Background: The increasing number of elderly people in nursing homes with failing competence to give consent represents a great challenge to healthcare staff’s protection of patient autonomy in the issues of life-prolonging treatment, hydration, nutrition and hospitalisation. The lack of national guidelines and internal routines can threaten the protection of patient autonomy. Objectives: To place focus on protecting patient autonomy in the decision-making process by studying how relatives experience their role as substitute decision-makers. Design: A qualitative descriptive design with analysis (...) of the contents of transcribed in-depth interviews with relatives. Participants: Fifteen relatives of 20 patients in 10 nursing homes in Norway. Results and Interpretations: The main findings reveal deficient procedures for including relatives in decision-making processes. Relatives have poor knowledge about the end of life, and there is little discussion about their role as substitute decision-makers for patients who are not competent to give consent. Few relatives understand the concept of patient autonomy. In Norway the treating physician is responsible for patient treatment. When relatives are included in discussions on treatment, they perceive themselves as responsible for the decision, which is a burden for them afterwards. This qualitative study describes relatives’ experiences, thus providing important information on the improvement potential with the main objective of safeguarding patient autonomy and caring for relatives. Conclusion: The study reveals failing procedures and thus a great potential for improvement. Both ethical and legal aspects must be addressed when considering patient autonomy. (shrink)

What is the basis for arguing that a volunteer army exploits citizens who lack civilian career opportunities? How do we determine that a doctor who has sex with his patients is exploiting them? In this book, Alan Wertheimer seeks to identify when a transaction or relationship can be properly regarded as exploitative--and not oppressive, manipulative, or morally deficient in some other way--and explores the moral weight of taking unfair advantage. Among the first political philosophers to examine this important topic from (...) a non-Marxist perspective, Wertheimer writes about ordinary experience in an accessible yet philosophically penetrating way. He considers whether it is seriously wrong for a party to exploit another if the transaction is consensual and mutually advantageous, whether society can justifiably prohibit people from entering into such a transaction, and whether it is wrong to allow oneself to be exploited. Wertheimer first considers several contexts commonly characterized as exploitive, including surrogate motherhood, unconscionable contracts, the exploitation of student athletes, and sexual exploitation in psychotherapy. In a section outlining his theory of exploitation, he sets forth the criteria for a fair transaction and the point at which we can properly say that a party has consented. Whereas many discussions of exploitation have dealt primarily with cases in which one party harms or coerces another, Wertheimer's book focuses on what makes a mutually advantageous and consensual transaction exploitive and analyzes the moral and legal implications of such exploitation. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

In a provocative 1974 article entitled “Harvesting the Dead,” Willard Gaylin explored potential uses of “neomorts,” or what are currently referred to as “heart-beating cadavers”—that is, humans determined to be dead by neurological criteria and whose cardiopulmonary function is medically maintained by ventilators, vasopressors, and so forth. Medical research was one of the potential uses Gaylin identified. He pointed out that tests of drugs and medical procedures that would have unacceptable health risks if performed on living human subjects could be (...) performed on neomorts without any health risks. According to Gaylin, the potential benefits of such research could be enormous, including not subjecting patients to ineffective or harmful medical procedures and eliminating delays in providing effective therapies to dying patients. (shrink)

Many commentators have expressed concern that large investments in biomedical research over the past two decades have not been translated effectively into clinical applications. In its Critical Path Report, the Food and Drug Administration characterized the problem as a “technological disconnect between discovery and the product development process,” and documented that the number of investigational new drugs submitted to the agency had declined “significantly” since 2000. Along a similar vein, another study found that only five of 101 basic science studies (...) showing significant therapeutic promise were successfully translated into clinical applications.This perceived translational lag is stimulating a shift toward human testing of study interventions earlier in the drug development process. One indication of this trend is a recent guidance encouraging sponsors to pursue human “exploratory” studies before embarking on phase I trials. (shrink)

If people sometimes participate in research because of altruism—because they want to help in the search for treatments—should we revise our views about what kinds of experiments are ethical? If participants act out of altruism, we might let them accept greater risks than we would if they are motivated only by a desire for personal gain. But how can we know when participants are genuinely altruistic?

