How is a terminally ill patient treated by the surrounding people in the U.S. and Japan? How does a terminally ill patient decide on his or her own treatment? These questions will be examined in a study of intensive medical care, received by a terminally ill Japanese cancer patient in the U.S. and Japan. This casereflects the participant observation by a Japanese anthropologist for about 8 years in the United States and Japan on one patient who was hospitalized (...) in both countries on and off for about eight years. The objective of this study is to illuminate the different concept of personhood between the U.S. and Japan that appeared in different cultural practices of both countries and in the subject’s own decision making process. The significant differences appeared between theU.S. and Japan in the concepts of (1) science, (2) suffering, (3) Power of Attorney and Doisho (Consent Form), and (4) organized care. The interpretation of such differences indicates that seemingly universal practices across countries suggest cultural specific concepts and their management. Therefore, ethical norms appeared differently accordingly to each country. (shrink)

Providing health care in the most cost-effective way has become a priority in recent years. This book tackles the important issue of the potential conflict between economic expediency and the welfare of individual patients. Contributors examine different attitudes to this complex problem, along with a variety of legal and historical perspectives. The book addresses particular aspects of health care, such as medical expert systems, general practice, medical education, and clinical decision-making where the direct involvement of doctors (...) in allocating scarce and expensive resources is perhaps most obvious. (shrink)

I Conceptual Foundations Ethical problems emerging from modern medical technology have been evaluated on an issue-by-issue basis. ...

This text provides a comprehensive and timely examination of the most pertinent factors affecting institutional ethics committees, for ethicists, trustees, administrators, physicians, clergy, nurses, social workers, attorneys and others with an interest in ethics committees.

Through the Louisiana Purchase in 1803, the United States expanded its size by over 800,000 square miles. But neither President Thomas Jefferson nor Congress knew exactly what they had bought until 1806, when Meriwether Lewis and William Clark returned from their famous expedition. One of the most significant contributions of the Expedition was a better perception of the geography of the Northwest. Lewis and Clark prepared approximately 140 maps and filled in the main outlines of the previously blank map of (...) the northwestern United States. Robert I. Field has done much the same for the vast territory of U.S. health care regulation.On the front cover of Fields new book, Health Care Regulation in America: Complexity, Confrontation, and Compromise, is a picture of a giant three-dimensional labyrinth. Rarely is cover art so perfectly appropriate. (shrink)

Congress recently decided that undocumented aliens are ineligible for medical benefits under the 1966 Medicaid Act, overruling a judicial decision that would have required the federal government to reimburse states partially for the costs of providing free care. Is providing such care simply a matter of prudence and charity? Or do illegal aliens have strong moral claims to medical care that generate duties for hospitals and government agencies?

Medical ethics should show how an adequate description of morality is helpful in dealing with the problems that arise in the context of medical care. However none of the standard moral theories provide such a description. Further, all of these theories assume that there must be a unique correct answer to every moral question, though this answer may be that it is indifferent which of the proposed solutions one picks. The failure to recognize that there are unresolvable (...) moral disagreements leads many philosophers to think that their moral theories will enable them to determine which policies ought to be adopted. However, the correct role for moral theories is more limited: to rule out morally unacceptable policies. Moral theories almost never can settle disputes about which of two well supported health care policies ought to be adopted. (shrink)

From a giant of health care policy, an engaging and enlightening account of why American health care is so expensive -- and why it doesn't have to be. Uwe Reinhardt was a towering figure and moral conscience of health care policy in the United States and beyond. Famously bipartisan, he advised presidents and Congress on health reform and originated central features of the Affordable Care Act. In Priced Out, Reinhardt offers an engaging and enlightening account of (...) today's U.S. health care system, explaining why it costs so much more and delivers so much less than the systems of every other advanced country, why this situation is morally indefensible, and how we might improve it. The problem, Reinhardt says, is not one of economics but of social ethics. There is no American political consensus on a fundamental question other countries settled long ago: to what extent should we be our brothers' and sisters' keepers when it comes to health care? Drawing on the best evidence, he guides readers through the chaotic, secretive, and inefficient way America finances health care, and he offers a penetrating ethical analysis of recent reform proposals. At this point, he argues, the United States appears to have three stark choices: the government can make the rich help pay for the health care of the poor, ration care by income, or control costs. Reinhardt proposes an alternative path: that by age 26 all Americans must choose either to join an insurance arrangement with community-rated premiums, or take a chance on being uninsured or relying on a health insurance market that charges premiums based on health status. An incisive look at the American health care system, Priced Out dispels the confusion, ignorance, myths, and misinformation that hinder effective reform. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Managed Health Care: New Ethical Issues for All*Martina Darragh (bio) and Pat Milmoe McCarrick (bio)Changes in the way that health care is perceived, delivered, and financed have occurred rapidly in a relatively short time span. The 50-year period since World War II encompasses enormous growth in medical technology, soaring health care costs, and significant fragmentation of the two-party patient- physician relationship. This relationship first grew (...) to include the third-party payer, the health insurance industry, and now “with great speed and relatively little public awareness, a significant change has occurred in the way some decisions are made about a patient’s medical care” (III, Institute of Medicine 1989).The new means of providing health care bring an increasing number of parties into clinical decision-making processes. With this change, ethical issues that once concerned only health care professionals, the physician or the nurse, have expanded to include the patient and the groups who “manage” care—e.g., health maintenance organizations (HMOs), preferred provider organizations (PPOs), point of service groups (POSs), independent practice associations (IPAs), insurance reviewers, hospital administrators, institutional managers, and, the most recent players, purchasers of group health care who base their decisions on competitive pricing.The term “managed care” refers to a variety of continually adapting and developing arrangements that involve four groups. These groups, which have been labeled by the world of business, not health, are the “consumer” (once the patient), the “provider” (the physician and other health care professionals), the “insurer” (the reimburser for any care), and the “purchaser of care” or the primary buyer of health services (the large employer organization). Capitation is a common way to pay for health services in managed care systems. A certain dollar amount is negotiated for health services for a specified number of patients whether the care is delivered or not; the provider shares with the [End Page 189] insurer any financial risk for the actual cost of care (III, Centers for Disease Control 1995).When the Clinton administration’s health care reform movement failed to gain support in the U.S. Congress, the use of managed care to control rising health care costs accelerated. The literature on managed care and its effect on the patient-physician relationship reflects this shift. During the era of health care reform, “debate centered on how managed care could control costs, on the use of technology and patient satisfaction, [and] on access and barriers to care” (IV, Emanuel and Dubler 1995). When managed care organizations began contracting with physicians to provide health care services subject to the plans’ provisions, these plans became agents in clinical decision making on a wide-spread basis. HMO enrollment grew to 51 million persons by 1994 (III, Centers for Disease Control 1995). This “corporatization” of health care has sparked a plethora of articles about the effects of the marketplace on the physician’s ability to do what is best for the patient, and on the patient’s ability to trust the physician to do so.Many authors make it clear that managed care itself is not the problem, but rather the development of for-profit managed care plans by “corporate conglomerates with billions of dollars in assets that compensate their executives as grandly as basketball players” (V, Kassirer 1995) “in a marketplace that is largely unregulated” (I, Zoloth-Dorfman and Rubin 1995). “Some, mostly older plans that were created when cost containment was an unexpected benefit rather than their central purpose, deliver high-quality care economically. Unfortunately, others cut costs by recruiting the healthiest patients, excluding the sickest, rationing care by making it inconvenient to obtain, and denying care by a variety of mechanisms” (V, Kassirer 1995).These cost-containment features now play an intimate role in clinical practice. When a managed care plan contracts with a physician, the doctor becomes a “double agent” with contractual obligations to the plan to provide a preset amount of services and professional responsibilities to each patient to authorize necessary treatment (V, Angell 1993). This duality can undermine the physician’s fiduciary responsibility to the patient wherein the physician “has power over the affairs of [the patient]...and is required by law to act on that person’s... (shrink)

