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The Helsinki Declaration, adopted in 1964, became a landmark document for research ethics and for the protection of human subjects. Since then, additional complexities have emerged. The advance in biomedical research protocols and medical technologies dictates further discussion of the emerging concerns in this field. This article explores the following concerns related to research with no consent given in advance, using incompetent subjects, international participation, and the role of independent research committees.

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.

Men who pursue active treatment for metastatic prostate cancer face a choice between medical or surgical castration. While both alternatives have documented side-effects (e.g. loss of libido, breast enlargement and tenderness, hot flashes, and nausea), their psychosocial impacts are not well understood. As part of a study of patients' treatment decision making, we have sought to construct a patient-based measure of the salient disease and treatment-related qualities of life experienced by these men subsequent to treatment. Focus groups (15 with patients, two with wives) were used to develop candidate Likert scale questionnaire items representing quality of life issues that patients said were important. These items were combined with assessments of symptoms, comorbidity, and generic measures of functional status and well-being in a mail survey of patients treated at the Houston VAMC and two other Houston hospitals (n = 201, response rate = 63%). Psychometric analyses (principal components and multitrait scaling) were used to identify distinct dimensions of life quality; correlations with generic measures, and symptom reports were used in validation analyses. Qualitative analyses of focus group data identified three major domains of life quality: self-perceptions, anxiety about the effects of treatment, and concern with the process of decision making and treatment. Psychometric analyses identified nine reliable and valid indicators of prostate cancer-related quality of life: body image, sexual problems, spouse affection, spouse worry, masculinity, cancer-related self-image, cancer distress, cancer acceptance, and regret of treatment decision. Internal consistency (alpha) ranged form 0.71 to 0.90. Correlations with reference scales (e.g. MOS Mental Health Index, Profile of Mood States) and symptom status supported concurrent validity. Prostate cancer patients perceive a number of important psychosocial consequences of their treatment. These consequences are represented by nine scales comprising a brief (35 items) disease and treatment sensitive health-related quality of life instrument, which we will use in monitoring the outcomes of patients' treatment choices.

Unlike medications, the dissemination of surgical procedures into practice is not regulated. Before marketing, pharmaceutical products are required to be shown safe and efficacious in comparative clinical trials which utilize bias-reducing strategies designed to reduce the distortion of estimates of treatment effect by predispositions towards the investigational intervention or control. Unless an investigational device is involved, the corresponding process for surgical innovations is usually unregulated and therefore may not be based upon adequate evidence. Given these differences, we sought to evaluate the state of clinical research on invasive procedures. We conducted a systematic review of publications from 1999–2008 that reported the results of studies evaluating the effects of invasive therapeutic procedures, focusing on trials which appeared to influence practice. Our objective was to determine what proportion of studies evaluating surgical procedures use a comparative clinical trial design and methods to control bias. This paper reports our results and raises concerns about the methodological, and therefore the ethical, quality of clinical research used to justify the implementation of surgical procedures into practice.

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.

Can a medical ethic be developed for a liberal state? This is the issue posed by the authors of both of the works under review. Brennan in Just Doctoring thinks that the answer is yes and that his theory of just doctoring provides just such an ethic. Emanuel in The Ends of Human Life thinks that the answer is no and that an adequate resolution of the dilemmas of medical ethics requires an alternative political philosophy, liberal commun itarianism.

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.

This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical agents? This paper describes a research project aimed at examining the interplay and sometimes apparent conflict between ethical standards for human research and standards for methodological rigor in trials of invasive procedures. The paper discusses how the authors plan to develop a set of consensus standards that, if met, would result in substantial and much-needed improvements in the methodological and ethical quality of such trials.

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.

Pharmacogenetics--the effect of genotype on drug response--holds the promise of safer and more effective drug therapy. Genetic tests would be routinely given to patients prior to prescription of a drug, with therapeutic decisions based on the patient's drug-response profile. This paper examines the operational changes and the ethical, legal, and policy challenges that pharmacogenetic medicine poses for key actors in the health care system. Adaptation by drug companies, regulatory agencies, physicians, patients, insurers, and public funding agencies will be necessary to integrate pharmacogenetic medicine into health care.