In the literature on medical ethics, it is generally admitted that vulnerable persons or groups deserve special attention, care or protection. One can define vulnerable persons as those having a greater likelihood of being wronged – that is, of being denied adequate satisfaction of certain legitimate claims. The conjunction of these two points entails what we call the Special Protection Thesis. It asserts that persons with a greater likelihood of being denied adequate satisfaction of their legitimate claims deserve special attention, (...) care or protection. Such a thesis remains vague, however, as long as we do not know what legitimate claims are. This article aims at dispelling this vagueness by exploring what claims we have in relation to health care – thus fleshing out a claim-based conception of vulnerability. We argue that the Special Protection Thesis must be enriched as follows: If individual or group X has a greater likelihood of being denied adequate satisfaction of some of their legitimate claims to physical integrity, autonomy, freedom, social provision, impartial quality of government, social bases of self-respect or communal belonging, then X deserves special attention, care or protection. With this improved understanding of vulnerability, vulnerability talk in healthcare ethics can escape vagueness and serve as an adequate basis for practice. (shrink)

Despite its title, Alan Wertheimer’s new book is not another tiresome exploration of Marxist economic theories. Indeed, there is virtually no extended discussion of Marxism at all, since Wertheimer believes that what is unique to that perspective is highly problematic, given that when Marxists simply assert that capitalists do exploit wage laborers they are appealing to “the ordinary notion that one party exploits another when it gets unfair and undeserved benefits from its transactions or relationships with others”. His goal is (...) to analyze this ordinary sense of exploitation, to explore in detail some of the many forms it can take, and to begin some serious thinking about what he terms its moral weight and its moral force. This groundbreaking work, the first book-length treatment of its subject from a broadly analytic standpoint, should do much to disabuse non-Marxist philosophers of the notion that exploitation is largely peripheral to the central questions of moral and political philosophy. (shrink)

The concept of vulnerability has long played a central role in discussions of research ethics. In addition to its rhetorical use, vulnerability has become a term of art in U.S. and international research regulations and guidelines, many of which contain specific provisions applicable to research with vulnerable subjects. Yet, despite the frequency with which the term vulnerability is used, little consensus exists on what it actually means in the context of human subject protection or, more importantly, on how a finding (...) of vulnerability should affect the process of research ethics review.The Common Rule, the centerpiece of the U.S. human subject protection regulations, uses the word vulnerable three times. First, it provides that institutional review boards that regularly review research involving a vulnerable category of subjects should consider including one or more individuals who are knowledgeable about and experienced in working with these subjects. (shrink)

People in extraordinary situations are vulnerable. As research participants, they are additionally threatened by abuse or exploitation and the possibility of harm through research. To protect people against these threats, informed consent as an instrument of self-determination has been introduced. Self-determination requires autonomous persons, who voluntarily make decisions based on their values and morals. However, in nursing research, this requirement cannot always be met. Advanced age, chronic illness, co-morbidity and frailty are reasons for dependencies. These in turn lead to limited (...) abilities or opportunities for decision-making and self-determination. Exclusion of vulnerable people from research projects would disadvantage them by not covering their needs, which would violate the ethical principles of justice and beneficence. Commonly, vulnerability is attributed to social groups. The consequence for individuals, attributed as belonging to such a vulnerable group, is that the principles of respect for autonomy, justice and beneficence are subordinated to the principle of non-maleficence, understood as avoiding the risk to cause more harm than good. In addition, group-specific attribution could lead to stigmatizing because labelling a person as deviation from a norm violates integrity. For clinical nursing research, the question arises how the protection of vulnerable people could be granted without compromising ethical principles. The concept of relational ethics provides a possible approach. It defines vulnerability as the relation between a person’s health status and the extent to which this person is dependent on the researcher and the research context. Vulnerability is not attributed solely to a person but to a situation, meaning the person is viewed in context. By combining vulnerability as a context-related and situational concept with existing approaches of informed consent, the different ethical principles can be balanced and preserved at every step of the research process. (shrink)

In 2008, researchers reported that Timothy Brown , a man with HIV infection and leukemia, received a stem-cell transplant that removed HIV from his body as far as can be detected. In 2013, an infant born with HIV infection received anti-retroviral treatment shortly after birth, but was then lost to the health care system for the next six months. When tested for HIV upon return, the child had no detectable viral load despite cessation of treatment. These remarkable clinical developments have (...) helped reinvigorate the field of ‘HIV cure’ research. (shrink)

Interest and excitement surround the possibility of developing measures that produce sustained or permanent HIV remission in infected individuals. First-in-human (FIH) trials are one step in exploring this possibility. Initial human trials raise the usual ethical issues associated with human research, and a set of distinct issues. Because the potential direct benefits to FIH trial volunteers will be either small or non-existent, trial risks must be justified by the social value of the information the trials are expected to produce. To (...) minimise and justify risks, researchers must have solid preclinical evidence that FIH trials will be safe and produce information relevant to human health improvements. Researchers must also adopt adequate study safeguards to protect FIH subjects. An ethically defensible study population must be selected as well. (shrink)