The United States is in its fifth year of what is now widely referred to as “the new medical malpractice crisis.” Although some professional liability insurers have begun to report improvements in their overall financial margins, there are few signs that the trend toward higher costs is reversing itself - particularly for doctors and hospitals. In 2003-2004, the presidential election and tort reform proposals in Congress brought heightened public attention to the need for some type of policy intervention to (...) ease the effects of the crisis.The darling of tort reformers at both the federal and state levels has been legislation to limit, or “cap,” damages awarded to plaintiffs in malpractice cases. Health care provider groups, liability insurers, and the Bush Administration have all seized on the example of California's MICRA law, which since 1975 has capped noneconomic damages in malpractice cases at a flat $250,000, as the path to financial recovery. (shrink)

Over the past decades the mortality rate in the United States has decreased and life expectancy has increased. Yet a number of recent studies have drawn Americans attention to the fact that racial and ethnic disparities persist in health care. It is clear that the U.S. health care system is not only flawed for many reasons including basic injustices, but may be the cause of both injury and death for members of racial and ethnic minorities.In 2002, an Institute (...) of Medicine report requested by Congress listed more than 100 studies documenting a wide range of disparities in the United States health care system. This report found that people belonging to racial and ethnic minorities often receive lower quality of health care than do people of European descent, even when their medical insurance coverage and income levels are the same as that of the latter. (shrink)

Next SectionIn response to public outrage stemming from exposés of animal abuse in research laboratories, the US Congress in 1985 mandated Institutional Animal Care and Use Committees (IACUCs) to oversee animal use at institutions receiving federal grants. IACUCs were enjoined to respect public concern about the treatment of animals in research, but they were not specifically instructed whether or not to perform ethical cost-benefit analyses of animal research protocols that IACUCs have chosen, with approval contingent upon a balancing of (...) animal pain and suffering against a reasonable expectation of resultant human benefit. IACUCs have chosen not to make such ethical judgments but, rather, restrict themselves to an advisory role, often tweaking the details of animal-use protocols, but eventually approving all of them. This disinclination by IACUCs to take a broader ethical view of their authority and responsibilities may reflect a membership composition highly skewed towards animal researchers themselves (67%) and institutional veterinarians (15%), both with vested interests in continuing animal research. The resultant ethical monoculture may impair IACUC's ability to meet public concern for laboratory animal welfare. Psychological research has established that unconscious bias affects us all, that deliberations among the like-minded lead to adapting extremist positions, and that groupthink blinds organisations to alternatives that might be obvious to outsiders. Taken together, skewed IACUC membership composition and psychological research insights into unconscious bias and groupthink suggest that an infusion of ethical diversity by increasing the percentage of institutionally unaffiliated members on IACUCs would broaden their ethical perspectives and enable them to better address public concerns about laboratory animal welfare. (shrink)

Philosophers should be wary of using the methods they use in philosophy when engaging in discussions about policy makingThe beginning of November last year was a busy time in the bioethics calendar with four conferences taking place in New Zealand and Australia. The Fifth International Conference on Priorities in Health Care took place in Wellington; the Fifth Feminist Approaches to Bioethics congress, the Seventh World Congress of Bioethics, and the meeting of the Australasian Bioethics Association were all in Sydney.One (...) of the interesting features of these meetings was a move to a deeper exploration of the relations between ethics and political theory and political philosophy. The factors that drive this exploration are manifold but the four most important seem to be: 1) that ethicists often comment on, or propose political action and regulation; 2) that there is a growing awareness that the basic national and international societal and legal structures profoundly influences ethical issues; 3) the growing interest in global and third world issues, and 4) the move in many countries toward greater public participation in decision making concerning ethically contentious issues. All of these developments move the focus from the traditional subject matter of medical ethics—that is, the individual ethically charged action, to the question of how ethics should influence political action and regulation.To …. (shrink)

