It is obvious that every inventor should be rewarded for the intellectual effort, and at the same time be encouraged to successively improve his or her discovery and to work on subsequent innovations. Patents also ensure that patent owners are officially protected against intellectual piracy, but protection of intellectual property may be difficult to accomplish. Nevertheless, it all comes down to this basic question: Does a contradiction exist between medical ethics and the “Medical and Surgical Procedure (...) class='Hi'>Patents” system? It may well turn out that medical-procedure patents can have a negative influence on the standard of medical care. Medical-method patents may also interfere with the physician-patient relationship. At present, physicians do not question the usefulness of patent protection for medicines, biotechnology, equipment and devices, but they strongly oppose it for surgical procedures. (shrink)

Considerable controversy has recently arisen regarding the patenting of medical and surgical processes in the United States. One such patent, viz. for a "chevron" incision used in ophthalmologic surgery, has especially occasioned heated response including a major, condemnatory ethics policy statement from the American Medical Association as well as federal legislation denying patent protection for most uses of a patented medical or surgical procedure. This article identifies and discusses the major legal, ethical and public policy considerations offered (...) by proponents and opponents of such patents. The existing literature divides up into those who favor such patents essentially without qualification, and those who condemn and wish to outlaw them. We advance a compromise position where administrative and legislative action is called for to provide more specific guidelines regarding the patentability of such processes by the Patent and Trademark Office. Our position, in sum, will be that too much is at stake in this complicated area for either the blanket prohibition, or wholesale, uncritical acceptance, of the patenting of medical and surgical processes or techniques. (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)

Only 19 new molecular entities and 3 biologics were approved by the Food and Drug Administration in 2007, the lowest rate in 24 years. This disappointing output occurred despite steady clinical trial and regulatory review times, the FDA maintaining high approval rates, and the pharmaceutical industry consistently reporting increasing revenues. A government report suggests that fewer new drug applications have been submitted to the FDA by the pharmaceutical industry in recent years. These data have rekindled the debate as to the (...) origins of pharmaceutical innovation and the comparative importance of public and private sources in contributing to drug discovery. The pharmaceutical industry contends that its research is responsible for most new medicines, and that the primary public institution supporting U.S. biomedical research, the National Institutes of Health, supports medical innovation “distinct from the process of drug development.”. (shrink)

Medically unexplained symptoms (MUS) are common and costly in both primary and secondary health care. It is gradually being acknowledged that there needs to be a variety of interventions for patients with medically unexplained symptoms to meet the needs of different groups of patients with such chronic long-term symptoms. The proposed intervention described herewith is called The BodyMind Approach (TBMA) and promotes learning for self-management through establishing a dynamic and continuous process of emotional self-regulation. The problem is the mismatch (...) between the patient’s mind-set and profile and current interventions. This theoretical article, based on practice-based evidence, takes forward the idea that different approaches (other than cognitive behaviour therapy) are required for people with MUS. The mind-set and characteristics of patents with MUS are reflected upon to shape the rationale and design of this novel approach. Improving services for this population in primary care is crucial to prevent the iterative spiralling downwards of frequent GP visits, hospital appointments, and Accident and Emergency attendance, all of which are common for these patients. The approach derives from embodied psychotherapy (authentic movement in dance movement psychotherapy) and adult models of learning for self-management. It has been developed from research and practice-based evidence. In this article the problem of MUS in primary care is introduced and the importance of the reluctance of patients to accept a psychological/mental health referral in the first instance is drawn out. A description of the theoretical underpinnings and philosophy of the proposed alternative to current interventions is then presented related to the design, delivery, facilitation and educational content of the programme. The unique intervention is also described to give the reader a flavour. (shrink)

Effective medical innovation is a common goal of policymakers, physicians, researchers, and patients both in the private and public sectors. With the recent slowdown in approval of new transformative prescription drugs, many have looked back to the “golden years” of the 1980s and 1990s when numerous breakthrough products emerged. We conducted a qualitative study of innovators directly involved in creation of groundbreaking drugs during that era to determine what made their work successful and how the process of conducting (...) medical innovation has changed over the past 3 decades. Transcripts were analyzed using standard coding techniques and the constant comparative method of qualitative data analysis to identify the positive features of and challenges posed by the past and present therapeutic innovation environments . Interviewees emphasized the continued central role played by individuals and the institutions they were a part of in driving innovation. In addition, respondents discussed the importance of collaboration between individuals and institutions to share resources and expertise. Strong underlying basic science was also cited to be a major contributing factor to the success of an innovation. The climate for modern-day medical innovation involves a greater emphasis on patenting in academia, difficulty negotiating the technology transfer process, and funding constraints. Regulatory demands or reimbursement concerns were not commonly cited as factors that influenced transformative innovation. This study suggests that generating future transformative innovation will require a simplification of the current technology transfer process, continued commitment to basic science research, and policy changes that promote meaningful collaboration between individuals from disparate institutions. (shrink)

