prior to the time that a clinical protocol is attempted in humans. Enhancement genetic engineering presents significant, and troubling, ethical concerns. Except where this type of therapy can be justified on the grounds of preventive medicine, enhancement engineering should not be performed. The fourth type, eugenic genetic engineering, is impossible at present and will probably remain so for the foreseeable future, despite the widespread media attention it has received. Keywords: genetic engineering, somatic cells, germ cells, enhancement, eugenics, humanhood CiteULike Connotea Del.icio.us What's this? (shrink)

Any suggestion of altering the genetic makeup of human beings through gene therapy is quite likely to provoke a response involving some reference to a 'slippery slope'. In this article the author examines the topography of two different types of slippery slope argument, the logical slippery slope and the rhetorical slippery slope argument. The logical form of the argument suggests that if we permit somatic cell gene therapy then we are committed to accepting germ line gene (...) therapy in the future because there is no logically sustainable distinction between them. The rhetorical form posits that allowing somatic cell therapy now will be taking the first step on a slippery slope which will ultimately lead to the type of genocide perpetrated by the Nazis. The author tests the validity of these lines of argument against the facts of human gene therapy and concludes that because of their dependence on probabilities that cannot be empirically proven they should be largely disregarded in the much more important debate on moral line-drawing in gene therapy. (shrink)

This chapter discusses some of the practical consequences of the recent and evolving situation in both science and industry, and forecasts how altering the law might affect each. It considers at least three possibilities: (1) justice demands eradicating patenting genes no matter what the consequences, (2) justice and economic efficiency demand altering the current system to meet both concerns, or (3) the economic effects of altering or eradicating the present system outweigh both the concerns of justice or economic efficiency, and (...) so the status quo should be maintained. The chapter explores each of these possibilities with an eye toward actually proposing rational public policy scenarios that could be adopted. Open Source essentially amounts to the ideal methods of the sciences applied to products in the marketplace. DNA in its natural state is the object of discovery and therefore the domain of science. (shrink)