The health care industry has moved at a rapid pace away from paper records to an electronic platform across almost all sectors — much of it at the encouragement and insistence of the federal government. Such rapid expansion has increased exponentially the risk to individuals in the privacy of their data and, increasingly, to their physical well-being when medical records are inaccessible through ransomware attacks. Recognizing the unique and critical nature of medical records, the United States Congress (...) established the Health Care Industry Cybersecurity Task Force under the Cybersecurity Information Sharing Act of 2015 for the purpose of reviewing cybersecurity risks within the health care industry and identifying who will lead and coordinate efforts to address such risks among the various agencies. The Task Force has since issued a report setting forth six high-level imperatives that the health care industry needs to achieve in order to combat cybersecurity, and, notably, many of the vulnerabilities plaguing the industry identified in the Report as requiring correction are not necessarily related to specific flaws in the current cybersecurity framework, but rather susceptibilities presented by the infrastructure and associated regulatory regime that has evolved over the last few decades over the health care industry generally. That is, the current health care infrastructure by its nature exacerbates cybersecurity risk. Between a lack of information sharing of industry threats, risks, and mitigations, disparate leadership and governance goals for cybersecurity, the confluence and contradiction of existing federal and state laws, fragmentation in the fee-for-service delivery system, lack of care coordination, and disparate resources across and among sectors, the industry suffers from heightened cyber risk. Solutions that are reactive to problems within the current infrastructure will likely have little long term impact toward reducing cybersecurity vulnerabilities because they do not address the underlying system challenges. All of these confluences causes one to wonder whether if in fact the current health care delivery infrastructure is a contributing factor to the incidents of cybersecurity attacks and the exorbitant costs associated with resolving data breaches, should Congress look not just to curb breach incidents, but to address root cause systematic challenges in the health industry infrastructure that create increased exposure of cybersecurity threats? This article argues that cybersecurity risks will continue to be heightened and more costly to the health care industry as compared to other industries unless and until some general system redesign is achieved that allows for greater sharing of resources among industry participants to ensure the same protections are implemented at all levels of the industry, which can be strengthened through greater interoperability of systems across the health care industry; and increased focus and attention on the importance of cybersecurity issues as a priority among system reforms. (shrink)

Genetic discrimination is becoming an increasingly important problem in the United States. Information acquired from genetic tests has been used by insurance companies to reject applications for insurance policies and to refuse payment for the treatment of illnesses. Numerous states and the United States Congress have passed or are considering passage of laws that would forbid such use of genetic information by health insurance companies. Here we argue that much of this legislation is severely flawed because of the difficulty in (...) distinguishing genetic from nongenetic tests. In addition, barring the use by insurance companies of a genetic test but not a nongenetic test (conceivably for the same multifactorial disease) raises issues of fairness in health insurance. These arguments suggest that ultimately the problems arising from genetic discrimination cannot be solved by narrowly focused legislation but only by a modification of the entire health care system. (shrink)

Those are the words of Pope John Paul II, speaking in March 2004 to an international congress held in Rome. The conference was on "Life-sustaining Treatments and Vegetative State: Scientific Advances and Ethical Dilemmas," and it was organized by the World Federation of Catholic Medical Associations and the Pontifical Academy for Life. The pope was able to cut through all the ethical dilemmas. Although he acknowledged that a patient in a persistent vegetative state, or PVS, "shows no evident sign (...) of selfawareness or of awareness of the environment, and seems unable to interact with others or to react to specific stimuli," he said that they should be kept alive indefinitely. Such patients, he insisted, "retain their human dignity in all its fullness" and "the loving gaze of God the Father continues to fall upon them." For this reason, he said, it is obligatory to continue to provide them with food and water, even if this can only be done through a tube. The pope added that to withdraw the tube, knowing that it will lead to the death of the patient, is "euthanasia by omission.". (shrink)

The aim of this study was to assess the opinions and role of intensive care unit (ICU) nurses regarding the distribution of ICU beds. We conducted this research among 30% of the attendees at two ICU congresses in Turkey. A self-administered questionnaire was used, which included 13 cases and allocation criteria. Of the total (136 nurses), 53.7% participated in admission/discharge decisions. The most important criterion was quality of life as viewed by the physician; the least important was the patient’s (...) social status. According to the findings, the nurses thought that medical benefit and avoiding discrimination were important. On the other hand their ignorance of patients’ autonomous preferences arouses suspicions about these nurses’ role in advocating for patients’ rights. For this reason, nurses’ role in allocation decisions should be clearly described and should also be the basis on which intensive care nurses’ duties in allocation decisions should be determined. (shrink)

Modern medicine has put a new twist on one of our most fundamental values: self-determination. Although advance directives may be used to request treatment, this volume limits its focus to their more common function--the refusal of treatment. Timely and comprehensive, it provides a stimulating overview of this relevant topic, addressing such questions as: What are the individual and societal benefits of advance directives? Does an advance directive tamper with the sanctity of life? Will normalizing directives have an adverse effect on (...) the practice of medicine? Should a patient specify treatments to be withheld within a directive? What legal sanctions should apply against those who ignore directives? and What is a physician's role in helping his patient formulate an appropriate directive? (shrink)

The opinion of Mr. Justice Francis of the English High Court which denied the parents of Charlie Gard, who had been born with an extremely rare mutation of a genetic disease, the right to take their child to the United States for a proposed experimental treatment occasioned world wide attention including that of the Pope, President Trump, and the US Congress. The case raise anew a debate as old as the foundation of Western medicine on who should decide and on (...) what standard when there is a conflict between a family and the treating physicians over a possible treatment. This paper will explore the different approaches of the British and American courts on the issue and the various proposals from that of John Rawls in his A Theory of Justice to a processed-based approach for resolving such disputes. As carefully crafted as the opinion of Mr Justice Nicholas Francis in the Gard case proved to be, it left commentators unsatisfied. A widespread criticism, captured in an article by Michael Dougherty in The National Review was for the state to ‘get out of the way of the parents trying to act in the best interests of the child’.1 Although he conceded the parents could be adding to the suffering of the child by taking Charlie to America for an experimental therapy and agreed that such a choice ‘may be the wrong decision,’ in Dougherty’s view, it should still be ‘their decision’. Dougherty’s stand was the popular response to the question of ‘Who should decide?’ It fails, however, to propose any rationale for the decision. It provided no norms, no standards and no guidelines for the parents. Their motive could equally well be indifference to the suffering of the child as concern for his well-being. Furthermore, even good, loving parents may make …. (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)

