Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now (...) are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)

Most of the literature on phase one trials has focused on ethical and safety issues in research on patients with advanced cancer, but this article focuses on healthy, adult subjects. The article makes six specific recommendations for protecting the rights and welfare of healthy subjects in phase one trials: 1) because phase one trials are short in duaration (usually 1 to 3 months), researchers should gather more data on the short-term and long-term risks of participation in phase one studies by (...) healthy subjects; 2) researchers should develop strict inclusion/exclusion criteria that exclude unhealthy or vulnerable subjects, such as decisionally impaired people, in phase one studies; 3) subjects should not participate in more than one phase one study at the same time and should wait at least 30 days between participating in different studies; 4) researchers should develop a database to keep track of phase one participants; 5) subjects should be guaranteed a minimum wage equivalent to the equivalent type of unskilled labor, but there should be no upper limits on wages; and 6) subjects should be allowed to engage in collective bargaining with research sponsors. *Disclaimer: The ideas and opinions expressed in this article are the authors' personal views and do not represent the views of the National Institute of Environmental Health Sciences, the National Institutes of Health, or the United States government. (shrink)

The furore over the retention of organs at postmortem examination, without adequate consent, has led to a reassessment of the justification for, and circumstances surrounding, the retention of any human material after postmortem examinations and operations. This brings into focus the large amount of human material stored in various archives and museums, much of which is not identifiable and was accumulated many years ago, under unknown circumstances. Such anonymous archival material could be disposed of, used for teaching, used for research, (...) or remain in storage. We argue that there are no ethical grounds for disposing of the material, or for storing it in the absence of a teaching or research rationale. Nevertheless, with stringent safeguards, it can be used even in the absence of consent in research and teaching. Regulations are required to control the storage of all such human material, along the lines of regulations governing anatomy body bequests. (shrink)

If one believes that the brain is, in some as yet unspecified way, the organ of mind and behaviour, then all human behaviour has a neurobiological basis. Neuroscience research over the past several decades has provided more specific reasons for believing that many addictive phenomena have a neurobiological basis. The major psychoactive drugs of dependence have been shown to act on neurotransmitter systems in the brain (Nutt 1997; Koob 2000); common neurochemical mechanisms underlie many of the rewarding effects of these (...) drugs and the phenomena of tolerance and withdrawal symptoms (Hyman & Malenka 2001; Koob 2000), and there is evidence for a genetic vulnerability to addiction (Nestler 2001; Uhl 1999) that is mediated by genes that regulate the metabolism of psychoactive drugs and the brain neurotransmitter systems on which they act (Uhl 1999). (shrink)

Traffic research shares a fundamental dilemma with other areas of empirical research in which humans are potentially put at risk. Research is justified because it can improve safety in the long run. Nevertheless, people can be harmed in the research situation. Hence, we need to balance short-term risks against long-term safety improvements, much as in other areas of research with human subjects. In this paper we focus on ethical issues that arise when human beings are directly affected in the performance (...) of research by examining how the ethical requirements in biomedical research can inform traffic research. After introducing the basic ethical requirements on biomedical research, each of the major requirements is discussed in relation to traffic research. We identify the main areas where biomedical research and traffic research differ, and where the ethical requirements from the former cannot easily be transferred to the latter. Finally, we argue that there is a need for systematic studies of the ethics of traffic research and point to some of the issues that need to be addressed. (shrink)

This paper attempts to provide a broader view into the ethical issues surrounding the field of emergency medicine (EM) research. It starts from defining bioethically relevant features of EM and presents this field in the context of different models of health care provider–patient relationship. The paper also provides a short overview of the “post-Nuremberg” evolution of the main international research ethics guidelines relevant to EM research which demonstrates a tendency of liberalization of research on incapable persons. This tendency culminates with (...) the exceptions to informed consent for EM research which is supposed to be balanced by other research ethics principles, especially a careful rationing of risks and benefits. This finally brings us towards a critical analysis of the minimal risk standard which is one of the main fundamental safeguards in EM research. (shrink)

