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Biotechnological inventions are sometimes based upon the traditional knowledge of indigenous communities about the beneficial properties of plants and animals. Some institutions have adopted the uniqueness of traditional knowledge approach, which maintains that the indigenous communities have sui generis rights to a share of the profits from these inventions. Others have adopted the protection of inventive steps approach, which maintains that the inventors are entitled to the full profits from the invention if it involves a non-obvious and novel inventive step. The article analyzes this debate at the Convention on Biological Diversity, at the World Intellectual Property Organization, and at the World Trade Organization. It concludes that the adherents of the uniqueness of traditional knowledge approach have not justified their claims.

Continuing the discussion begun in the March 2006 issue of the Kennedy Institute of Ethics Journal, this paper further documents the failure of the United States to adequately consider possible modifications in the traditional robust system of intellectual property rights as applied to biotechnology. It discusses concrete suggestions for alternative disclosure requirements, for exemptions for research tools, and for improved access to clinical advances. In each of these cases, the modifications might be more responsive to the full set of relevant values.

Pharmacogenetics offers the prospect of an era of safer and more effective drugs, as well as more individualized use of drug therapies. Before the benefits of pharmacogenetics can be realized, the ethical issues that arise in research and clinical application of pharmacogenetic technologies must be addressed. The ethical issues raised by pharmacogenetics can be addressed under six headings: (1) regulatory oversight, (2) confidentiality and privacy, (3) informed consent, (4) availability of drugs, (5) access, and (6) clinicians' changing responsibilities in the era of pharmacogenetic medicine. We analyze each of these categories of ethical issues and provide policy approaches for addressing them.

BACKGROUND: Conflicts of interest pose a threat to the integrity of scientific research. The current regulations of the U.S. Public Health Service and the National Science Foundation require that medical schools and other research institutions report the existence of conflicts of interest to the funding agency but allow the institutions to manage conflicts internally. The regulations do not specify how to do so. METHODS: We surveyed all medical schools (127) and other research institutions (170) that received more than $5 million in total grants annually from the National Institutes of Health or the National Science Foundation; 48 journals in basic science and clinical medicine; and 17 federal agencies in order to analyze their policies on conflicts of interest. RESULTS: Of the 297 institutions, 250 (84 percent) responded by March 2000, as did 47 of the 48 journals and 16 of the 17 federal agencies. Fifteen of the 250 institutions (6 percent)--5 medical schools and 10 other research institutions--reported that they had no policy on conflicts of interest. Among the institutions that had policies, there was marked variation in the definition and management of conflicts. Ninety-one percent had policies that adhered to the federal threshold for disclosure ($10,000 in annual income or equity in a relevant company or 5 percent ownership), and 9 percent had policies that exceeded the federal guidelines. Only 8 percent had policies requiring disclosure to funding agencies, only 7 percent had such policies regarding journals, and only 1 percent had policies requiring the disclosure of information to the relevant institutional review boards or to research subjects. Twenty journals (43 percent) reported that they had policies requiring disclosure of conflicts of interest. Only four federal agencies had policies that explicitly addressed conflicts of interest in extramural research, and all but one of the agencies relied primarily on institutional discretion. CONCLUSIONS: There is substantial variation among policies on conflicts of interest at medical schools and other research institutions. This variation, combined with the fact that many scientific journals and funding agencies do not require disclosure of conflicts of interest, suggests that the current standards may not be adequate to maintain a high level of scientific integrity.

This paper distinguishes four major types of futility (physiological, imminent demise, lethal condition, and qualitative) that have been advocated in the literature either in a patient dependent or a patient independent fashion. It proposes five criteria (precision, prospective, social acceptability, significant number, and non-agreement) that any definition of futility must satisfy if it is to serve as the basis for unilaterally limiting futile care. It then argues that none of the definitions that have been advocated meet the criteria, primarily because their proponents have not paid sufficient attention to the problematic nature of the data supporting the use of their definitions.