In 1992, the United States Supreme Court, in Planned Parenthood of Southeastern Pennsylvania v. Casey, upheld the ruling in Roe v. Wade, namely that women have a right “to choose to have an abortion before viability and to obtain it without undue interference from the State.”1 However, since this ruling, some states have imposed regulations that greatly limit this right by restricting access. Texas is a recent example of this. Two proposed restrictions in House Bill 2, which will be discussed (...) in detail below, will force all but eight clinics that are located in metropolitan areas to shut down. The U.S. Supreme Court put the proposed restrictions on hold in October 2014, allowing several clinics to remain open while the restrictions are being appealed in the U.S. Court of Appeals for the Fifth Circuit. If the restrictions are passed, however, those clinics will be forced to shut down and, as a result, many women in Texas will be required to travel more than 100 miles in order to access a safe and legal abortion. Much of the focus of these restrictions has been on women and rightly so. However, I want to turn the attention to physicians. The requirements exacerbate unfair treatment of abortion providers compared with other physicians. Abortion providers face threats from the public—some of which turn into violent attacks—and they are often ostracized by their fellow medical practitioners. There are so few abortion providers to begin with and the proposed requirements limit these physicians’ opportunities to practice the branch of medicine of their choosing. Although the HB 2 requirements may not result in an unconstitutional undue burden on physicians, the challenges created by the bill limit physicians’ abilities to provide abortions. As a result of these limits, HB 2 creates an unconstitutional undue burden for women seeking abortions by creating barriers directed at abortion providers and clinic staff who are willing and able to provide abortions. The first of the two controversial HB 2 requirements is the admitting privileges requirement: “A physician performing or inducing an abortion must, on the date the abortion is performed or induced, have active admitting privileges at a hospital that is located not further than 30 miles from the location at which the abortion is performed or induced.”2 The second requirement is the ambulatory surgical center requirement: “The minimum standards for an abortion facility must be equivalent to the minimum standards adopted under [Texas Health & Safety Code] [...] for ambulatory surgical centres.”3 In order to meet these state-mandated obligations, some abortion clinics would have to spend more than $1 million in upgrades if they wish to remain open. The District Court decided that the ambulatory surgical center requirement places an unconstitutional undue burden on women, and that the two requirements together place an undue burden on women in Texas and especially in the Rio Grande Valley where the nearest clinic is a couple hundred miles away.4 Later, the U.S. Court of Appeals for the Fifth Circuit reversed the District Court’s decision and argued, “the admitting privileges requirement is constitutional on its face.”5 While the regulations are being appealed, the Supreme Court granted a stay of injunction, allowing about twelve abortion clinics to reopen until a final decision regarding the regulations is made. The District Court ruled that the purpose of the two regulations was to create a substantial obstacle for women seeking abortions in Texas. While the defendants argued that the regulations were designed to make abortions safer and reduce risk, the Court decided that this was not the case. An abortion, especially a first-term abortion, is a very safe procedure and is safer than many other routine surgical procedures. As stated in Planned Parenthood v. Casey, “Unnecessary health regulations that have the purpose or effect of presenting a substantial obstacle to a woman seeking an abortion impose an undue burden on the right.”6 The undue burden in this case is imposed, not through restricting women’s access directly, but by restricting physicians’ freedom to perform abortions. The admitting privileges requirement has reduced the number of physicians who can perform abortions and the ambulatory surgical center requirement has reduced the number of clinics where abortions can be performed. The American Medical Association states, “[t]he Principles of Medical Ethics of the AMA do not prohibit a physician from performing an abortion in accordance with good medical practice and under circumstances that do not violate the law.”7 This means that physicians are not required to perform abortions, except in emergency situations, but can as long as the procedure is done safely and does not violate the law. The new Texas regulations, however, are so restrictive that few abortion providers, limited to only four urban areas, can legally perform abortions. Physicians do not have an absolute right to perform abortions as opposed to women who have an absolute right to have access to an abortion. Physicians do face many challenges that other professionals face in terms of obtaining qualifications and finding work. Abortion providers, however, face challenges that most other physicians do not. The restrictions imposed by these regulations exacerbate unfair treatment toward abortion providers and place further obstacles in their path in terms of providing the service they want and are qualified to provide. Both abortion clinics and abortion providers are being treated differently from other medical clinics and physicians. For instance, “grandfathering of existing facilities and the granting of waivers from specific requirements is prohibited for abortion providers, although other types of ambulatory surgical facilities are frequently granted waivers or are grandfathered.”8 Many abortion clinics cannot afford the necessary upgrades. Furthermore, it is extremely expensive to open a brand new clinic that complies with the ambulatory surgical center requirements. Being grandfathered in would be the only option available to abortion clinics that cannot afford the upgrade. However, unfair treatment of abortion clinics and providers is preventing those clinics from being grandfathered into the new system. As a result, many abortion clinics may be forced to close. Admitting privileges are proving difficult or impossible for physicians both to obtain and, for those who have already been granted privileges, to keep. Dr. Sherwood Lynn, an obstetrician-gynecologist who has performed abortions for decades, describes the process of obtaining admitting privileges and the difficulties abortion providers face. After sending in an application a physician must wait for the hospital to send them the required materials, “but if the address of the practice on the application is of an abortion provider or clinic, [the hospital] won’t send [them] the package of materials required. [They] simply can’t apply.”9 Dr. Lynn and several other physicians have surmised that hospitals are only withholding privileges from qualified physicians who perform abortions and that other physicians do not face this discriminatory treatment. Hospitals have also revoked privileges granted to physicians after learning that the physicians perform abortions. For instance, in Texas two doctors, “received notices [...] informing them that their admitting privileges to the University General Hospital of Dallas have been revoked, with the hospital’s CEO claiming the hospital was unaware they were providing abortion care and that the hospital believed such care would damage its reputation.”10 What is curious about this revocation is that, “federal and state laws [...] forbid hospitals from discriminating against doctors who perform abortions,” and yet hospitals are clearly doing just that.11 Dr. Pamela Richter, another abortion provider in Texas, had her temporary admitting privileges revoked with no explanation and because of this, the clinic where she performed abortions, Reproductive Services, can no longer provide abortions at all.12 As the hospital gave no reason for the revocation, it not clear Dr. Richter’s privileges were revoked because she performs abortions. Dr. Richter, however, has performed over 17,000 abortions and her privileges were revoked soon after HB 2 was introduced.13 According to the Texas Hospital Association, giving admitting privileges to doctors who do not work for the hospital is expensive and time-consuming but this does not account for the fact that hospitals are revoking previously granted privileges from physicians whom they learn are providing abortion services.14 As mentioned previously, the District Court found that the admitting privileges requirement and the ambulatory surgical center requirement do not further ensure the health and safety of women undergoing an abortion. Several physicians have testified to this fact. Dr. Lynn stated in an interview: The admitting privileges requirements are [...] absolutely unnecessary. If you have a number of patients waiting for procedures, and something happens and a patient needs to be transferred to a hospital, you’re not going to leave everyone else and go to the hospital. That makes no sense. You’re going to refer that person to a gynecologist at the hospital. There is no safety issue involved here. If a patient shows up with an emergency, every hospital is required to admit that patient. They have to by law.15 It is rare that complications will arise from an abortion performed in a clinic. Dr. Richter, for example, has performed more than 17,000 abortions and not once had to send a patient to a hospital because of complications resulting from the procedure. According to Dr. Lynn even if abortion providers were granted privileges to hospitals, it is unlikely that they will exercise them. In essence, having admitting privileges at a hospital does nothing to further ensure the safety of an already safe procedure. The only result of the admitting privileges requirement is to limit certain physicians’ ability to perform legal abortions. Not only do the HB 2 requirements fail to further ensure the health and safety of women, the HB 2 requirements may actually create more health risks