Conflicts of interest are receiving increased attention in medical research, clinical practice and education. Criticism of, and penalties for, conflicts of interest have been insufficiently discussed and have been applied without adequate conceptual backing. Genuine conflicts of interest are situations in which alternative courses of action are ethically equivalent, decision-making being less a matter of moral deliberation than of personal weighing of interest. In contrast, situations usually thought of as conflicts of interest are mostly temptations to follow an attractive but (...) undue option that causes harm by failing to uphold well-entrenched ethical standards. Examples of moral quandaries that pose as ethically neutral conflicts of interest are healthcare providers enticed to favour certain products; patients being referred to non-therapeutic trials entailing risks and non-optimal healthcare; industry-supported scientists failing to deliver unbiased research results and reports or participating in ghost-writing; and sponsored educators who praise their supporters beyond objective evidence. All these are moral blemishes, where integrity gives way to material incentives at the cost of provoking risky and harm-producing situations, thus constituting false conflicts of interest when they are in fact ethical misdemeanours. Disclosure has been the most widely recommended response to avoid the concealment of conflicting and ethically suspect interests. Regulations regarding disclosure reveal a utilitarian stance that shows more concern for the magnitude of support or sponsorship than for the underlying ethical transgression. Education and oversight should directly address and help correct the moral attitude towards undue influence of inducements and marketing strategies falsely posing as conflicts of interest. (shrink)

Time and communication are important aspects of the medical consultation. Physician behavior in real-life pediatric consultations in relation to ethical practice, such as informed consent (provision of information, understanding), respect for integrity and patient autonomy (decision-making), has not been subjected to thorough empirical investigation. Such investigations are important tools in developing sound ethical praxis.

Clinical and research practices designed by developed countries are often implemented in host nations of the Third World. In recent years, a number of papers have presented a diversity of arguments to justify these practices which include the defence of research with placebos even though best proven treatments exist; the distribution of drugs unapproved in their country of origin; withholding of existing therapy in order to observe the natural course of infection and disease; redefinition of equipoise to a more bland (...) version, and denial of post-trial benefits to research subjects. These practices have all been prohibited in developed, sponsoring countries, even though they invariably have pockets of poverty where conditions comparable to the Third World prevail. Furthermore, the latest update of the Declaration of Helsinki clearly decries double ethical standards in research protocols. Under these circumstances, it does not seem appropriate that First World scholars should propose and defend research and clinical practices with less stringent ethical standards than those mandatory in their own countries. Recent years have witnessed frequent reports of less stringent ethical standards being applied to both clinical and research medical practices, for the most part in the field of drug trials and drug marketing, initiated by developed countries in poorer nations. Still more unsettling, a number of articles have endorsed the policy of employing ethical norms in these host countries, which would be unacceptable to both the legislations and the moral standards of the sponsor nations. Also, these reformulations often contravene the Declaration of Helsinki or one of its updates. This paper is not so much concerned with the actual practices, which have been subjected to frequent scrutiny and publicly decried when gross misconduct occurred. Rather, my concern relates to the approval and support such practices have found in the literature on bioethics from authors who might be expected to use their energy and scholarship to explore and endorse the universalisability of ethics rather than to develop ad hoc arguments that would allow exceptions and variations from accepted moral standards. To this purpose, issue will be taken with arguments in three fields: medical and pharmaceutical practices, research strategies, and local application of research results. (shrink)

Little is known about how researchers view ethically salient aspects of human studies. As part of a National Institutes of Mental Health-funded study, the authors performed a confidential written survey to assess the attitudes, views, and experiences of researchers with institutional review board approved protocols at the University of New Mexico. A total of 363 researchers (57% response rate) participated. Investigators overall held favorable views of general ethical aspects of research and ethics-based safeguards, and they identified a positive role of (...) ethics training. Investigators with more experience encountering ethical problems (p < .001), more ethics training (p = .001), and a PhD or MD/PhD (p = .003) held more favorable general ethical perspectives. Women investigators (p < .03), nonphysician investigators (p < .001), those whose training had been helpful in resolving ethical dilemmas (p = .006), and those for whom spirituality is important (p = .008) more strongly endorsed ethical safeguards. Investigators perceive the scientific and ethical aspects of their work as valuable and linked, and they affirm the role of safeguards in human studies. Formal ethics preparation and training initiatives were also viewed positively by investigators. (shrink)

(2003). The Ethics and Governance of Medical Research: What does regulation have to do with morality? New Review of Bioethics: Vol. 1, No. 1, pp. 41-58.