There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences (CIOMS), the International Conference on Harmonization's standards for industry (ICH), and the CONSORT group's reporting norms (Consolidated Standards of Reporting Trials), in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's (FDA) body of regulations, and information sheets by the Department of Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”

The emergence of the human immunodeficiency virus (HIV) as a serious public health threat has rekindled long dormant debate about individual physicians' duty to treat potentially contagious patients. Because of the widely accepted common-law tenet of the "no duty [to treat] rule," previous work on a duty to treat focused on historical reviews, medical society position statements, and the ethical arguments upon which the statements are based. The passage of the Americans with Disabilities Act has rendered these discussions moot by creating, through federal civil rights mechanisms, a legal duty to treat patients with HIV, enforceable under considerable penalties. The paper also concludes that there has been inadequate attention paid to similar civil rights concerns of infected physicians.

The issue of biopiracy has attracted considerable attention in recent years. The Convention on Biological Diversity adopted a principle of state sovereignty over biological resources and the genetic information contained within those resources to address this issue. It is argued that this principle has not been adequately justified and that there are other solutions to the issue of biopiracy, based on different theories of justice, that deserve greater consideration. These alternatives include the common heritage of mankind principle and the global commons principle.

Background Innovative approaches are needed to allow for research in the emergency setting while not compromising either the rights or the interests of the subjects enrolled in such research. The emergency consent exception was developed to meet this need. Purpose The goal was to describe the timing of initial contact with relatives and the timing of obtaining informed consent for a research study in patients with severe traumatic brain injury. Methods The study was designed as a prospective, observational study of 129 patients enrolled in an emergency study of traumatic brain injury conducted under the emergency consent exception. Detailed descriptive information was collected both about the availability of relatives of patients enrolled in a study of traumatic brain injury to give prospective consent within the time period required for entering the study and about the extent to which they did give prospective consent during that time period. Results The number of patients with relatives who could be contacted by research staff increased with time after injury, with 3% (95% CI=0 to 6%), 25% (95% CI=18 to 32%), and 43% (95% CI=35 to 52%) having family at 1, 3, and 6 h, respectively postinjury. An additional 15% were available within the next 6 h. The median time after injury to the initial family contact by the research staff was 2.0 h for patients who had relatives already present at the hospital and 5.7 h for patients whose family had already been contacted by the hospital. The percentage of family members actually giving prospective research consent was much smaller; only 18% actually gave prospective consent within 6 h postinjury. The proportion of critically ill patients with family available to give prospective consent for enrollment in emergency research studies depends primarily on the time period allowed for enrollment in the individual study and the length of the transition from initial contact to completed prospective consent. Limitations The study was performed in a specific patient population and may not be generalizable to other settings. Conclusions Careful attention should be paid by investigators and IRBs as to whether the emergency consent exception is really required for a particular study, or whether the study could proceed using only prospective consent with a longer recruitment period, more research sites, and a higher yield of available family members giving prospective consent. Measures that could shorten the time between initial contact and obtaining informed consent (for example, allowing consent over the phone rather than requiring written consent) might decrease the need for the emergency consent exception. Clinical Trials 2007; 4: 631—637. http://ctj.sagepub.com

The European patent system allows for the introduction of moral issues into decisions about the granting of patents. This feature has greatly impacted European debates about the patenting of biotechnology. This essay explores the European experience, in both the European Union and the European Patent Organization. It argues that there has been great confusion surrounding these issues primarily because the Europeans have not developed a general theory about when exclusion from patentability is the best social mechanism for dealing with morally offensive technologies.

In the development of biotechnology in the United States, many questions were raised about the appropriateness of applying to this area a traditional robust system of intellectual property rights. Despite these hesitations, the U.S. rejected suggested modifications. This was a mistake, and there is a need to develop a modified system that promotes more of the relevant ethical values.