Although some have argued that COVID-19 vaccine patents are morally justified, a broader argument on the morality of breaching contracts is necessary. This article explores the ethics of breaching unfair contracts and argues that it is morally justified to breach contracts with pharmaceutical companies concerning vaccine patents. I offer two arguments to support this view. Firstly, contracts may be breachable in some situations. The ones I point out are that contracts can be broken when the costs of not (...) violating vaccine patents are too high or when the process for agreement is not fair, or when an urgent ethical issue needs to be addressed and it is possible to compensate the other party for their loss. Secondly, I argue that because the contracts with the pharmaceutical companies do not treat people as ends in themselves, there is no moral obligation to respect them. (shrink)

This paper attempts to better define the areas of conflict and agreement between value ethics and the theoretical ethics of the market processes at work in the biotechnology industry. Despite the apparent lack of ethics in an oligopolistically competitive pharmaceuticals industry, the paper concludes that the current stage of development of the medical biotechnology subindustry offers unparalleled opportunities for ethical systems to influence the market-based development of biotechnology. Ethical conversations between doctors and biologists with ethicists can help the market (...) absorb more of the reflective wisdom that ethics brings when discussing such issue areas as justice, patents of the human genome, and modifications of the human genome. If conversations between ethicists and biotechnological managers and doctors are successful the metaphors of market-based financing may be refined and the knowledge base of the good increased. (shrink)

The genome is one of the primordial elements of the human being and is responsible for human identity and its transmission to descendants. The gene as such ought not be appropriated or owned by man. However, any sufficiently complete description of a gene should be capable of being protected as intellectual property. Furthermore, all utilisations of a gene or its elements that permit development of processes or new products should be patentable. Ethics, in the sense of moral action, should come (...) into play from the very first stages of research into the human genome. Protection of intellectual and industrial property is of purely legal concern and need not provoke ethical consideration. By contrast, the use of the results of, and in particular the commercialisation of products deriving from, research into the human genome, ought to be subjected to ethical consideration and control. Considering the economic and societal stakes of such research, ethical analysis ought to be at an international level if mistakes and unforeseen risks of conflict are to be avoided. (shrink)

This book is devoted to showing that with the single exception of patents on people's whole genomes, DNA patents are morally permissible. Resnik begins with three useful background chapters: one on recent controversies over DNA patents in the United States and abroad; another on the basic science of DNA, as well as research and product development related to DNA; and another, especially useful, chapter on the legal nature of patents and intellectual property. The focus of moral (...) evaluation is patents as they are set out in American law. These give their holders a right to exclude others from producing, using, or commercializing the patented item for twenty years. Items that can be patented include products, processes, and improvements thereof. However, a patentable item must issue from human ingenuity (as opposed to nature); this rules out laws of nature, natural phenomena, and naturally occurring living things and chemical compounds. Of course, in its natural form, DNA is not a product of human nature and therefore not a candidate for patenting. However, since 1980 American law has deemed it patentable in isolated and purified form (in this form, Resnik reports, up to 95% of the sequences in the artificial sequence are in the natural sequence). Turning to ethical issues, Resnik argues for the permissibility of both the general practice of patents, as well as patents on DNA. The general practice is morally defensible because patents produce public benefits, protect private rights of ownership, and strike a reasonable balance in doing so. The public benefits include, in the near term, scientific, medical and agricultural discoveries and innovations; the central long-term benefit is the lower prices that come after the patent has expired and the patented item is publicly disclosed for others to market. Patents help to bring about all of these benefits by providing a legally protected twenty-year monopoly, thus functioning as powerful economic incentives. They thereby also protect private rights of ownership; but even here the public good is not overlooked, since patent-based monopolies are constrained in various ways to protect the public good (e.g.. (shrink)