For nearly two decades, nonengineered human DNA was patented without challenge. The US Supreme Court recently agreed that many of those patents do not fit accurately into any currently accepted scheme of intellectual property protection. One should consider: whether DNA fits into other forms of property protection (land, moveables, chattels, etc.); whether DNA warrants a new and unique form of property protection, or whether DNA belongs to the class of objects generally considered to be as “the commons.” Current schemes (...) of patent protection for genes are entirely new, unwarranted by precedent, and utterly aberrant in applying the law of patent. Nonetheless, it bears examining how intellectual property schemes might serve as guidance for new forms of intellectual property protection for genes, if indeed those genes fit into classical dimensions of intellectual property. Private ownership of property has emerged as the dominant legal institution covering modes of possession. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.2 (2000) 171-174 [Access article in PDF] Bioethics Inside the Beltway The Oversight of Human Gene Transfer Research LeRoy Walters Jesse Gelsinger's death last September in a gene transfer study being conducted at the University of Pennsylvania has helped to spark a national debate. In part, this debate parallels the broader discussion of how human subjects research should be reviewed (...) and regulated in the United States. However, human gene transfer research is one of a handful of biomedical technologies that seem to deserve special attention, at least in the early years of their development.The major participants in the national debate on human gene transfer include the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the National Bioethics Advisory Commission, members of Congress, biotechnology and pharmaceutical companies, disease-oriented advocacy groups, reporters, and academics. At the December 1999 meeting of the NIH Recombinant DNA Advisory Committee (RAC), the protocol that involved Jesse Gelsinger was a central focus of discussion, but other topics emerged as well. One ad hoc panel reviewed adverse events that had occurred in other research protocols using adenovirus vectors, while a second proposed changes in the general system for reporting adverse events to NIH and the RAC.During the first several months of the year 2000, the United States Congress also became involved in the human gene transfer debate. In February, Senator Bill Frist (R-TN) convened a hearing to which Jesse Gelsinger's father, representatives of NIH and FDA, and several other witnesses were invited. At approximately the same time, the House Commerce Committee and its Subcommittee on Oversight and Investigations initiated their own inquiries, asking the Office of Inspector General at the Department of Health and Human Services to review the oversight roles of NIH and FDA. In March and April, the House committee also wrote directly to the NIH Director, the FDA Commissioner, and the President of the University of Pennsylvania, requesting extensive documentation on gene transfer, in general, and the trial in which Jesse Gelsinger was involved, in particular. Congressman Henry Waxman (D-CA) and Senator Edward Kennedy (D-MA) have also raised questions and proposed solutions in multiple letters to the NIH Director and the Secretary of Health and Human Services. [End Page 171]The major general questions that have emerged from this discussion are the following:(1) What kinds of information about adverse events should be reported by researchers or sponsors during the course of human gene transfer trials?(2) To what group or groups should adverse-event information be reported? How often and in what ways should the information be analyzed?(3) Should the information about adverse events remain confidential, or should it be discussed publicly?(4) How can the disclosure and consent process in gene transfer trials be improved?(5) Which federal agency should have primary responsibility for overseeing human gene transfer research, and how can it best fulfill its oversight role?How these questions are answered will have immediate relevance to the field of human gene transfer research as it enters into its next phase. At the same time, the models that are created for this important cutting-edge field also may be useful in other complex or controversial arenas of biomedical research, for example, xenotransplantation or human embryonic stem-cell research. In addition, the lessons learned from this one important area of human subjects research may suggest ways to improve protections for all the volunteers who make clinical research--and medical progress--possible.In the remainder of this article, I will turn from reporting, in as objective a way as possible, on the status of the public policy debate about human gene transfer research to suggesting measures for improving the current oversight system for such research. My initial general recommendation is that we should not expect a single regulatory agency to be solely responsible for a field as large and dynamic as human gene transfer research. Rather, there should be some helpful redundancy or, to change the metaphor, checks and balances in the public oversight of this field. Thus, an... (shrink)

: This paper discusses the morality of patenting human genes and genetic technologies. After examining arguments on different sides of the issue, the paper concludes that there are, at present, no compelling reasons to prohibit the extension of current patent laws to the realm of human genetics. However, since advances in genetics are likely to have profound social implications, the most prudent course of action demands a continual reexamination of genetics laws and policies in light of ongoing developments (...) in science and technology. (shrink)

Änderungen im Bereich der medizinischen Technologie können Änderungen der Begriffswelt, Änderungen der ethischen Perspektiven und Änderungen im Recht hervorrufen. Neue Entwicklungen der Reproduktionstechnik, z.B. in vitro Fertilisation, Leihmutterschaft etc., bilden eine Herausforderung für die traditionellen Konzepte von "Elternschaft", die von uns verlangen, die sonst vorausgesetzte Identität von genetischer Mutter, Geburtsmutter und Sozialmutter etc. zu überdenken. Ich untersuche in diesem Beitrag die möglichen Auswirkungen des Genomprojekts auf einige der geläufigen Annahmen über menschliche Beziehungen, Willensentschlüsse und Tugenden. Ein Beispiel: Würden Sie jemanden (...) heiraten, von dem bekannt ist, daß er/sie in einigen Jahren die Alzheimersche Krankheit ausbilden wird? Würde die Idee einer "lebenslangen Verbindung" hier eine andere moralische Bedeutung erlangen, vielleicht schlicht veralten oder sogar als supererogatorisch einzuschätzen sein? (shrink)

The ethics of gene patenting is concerned with whether human genes are the kind of thing that is appropriate for patenting, and whether it is ethical to do so. Is genetic technology a special case compared to other medical technology that have been patented? Much of the debate has revolved around the benefits and harms of allowing gene sequences to be patented. In this paper, I am concerned with a non-consequential consideration: Can someone patent my genes? If (...) genes are the common property of humankind, are genes patentable? I present an objection to the patenting of processes used to manipulate our genes that have the potential to change human nature. Should not all members of the human species have a say regarding genetic engineering that can be used to irreversibly change what makes each one a human? I conclude with an examination of how genetic research may be democratically controlled. (shrink)