Research to improve the health of pregnant and fetal patients presents ethical challenges to clinical investigators, institutional review boards, funding agencies, and data safety and monitoring boards. The Common Rule sets out requirements that such research must satisfy but no ethical framework to guide their application. We provide such an ethical framework, based on the ethical concept of the fetus as a patient. We offer criteria for innovation and for Phase I and II and then for Phase III clinical trials (...) to improve the health of pregnant patients and of fetal patients and also criteria to responsibly manage the transition from investigation to clinical practice. Basing ethical criteria for research involving pregnant women on the ethical concept of the fetus as a patient insulates the proposed ethical framework and therefore research on pregnant women from the divisive and politicized concepts and discourses of personhood, fetal rights, and unborn child. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of (...) this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

The highly publicized deaths of research participants Ellen Roche and Jesse Gelsinger are stark reminders that risk is inherent in medical research and while untoward outcomes are infrequent when compared to individual and societal benefits, injury and even death will happen. Who is responsible for the welfare of research subjects and what are they owed? Why were they put at risk to begin with? Are obligations, if any, to research subjects dependent on the type of study in which they participate, (...) in recognition that there may be personal benefit from participation in some studies?The issue of injury resulting from participation in research and answers to questions such as those just posed were last considered in depth nearly 20 years ago by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. (shrink)

Complementary and alternative medicine is used by many in hopes of achieving important health-related goals. Survey data indicate that 42 percent of the U.S. population uses CAM, accounting for 629 million “office” visits a year and expenditures of 27 billion dollars. This high prevalence of use calls for a careful evaluation of CAM so as to ensure the well-being of those using its modalities. Such an evaluation would obviously include assessments of the safety and efficacy of particular approaches, the training (...) and integrity of practitioners, and the appropriateness of modalities for different conditions or uses. Given the lack of published data concerning many of these aspects of CAM, the likely unfamiliarity of its practitioners to the approaches available to clinicians practicing modern scientific medcine, and the need to respect the unique preferences of persons seeking assistance with achieving health-related goals, it is also important to assess the potential roles of informed consent for the use of CAM. Examining such roles is the central task of this paper. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim (...) of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

Reproductive counseling includes counseling of prospective parents by obstetricians, clinical geneticists, and genetic counselors regarding, for example, the use of assisted reproductive technologies, prenatal testing, and preimplantation genetic diagnosis. Two different views on wisdom and the goal of reproductive counseling are analyzed. According to the first view, the goal of reproductive counseling is to help prospective parents reach a wise decision. A specific course of action is recommended by the counselor in contrast to other possible alternatives. According to the second (...) view, the goal of reproductive counseling is not to help prospective parents reach a wise decision but to help them reach their own decision wisely. It is the prospective parents who should make the decision, and it is their value commitments that should be decisive. It is argued that the second approach is to be preferred to the first. It combines respect for autonomy with a recognition of the need for assistance in decision-making. Both the first and second views relate the goal of reproductive counseling to wisdom. A problem is, however, what wisdom more precisely means — there are many different views. A casuistic view of wisdom is investigated. This view roughly defines wisdom as practical prudence in dealing with particular cases. What characterizes a casuistic decision-making method is elaborated in more detail. Applied to the second view, a casuistic view of wisdom implies that the counselor should encourage prospective parents to take into consideration the nature of the particular problem at hand, the context of the problem, their own individual identities, their personal value commitments, and various alternative perspectives, values and arguments. (shrink)

This article addresses the impact of the potential conflict between the roles of physicians who are both clinicians and researchers on the recruitment of persons into research trials. It has been proposedthat a physician breaches inter-role confidentiality when he or she uses information gathered in his or her clinical role to inform patients about trials for which they may be eligible and that clinician-researchers should adopt a model of preliminary consent to be approached about research prior to commencing a clinical (...) relationship. This article argues that even if we grant the legitimacy of inter-role confidentiality (which is open to question), there are circumstances in which other obligations physicians bear override the obligation of inter-role confidentiality. Moreover, it is argued that the practice of preliminary consent is morally suspect and that such consent cannot be deemed valid. The article concludes with a series of recommendations of ways in which the legitimate concern regarding the conflicting roles of clinician-researchers can be addressed in the recruitment stage of research. (shrink)

There is a growing interest in ethical competence-building within nursing and health care practising. This tendency is accompanied by a remarkable growth of ethical guidelines. Ethical demands have also been laid down in laws. Present-day practitioners and researchers in health care are thereby left in a virtual cross-fire of various legislations, codes, and recommendations, all intended to guide behaviour. The aim of this paper was to investigate the role of ethical guidelines in the process of ethical competence-building within health care (...) practice and medical research. A conceptual and critical philosophical analysis of some paragraphs of the Helsinki Declaration and of relevant literature was performed. Three major problems related to ethical guidelines were identified, namely, the interpretation problem (there is always a gap between the rule and the practice, which implies that ethical competence is needed for those who are to implement the guidelines); the multiplicity problem (the great number of codes, declarations, and laws might pull in different directions, which may confuse the health care providers who are to follow them); and the legalisation problem (ethics concerns may take on a legal form, where ethical reflection is replaced by a procedure of legal interpretations). Virtue ethics might be an alternative to a rule based approach. This position, however, can turn ethics into a tacit knowledge, leading to poorly reflected and inconsistent ethical decisions. Ethical competence must consist of both being (virtues) and doing (rules and principles), but also of knowing (critical reflection), and therefore a communicative based model is suggested. (shrink)