Research uses of human bodies maintained by mechanical ventilation after being declared dead by neurological criteria, were first published in the early 1980s with a renewed interest in research on the newly or nearly dead occurring in about last decade. While this type of research may take many different forms, recent technologic advances in genomic sequencing along with high hopes for genomic medicine, have inspired interest in genomic research with the newly dead. For example, the Genotype-Tissue Expression program through the (...) National Institutes of Health aims to collect large numbers of diverse human tissues with the eventual goal of elucidating the genetic bases of common diseases through a better understanding of the relationship between genetic variation and gene expression. (shrink)

Reigning regulatory frameworks for biomedical research impose on researchers and research ethics committees an obligation to protect research participants from risks that are unnecessary, disproportionate to potential research benefits, and non-minimized. Where the research has no potential to produce results of direct benefit to the subjects and the subjects are unable to give consent, these requirements are strengthened by an additional condition, that risks should not exceed a certain minimal threshold. In this article, I address the question of whether there (...) should be limits of permissible risks in non-therapeutic research involving competent and healthy subjects. Some commentators argue that competent and informed individuals should have a right to participate even in extremely risky research and that research ethics committees should never reject studies because they are too dangerous. To use David Shaw's expression, competent volunteers should have ‘a right to participate in high-risk research’. I argue that this idea is ill-founded, as it does not take into account the social mission and complex collaborative nature of research practice as well as the inequity of power between researchers and subjects. Imposition of limits on permissible risks for healthy volunteers is justified by the need to protect research enterprise and the need to protect the weaker party, namely the subjects. Also, I suggest that the best way to set boundaries on research risks is to leave the judgment of risk acceptability to research ethics committees. (shrink)

The question "When are research risks reasonable in relation to anticipated benefits?" is at the heart of disputes in the ethics of clinical research. Institutional review boards are often criticized for inconsistent decision-making, a problem that is compounded by a number of contemporary controversies, including the ethics of research involving placebo controls, developing countries, incapable adults and emergency rooms. If this pressing ethical question is to be addressed in a principled way, then a systematic approach to the ethics of risk (...) in research is required. Component analysis provides such a systematic approach. (shrink)

Background: Brain-dead humans retain many of the physiologic functions of living humans, but they are legally dead and cannot be physically harmed by participation in research. Stakeholder opinions...

First-in-human clinical trials represent a critical juncture in the translation of laboratory discoveries. However, because they involve the greatest degree of uncertainty at any point in the drug development process, their initiation is beset by a series of nettlesome ethical questions [1]: has clinical promise been sufficiently demonstrated in animals? Should trial access be restricted to patients with refractory disease? Should trials be viewed as therapeutic? Have researchers adequately minimized risks? The resolution of such ethical questions inevitably turns on claims (...) about future events like harms, therapeutic response, and clinical translation. Recurrent failures in clinical translation, like Eli Lilly's Alzheimer candidate semagacestat, highlight the severe limitations of current methods of prediction. In this case, patients in the active arm of the placebo-controlled trial had earlier onset of dementia and elevated rates of skin cancer [2]. Various authoritative accounts of human research ethics state that decision-making about risk and benefit should be careful, systematic, and non-arbitrary [3]–[5]. Yet, these sources provide little guidance about what kinds of evidence stakeholders should use to ensure their estimates of such events ground responsible ethical decisions. In this article, we suggest that investigators, oversight bodies, and sponsors often base their predictions on a flawed and inappropriately narrow preclinical evidence base. (shrink)

Rapid tissue donation (RTD) is an advancing oncology research procedure for collecting tumors, metastases, and unaffected tissue 2–6 h after death. Researchers can better determine rates of progression, response to treatment, and polymorphic differences among patients. Cancer patients may inquire about posthumous body donation for research to offer a personal contribution to research; however, there are barriers to recruiting for an RTD program. Physicians must reassure the patient that their treatment options and quality of care will not be compromised due (...) to participating in RTD. In this commentary we discuss how theories of altruism may explain cancer patients’ desire to participate in an RTD program, the ethical concerns of health care professionals and patients and the use of altruism as a recruitment strategy. We offer recommendations for examining the cultural and ethical climate of the institution prior to initiating such a program such as examining the relationship of healthcare professionals and patients, identifying ethical concerns, and examining ways to promote acceptance and buy-in across professionals, patients, and families. (shrink)