ABSTRACT Monoclonal antibodies played a key role in the development of the biotechnology industry of the 1980s and 1990s. Investments in the sector and commercial returns have rivaled those of recombinant DNA technologies. Although the monoclonal antibody technology was first developed in Britain, the first patents were taken out by American scientists. During the first Thatcher government in Britain, blame for the missed opportunity fell on the scientists involved as well as on the National Research and Development Corporation, which (...) had been put in place after World War II to avoid a repeat of the penicillin story, when patent rights were not sought. Instead of apportioning the blame, this essay suggests that despite past experiences and despite the new channels that were in place, Britain was not in a “patent culture” in the 1970s. It traces the long and painful process that made a commercial attitude among publicly funded British research scientists and in a civil service institution like the Medical Research Council both possible and desirable. In this process the meaning of the term “public science” also changed dramatically. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Removing the Mask: Hopeless Isolation to Intersex AdvocacyAlexandra von KlanStrangers undoubtedly perceive me as female, but I identify as an intersex woman. My karyotype is 46,XY, a typically defined marker of male biological sex, and I was born with undeveloped, non–functioning gonads. As an intersex person, I know firsthand the negative consequences of pathologizing intersex people’s lived experience by categorizing otherwise healthy, functioning organs and bodies as abnormal. The (...) following narrative recounts conversations and interactions with medical providers during my diagnosis and subsequent treatment of pure XY gonadal dys-genesis, sometimes referred to as Swyer Syndrome. I hope to elaborate upon emotionally significant actions and inactions of medical care providers to expose consequential effects on my emotional processing, physical health, and self–actualization.In December 1988, I was born with “typical” female genitalia. No one knew I was an intersex woman with 46,XY karyotype. Thus, there was no hesitation in the announcement of the birth of a girl in the delivery room or later, on my birth certificate. My parents raised me as a girl and dressed their firstborn in culturally normative feminine garments and accessories: lace frilly frocks, oversized bows, white stockings, and black patent leather Mary Jane’s. I embraced femininity and expressed this gender identity throughout my childhood and adolescence. I’m the eldest of six children split between two households.In January 2005, a month after my sixteenth birthday, delayed puberty and absent menstruation prompted an appointment to a local women’s health center. Nurses collected blood samples and administered an MRI scan on my pelvic region. A week later, my father received a perplexing phone call. An inexperienced doctor told him “there must be something wrong” with me, because lab results revealed I was “chromosomally male.” My father recalls the information presented like, based on the evidence, “your daughter may not be completely female,” and that is that. His impression was that she knew little about the subject and was a bit clueless. She did not mention Swyer Syndrome, or any diagnosis for that matter.Up to this point, I was unaware that a member of my extended family also had Swyer Syndrome. Born in the 1950s, secrecy engulfed her medical treatment and doctors warned her parents against revealing her true chromosomal sex in order to prevent the hysterical panic and depression they [End Page E14] thought the truth would bring. Years later, she sought her medical records and unearthed the truth. Shortly after my father received that dubious phone call, my relative’s endocrinologist provided a referral to his mentor, “Doctor A,” a clinical reproductive endocrinologist.Under Doctor A’s care, I experienced the first of many pelvic exams. Much to my discomfort, Doctor A inspected my semi–clothed body with a male resident in the room. As a people–pleasing teen, I granted permission for his presence; I didn’t voice my preference for a female alternative. Doctor A’s cold hands pressed around each undeveloped breast, pulled a gown away from my hips to inspect a sparse patch of pubic hair, and conducted an examination of my vaginal canal.Shortly after the examination, Doctor A charted Swyer Syndrome as the official diagnosis. Speaking to my father and me, he described my condition as an extremely rare genetic mutation. He told us that Swyer Syndrome was an intersex condition, a group of congenital disorders impacting a person’s internal or external reproductive systems, including endocrine function and genitalia. He explained I had atypical streak gonads instead of ovaries and that, despite having typical male sex chromosomes, I was still very much a girl. He disclosed that my vaginal canal was moderate in length, perhaps further evidence—or consolation—that my body possessed normative female reproductive attributes after all.Next, Doctor A identified a pressing medical concern—golf–ball–sized benign tumors had developed on each streak gonad; if allowed to remain, they would pose an increasing risk of malignancy. We scheduled an appointment for laparoscopic gonadectomy six months later. I left his office with a 3–month prescription for estrogen and progesterone oral tablets. On the way home, we drove to an electronics store where my father... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Bringing Cancer Care to Those who Don't Have ItLawrence N. ShulmanI have been treating cancer patients in the Harvard Medical School hospitals since 1977, and in those 35 years we have made tremendous progress. Though work still needs to be done, and far too many patients still die of cancer, many are cured. In particular, children and young adults have a high rate of cure from such diseases (...) as Hodgkin's lymphoma, non-Hodgkin's lymphoma, acute lymphoblastic leukemia, and childhood sarcoma. Patients with breast cancer in the US have a greater than 80% chance for long-term survival. The death rate from cervical cancer in the US is very low. These results have been achieved by making diagnoses earlier, in many cases surgical excision, and often systemic therapies such as chemotherapy, hormonal therapy, radiation therapy, and more recently by using so-called "targeted" therapies—those directed at particular molecular characteristics of the cancer cells.Princess Dina Mired has said that the opportunity to survive cancer should not be an accident of geography. In cases where we already have effective and inexpensive tools to cure cancer, these treatments should be considered a basic human right, a life-saving medical service.I met Patty, a young woman living in the U.S. during November of her senior year in high school, after she discovered a small lump above her left collar bone. Though she felt entirely well, she called her primary care doctor who saw her the next day, felt the enlarged lymph node, and referred her to a surgeon, who did a biopsy later that week. Her primary care doctor also called me, and we scheduled a visit when the pathology results were available. The following week the pathologist notified Patty's pediatrician that the biopsy showed Hodgkin's lymphoma. When I met Patty, she was a bright and focused young woman, waiting to hear about her college applications and enjoying her senior year. Her cancer diagnosis was completely out of context with her life as she planned it, but with the support of her family and boyfriend, she seemed prepared to take things one step at a time. A PET CT scan demonstrated a modest mass in the mediastinum (chest), but no other disease. She was in an early stage of the disease with an excellent prognosis. We recommended and administered six months of chemotherapy with doxorubicin, bleomycin, vinblastine, and dacarbazine—four chemotherapy agents that are off-patent, and relatively inexpensive. She lost her hair, not a trivial issue for her, but otherwise felt reasonably well during the treatment. She was determined to graduate with her classmates, and was able continue to attend school and keep up with her work. In June, seven months into her cancer diagnosis and treatment, she graduated with honors, and was on track to enroll in college in September.Like other 18-year-old women with Hodgkin's lymphoma, Patty had an over 80% chance for cure with the potential for a long and productive life ahead of her because we could perform a biopsy, make a diagnosis, and safely and effectively treat her with four inexpensive, off-patent, chemotherapy drugs. She had nearly the same likelihood of living a long and fruitful life as her classmates, and had the same chances for childbearing. In my line of work, with the knowledge we now possess, to allow someone like Patty to die without a chance of curative care is simply unacceptable. Treatment of curable cancers should be considered on par with the right to clean water, adequate nutrition, treatment for infectious disease, and access to maternal and child healthcare services.But in many places in the world, people with cancers we could easily eradicate in Boston have no access to cancer services, and do die unnecessarily. The local healthcare infrastructure has no [End Page E10] capacity to evaluate a patient, perform or process a biopsy, make a diagnosis, or treat the patient with potentially curative surgery, chemotherapy and radiation. I have rounded on the wards of hospitals in developing countries, stopping to talk with numerous patients like Patty: young women, some of whom might have had Hodgkin's lymphoma, but no... (shrink)

