VULNERABILITY IN RESEARCH AND HEALTH CARE; DESCRIBING THE ELEPHANT IN THE ROOM?

Despite broad agreement that the vulnerable have a claim to special protection, defining vulnerable persons or populations has proved more difficult than we would like. This is a theoretical as well as a practical problem, as it hinders both convincing justifications for this claim and the practical application of required protections. In this paper, I review consent-based, harm-based, and comprehensive definitions of vulnerability in healthcare and research with human subjects. Although current definitions are subject to critique, their underlying assumptions may be complementary. I propose that we should define vulnerability in research and healthcare as an identifiably increased likelihood of incurring additional or greater wrong. In order to identify the vulnerable, as well as the type of protection that they need, this definition requires that we start from the sorts of wrongs likely to occur and from identifiable increments in the likelihood, or to the likely degree, that these wrongs will occur. It is limited but appropriately so, as it only applies to special protection, not to any protection to which we have a valid claim. Using this definition would clarify that the normative force of claims for special protection does not rest with vulnerability itself, but with pre-existing claims when these are more likely to be denied. Such a clarification could help those who carry responsibility for the protection of vulnerable populations, such as Institutional Review Boards, to define the sort of protection required in a more targeted and effective manner.     

Weaponizing Principles: Clinical Ethics Consultations & the Plight of the Morally Vulnerable

Internationally, there is an on‐going dialogue about how to professionalize ethics consultation services (ECSs). Despite these efforts, one aspect of ECS‐competence that has received scant attention is the liability of failing to adequately capture all of the relevant moral considerations in an ethics conflict. This failure carries a high price for the least powerful stakeholders in the dispute. When an ECS does not possess a sophisticated dexterity at translating what stakeholders say in a conflict into ethical concepts or principles, it runs the risk of naming one side's claims as morally legitimate and decrying the other's as merely self‐serving. The result of this failure is that one side in a dispute is granted significantly more moral weight and authority than the other. The remedy to this problem is that ECSs learn how to expand the diagnostic moral lens they employ in clinical ethics conflicts.     

Enriching the concept of vulnerability in research ethics: An integrative and functional account

The concept of vulnerability is widely used in research ethics to signal attention to participants who require special protections in research. However, this concept is vague and under‐theorized. There is also growing concern that the dominant categorical approach to vulnerability (as exemplified by research ethics regulations and guidelines delineating vulnerable groups) is ethically problematic because of its assumptions about groups of people and is, in fact, not very guiding. An agreed‐upon strategy is to move from categorical towards analytical approaches (focused on analyzing types and sources of vulnerability) to vulnerability. Beyond this agreement, however, scholars have been advancing competing accounts of vulnerability without consensus about its appropriate operationalization in research ethics. Based on previous debates, we propose that a comprehensive account of vulnerability for research ethics must include four components: definition, normative justifications, application, and implications. Concluding that no existing accounts integrate these components in a functional (i.e., practically applicable) manner, we propose an integrative and functional account of vulnerability inspired by pragmatist theory and enriched by bioethics literature. Using an example of research on deep brain stimulation for treatment‐resistant depression, we illustrate how the integrative‐functional account can guide the analysis of vulnerability in research within a pragmatist, evidence‐based approach to research ethics. While ultimately there are concerns to be addressed in existing research ethics guidelines on vulnerability, the integrative‐functional account can serve as an analytic tool to help researchers, research ethics boards, and other relevant actors fill in the gaps in the current landscape of research ethics governance.     

Relationships and burden: An empirical‐ethical investigation of lived experience in home nursing arrangements

Quantitative research has called attention to the burden associated with informal caregiving in home nursing arrangements. Less emphasis has been placed, however, on care recipients’ subjective feelings of being a burden and on caregivers’ willingness to carry the burden in home care. This article uses empirical material from semi‐structured interviews conducted with older people affected by multiple chronic conditions and in need of long‐term home care, and with informal and professional caregivers, as two groups of relevant others. The high burden of home‐care arrangements is unanimously stressed by all three groups involved in the triangle of care. An empirical‐ethical investigation of what can be legitimately expected from family members and informal caregivers, informed by Frith's symbiotic empirical ethics approach, was undertaken. Key tenets from the special goods theory and nursing professionalism are used as analytical tools. The study concludes that the current situation may hinder professional development and can reinforce feelings of being a burden to relevant others.     