to women who cannot access the eight remaining clinics. The first risk is that the remaining clinics would have an influx of patients that they may not be able to handle, forcing women to wait longer for an appointment. As stated by the District Court, “[e]ven assuming every woman in Texas who wants an abortion [...] could travel to one of the four metropolitan areas where abortions will still be available, the cumulative results of HB 2 are that, at most, eight providers would have to handle the abortion demand of the entire state.”16 Furthermore, “[t]hat the State suggests that these seven or eight providers could meet the demand of the entire state stretches credulity.”17 Abortion is a time sensitive procedure. It is safest when performed early in a pregnancy. The increase in patients to these remaining clinics, assuming all women in Texas can access them, will increase wait times and may force women to have abortions later in pregnancy. In the worst-case scenario, a woman would not see an abortion provider at all before viability. Such instances may be rare, but they are possible. In such cases, women’s access to legal abortions becomes impossible and thereby violate the ruling in Roe. Clinics may be able to avoid the aforementioned problems if they hire more physicians. However, there are two barriers to hiring more physicians. First, as mentioned previously, admitting privileges to Texas hospitals are difficult, if not impossible, for abortion providers to obtain. Second, given the negative treatment of abortion providers by anti-abortion groups, many physicians are not willing to perform abortions. The harassment abortion providers face is unique to those physicians and many physicians will not perform abortions for that reason. In an article published in the Austin Chronicle, anti- abortion activist Abby Johnson, “discusses how her group investigated appraisal district records to find the new location of where an Austin abortion physician plans to work.”18 Johnson states, “These abortionists are feeling the pressure from the pro-life movement in Texas. I think they feel like they’re on the run. And that’s how we want to keep it.”19 If the HB 2 requirements are passed and there remain at most eight abortion providers in Texas, these activists will concentrate on those clinics and, “the dangerous impact of their intimidation tactics will be exacerbated.”20 Even if the number of physicians needed to meet the demand in Texas can obtain admitting privileges and work at one of the remaining clinics, they may choose not to do such work because they are putting themselves at risk. The harm abortion providers face from such anti-abortion groups is not unique to Texas. There are stories from all over the country and from other countries where abortion is legal of physicians receiving death threats. Dr. George Tiller, an abortion provider in Kansas, was killed outside his church and had received numerous death threats prior to this. The HB 2 requirements are making it so that abortion providers either cannot provide their services any longer or will face increased threats and increased danger to themselves. Physicians are allowed to conscientiously object to providing medical interventions in certain circumstances for moral and religious reasons. However, there are limits on this right. According to the American Congress of Obstetricians and Gynecologists, “[w]hen conscientious refusals conflict with moral obligations that are central to the ethical practice of medicine, ethical care requires that the physician provide care despite reservations or that there be resources in place to allow the patient to gain access to care in the presence of conscientious refusal.”21 I would argue fear for one’s safety in the face of immediate threats is perhaps a stronger ground on which to refuse to provide care than a personal belief that abortion is immoral or against one’s religion. ACOG also states, “[p]roviders with moral or religious objections should either practice in proximity to individuals who do not share their views or ensure that referral processes are in place so that patients have access to the service that the physician does not wish to provide.”22 This responsibility has been largely disputed by the medical community but in cases of rape, incest, and health risks to women, referrals must be made without exception. However, under the requirements of HB 2, working in proximity to an abortion provider may not be possible because they are so geographically limited. Referrals are supposed to be made within reason. Some areas of Texas, such as the Rio Grande Valley, are up to 200 miles away from the nearest clinic that would remain open if HB 2 is passed. Referrals may simply not be feasible given the geographical distances and the decreasing number of available physicians. As mentioned above, there are two risks to the health and safety of women as a result of HB 2. The second of these is that if a woman cannot access one of the remaining clinics, she may seek out a more convenient but illegal and unsafe abortion, which is far more likely to result in a dangerous complication. Dr. Lynn states, “[b]ecause of the restrictions lawmakers impose, women will seek abortions illegally, and we’re going to see a rise in septic abortions.”23 Some areas of Texas might effectively revert back to a pre-Roe era where abortions were performed in unsanitary conditions by unqualified people resulting in dangerous medical complications far more often than legal abortion procedures do now. Physicians like Dr. Lynn who want to prevent this from happening generally cannot do so without facing legal sanction. Physicians have a duty to provide safe medical care and if they cannot obtain admitting privileges, they cannot exercise this duty. ACOG released a statement expressing their objections to the new requirements. They state that HB 2 is, “plainly intended to restrict the reproductive rights of women in Texas through a series of requirements that improperly regulate medical practice and interfere with the patient-physician relationship.”24 Executive Vice-President of ACOG, Hal C. Lawrence III stated: The Texas bills set a dangerous precedent of a legislature telling doctors how to practice medicine and how to care for individual patients. ACOG opposes legislative interference, and strongly believes that decisions about medical care must be based on scientific evidence and made by licensed medical professionals, not the state or federal government.25 Abortion is one of only a few areas of medicine where the legislature imposes so many regulations restricting particular physicians’ ability to practice medicine. Not only are abortions providers being regulated by the state, they are also facing clear discrimination from others within the medical community. The state is closing down clinics that do not meet the ambulatory surgical center requirements and hospitals are denying physicians admitting privileges because they perform abortions. In summary, abortion providers are being discriminated against both by the legislature and other members of the medical community. Other physicians who do not perform abortions are not denied admitting privileges on discriminatory grounds. Clinics that cannot afford upgrades to become an ambulatory surgical center are being grandfathered in, while abortion clinics are being forced to close down. Ob-Gyns who conscientiously object to performing abortions and who are not located in close proximity to at least one abortion provider cannot effectively fulfill their duty to refer patients. Lastly, given the barriers these regulations will create, there will likely be a rise in complications resulting from abortions provided under grossly unsafe conditions. Physicians, whose duty it is to provide safe and effective medical care, are being denied the right to exercise this duty. While this denial may not be unconstitutional, it is certainly unjust and discriminatory and creates obstacles that other physicians do not face. Most importantly, these obstacles are creating an undue burden for women. The HB 2 requirements do not increase the health and safety of abortions; all they do is create substantial obstacles for women. In light of these observations, the requirements seem to me to be in clear violation of Casey, in which it was decided that, “[u]nnecessary health regulations that have the purpose or effect of presenting a substantial obstacle to a woman seeking an abortion impose an undue burden on that right.”26 These regulations do just what Casey was meant to prohibit and this is accomplished through limiting physicians’ ability to practice safe abortions across the state of Texas. Therefore, the HB 2 requirements may not impose an undue burden on doctors but they do impose an undue burden on women. PDF available: Rachel Hill, "Texas HB 2," Voices in Bioethics. References: 1 Planned Parenthood of Southeastern Pennsylvania v. Casey, pg. 2. 2 Whole Women’s Health v. Lakey, pg. 2. 3 Ibid. 4 Ibid., 4. 5 Ibid., 2. 6 Planned Parenthood v. Casey, pg. 16 7 AMA Code of Medical Ethics, “Opinion 2.01 – Abortion,” American Medical Association. 8 Whole Women’s Health v. Lakey, pg. 10. 9 Dr. Sherwood Lynn, “A Texas Ob-Gyn Details the Horrific Consequences of Abortion Restrictions,” Cosmopolitan. 10 Feminist Newswire, “Texas Hospitals Revoke Admitting Privileges to Abortion Providers,” Feminist Majority Foundation Blog. 11 Ibid. 12 Ibid. 13 Ibid. 14 Glenn Hegar, “Texas Hospital Association’s Statement of Opposition to Section 2 of the Committee Substitute for Senate Bill 5,” Texas Hospital Association. 15 Dr. Lynn, “A Texas Ob-Gyn.” 16 Whole Women’s Health v. Lakey, pg. 10. 17 Ibid. 18 Mary Tuma, “Undercover Audio Reveals Anti-Abortion Tactics: Anti-abortion activists monitor and track providers, patients,” Austin Chronicle. 19 Ibid. 20 Ibid. 21 Committee on Ethics, “The Limits of Conscientious Refusal in Reproductive Medicine,” The American Congress of Obstetricians and Gynecologists. 22 Ibid. 23 Dr. Lynn, “A Texas Ob-Gyn.” 24 “Ob-Gyns Denounce Texas Abortion Legislation: Senate Bill 1 and House Bill 2 Set Dangerous Precedent,” The American Congress of Obstetricians and Gynecologists. 25 Ibid. 26 Planned Parenthood v. Casey, pg. 16. (shrink)