Nanotechnology, which involves manipulation of matter on a ‘nano’ scale, is considered to be a key enabling technology. Medical applications of nanotechnology are expected to significantly improve disease diagnostic and therapeutic modalities and subsequently reduce health care costs. However, there is no consensus on the definition of nanotechnology or nanomedicine, and this stems from the underlying debate on defining ‘nano’. This paper aims to present the diversity in the definition of nanomedicine and its impact on the translation of basic (...) science research in nanotechnology into clinical applications. We present the insights obtained from exploratory qualitative interviews with 46 stakeholders involved in translational nanomedicine from Europe and North America. The definition of nanomedicine has implications for many aspects of translational research including: fund allocation, patents, drug regulatory review processes and approvals, ethical review processes, clinical trials and public acceptance. Given the interdisciplinary nature of the field and common interest in developing effective clinical applications, it is important to have honest and transparent communication about nanomedicine, its benefits and potential harm. A clear and consistent definition of nanomedicine would significantly facilitate trust among various stakeholders including the general public while minimizing the risk of miscommunication and undue fear of nanotechnology and nanomedicine. (shrink)

The attitudes of physicians and drug manufacturers in the US toward patenting pharmaceuticals changed dramatically from the mid-nineteenth century to the mid-twentieth. Formerly, physicians and reputable manufacturers argued that pharmaceutical patents prioritized profit over the advancement of medical science. Reputable manufactures refused to patent their goods and most physicians shunned patented products. However, moving into the early twentieth century, physicians and drug manufacturers grew increasingly comfortable with the idea of pharmaceutical patents. In 1912, for example, the American (...) Medical Association dropped the prohibition on physicians holding medical patents. Shifts in wider patenting cultures therefore transformed the ethical sensibilities of physicians. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Diacritics 30.4 (2000) 38-58 [Access article in PDF] Giorgio Agamben and the Politics of the Living Dead Andrew Norris Death is most frightening, since it is a boundary. —Aristotle, Nicomachean EthicsAnd as the same thing there exists in us living and dead and the waking and the sleeping and young and old: for these things having changed round are those, and those having changed round are these. —Heraclitus, Fragment (...) 88 What is politics today? What is its relationship to the tradition from which it emerges? The questions are difficult ones to answer in part because contemporary politics seems so schizophrenic. In affluent Western countries politics is increasingly a matter of spectacle on the one hand and managed economies on the other. Hannah Arendt seems quite confirmed in her claim that the once-glorious public realm of appearance is fundamentally degraded when it is overrun by concerns more appropriate to the private realm, such as household management and gossip. If this "unnatural growth of the natural" [47] inclines us to nostalgia for a time when the two realms were more decisively separated, such nostalgia is likely intensified by the "ethnic cleansing," rape camps, and genocide that we now associate with names such as "Yugoslavia" and "Rwanda." But as improbable as any flight to the past may be, it is even less likely that the politics of that past could help us navigate the treacherous waters of our current technological society. I have in mind not only the familiar claim that the attempted genocides of our time are only made possible by quite modern forms of technology, organization, and experience, 1 but also recent scientific and "medical" advances. Consider just two: first, the corporate driven and controlled development of biotechnologies, in which huge multinationals are acquiring patents to genetic "information" such as "all human blood cells that have come from the umbilical cord of [any] newborn child." If there is any doubt that such developments will lead us to redefine the human being, these may be laid to rest by the case of John Moore, an Alaskan businessman who found his own body parts had been patented, without his knowledge, by the University of California at Los Angeles and licensed to the Sandoz Pharmaceutical Corporation [Rifkin 60-61]. So much for Locke's attempt to ground the institution of private property in the fact that "every Man has a Property in his own Person"! 2 In its place we seem to be moving [End Page 38] toward something more like the "logical synthesis of biology and economy" called for by the National Socialist Institut allemand in Paris in 1942 [Agamben, Homo Sacer 145]. A similar process of redefinition is already underway in the field of death, a phenomenon that scientists and lawyers are having a harder and harder time pinning down. Where once death was defined by the cessation of the movement of the heart and lungs, recent life support technologies have forced scientists to define death in terms of such technologies. Witness Doctor Norman Shumway's defense of the definition of death as brain death: "I'm saying that anyone whose brain is dead is dead. It is the one determinant that would be universally applicable, because the brain is the one organ that can't be transplanted" [163]. By implication, if and when technology is developed that allows for brain transplants, even those whose brains are "dead" will be brought back to some kind of life, perhaps as organ farms for others who are less ambiguously alive.Giorgio Agamben, from whose book Homo Sacer: Sovereign Power and Bare Life I take both this last grisly example and its analysis, argues that, contrary to appearances, such developments do not represent a radical break with the tradition. His analysis both builds upon and corrects Michel Foucault's claim that politics in our time is constituted by disciplines of normalization and subjectification that Foucault labels "bio-power." For Foucault, biopower is fundamentally modern. "What might be called a society's 'threshold of modernity,'" he writes, "has been reached when the life of the species is wagered... (shrink)

The 2011 Varsity Medical Debate, between Oxford and Cambridge Universities, brought students and faculty together to discuss the waiving of patents for antiretroviral therapies in the developing world. With an estimated 29.5 million infected by Human Immunodeficiency Virus (HIV) in low- and middle-income countries and only 5.3 million of those being treated, the effective and equitable distribution of anti-retroviral therapy (ART) is an issue of great importance. The debate centred around three areas of contention. Firstly, there was disagreement (...) about whether patents were the real barrier to the access of anti-retroviral therapy in the developing world. Secondly, there were differing views on the effectiveness of a patent pool. Thirdly, concerns were raised over the impact of waiving patents on research to produce new and better anti retro-viral drugs. (shrink)

We compare methods of aggregating repeated decisions from a single decision maker to improve medical image decision making using metacognitive processes (confidence judgments) and representational similarity from artificial neural networks for both novice and expert participants.

“No one has advanced a just and logical reason why reward for service to the public should be extended to the inventor of a mechanical toy and denied to the genius whose patience, foresight, and effort have given a valuable new [discovery] to mankind” . The law around the world permits the granting of patents for drugs, medical devices, and cosmetic treatment of the human body. At the same time, patentability for a method of treatment of the same (...) body is denied in some countries on various public policy grounds. Is there any logical justification for this distinction? Are methods of medical treatment not as vital to the health or even to the life of a patient as drugs or medical devices? Why is a cosmetic result patentable and a curative result not? (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)

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)

Drugs are much more expensive whilst they are subject to patent protection than once patents expire: patented drugs make up only 20% of NHS drugs prescriptions, but consume 80% of the total NHS drugs bill. This article argues that, given the relatively uncontroversial assumption that we should save the greater number in cases where all are equally deserving and we cannot save both groups, it is more difficult than is usually thought to justify why publicly funded healthcare systems should (...) pay for patented treatments. The claim to medical treatment of those who will be sick with a given condition once the patent runs out is just as strong as those who are sick with it now, but we will be able to treat more people with the same unit of resource in the future. Hence, when resource constraints entail that both cannot be funded, publicly funded healthcare systems ought to wait until patents expire before approving drugs for general use in the publicly funded system. (shrink)

The 2014 Varsity Medical Ethics debate convened upon the motion: “This house believes that genetic information should not be commoditised”. This annual debate between students from the Universities of Oxford and Cambridge, now in its sixth year, provided the starting point for arguments on the subject. The present article brings together and extends many of the arguments put forward during the debate. We explore the circumstances under which genetic material should be considered patentable, the possible effects of this on (...) the research and development of novel therapeutics, and the need for clear guidelines within this rapidly developing field. (shrink)