The primary theme of this paper is the normative case against ownership of one's genetic information along with the source of that information (usually human tissues samples). The argument presented here against such “upstream” property rights is based primarily on utilitarian grounds. This issue has new salience thanks to the Human Genome Project and “bio-prospecting” initiatives based on the aggregation of genetic information, such as the one being managed by deCODE Genetics in Iceland. The rationale for (...) class='Hi'>ownership is twofold: ownership will protect the basic human rights of privacy and autonomy and it will enable the data subjects to share in the tangible benefits of the genetic research. Proponents of this viewpoint often cite the principle of genetic exceptionalism, which asserts that genetic information needs a higher level of protection than other kinds of personal information such as financial data. We argue, however, that the recognition of such ownership rights would lead to inefficiency along with the disutility of genetic discoveries. Biomedical research will be hampered if property rights in genes and genetic material are too extensive. We contend that other mechanisms such as informed consent and strict confidentiality rules can accomplish the same result as a property right without the liabilities of an exclusive entitlement. (shrink)

Why would an empiricist look at a poem? And if he did, what could he find? This paper begins with Hume's programmatic statement for literary renewal based on the empirical principles set forth in the first Enquiry, and raises the question about the worth of poetry according to those principles. There is little "abstract reasoning concerning quantity or number, or experimental reasoning concerning matter of fact and existence" in poetry and so "commit it to the flames." The second Enquiry allows (...) that since disputation among men is based on the passions, poetry might have a place as a means to speak to the affections, to inforce particular sophistries close to our hearts. The second half of the paper defends poetry on grounds opposed to the premises of empirical science. Specifically, whereas in science knowledge is power, in the arts knowledge is suffering, or,where science aims at mastery and ownership, poetry relates us to that in being which is not ours. This view is explicated by use of King Lear. (shrink)

The pinnacle of the physician's clinical skills is his ability to develop the autonomy of his patients in the management of their health affairs. To do this requires the forging of a relationship in which patients' attitudes toward their health and illness are products of the doctor-patient relationship rather than unilateral behavior by either one. Modern medicine is beset with problems that make it difficult for physicians to develop and exercise the skills that lead to patient autonomy. An erosion of (...) public confidence in physicians is being caused by several mojar forces that include: (1) the power of science over life; (2) medical technology's dehumanizing effect; (3) legalization of medical ethics; and (4) industrialization and commercialization of medical care. To restore the kind of confidence that makes the physician an effective proponent of his patient's autonomy will require a major emphasis upon all aspects of medical ethics in the medical curriculum and in medical practice. Clinical investigation of this subject is highly appropriate. Clinical faculties should be developed in greater numbers who are authorities in the humanities as well as in science. Our medical schools need also to develop and to utilize models of health care in which relations with patients are personalized, continuous, and comprehensive so that ethical ideals such as patient autonomy can be demonstrated by precept and example, and can also be researched. (shrink)

This study is the most comprehensive account to date of modern treatments of the love commandment. Gene Outka examines the literature on agape from Nygren's Agape and Eros in 1930. Both Roman Catholic and Protestant writings are considered, including those of D'Arcy, Niebuhr, Ramsey, Tillich, and above all, Karl Barth. The first seven chapters focus on the principal treatments in the theological literature as they relate to major topics in ethical theory. The last chapter explores further the basic normative (...) content of agape and discusses some of the most characteristic problems. "The book is in my judgment the best recent work in religious ethics. Outka brings together analytic moral philosophy and theological ethics, providing a masterly survey of views and issues arising in the past forty years.... I can think of few books of interest to scholars in both philosophy and theology, but Outka's is one. Unlike some scholars who are at home in continental theology, Outka is also at home in secular analytic philosophy; he brings them together in a mutually illuminating way."--Donald Evans "Outka has mastered this vast literature on love, and has brought a critical and clarifying analysis to bear upon it. This is a most important book on a most important subject, and brings the whole discussion into a new phase."--John Macquarrie "The first thing to be said about Outka's book quite simply is that it is excellent; in fact, it is probably the very best available book about contemporary Christian ethical theory."--The Humanities Association Review. (shrink)