No provision of the Patient Protection and Affordable Care Act has proven to be more contentious than the so-called “individual mandate.” Starting in 2014, the mandate will impose a penalty on non-exempt individuals who lack health insurance. According to Congress, the mandate is essential to ensuring near universal coverage. Without it, PPACA’s insurance reforms will lead healthy individuals to delay purchasing health insurance until they require medical care, resulting in risk pools with a disproportionate share of high-risk (...) people. The price of insurance will then climb, causing more and more not-so-sick people to forego health insurance. The resulting “death spiral” will make insurance unaffordable to many more Americans. (shrink)

The price of sequencing all the DNA in a person's genome is falling so fast that, according to one biotech leader, soon it won't cost much more than flushing a toilet. Getting all that genomic data at an ever‐lower cost excites the imaginations not only of biotech investors and researchers but also of the President and many members of Congress. They envision the data ushering in an age of “personalized medicine,” where medical care is tailored to persons’ genomes. (...) The new name “precision medicine” should not distract us from the fact that the genomic information it depends on is more complex, uncertain, and ambiguous than anyone had hoped, nor should it distract us from an important ethical point. Unfortunately, several developments of the last fifteen years suggest that, in our excitement about the technological capacity to gather genomic data at an ever lower cost, we are drifting away from what has long been a basic ethical commitment: to offer persons a process that enables them to provide informed consent before they or anyone else accesses their genetic information. (shrink)