The vulnerable and the susceptible

Human beings are essentially vulnerable in the view that their existence qua humans is not given but constructed. This vulnerability received basic protection from the State, expressed in the form of the universal rights all citizens are meant to enjoy. In addition, many individuals fall prey to destitution and deprivation, requiring social action aimed at recognising the specific harms they suffer and providing remedial assistance to palliate or remove their plights. Citizens receive protection against their biologic vulnerability by means of an in rem right to health [care], which is more an attitude of protection than a specific programme. When individuals become susceptible, that is, biologically weak or diseased, they also increase their predisposition to additional harm, and require social actions to treat their demeaned condition. Such assistance takes the form of positive healthcare rights. Research on human beings has been slow to observe that the subjects recruited are susceptible, especially so if research is done in less developed countries. By mislabelling them as vulnerable--a characteristic they share with all humans--sponsors avoid registering the deprivation these people suffer, and the ethical obligation to offer them remedial help. The distinction between vulnerability and susceptibility also marks the difference between being intact but fragile--vulnerable--and being injured and predisposed to compound additional harm--susceptible. Awareness of this difference should give additional force to the rejection of double standards in research ethics.     

Statement on Cancer Cures by the Cancer Commission of the C.M.A

In recent months there has been a recrudescence in the daily press of claims for certain alleged cancer cures. Most of these receive the scant attention which they deserve and are soon forgotten. A few receive sensational publicity and are a source of considerable distress, both psychic and economic, to patients with cancer. In order to bring up to date the opinion of the Cancer Commission on this general question, it was resolved at the regular meeting of the Commission held in Los Angeles, May 1951, that a suitable statement bearing on this subject be prepared and issued to the press or to interested persons. The following is the statement as approved by the Commission:     

The death of dignity is greatly exaggerated: Reflections 15 years after the declaration of dignity as a useless concept

Fifteen years ago, Ruth Macklin shook the medical community with her claim in the BMJ that dignity is a useless concept. Her essay provoked a storm of reactions. What have we learned from the debate? In this article I analyse the responses to her essay and the following debate to investigate whether she was right that “[d]ignity is a useless concept in medical ethics and can be eliminated without any loss of content.” While some of the commentaries misconstrued her claim and argue against strawmen, others forcefully maintained that the concept of dignity has functions beyond “respect for persons and their autonomy.” One important point that came out of the debate is that dignity is a generic concept that covers more ground than “respect for persons or their autonomy.” In particular, dignity seems to have a wide range of protective functions as well as having reciprocal, relational, and social aspects. Dignity appears more attributional and norm-formative than respect for persons and autonomy. While the claim that dignity is unclear, vague, and can be used sloganistically seems highly relevant, it is argued that this vagueness fulfils important functions in ethics. Moreover, dismissing dignity because of its lack of clarity has implications for “respect for persons” and “autonomy,” which are also used vaguely and sloganistically. No doubt medical ethics should use as a clear concept as the context requires. Nonetheless, dignity still seems to be a widely used generic concept in ethical debates and doing as much ethical work as “respect for persons” or “respect for autonomy.” Therefore, the death of dignity seems to be greatly exaggerated.     

Research in the ranks: vulnerable subjects, coercible collaboration, and the hepatitis E vaccine trial in Nepal

Concern over the diminished autonomy of members of the armed forces has resulted in the classification of these groups as "vulnerable" in many international codes of research ethics, a designation that places the onus on researchers to provide special justification for the inclusion of these persons in research. This paper examines the application of these ethical requirements to a recent trial carried out by U.S. Army researchers among soldiers of the Royal Nepal Army (RNA) and concludes that the requirements to justify conducting research in this population were not met. Furthermore, noting the human rights abuses rampant in the RNA, it is appropriate to question the choice of this institution as both a partner and a subject pool for U.S. state-sponsored research. This case study raises another important ethical question about the vulnerability to coerced collaboration of groups or institutions. In response, I propose the idea of "institutional vulnerability" as an extension of the idea of individual "juridic vulnerability." The recent military and financial assistance that the RNA received from the U.S. Army, in light of their partnership in this biomedical research trial, constitutes an appropriate and revealing context in which to ground this discussion.     