Data protection law has a linear logic, in that it purports to trace the lifecycle of personal data from creation to collection, processing, transfer, and ultimately its demise, and to regulate each step so as to promote the data subject’s control thereof. Big data defies this linear logic, in that it decontextualizes data from its original environment and conducts an algorithmic nonlinear mix, match, and mine analysis. Applying data protection law to the processing of big data does not work well, (...) to say the least. This Article examines the case of big medical data. A survey of emerging research practices indicates that studies either ignore data protection law altogether or assume an ex post position, namely that because they are conducted after the data has already been created in the course of providing medical care, and they use de-identified data, they go under the radar of data protection law. These studies focus on the end-point of the lifecycle of big data: if sufficiently anonymous at publication, the previous steps are overlooked, on the claim that they enjoy immunity. I argue that this answer is too crude. To portray data protection law in its best light, we should view it as a process-based attempt to equip data subjects with some power to control personal data about them, in all phases of data processing. Such control reflects the underlying justification of data protection law as an implementation of human dignity. The process-based approach fits current legal practices and is justified by reflecting dignitarian conceptions of informational privacy. (shrink)

Purpose To examine process factors that either facilitate or inhibit learning medical ethics during case-based learning. Methods A qualitative research approach using microanalysis of transcribed videotaped discussions of three consecutive small-group learning sessions on medical ethics teaching for three groups, each with 10 students. Results This research effort revealed 12 themes of learning strategies, divided into 6 coping and 6 evasive strategies. Cognitive-based strategies were found to relate to Kamin's model of critical thinking in medical education, (...) thereby supporting our distinction between the themes of coping and evasive strategies. The findings also showed that cognitive efforts as well as emotional strategies are involved in discussions of ethical dilemmas. Based on Kamin's model and the constructivist learning theory, an examination of the different themes within the two learning strategies—coping and evasive—revealed that these strategies may be understood as corresponding to process factors either facilitating or inhibiting MET in SGL, respectively. Conclusions Our classification offers a more nuanced observation, specifically geared to pinpointing the desired and less desired process factors in the learning involved in MET in the SGL environment. Two key advantages of this observation are: it brings to the forefront process factors that may inhibit and not merely facilitate MET in SGL and it acknowledges the existence of emotional and not just cognitive process factors. Further enhancement of MET in SGL may thus be achieved based on these observations. (shrink)

The number of admissions to hospitals of patients without a proxy decision maker is rising. Very often these patients need fairly immediate medical intervention for which informed consent—or informed refusal—is required. Many have recommended that there be a process in place to make these decisions, and that it include a variety of perspectives. People are particularly wary of relying solely on medical staff to make these decisions. The University Hospitals Case Medical Center recruits community members from (...) its Ethics Committee to serve on a subcommittee, the Patients Without Proxies (PWP) Committee, which works with medical staff during the decision-making process for these patients. Generally, the community members go to the bedside to observe patients. This article looks at how those unused to observing hospitalized patients who are sick and/or dying are affected, comparing them to mock jurors in a research study who are exposed to graphic photographs related to a fabricated crime scene. Judgments made by the mock jurors are affected by viewing such images. The personal experience of witnessing unfamiliar and shocking scenes affects their subsequent judgments. While it may be difficult to tease out whether observing patients causes PWP members to be benefited or harmed, they are affected by what they see. If a variety of perspectives is desirable to reduce possible bias or error, this article argues that at least one community member should refrain from seeing the patient in order to add a different and valuable voice to the decision-making process. Members of the subcommittee base their judgments on the various kinds of information available. Sometimes the things they see, hear, or feel may affect them particularly deeply, and affect their judgments as well. In this article I explore the idea that something like this may be happening in a particular kind of clinical ethics case consultation. (shrink)

Patent landscaping is the process of finding patents related to a particular topic. It is important for companies, investors, governments, and academics seeking to gauge innovation and assess risk. However, there is no broadly recognized best approach to landscaping. Frequently, patent landscaping is a bespoke human-driven process that relies heavily on complex queries over bibliographic patent databases. In this paper, we present Automated Patent Landscaping, an approach that jointly leverages human domain expertise, heuristics based on patent metadata, (...) and machine learning to generate high-quality patent landscapes with minimal effort. In particular, this paper describes a flexible automated methodology to construct a patent landscape for a topic based on an initial seed set of patents. This approach takes human-selected seed patents that are representative of a topic, such as operating systems, and uses structure inherent in patent data such as references and class codes to “expand” the seed set to a set of “probably-related” patents and anti-seed “probably-unrelated” patents. The expanded set of patents is then pruned with a semi-supervised machine learning model trained on seed and anti-seed patents. This removes patents from the expanded set that are unrelated to the topic and ensures a comprehensive and accurate landscape. (shrink)