Over the past decade or so, no issue in medical ethics or bioethics law has raised more concerns about federal intervention in the practice of medicine, about judicial attempts to craft health policy, or about the wisdom of public mandates directing specific health care initiatives than the issue of physician-assisted suicide. State voter referenda, lower and federal court cases, proposed legislation in both houses of Congress, and orders and determinations from agencies within the executive branch of two administrations (...) are representative of the kinds of actions taken in the last ten years implicating medical care at the end of life. Whether the intent was to codify into law physician-assisted suicide, to deny a constitutional right of assisted suicide, or to make “easier” physicians' efforts to alleviate intractable suffering at the risk of hastening death, or to prohibit physician aid in dying altogether, the impact on the patient-doctor relationship and on our understanding of what constitutes dignified and humane care at the end of life is undeniable. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Genetic Testing and Genetic ScreeningPat Milmoe McCarrick (bio)In recent years there has been an enormous expansion in the knowledge that may be gleaned from the testing of an individual's genetic material to predict present or future disability or disease either for oneself or one's offspring. The Human Genome Project, which is currently mapping the entire human gene system, is identifying progressively more genetic sequencing information (see Scope Note 17, (...) The Human Genome Project). Information obtained from genetic testing raises ethical and legal questions about its uses by society. The ethical dilemmas were foreseen two decades ago by bioethicists who asked whether questionable applications could stop "legitimate pursuits" (IV, Gaylin 1972) and whether genetic disease might come to be viewed as "transmissible" in the sense of being contagious (IV, Veatch 1974).Not only has knowledge expanded, but the practice of genetic testing and screening has greatly increased as well. For example, in the case of testing for cystic fibrosis (CF), the U.S. Congress' Office of Technology Assessment (OTA) estimates that instances of screening jumped from 9310 tests in 1991 to 63,000 tests in 1992 (I, OTA [Cystic Fibrosis] 1992). In addition, the OTA estimates that within the next few years, the six million women who become pregnant each year routinely will be informed of available CF carrier tests (I, OTA [Cystic Fibrosis] 1992).Following the recent identification of a gene linked to breast cancer, Dr. Francis Sellers Collins, director of the National Center for Human Genome Research, said that "it is not inconceivable that every woman in America may want to be screened for this gene. The economic, ethical, and counseling issues will be very daunting." Dr. Collins opines that in the near future physical examinations for 18-year-olds will include DNA testing for diseases with genetic components and that physicians, in the interests of preventive medicine, will make risk-based recommendations for a healthy life-style (IV, Breo 1993). The U.S. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research predicted as early as 1983 that before the end of the century genetic screening and counseling would become major components of both public health and individual medical care (I, U.S. President's Commission 1983). [End Page 333]The OTA defines genetic testing as "the use of specific assays to determine the genetic status of individuals already suspected to be at high risk for a particular inherited condition. The terms genetic test, genetic assay, and genetic analysis are used interchangeably to mean the actual laboratory examination of samples." In contrast, genetic screening usually uses the same assays employed for genetic testing but is distinguished from genetic testing by its target population (I, OTA [Genetic Monitoring] 1990). The National Academy of Sciences (NAS) defines screening as the systematic search of populations for persons with latent, early, or asymptomatic disease (III, NAS 1975). Some of the literature annotated for this Scope Note appears to use the terms "testing" and "screening" interchangeably.Philip Boyle of the Hastings Center points out that the language used to describe genetic variation is important and asks what words should be used: "Defects, flaws, deleterious genes, disorders, or the more neutral conditions? Using words such as normal—and its corollary, abnormal—is likely to foster stigmatization and discrimination" (III, Genetic Grammar, Boyle 1992).Areas of focus in genetic testing include: prenatal diagnosis, newborn screening, carrier screening, forensic screening, and susceptibility screening.Prenatal diagnosis discerns whether a fetus is at risk for various identifiable genetic diseases or traits. Prenatal diagnosis is made using amniotic fluid, fetal cells, and fetal or maternal blood cells obtained during amniocentesis testing; alpha fetoprotein assays or chorionic villus sampling; or ultrasound tomography, which creates fetal images on a screen. Another method, known as fetoscopy, uses a camera on a needle inserted in the uterus to view the fetus. Since prenatal screening began in 1966 (I, U.S. President's Commission 1983), the number of metabolic defects and genetic disorders that can be diagnosed prenatally has expanded greatly. There is also discussion of requiring testing for parents who are participating in an in vitro fertilization program and are at genetic... (shrink)

Prominent among the principles put forward by Professor Bernard Williams in ‘The Idea of Equality’ were that for every difference in the way men are treated a relevant reason should be given and the proper ground of the distribution of medical care is ill health. Prominent among his conclusions was that we are confronted with an irrational state of affairs where wealth functions as a necessary condition for receiving medical care. In ‘The Idea of Equality Reconsidered’ (...) Philosophy 85–90), I argued that, on his principles alone, this conclusion though correct was one-sided. (shrink)

In Britain before 1911, the vast majority of the population provided medical care for themselves and had evolved a variety of schemes that checked the power of organized medicine and encouraged a steady improvement in standards. The evidence is that at the end of the nineteenth century about 5–6 percent of the population relied on the poor law, 10–15 percent on free care from charitable institutions, 75 percent on mutual aid, and the remainder paid fees to private (...) doctors. (shrink)

With the escalation of terrorism worldwide in recent years, situations arise in which the perpetration of violence and the defense of human rights come into conflict, creating serious ethical problems. The Geneva Convention provides guidelines for the medical treatment of enemy wounded and sick, as well as prisoners of war. However, there are no comparable provisions for the treatment of terrorists, who can be termed unlawful combatants or unprivileged belligerents. Two cases of severely injured terrorists are presented here to (...) illustrate the dilemmas facing the medical staff that treated them. It is suggested that international legal and bioethical guidelines are required to define the role of the physician and auxiliary medical staff vis a vis injured terrorists. There are extreme situations where the perpetration of violence and the defense of human rights come into conflict, leading to serious ethical and psychological discord. Terrorists, using violence to create fear in order to further their political objectives, might require life-saving medical care if injured during the course of their terror activities. (shrink)

With the escalation of terrorism worldwide in recent years, situations arise in which the perpetration of violence and the defense of human rights come into conflict, creating serious ethical problems. The Geneva Convention provides guidelines for the medical treatment of enemy wounded and sick, as well as prisoners of war. However, there are no comparable provisions for the treatment of terrorists, who can be termed unlawful combatants or unprivileged belligerents. Two cases of severely injured terrorists are presented here to (...) illustrate the dilemmas facing the medical staff that treated them. It is suggested that international legal and bioethical guidelines are required to define the role of the physician and auxiliary medical staff vis a vis injured terrorists. There are extreme situations where the perpetration of violence and the defense of human rights come into conflict, leading to serious ethical and psychological discord. Terrorists, using violence to create fear in order to further their political objectives, might require life-saving medical care if injured during the course of their terror activities. (shrink)