The recent medical literature in the United States has contained an extensive discussion of the issue of medical futility. Inspired by cases such as that of Helen Wanglie (Angell, 1991), in which the husband of an elderly woman in a persistent vegetative state demanded continued life-prolonging interventions, clinicians and ethicists have debated whether or not patients are entitled to receive life prolonging interventions (demanded by them or the surrogates who speak for them) even when the clinicians judge those interventions to be futile. Some (Blackhall, 1987) have emphasized the objectivity of the clinical judgements that the interventions in question are futile, and have permitted physicians in such cases to unilaterally decide to limit those futile interventions. Others (Youngner, 1988) have emphasized the value-laden nature of such judgements, and have insisted that it is the patient or the family who must decide which interventions will be provided.

Over the last twenty years, considerable attention has been paid to ethical issues arising out of the provision of care in intensive care units (ICUs). This is not surprising. After all, so much of the literature of medical ethics is an attempt to evaluate the appropriateness of medical interventions (usually high-technology interventions) designed to prolong life when the effectiveness in terms of life-extension is uncertain, the resulting quality of the life prolonged is questionable, and the costs (economic and otherwise) of providing the intervention are high. This type of evaluation is particularly needed in intensive care units where, because of the severity of the patient’s illness, the outcomes are especially uncertain and questionable and the costs are extremely high.

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.

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.

n the early 199os, the National Institutes of Health (NIH) adopted a policy for the management of conflicts of interest on the part of clinical investigators (45 CFR 50.6045). This policy emphasized disclosure of potential or actual conflicts to institutional officials who would then develop strategies for managing them. The policy was adopted as an alternative to an earlier proposal that had emphasized mandated standards and mandated external disclosures.' Recent studies of the actual operation of conflict of interest policies cast doubt on the adequacy of the approach adopted by the NIH.',3 They indicate that as a result of the discretion allowed to institutional officials, there currently exist few uniform standards and very little accountability. These studies have suggested that to increase accountability, the scope of disclosure should be widened.

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

Book reviewed in this article: Morality, Mortality: Death and Whom to Save from It. By Frances Kamm.

This paper will attempt to defend the thesis that it is impossible to understand the proper role of private philanthropy in a free and democratic society without examining certain fundamental questions about the proper roles of the state and about the rights and obligations of owners of private property. It will defend that thesis by presenting arguments for four subordinate theses: (a) there are historical and philosophical reasons for being skeptical about the role of private philanthropy in a free and democratic state; (b) these reasons can be met by certain familiar responses, but these responses are not fully satisfactory; (c) certain radical libertarian views, and more moderate versions of those views, would provide a basis for an alternative understanding of the role of private philanthropy in a free and democratic state; (d) whether or not one accepts those views, one can also better understand that role if one adopts a view of the state which emphasizes its role in the promotion of the virtues.(1) Historical and Philosophical DoubtsThe skeptical challenge to the claim that there is an important role for private philanthropy in a free and democratic state can be put very simply. It is the challenge that the emergence of strong but democratic states, with the concurrent emergence of a proper understanding of the extensive nature of legitimate state functions, has undercut the need for private philanthropy and its corresponding favorable tax treatment. It is the further claim that these developments, both historical and conceptual, have left private philanthropy with no significant role.

Health care seems to be a basic need of all individuals. It goes with such other basic needs as food, clothing, and shelter. This may help explain our national commitment (in such programs as Medicaid and Medicare) to providing adequate health care for the indigent. Despite this commitment, and the great costs incurred in trying to meet it, the problem of providing adequate health care for the medically indigent (the have-nots) at an affordable cost to the taxpayers (the haves) seems to be unsolved. Some see the problem as being one of excessive costs. Some see the problem as being one of inadequate coverage; too many Americans who are medically indigent are not assured of adequate medical care. Some see the problem as being one of quality control; the medically indigent are receiving second-rate medical care. In truth, all of these problems are present. We are providing inadequate health care to an insufficient number of people at an excessive and rapidly increasing cost.

impact on women's experience of birth. Martin points out that women's ability to resist medical treatment during birth is also obviously affected by their race and their class. The Woman in the Body is a very different book than In Search of Parenthood. It sets an ideological context for women's experiences. It does not accept at face value the medical constructions of that experience, and it analyzes rather thanjust repeats women's quotations, so that the thoughts and constructions women put on their own lives are reconstructed for us in the text. Martin leaves us with a powerful set of images relating to the medical profession and to women's lived experience; a strong faith in women's resistance; and an uneasy anticipation of the future for women and birth as technology takes more and more control.