Some attention is beginning to be paid in the recent literature of bioethics and health policy to a variety of ethical issues that arise in the business aspects of the practice of medicine. These include such questions as advertising in medicine, physician self-referral, physician fees, and conflicts of interest in clinical trials. These questions arise primarily, but not exclusively, in those settings in which physicians practice fee-for-service medicine, and there are many such settings in the United States and elsewhere. I want to suggest that the controversies surrounding these issues result from neither society in general nor physicians in particular having decided which of two models of the physician is the more appropriate model, and that progress in resolving these issues requires an unequivocal adoption of one of them. In the first section of this article, I will present an outline of these two models. In the next two sections

Successful practice of cardiovascular medicine requires familiarity with the complex ethical issues that accompany therapeutic innovation and diffusion. Even as technologies transition from experimental to standard care, challenges remain. Mechanical circulatory support devices, for instance, are increasingly conceptualized as conventional therapies. Despite this, or perhaps because of it, the ethical issues surrounding the use of these devices in patients with end-stage organ dysfunction are becoming increasingly apparent. In this paper, we provide an introduction to ethical considerations related to the use of ventricular assist devices (VADs) in end-stage organ failure, focusing on three stages or decision points: initiation, continued use, and deactivation. Our goal is not to exhaustively resolve these dilemmas but to illustrate how ethical considerations relate to decision making.

MORAL PLURALISM IS A VALUABLE ASPECT OF A free society but sometimes creates conflicts in medical care when individual physicians object to providing certain legal but morally controversial services, such as abortion, physician-assisted suicide (where it is legal), and palliative sedation to unconsciousness. Genuine conscience-based refusals (CBRs) are refusals in which a physician believes that providing the requested service would violate his or her core moral beliefs (religious or secular), thereby causing personal moral harm. Conscience-based refusals should be a “shield” to protect individual physicians from being compelled to violate their core moral beliefs rather than a “sword” to force their beliefs onto patients. This partially explains why many physicians who invoke CBRs refer their patients to physicians willing to provide the requested care. Savulescu has characterized CBRs as self-serving acts accomplished at the expense of patients. Others accept CBRs as legitimate acts to protect moral integrity despite the potential negative consequences for patients. Both characterizations neglect a complexity: society may obtain higherquality medical care in aggregate by accommodating some CBRs. In this Commentary, CBRs are addressed from this societal perspective.

There is a growing interest in comparison of international health care data with the hope that such studies will enable individual systems to learn from other systems. Such comparisons, however, presuppose that there exist common criteria for evaluating health care systems. The main thesis of this paper is that these comparative studies are misleading because they employ inappropriate operationalizations of these criteria because the operationalizations are based upon mistaken global conceptualizations of the criteria in question. The essay provides a methodological critique of what has been done and sets a new agenda for future research.

Empirical research can aid ethical reflection in bioethics by identifying issues, by seeing how they are currently resolved, and by assessing the consequences of these current resolutions. This potential can be misused when the ethical issues in question are fundamentally non-consequentialist or when they are consequentialist but the empirical research fails to address the important consequences. An example of the former problem is some recent studies about bad consequences resulting from commercialized living kidney donor programs. These consequences could be avoided, but the crucial non-consequentialist ethical issues about exploitation and commercialization would still remain. Examples of the latter problem are provided by recent studies of the allocation of ICU beds and of physician deception, where important consequences were not adequately studied.

The patient in a persistent vegetative state (hereafter, the PVS patient) has played a central role in recent American bioethical discussions and in recent litigation involving bioethical issues. From Quinlan’ to Cruzan and Wanglie, some of the most important cases involving ethical issues at the end of life have involved PVS patients. Major American medical groups such as the AMA and the American Academy of Neurology have adopted important policy statements on the care of such patients, statements that have been followed by at least one European group.I have always found this activity a bit of a mystery. There is, after all, a relatively clear consensus about decision-making at the end of life, a consensus embodied in such documents as a report from the President's Commission and a report from the Hastings Center.

This paper identifies four major forms of scholarship in bioethics: empirical research, the articulation of mid-level principles of bioethics, the relating of these principles to fundamental moral theories, and discussions of the bioethical implications of legal principles and health delivery policies. It develops a reflective equilibrium approach to the relation between these four forms of scholarship. It then presents, in light of this approach, criteria for quality research in each of these forms of scholarship in bioethics.