That a standard of medical care must outline services that benefit the patient is relatively uncontroversial. However, one must determine how the practices outlined in a medical standard of care should benefit the patient. I will argue that practices outlined in a standard of medical care must not detract from the patient’s well-functioning and that clinicians can refuse to provide services that do. This paper, therefore, will advance the following two claims: (1) a standard (...) of medical care must not cause dysfunction, and (2) if a physician is medically rational to not provide some service which fails to meet the above condition (i.e. fails to be a standard of medical care), then she may refuse to do so. I then apply my thesis to the prescription of puberty blockers to children with gender dysphoria. (shrink)

The articles in this issue explore a number of difficult choices in medical care and research. They investigate ethical complexity in a range of decisions faced by policymakers and clinicians, and offer new evidence or normative approaches for navigating this complexity. In this issue’s feature article, Ford and colleagues engage with an ethical challenge faced by policymakers in relation to health research: should free text data contained in medical records be shared for research purposes?1 While some types (...) of data from electronic medical records are used widely in health research, privacy concerns have limited the use of free text data specifically. Ford and colleagues highlight the richness of the clinical information in free text and its centrality to some areas of healthcare such as mental health and primary care. In their view, while text analytic technology is developing rapidly, ‘policy makers routinely judge that the risk of re-identifying patients from text data is too high for these data uses’. Their citizens’ jury study in the UK found that participants were largely in favour of medical free text data being shared outside the NHS for research using an opt-out model: ‘the majority of jurors believed the benefits of sharing data for research outweighed the privacy risks’. In their commentary on this research, Largent and Morain raise some important issues about policymakers’ use of empirical findings …. (shrink)

Crowdfunding websites allow users to post a public appeal for funding for a range of activities, including adoption, travel, research, participation in sports, and many others. One common form of crowdfunding is for expenses related to medical care. Medical crowdfunding appeals serve as a means of addressing gaps in medical and employment insurance, both in countries without universal health insurance, like the United States, and countries with universal coverage limited to essential medical needs, like Canada. (...) For example, as of 2012, the website Gofundme had been used to raise a total of 8.8 million dollars for seventy-six hundred campaigns, the majority of which were health related. This money can make an important difference in the lives of crowdfunding users, as the costs of unexpected or uninsured medical needs can be staggering. In this article, I offer an overview of the benefits of medical crowdfunding websites and the ethical concerns they raise. I argue that medical crowdfunding is a symptom and cause of, rather than a solution to, health system injustices and that policy-makers should work to address the injustices motivating the use of crowdfunding sites for essential medical services. Despite the sites’ ethical problems, individual users and donors need not refrain from using them, but they bear a political responsibility to address the inequities encouraged by these sites. I conclude by suggesting some responses to these concerns and future directions for research. (shrink)

The aging of the population presents modern Western society with a variety of different challenges, especially in the areas of health and medicine. On the one hand, there is the demand of the elderly patients to receive medical treatments that are supposed to improve or preserve the existing quality of life and to prevent the extension of a life without quality, with suffering and pain. On the other hand, aging is accompanied by the appearance and exacerbation of chronic illnesses, (...) reduces the treatment benefits of medical activities and increases the risks of irreversible physical dependence. Furthermore, the lack of consensus among the physicians regarding the willingness of treatment and the proper timing of the treatment of the elderly – pose questions about the quality of the treatment for the elderly. Thus, in the opinion of different care-providers and in comparison to other age groups in modern Western society, the elderly do not enjoy the treatment advantages of medical activities proven in the treatment of other age groups in society. (shrink)

Challenges in Medical Care Edited by Andrew Grubb School of Law and Centre of Medical Law and Ethics, King’s College, London, UK The sixth volume in the series of King’s College Studies takes a reflective view of medical law and ethics, the health care system and challenges raised by modern technology. A distinguished team of authors returns to problems and controversies that have long challenged medical law and ethics, and shows how new issues are (...) constantly arising as a result of developments in medical care. Topics such as the legal status of the frozen human embryo, medical accountability and the future of the National Health Service are discussed. The need for responsibility, accountability and respect for individual human rights forms a strong linking theme throughout the book. This thought-provoking collection constitutes a useful and informative reference source which will be of value to a wide range of professionals and students including doctors, nurses, lawyers, philosophers and medical sociologists. (shrink)

Outcomes from cardiopulmonary resuscitation (CPR) remain distressingly poor. Overuse of CPR is attributable to unrealistic expectations, unintended consequences of existing policies and failure to honour patient refusal of CPR. We analyzed the CPR outcomes literature using the bioethical principles of beneficence, non-maleficence, autonomy and justice and developed a proposal for selective use of CPR. Beneficence supports use of CPR when most effective. Non-maleficence argues against performing CPR when the outcomes are harmful or usage inappropriate. Additionally, policies which usurp good clinical (...) judgment and moral responsibility, thereby contributing to inappropriate CPR usage, should be considered maleficent. Autonomy restricts CPR use when refused but cannot create a right to CPR. Justice requires that we define which medical interventions contribute sufficiently to health and happiness that they should be made universally available. This ordering is necessary whether one believes in the utilitarian standard or wishes medical care to be universally available on fairness grounds. Low-yield CPR fails justice criteria. Cardiopulmonary resuscitation should be performed when justified by the extensive outcomes literature; not performed when not desired by the patient or not indicated; and performed infrequently when relatively contraindicated. (shrink)

Doctor's Dilemmas, a fascinating study of the moral dilemmas confronting health professionals and patients alike, examines areas of health care where ethical conflicts often arise. Gorovitz illuminates these conflicts by clearly explaining and applying a broad range of philosophical concepts. He lays the groundwork for informed ethical decision-making and provides the general reader with a lucid overview of the complexities of medical practice. Written in accessible, conversational style and making extensive use of anecdotes, examples, and references to literature, (...) Doctor's Dilemmas offers profound insights into medical ethics for all those involved with the health professions--be they doctors, nurses, administrators, or patients. (shrink)