Ethical Questions Raised by the Persistent Vegetative Patient Ms. T is a twenty-eight-year-old patient diagnosed in a persistent vegetative state who has been in a hospital and/or its affiliated nursing home for the last two and one-half years. When she was twenty-five, she was in a motorcycle accident in which she suffered extensive head injuries. While she is able to breathe on her own and has some brainstem reflexes, she has been unresponsive since the time of her accident and has shown no other evidence of higher brain functioning, although she is certainly not brain dead. Most of the time she receives only nursing care: she regularly needs to have her airway suctioned to prevent secretions from blocking it, and she is regularly turned in bed to avoid bed sores. She is fed and she excretes through tubes. Her major medical needs arise from serious infections that require a careful workup and extensive antibiotic treatment. When necessary, she is transferred from the affiliated nursing home to the hospital, as was recently the case. Ms. T's parents have been devastated since their daughter's accident. Ms. T is their only child, and they had taken great pride in all of her achievements. They cannot bring themselves to accept the fact tht she will never recover. They feel certain that with full and comprehensive treatment, she can survive for years. Hoping for an eventual miracle or for some medical advance, they want this level of treatment to continue. As things stand now, the family's life centers around their regular extended daily visit, where they sit at their daughter's bedside. Often they talk to her, begging her to respond to them. The futility of the situation has been repeatedly conveyed to Ms. T's parents, but they have insisted in the past, and continue to insist in this hospitalization, that their daughter's infection be managed aggressively. They report no conversations with their daughter about these matters prior to her accident. Those who have to care for Ms. T are frustrated by the situation; they see her care as a waste of their time and a misuse of their abilities. They also feel her parents would benefit from Ms. T's death, as they then could attend to their own lives. Finally, they are worried about the cost to society of continuing to provide care to Ms. T. Since her insurance coverage expired long ago, the entire cost of Ms. T's care now falls upon a public hospital with a limited budget. The staff believes that the provision of care to many other patients is impeded because of the allocation of time and resources to Ms. T. This story is actually a composite of several real cases that I have been following for some years. The account brings together most of the special features of each case that give rise to major ethical issues. Among the most prominent issues raised by Ms. T's case are the following: (1) Regardless of how the current statutes define brain death, is this patient really dead? What are the implications of such a determination? Would that at least mean that all further care could be withdrawn? What if the parents continue to object? (2) Suppose the parents agreed with the staff that their daughter should be allowed to die. What forms of care could be withdrawn? Antibiotics? Food and fluids? (3) If the parents do not change their minds, and Ms. T does not satisfy criteria for determination of death, could care be withdrawn against the parental wishes? Could the parents be requested to find other caregivers to provide the desired level of care? Pluralistic Casuistry In thinking about serious ethical issues raised by real medical cases, it is important to ground the process of reasoning in some basic theoretical structure. The approach that seems most useful is the model of conflicting values. According to this model, there are a number of very distinct but equally legitimate and nonreducible moral appeals that need to be employed in the evaluation of a particular case. …

One of the most frustrating aspects of discussions about abortion is the way in which they rapidly turn into a discussion of the status of the foetus and of whether destroying the foetus constitutes the taking of a human life. Since these latter questions seem difficult, if not impossible, to resolve upon rational grounds, frustration results. It therefore seems desirable to find aspects of the abortion problem that can be resolved independently of the status of the foetus problem. One such possibility is the question of whether there should be a law against abortions performed by licensed physicians upon the request of the mother (or perhaps the parents). There are, after all, many people who, while opposed to abortion on the grounds that it involves the taking of a human life, maintain that it would still be wrong (or at least inappropriate) for a state to legislate against such abortions. If their claim can be shown to be right, then we could at least resolve the legal problem about abortion. This paper is an attempt to assess their claim.