In Reply. —We are pleased that Drs Bauman and Vawter support the general direction of the Houston policy and that their groups are in the process of developing similar policies. We agree with Bauman that society as a whole needs to address the issues of resource allocation and rationing. However, that does not free institutions from their duty as responsible stewards of the resources made available to them, to consider the allocation of those resources as they decide whether providing demanded interventions is appropriate. Institutional integrity, we have argued, demands that this be considered. We also believe, in disagreement with Bauman, that a failure to provide the intervention unless the patient ultimately agrees is not abandonment. It must be remembered that all appropriate care would, according to step 7 of our protocol, continue to be provided, and abandonment is only the failure to provide appropriate care. A failure to provide inappropriate care

AN INFANT born with multiple congenital abnormalities that rendered survival unprecedented required high-dose vasopressors to maintain blood pressure. After several days, gangrene developed in the extremities, and the parents sequentially demanded amputations of several limbs in an attempt to "do everything." The surrogate decision maker for a comatose woman dying of multisystem organ failure in an intensive care unit (ICU) was her estranged husband; they separated because of repeated spousal abuse. Despite many conferences with the husband recommending comfort measures and a do-not-resuscitate order, the husband demanded that the medical staff "do everything to my wife." A public hospital serving an indigent community of several hundred thousand had a full ICU, and 3 patients were being kept in the emergency department on ventilators. One of the patients in the ICU was a gentleman who had been ventilator dependent and unresponsive for 41/2 months after a cardiac arrest; his daughter insisted

Objective. —To assess pairwise differences between placebo, unopposed estrogen, and each of three estrogen/progestin regimens on selected heart disease risk factors in healthy postmenopausal women. Design. —A 3-year, multicenter, randomized, double-blind, placebo-controlled trial. Participants. —A total of 875 healthy postmenopausal women aged 45 to 64 years who had no known contraindication to hormone therapy. Intervention. —Participants were randomly assigned in equal numbers to the following groups: (1) placebo; (2) conjugated equine estrogen (CEE), 0.625 mg/d; (3) CEE, 0.625 mg/d plus cyclic medroxyprogesterone acetate (MPA), 10 mg/d for 12 d/mo; (4) CEE, 0.625 mg/d plus consecutive MPA, 2.5 mg/d; or (5) CEE, 0.625 mg/d plus cyclic micronized progesterone (MP), 200 mg/d for 12 d/mo. Primary Endpoints. —Four endpoints were chosen to represent four biological systems related to the risk of cardiovascular disease: (1) high-density lipoprotein cholesterol (HDL-C), (2) systolic blood pressure, (3) serum insulin, and (4) fibrinogen. Analysis. —Analyses presented are by intention to treat. P values for primary endpoints are adjusted for multiple comparisons; 95% confidence intervals around estimated effects were calculated without this adjustment. Results. —Mean changes in HDL-C segregated treatment regimens into three statistically distinct groups: (1) placebo (decrease of 0.03 mmol/L [1.2 mg/dL]); (2) MPA regimens (increases of 0.03 to 0.04 mmol/L [1.2 to 1.6 mg/dL]); and (3) CEE with cyclic MP (increase of 0.11 mmol/L [4.1 mg/dL]) and CEE alone (increase of 0.14 mmol/L [5.6 mg/dL]). Active treatments decreased mean low-density lipoprotein cholesterol (0.37 to 0.46 mmol/L [14.5 to 17.7 mg/dL]) and increased mean triglyceride (0.13 to 0.15 mmol/L [11.4 to 13.7 mg/dL]) compared with placebo. Placebo was associated with a significantly greater increase in mean fibrinogen than any active treatment (0.10 g/L compared with -0.02 to 0.06 g/L); differences among active treatments were not significant. Systolic blood pressure increased and postchallenge insulin levels decreased during the trial, but neither varied significantly by treatment assignment. Compared with other active treatments, unopposed estrogen was associated with a significantly increased risk of adenomatous or atypical hyperplasia (34% vs 1%) and of hysterectomy (6% vs 1%). No other adverse effect differed by treatment assignment or hysterectomy status. Conclusions. —Estrogen alone or in combination with a progestin improves lipoproteins and lowers fibrinogen levels without detectable effects on postchallenge insulin or blood pressure. Unopposed estrogen is the optimal regimen for elevation of HDL-C, but the high rate of endometrial hyperplasia restricts use to women without a uterus. In women with a uterus, CEE with cyclic MP has the most favorable effect on HDL-C and no excess risk of endometrial hyperplasia. ( JAMA . 1995;273:199-208)