Objectives: The objectives of the study were to assess similarities and differences between breast cancer patients and their husbands in terms of doctor-patient/spouse relationships and shared decision making; and to investigate the association between breast cancer patients and husbands in terms of preference of type of doctor, doctor-patient relationship, and shared decision making regarding medical treatment. Method: Fifty-seven women with breast cancer, and their husbands, completed questionnaires measuring doctor-patient/spouse relationships, and decision making regarding medical treatment. Results: Patients believe (...) they have a key role in the medical decision-making process and that the participation of their husbands, and their agreement with the decision, is important. Both breast cancer patients and their husbands prefer a shared decision-making process to paternalistic or autonomy-based approaches. Conclusion: In contrast to legal and bioethical approaches, which focus on the patient as the primary decision maker, this study reflects a practical recognition of the role of the breast cancer patient's husband in the decision-making process. It also reflects a relational rather than an individualistic perception of patient autonomy. (shrink)

Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] 304 ALR 1At the heart of some disputes regarding medical treatment is the conceptual difficulty of finding the appropriate legal framework. The diagnosis and treatment of medical conditions are clearly subject to professional standards and thus sit within the negligence framework, but what of those who develop and provide that diagnosis and treatment? Do innovative approaches give rise to a patentable interest and can the intellectual property in a method (...) of treatment be protected under existing patent law? This question was recently addressed by the High Court in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] 304 ALR 1.The technical arguments are clearly set out in the judgment and do not warrant repetition. For present purposes it is sufficient to highlight the central legal question, which was whether a method of medical treatment could be a “manner of manufacture” and therefore patentable.The DecisionThe High Court .. (shrink)

IntroductionRheumatologists are the primary healthcare professionals responsible for patients with rheumatic diseases and should acquire medical ethical competencies, such as the informed consent process. The objective clinical structured examination is a valuable tool for assessing clinical competencies. We report the performance of 90 rheumatologist trainees participating in a station designed to evaluate the ICP during the 2018 and 2019 national accreditations.MethodsThe station was validated and represented a medical encounter in which the rheumatologist informed a patient with systemic (...) lupus erythematosus with clinically active nephritis about renal biopsy. A trained patient–actor and an evaluator were instructed to assess ICP skills in obtaining formal informed consent, delivering bad news and overall communication with patients. The evaluator used a tailored checklist and form.ResultsCandidate performance varied with ICP content and was superior for potential benefit information but significantly reduced for potential complications and biopsy description. Only 17.8% of the candidates mentioned the legal perspective of ICP. Death was omitted by the majority of the candidates ; after the patient–actor challenged candidates, only 57.1% of them gave a clear and positive answer. Evaluators frequently rated candidate communications skills as superior, but ≥1 negative aspect was identified in 69% of the candidates.ConclusionsEthical competencies are mandatory for professional rheumatologists. It seems necessary to include an ethics competency framework in the curriculum throughout the rheumatology residency. (shrink)

Organized into three main parts, this paper examines some challenges for the informed-consent process in medical research where DNA databanks are employed. In Part 1, we briefly describe the principle of informed consent and show why it is ethically important. Part 2 focuses on some specific challenges that that arise for the traditional informed-consent process in population-wide genetics/genomics research, especially where data-mining techniques are used. In the third and final section, we defend a model of consent based (...) on the notion of a "charitable trust," which we believe can help to preserve the integrity of the consent process in the context of medical and genetic research involving DNA databanks. (shrink)

Background Making the right decisions, while simultaneously showing respect for patient autonomy, represents a great challenge to nursing home staff in the issues of life-prolonging treatment, hydration, nutrition and hospitalisation to dying patents in end-of-life. Objectives To study how physicians and nurses protect nursing home patients' autonomy in end-of-life decisions, and how they justify their practice. Design A qualitative descriptive design with analysis of the content of transcribed in-depth interviews with physicians and nurses. Participants Nine physicians and ten nurses (...) in 10 nursing homes in Norway. Results and interpretations Assessment of the patient's competence to consent to treatment is almost absent. The physicians build their practice on the principles of beneficence and nonmaleficence. Nurses tend to trust the patients' rejection of life support, even when the patients have difficulty speaking or suffer from dementia. Relatives were, according to the health personnel, included in decision-making processes to a very limited extent. However, futile life support is sometimes provided contrary to the physicians' judgement of what constitutes the patient's best interest on occasions when they are pressurised by next of kin. Conclusions The study reveals a need to improve decision-making routines according to ethical ideals and legislation. Conflicts between relatives and healthcare professionals in the decision-making process deflect the focus from searching for the best possible treatment for the terminal patient. Further discussion is required as to whether the concept of autonomy is applicable in situations in which the patient is impaired and dying. (shrink)

Instead of impeding access to essential medicines in developing countries, the essay explores why and how patents can serve as a source of funding for the much needed access to medicine. Instead of a weakening of patents, prolonged protection periods are suggested in circumstances where there is widespread lack of access. The revenues from extended patents are seen as a source of funding for drug donations to the least developed countries.