Mainstream academic debate on the ethics of human gene editing is currently not as inclusive as it should be. For example, it currently does not give due consideration to Indigenous groups and cultures, such as those living in rural and remote areas of Canada. Once such people are given due consideration, then several important points emerge, which have so far gone unnoticed or under‐emphasized in the debate. This article focuses on two of those points: (a) Some vulnerable people (...) who are currently being ignored in the debate may not desire to use gene editing, even if it is safe, effective and affordable, and they will have compelling reasons for making this decision; and (b) even if such people do decide to use the technology, the gene editing enterprise itself is unlikely to do much good for them (and may even be harmful to them), as it alarmingly misses the point regarding the underlying contributing causes of the most pressing problems that those people are facing. Therefore, the promise of the gene editing enterprise is a hollow one for some groups of vulnerable people. These considerations should be used more prominently to guide debate on the ethics of human gene editing. (shrink)

Prefaced by an argument that the ancients understood mimesis as fundamental to being human, and art as therefore essential to human moral and intellectual development, this book starts from the problematic status of the (happily ending) Iphigenia in Poetics. How Aristotle must explicate tragedy to hold Iphigenia as the best thus sets up the exploration of comedy. Chapter two shows that comedy aims at the catharsis of desire and sympathy. This analysis is then applied in detail to Aristophanes’ (...) Acharnians, Shakespeare’s As You Like It and Stoppard’s Arcadia, exhibiting the cross-cultural application of the theory which Aristotle would expect. (shrink)

Theological and secular concepts ofstewardship evolved markedly in the 20thcentury. During this period of evolution, theAmerican Country Life Association through itschurch, academic, farm organization, andgovernmental affiliations, served as a bridgingand bonding agent in developing the stewardshipidea. As in any evolutionary process, thestewardship concept was subjected to a broadarray of influences and characterized bynotable highlights such as the Lynn Smithcritique of the Judaeo-Christian ethic, theman-in-nature statement of Douglas John Hall,and the environmental concerns of ecologistsand philosophers of the post-Rachel Carson era.Some gains (...) have been made in understanding theplace of humans in nature, but the stewardshipidea continues as work in process. (shrink)

Kant admits that there are two kinds of human works that have something sublime about them, the work of the poet, e.g., tragedy, and the work of the politician, i.e., war. This paper will explore Kant's reasoning about the sublime element in these two human works.

Can gene editing and agroecology be complementary? Various formulations of this question now animate debates over the future of food systems, including in the UN Committee on World Food Security and at the UN Food Systems Summit. Previous analyses have discussed the risks of gene editing for agroecosystems, smallholders, and the concentration of wealth by and for agro-industry. This paper takes a different approach, unpacking the epistemic, socioeconomic, and ontological politics inherent in complementarity. I ask: How is complementarity (...) understood? Who is asking and defining this question? What are the politics of entertaining the debate at all? I sketch the epistemic foundations of science and technology that organize different notions of evidence used in agroecology and genetic engineering. On this base, I offer 8 angles on the compatibility question, exploring the historical contradictions that complementarity discourses reveal and the contemporary work they do. I work through questions of (1) technological neutrality, (2) “root cause” problems, (3) working with nature, (4) encoding racism, and dilemmas of (5) ownership and (6) access. These questions, I argue, require a reckoning with (7) ontologies of coloniality-modernity, which help us get underneath—and beyond—the complementarity question. Finally, I offer (8) a framework for thinking about and working toward technology sovereignty. (shrink)