Bioethics andCara Sui

Cara sui (care of the self) is a guiding thread in Foucault's later writings on ethics. Following Foucault in that inquiry, we are urged beyond our fairly superficial conceptions of consequences, harms, benefits, and the rights of persons, and led to examine ourselves and try to articulate the sense of life that animates ethical reasoning. The result is a nuanced understanding with links to virtue ethics and post-modern approaches to ethics and subjectivity. The approach I have articulated draws on the phenomenology of Levinas and Heidegger, the Virtue ethics of Baier, and the post-structuralist writing of Michel Foucault. The subject is seen as negotiable, embodied, provisional and able to be transformed in a way that denies essentialism about human beings, their moral status, and the idea of the good. The human being emerges as responsible because, properly, responsive to the context of discourse in which morality becomes articulated. When we import this style of thinking into bioethics we find that it reaches beyond issues of policy or right conduct and allows us to use the biomedical sciences and the clinical world to revise and interrogate our understanding of ourselves and the theoretical foundations of health care ethics.     

Kwaliteit van leven bij dementie

Different definitions of quality of life (QOL) are found in the literature. This raised the question which domains are viewed as really important by persons with dementia. In an explorative study the opinions of persons with dementia (community-dwelling and living in nursing homes), were compared to those of professional carers and instruments for QOL in dementia. Data were gathered through interviews, focus groups and literature study. Most QOL-domains mentioned as important by persons with dementia were also acknowledged by carers and in measurement instruments. Some domains, however, were not mentioned by the carers (‘sense of aesthetics’, ‘financial situation’, ‘being useful’ and ‘spirituality’), or not selected in the measuring instruments (‘security and privacy’, ‘self-determination and freedom’, ‘being useful’ and ‘spirituality’). This indicates differences in perspectives on quality of life between persons with dementia, professional caregivers and researchers. Subsequently it was studied to what degree professionals focus on the QoL-domains that persons with dementia consider essential. Caregivers working on 29 units and 3 day care facilities of 13 nursing homes and in 12 meeting centers filled out a questionnaire (N=374). They reported to focus at least to some degree on most domains considered important by persons with dementia. However, little attention was paid to the domains ‘financial situation’ and ‘being useful’. Professionals offering daytime activities focused more than 24-hour care staff on ‘attachment’, ‘enjoyment of activities’, ‘sense of aesthetics’, and ‘being useful’ This article is a translation and merging of 1) Dröes et al. Quality of life in dementia in perspective; an explorative study of variations in opinions among people with dementia and their professional caregivers, and in literature. Dementia: The International Journal 2006; 5 (4): 533–558, and 2) Gerritsen et al. Differences in perspective: do professional caregivers focus on the Quality of life domains that are important for people with dementia? American Journal of Alzheimer’s Disease and Other Dementias 2007; 22:176–183.     

心内科住院患者人性化护理问题的分析与对策研究

目的：探讨心内科实施人性化护理的问题及产生问题的原因,寻找有效的解决措施。这对提高护理质量,有效保证住院患者的安全,促进住院患者身心健康有重要意义,同时,也为临床护理提供依据。方法：对我院2011年1月-2011年3月心内科住院患者进行护理满意度和护理需求问卷调查。结果：调查数据显示,实施人性化护理患者的满意度为89．86％,较2010年有较大的提高。导致患者不满意的原因依次为护患沟通不足、护理人员专业素质差、护理人员缺乏经验和个别护理人员职业道德低下。根据患者需求调查数据显示,患者在病房环境、个人隐私尊重与保护、服务态度、医疗技术操作水平及职业道德5个方面还有较大需求。结论：人性化护理对改善医患关系,提高护理安全,促进患者的身心健康有积极的作用。依据调查的患者需求量,人性化护理还需要有针对性的改进和提高。     

Out-of-Pocket Payments,Health Care Access and Utilisation in South-Eastern Nigeria: A Gender Perspective