Patents for genetic material in theindustrialized North have expandedsignificantly over the past twenty years,playing a crucial role in the currentconfiguration of the agricultural biotechnologyindustries, and raising significant ethicalissues. Patents have been claimed for genes,gene sequences, engineered crop species, andthe technical processes to engineer them. Mostcritics have addressed the human and ecosystemhealth implications of genetically engineeredcrops, but these broad patents raise economicissues as well. The Catholic social teachingtradition offers guidelines for critiquing theeconomic implications of this new patentregime. The (...) Catholic principle of the universaldestination of goods implies that genes, genesequences, and engineered crop varieties areineligible for patent protection, although theprocesses to engineer these should be eligible.Religious leaders are likely to make a moresubstantive contribution to debates aboutagricultural biotechnology by addressing theselife patents than by speculating that geneticengineering is ``playing God.''''. (shrink)

In medical diagnostic examination three main stages may be distinguished: (a) initial exploration, (b) hypothesis-directed investigation, and (c) final diagnosis making. The purpose of this work is to study some methodological problems concerning the second of the above stages of the diagnosis and to prepare a background for a mathematical model [30] of this process.In diagnostic problem solving, the reasoning proceeds along the main lines traced by some initial suggestions and passes through various intermediate elements which are connected (...) with one another forming ramifying chains and nets of inferences and hypotheses. Such a complex mental construction is based on laws which form medical knowledge and reflect various regularities and relations, causal, structural, functional, and others. (shrink)

This article discusses the emergence of a patenting culture in university science. Patenting culture is examined empirically in the context of the increasing commerciali zation of science, and theoretically within debates over scientific "credibility." The article explores the translation of academic credit into patents, and vice versa, and argues that this process raises new questions for our understanding of scientific recognition and of scientists' networks. In particular, the analysis suggests that scientists must move between two distinct social worlds (...) to manage the rewards that academic and patent cultures carry. (shrink)

Although the U.S. Patent and Trademark Office (“PTO”) has granted patents on genes for over 20 years, the prudence of gene patenting continues to stir controversy. Some have questioned the ethics of monopolizing a resource that is so fundamental and basic to all living organisms. It has also been argued that patents unfairly restrict the use of genes, impeding both basic and commercial research. For the biotechnology industry, however, gene patents are the currency it uses to protect (...) its investment in research and development, and eventually, the products it brings to market. This paper examines the eligibility of genes for patenting, and considers whether the policy reasons that have led courts to decide that certain categories of subject matter are unpatentable, apply to the realm of genes. Even if this were the case, this does not mean that biotech companies have no way of protecting their inventions. Methods and processes of using the genes do not invoke the same policy considerations, and may provide a more appropriate way of rewarding industry for the narrow discovery of a gene’s specific use. (shrink)

The National Medical Commission of India introduced the Competency Based Curriculum in Medical Education for undergraduate medical students in 2019 with a new module named Attitude, Ethics and Communication (AETCOM) across the country. There was a consensus for teaching medical ethics in an integrated way, suggesting dedicated hours in each phase of undergraduate training. The AETCOM module was prepared and circulated as a guide to acquire necessary competency in attitudinal, ethical and communication domains. This study was (...) aimed to explore the perceptions of students and medical teachers and identify the challenges in teaching and learning process of the newly implemented AETCOM module. It was a mixed method designed study with structured questionnaires for students and teachers at various medical schools in India. Based on the quantitative data, in-depth interviews with medical teachers were undertaken. Challenges were perceived by both students and teachers. The students had a mixed perception, facing difficulties in passive learning with scarce resource materials. Challenges identified by teachers were a lack of knowledge and skills required for teaching bioethics, the logistics of managing large numbers of students in the stipulated time frame, interdisciplinary integration—both horizontal and vertical, and assessment program in terms competency-based education. The study draws the attention of all stakeholders for a revision and efforts for further improvement in the teaching and assessment process, and setting a standard model in medical education in India. (shrink)

In response to the great crises of the COVID-19 coronavirus, virtually all new technologies protected by patent rights have been used in practice from diagnostics, therapeutic, medical equipment, and vaccine to prevention, tracking, and containment of COVID-19. However, the moral justification of patent rights is questioned when pharmaceutical patents conflict with public health. This paper proposes a revised approach of deciding on how to address the conflicts between business ethics and patent protections and then compares the different mechanisms (...) of clearing patent thickets. Our findings highlight that patent pledges may not only contribute to achieving the maximized substantive justice of the public but also help patent pledgors fulfill procedural justice. The advantages of patent pledges have attracted many patent holders to make public statements during the COVID-19 pandemic. In contrast, the disadvantages of a free license may make patent pledges not sustainable for a long time without the related supporting measures. Our findings will be helpful for policymakers or company managers to make an appropriate decision on rationally utilizing patent portfolios for fighting against public health crises. (shrink)

Bioethicists think about families in terms of conflicting interests. This mistake results from an impoverished notion of informed consent. Only by adequately characterizing the process of informed consent can we capture the phenomenon of shared decisionmaking.