In the field of bioethics, scholars have begun to consider carefully the impact of structural issues on global population health, including socioeconomic and political factors influencing the disproportionate burden of disease throughout the world. Human rights and social justice are key considerations for both population health and biomedical research. In this paper, I will briefly explore approaches to human rights in bioethics and review guidelines for ethical conduct in international health research, focusing specifically on health research conducted in resource-poor settings. (...) I will demonstrate the potential for addressing human rights considerations in international health research with special attention to the importance of collaborative partnerships, capacity building, and respect for cultural traditions. Strengthening professional knowledge about international research ethics increases awareness of ethical concerns associated with study design and informed consent among researchers working in resource-poor settings. But this is not enough. Technological and financial resources are also necessary to build capacity for local communities to ensure that research results are integrated into existing health systems. Problematic issues surrounding the application of ethical guidelines in resource-poor settings are embedded in social history, cultural context, and the global political economy. Resolving the moral complexities requires a commitment to engaged dialogue and action among investigators, funding agencies, policy makers, governmental institutions, and private industry. (shrink)

Objectives: To determine the effects of risk and payment on subjects’ willingness to participate, and to examine how payment influences subjects’ potential behaviours and risk evaluations.Methods: A 3 × 3 , between subjects, completely randomised factorial design was used. Students enrolled at one of five US pharmacy schools read a recruitment notice and informed consent form for a hypothetical study, and completed a questionnaire. Risk level was manipulated using recruitment notices and informed consent documents from hypothetical biomedical research projects. Payment (...) levels were determined using the payment models evaluated by Dickert and Grady as a guide. Five dependent variables were assessed in the questionnaire: willingness to participate, willingness to participate with no payment, propensity to neglect to tell about restricted activities, propensity to neglect to tell about negative effects, and risk rating.Results: Monetary payment had positive effects on respondents’ willingness to participate in research, regardless of the level of risk. However, higher monetary payments did not appear to blind respondents to the risks of a study. Payment had some influence on respondents’ potential behaviours regarding concealing information about restricted activities. However, payment did not appear to have a significant effect on respondents’ propensity to neglect to tell researchers about negative effects.Conclusions: Monetary payments appear to do what they are intended to do: make subjects more willing to participate in research. Concerns about payments blinding subjects to risks could not be substantiated in the present study. However, the findings do raise other concerns—notably the potential for payments to diminish the integrity of a study’s findings. Future research is critical to make sound decisions about the payment of research subjects. (shrink)

Decisions by industry sponsors to end clinical trials early for commercial reasons have been the subject of controversy. I argue that the principal consideration in assessing these decisions ought to be the way in which the termination would affect the trial’s risk–benefit relationship. If there is not yet sufficient benefit to be gained from the study to offset the risks to which participants were exposed and it is expected that important scientific information would be obtained if the trial were continued, (...) early termination constitutes an unethical alteration of the risk−benefit relationship. This violates the grounds on which permission is given to conduct human research, patients consent to participate, and investigators agree to conduct studies. These knowable and avoidable changes in risk–benefit relationship should generally be seen as impermissible. (shrink)

Medical Genetics is a relatively new field of scientific work that involves a lot of enthusiastic professionals, both in routine (clinical) and research (scientific projects). In either field, different geneticists feel different responsibilities for their work, either because they are different people (personal responsibility) or because they have a different rank in the respective departments (professional responsibility). This paper presents the philosophical views of several authors on the sense of responsibility from the Classical times until the present and reveals the (...) practical, daily responsibilities that are met by these professionals, in four areas of responsibility: personal, professional, scientific and sociatal framework. (shrink)

Human research is accepted in our society because it is seen as generating valuable new knowledge that may alleviate suffering and bring benefit to ill persons now and in the future (Brody 1998; Fa...

This paper deals with ethical issues of particular relevance to longitudinal research involving children. First some general problems concerning information and lack of understanding are discussed. Thereafter focus is shifted to issues concerning information and consent procedures in studies that include young children growing up to become autonomous persons while the project still runs. Some of the questions raised are: When is it right to include children in longitudinal studies? Is an approval from the child needed? How should information to (...) children be handled? A general point stressed is that autonomy considerations underline the importance of adjusting the information given to meet demands. A “presumption of competence” may be needed in research involving children, in order to pay their views sufficient attention. (shrink)