Out-of-pocket (OOP) payments have severe consequences for health care access and utilisation and are especially catastrophic for the poor. Although women comprise the majority of the poor in Nigeria and globally, the implications of OOP payments for health care access from a gender perspective have received little attention. This study seeks to fill this gap by using a combination of quantitative and qualitative analysis to investigate the gendered impact of OOPs on healthcare utilisation in south-eastern Nigeria. 411 households were surveyed and six single-sex Focus Group Discussions conducted. This study confirmed the socioeconomic and demographic vulnerability of female-headed households (FHHs), which contributed to gender-based inter-household differences in healthcare access, cost burden, choices of healthcare providers, methods of funding healthcare and coping strategies. FHHs had higher cost burdens from seeking care and untreated morbidity than male-headed households (MHHs) with affordability as a reason for not seeking care. There is also a high utilisation of patent medicine vendors (PMVs) by both households (PMVs are drug vendors that are unregulated, likely to offer very low-quality treatment and do not have trained personnel). OOP payment was predominantly the means of healthcare payment for both households, and households spoke of the difficulties associated with repaying health-related debt with implications for the medical poverty trap. It is recommended that the removal of user fees, introduction of prepayment schemes, and regulating PMVs be considered to improve access and provide protection against debt for FHHs and MHHs. The vulnerability of widows is of special concern and efforts to improve their healthcare access and broader efforts to empower should be encouraged for them and other poor households.     

Healthcare systems and motivation

Despite the fact that most American physicians, at least until around the 1970s, stood in the way of developing a universal healthcare system, most are generally not happy with the current state of healthcare--or its lack thereof--today. The primary reasons for this general unhappiness are that insurance companies and managed care have successfully conspired to remove much of the physician's autonomy (via imposed time constraints, burdensome paperwork, the time-consuming chore of having to defend going against stringent treatment algorithms that are often inappropriate for some patients) and the satisfaction of knowing their patients. Few physicians in managed care organizations (MCOs) are able to practice without constant and blindly algorithmic interference concerning the diagnostic tests and therapeutic interventions they order. As copayments have increased, they often find that patients, even though "covered," cannot afford the therapy they deem necessary. While physicians expect to earn sufficient to pay back their not insignificant educational debts, provide their children with help through college, and assure retirements sufficient for themselves and their spouses, these should not be considered unreasonable expectations. Most physicians today do favor universal healthcare -- to the point of having included such language in their various professional codes of ethics (which, perversely enough, bioethicists as a group have failed to do). Contrary to the claims of our colleagues, Altom and Churchill, physicians seem to be genuinely frustrated as to what else they can do to change the current inequitable system.     

Biometrical Genetics with One or Two Loci: The Inheritance of Physiological Characters in Mice

Maximum likelihood methods have been used to compare the fit of twenty different genetic models to experimental data on fourteen characters, each measured on two parental strains, F(1) hybrids and both backcrosses. Although variation in all characters was continuous, differentiation between the various models was meaningful, the mean likelihood ratio between the best and worst models for each character being greater than 10(4). Models with only one or two loci were adequate to account for the observed genetic variation in eleven of the fourteen characters. These results indicate that even in species without special genetic advantages, it may be possible to identify individually some of the genes responsible for naturally-occurring variation within the range of normality.     

Making the health care system 'safe' for persons with HIV infection or AIDS.

If health care reform is implemented in states and nationally, the safety of this process needs to be examined for persons with human immunodeficiency virus (HIV) infection or the acquired immunodeficiency syndrome (AIDS). Reform should assure ongoing prevention and transmission control of HIV and continuous coverage of medical costs for persons ill with HIV or AIDS. These persons currently benefit from various state and federal categoric programs designed to assure access to preventive and personal care services. Washington State has passed health care reform legislation that envisions integrating these programs to provide a system of population-based and personal health care. This legislation was analyzed using existing epidemiologic and entitlement information about persons with HIV infection or AIDS in the state to assess its effect. The relationship between public health and personal care services will be a central concern for those with HIV infection or AIDS, and complete coverage of this group may be achieved relatively late in the process of implementing health care reform. Health personnel planning under health care reform will affect the delivery of HIV- and AIDS-related services. Including treatment of AIDS in the basic benefit package merits particular attention. These issues parallel those being faced by the nation as a whole as it seeks to ensure epidemic disease control and compassionate care for long-term disabling illness if health care reform is implemented.     