Brain death has been discussed extensively for the last 25 years. Most investigators now believe that requiring death of the entire brain as the criterion for brain death in the Uniform Determination of Death Act and the standard clinical tests of brain death outlined in the Report of the Medical Consultants to the President's Commission have produced a satisfactory resolution of the issues surrounding the determination of death. However, we show that satisfying the standard medical tests does not guarantee that all brain functions have actually ceased and that there is tension between the legal criterion and the standard clinical tests. After considering and rejecting six possible reconciliations, we present an alternative approach that does not acknowledge any sharp dichotomy between life and death and incorporates the proposition that the questions of when care can be unilaterally discontinued, when organs can be harvested, and when a patient is ready for the services of an undertaker should be answered independent of any single account of death.

This paper argues, contrary to what has sometimes been claimed, that public commissions need to be more philosophical than they have been in analyzing crucial bioethical issues. It argues (a) that the failure of the President's Commission to develop and use even simple distinctions between life and personhood led to flaws in both its discussion of death and its discussion of persistent vegetative patients, and (b) that its treatment of access to health care fails to develop a coherent approach precisely because it is based on no serious philosophical reflections about justice in health care.

This paper describes the activities of the Center for Ethics, Medicine, and Public Issues, a joint project of Baylor College of Medicine, the Institute of Religion of the Texas Medical Center, and Rice University. The center focuses on the clinical teaching of medical ethics, collaborative teaching and research involving ethicists and clinicians, and the training of future practitioners in the field. Problems as well as achievements in each of these areas are discussed.

In this paper questions are raised about the use of Halakhic material in discussions of medical ethics. Three ways in which one might use Halakhic material in such discussions are distinguished: (a) as a source for ideas about medical ethics which can be defended independently of their origin; (b) as a basis for mandating certain forms of behavior for members of the Jewish faith; (c) as the basis for claims about the Jewish view on disputed topics in medical ethics. The first two raise no methodological problems. The third use raises a number of theoretical and practical issues, with which the paper is concerned. The problems stem from the fact that Halakhah distinguishes between obligations, the fulfillment of which is required of the Jewish people, and obligations, the fulfillment of which is required of all people. With rare exceptions, the obligations imposed upon the Jewish people are more stringent. The pitfall lurking in the third of the three uses is that authors using Halakhic material may incorrectly conclude that obligations that are supposed to fall only upon the Jewish people fall upon all people. An analysis of this problem follows, along with a plea for a responsible use of Halakhic material in the third way, so as to avoid certain real pitfalls.Brody, who is Director of the Center for Ethics, Medicine, and Public Issues at Baylor College of Medicine, considers several theoretical and practical issues in applying Jewish religious law (Halakhah) to problems in medical ethics. According to Halakhah, certain obligations are demanded only of Jews while others are incumbent upon all people. Brody suggests ways of avoiding the pitfalls of inappropriately applying principles derived from Halakhah to general medical ethics.

This essay challenges the view that the provision of health care must take place within a competitive-free system. The author argues that, presuming that there is a requirement to meet the demands of those who cannot pay for health care, a competitive market provides a good way to deal with injustices within the health care system. The author concludes that the demands for justice are best met when indigent individuals use some portion of the funds they receive from the government to purchase one of the many competing forms of health care. This scheme requires a competitive market in the delivery of health care.

We studied the use of do-not-resuscitate (DNR) orders at three teaching hospitals that did not have official protocols for such orders to see whether their use meets the goals (decision making before a crisis and promoting patient autonomy) that have been identified for such orders. We found that 20% of all patients had or were being considered for DNR orders, that the patient and/or family was usually involved (83%) in the decision not to resuscitate, but rarely involved (25%) in decisions to resuscitate, or in cases of no decision, that a wide range of care was provided to patients with a DNR status, and that partial resuscitative efforts would be employed in some cases. Our main conclusion in light of our findings is that DNR orders are currently not fulfilling their major goals. We offer six proposals for improving future DNR protocols. ( JAMA 1985;253:2236-2239)