Factors regulating endogenous retroviral sequences in human and mouse

Endogenous retroviruses (ERVs) are stably integrated in the genome of vertebrates and inherited as Mendelian genes. The several human ERV (HERV) families and related elements represent up to 5-8% of the DNA of our species. ERVs may be involved in the regulation of adjacent genomic loci, especially promoting the tissue-specific expression of genes; some HERVs may have functional roles, e.g., coding for the placental fusogenic protein, syncytin. This paper reviews the growing evidence about factors that may modulate ERVs, including: cell and tissue types (with special attention to placenta and germ cells), processes related to differentiation and aging, cytokines, agents that disrupt cell functions (e.g., DNA hypomethylating agents) and steroids. Special attention is given to HERVs, due to their possible involvement in autoimmunity and reproduction, as well as altered expression in some cancer types; moreover, different HERV families may deserve specific attention, due to remarkable differences concerning, e.g., expression in tissues. A comparison with factors interacting with murine ERV-related sequences indicates that the mouse may be a useful model for studying some patterns of HERV regulation. Overall, the available evidence identifies the diverse, potential interactions with endogenous or exogenous factors as a promising field for investigating the roles of ERVs in physiology and disease.     

患者满意评价指数模型研究

医院是社会文明服务的窗口,医德医风关系到医院和医务人员自身的声誉。患者对于医疗服务的满意度对医院的生存和发展有着重要影响,随着医疗机构之间的竞争愈演愈烈,医疗服务的满意研究受到了更多的重视。患者的满意度与医院忠诚度二者是相辅相成的关系,只有满意的患者才能成为医院的忠诚顾客,再通过这些忠诚顾客的口碑影响其他患者,医院的形象才能得以提升。目前医院患者的满意研究出现了一个特殊的现象：对各类病人的满意研究得出了高的满意率,但社会对医院服务的强烈批评却屡见不鲜。本文分析了目前患者满意评价体系存在的问题,并以服务管理领域顾客满意理论为指导,通过分析患者满意的影响要素以及各要素的相互关系,探讨医院患者满意评价模型构建方法。     

Zorgzame vrienden en buren als mantelzorgers van oudere volwassenen: een vergelijking met kinderen

This study compared informal care to older, non-coresiding adults provided by friends and neighbours and informal care by children or their partners. Using data from a Dutch representative survey among informal caregivers conducted by CBS and SCP, caregivers of friends (n=133), neighbours (n=108) and parents (n=1,008) were compared with one another to investigate care that friends and neighbours provide to the elderly non-coresiding adults (age 55 and over). Nine percent of those providing care to someone outside the household were friends and nine percent were neighbours. Friends, like children, usually provide long-lasting care, up to four or five years. Friends are similar to neighbours in the number of hours that they provide care. Friends and neighbours experience a lower caregiver burden than children. However, when fulfilling multiple caring tasks, both friends and children, have a greater chance of experiencing higher levels of burden. When there were other caregivers to help, friends experienced a small reduction in burden. Friends and neighbours deserve to be recognized as informal caregivers by policy makers and they deserve attention and support along with family caregivers.     

Association between obesity and patient satisfaction

Objective: To examine the relationship between BMI and patient satisfaction with health care providers using a nationally representative survey. Research Methods and Procedures: This analysis examined the 9914 adult patients who completed the 2000 Medical Expenditure Panel Survey and had visited a health care provider within 12 months of the survey. Linear regression models were employed with patient satisfaction as the dependent variable. The patient satisfaction scale was based on ratings from five questions assessing the quality of provider interactions. The independent variable was BMI, with adjustments for the domains of demographics, social‐economic status, health attitudes and behavior, health status, and health care use. BMI (weight in kilograms/square of height in meters) was classified as normal weight (18.5 to 24.9), overweight (25.0 to 29.9), or obese (≥30.0). Hierarchical models were used to evaluate how each domain modified the BMI‐satisfaction association. Results: Obese patients reported significantly greater satisfaction with their health care providers than their normal‐weight counterparts did (p < 0.05). There were no significant differences in satisfaction between normal‐weight and overweight patients or between overweight and obese patients. The health status domain produced the largest modification in the BMI‐satisfaction relationship. Examination of interaction effects revealed that the association between BMI and satisfaction was confined to older persons. Discussion: In this nationally representative sample of individuals, obese persons were more satisfied than their normal‐weight counterparts. This finding counters those of previous studies. Incomplete adjustments for health care use and insurance status may have led to those conclusions.