Health Care Ethics Consortium of Georgia ...ethics in action

The objectives of the study are to understand the current practice of informed consent in medical research in public hospitals in Shanghai, and to share our views with other countries, especially developing countries.

In the study, 145 consent forms (CFs) of the selected research projects in eight public hospitals with ethics committees in Shanghai were audited, and the principle investigators (PIs) of these research projects and 40 student subjects who had participated in clinical drug tests were surveyed by questionnaires.

The CFs of medical researches in public hospitals with ethics committees in Shanghai were generally acceptable. However, there were some defects in the CFs. Although most of the surveyed PIs had correct recognition of informed consent, some processes of informed consent were not in accordance with generally accepted requirements. A large number of the PIs considered the greatest difficulty with informal consent was lack of correct recognition of subjects or legally authorised representatives on medical research.

Informed consent in medical research should consider the research ethics, the background of potential subjects, the local resources and culture of medical research. In addition, special protection is needed for student subjects in informed consent as well as efforts for building and restoring the public's trust in biomedical research.

The informed consent in Shanghai's public hospitals with ethics committees was generally acceptable and the achievement of adequate informed consent is influenced by many factors.

To evaluate whether the requirement of "minimal risk and burden" for paediatric research without direct benefit to the subjects compromises the ability to obtain data necessary for improving paediatric care. To provide evidence-based reflections on the EU recommendation that allows for a higher level of risk.

Systematic analysis of the approval/rejection decisions made by the Dutch Central Committee on Research involving Human Subjects (CCMO).

The analysis included 165 proposals for paediatric research without direct benefit that were reviewed by the CCMO between January, 2000, and July, 2007. A separate, in-depth analysis of all drug studies included 18 early phase drug studies and nine other drug studies without direct benefit.

11 out of 165 studies were definitively rejected because the CCMO did not regard the risk and/or burden to be minimal. In three of these 11 cases (including two early phase drug studies) the requirement of minimal risk and burden was cited as the only reason for rejection. Four other early phase drug studies also involved risks and/or burdens that were not regarded to be minimal but were nevertheless approved.

The requirement of minimal risk and burden, aiming to protect research subjects, occasionally leads to rejection of protocols. Early phase drug studies relatively often do not comply with the requirement. Committees may find ways to approve important studies that formally should be rejected, but that is not a desirable solution. The regulatory framework should be revised to make such occasional exceptions to the requirement legitimate and transparent.

Conducting ethically sound research is a fundamental principle of scientific inquiry. Recent research has indicated that ethical concerns are insufficiently dealt with in dissertations.

To examine which research ethical topics were addressed and how these were presented in terms of complexity of reasoning in Swedish nurses' dissertations.

Analyses of ethical content and complexity of ethical reasoning were performed on 64 Swedish nurses' PhD dissertations dated 2007.

A total of seven ethical topics were identified: ethical approval (94% of the dissertations), information and informed consent (86%), confidentiality (67%), ethical aspects of methods (61%), use of ethical principles and regulations (39%), rationale for the study (20%) and fair participant selection (14%). Four of those of topics were most frequently addressed: the majority of dissertations (72%) included 3–5 issues. While many ethical concerns, by their nature, involve systematic concepts or metasystematic principles, ethical reasoning scored predominantly at lesser levels of complexity: abstract (6% of the dissertations), formal (84%) and systematic (10%).

Research ethics are inadequately covered in most dissertations by nurses in Sweden. Important ethical concerns are missing, and the complexity of reasoning on ethical principles, motives and implications is insufficient. This is partly due to traditions and norms that discount ethical concerns but is probably also a reflection of the ability of PhD students and supervisors to handle complexity in general. It is suggested that the importance of ethical considerations should be emphasised in graduate and post-graduate studies and that individuals with capacity to deal with systematic and metasystematic concepts are recruited to senior research positions.

The full disclosure of all locations at which research is conducted is an important requirement of clinical trial registration. Yet, little is known about how well researchers and sponsors disclose this information in their registrations. The aim of this study is to examine the adequacy of study location disclosure on http://ClinicalTrials.gov/ for recent USA-sponsored research in the Russian Federation.

Information from advertisements for clinical research participation opportunities in Russia was compared with that in the corresponding trial registration in http://ClinicalTrials.gov/. Of 218 USA-sponsored trials advertised to Russian patients and physicians, nearly one-third did not disclose Russia as a study location in the registration. Longer trials were more likely to specify Russia as a study location.

This study found that recent USA-sponsored clinical trials advertised to patients and physicians in the Russian Federation often do not specify Russia as a study location in their registrations on http://ClinicalTrials.gov/. The failure to fully disclose the locations at which research takes place undermines patients' ability to access information about potentially beneficial research opportunities, limits access to information, which may be important for identifying or avoiding ethically questionable practices, and may frustrate the ability to interpret the results of research.

We analyse the system of ethical review of human research in the Baltic States by introducing the principle of equivalent stringency of ethical review, that is, research projects imposing equal risks and inconveniences on research participants should be subjected to equally stringent review procedures. We examine several examples of non-equivalence or asymmetry in the system of ethical review of human research: (1) the asymmetry between rather strict regulations of clinical drug trials and relatively weaker regulations of other types of clinical biomedical research and (2) gaps in ethical review in the area of non-biomedical human research where some sensitive research projects are not reviewed by research ethics committees at all. We conclude that non-equivalent stringency of ethical review is at least partly linked to the differences in scope and binding character of various international legal instruments that have been shaping the system of ethical review in the Baltic States. Therefore, the Baltic example could also serve as an object lesson to other European countries which might be experiencing similar problems.

This paper examines some ethical issues arising from whole-genome association studies for multigenic diseases, focusing on the case of autism. Events occurring following the announcement of a genetic test for autism in France (2005–2009) are described to exemplify the ethical controversies that can arise when genetic testing for autism is applied prematurely and inappropriately promoted by biotech companies. The authors argue that genetic tests assessing one or a few genes involved in highly multigenic disorders can only be useful if: (1) the genetic linkage found in the scientific study must be statistically convincing, reproducible and also applicable to the population to which the individual considered belongs (scientific validity); (2) the relative risk conferred by the ‘high-risk’ allele should be high enough to be significant to the patient (significant impact); (3) use of the test should lead to some improvement of outcome for the patient, resulting from adapted treatment if available, or at least from adjustment of lifestyle (or life goals) prompted by the new knowledge generated (clinical utility). Decisions concerning genetic testing for autism involve scientific judgement, value judgement and good knowledge of a constantly evolving therapeutic environment. The implementation of genetic tests for highly multigenic diseases thus requires strong mechanisms to ensure that they are used in a fashion that can benefit patients, and these mechanisms must be able to cope with rapid progress in scientific knowledge and therapeutic intervention.

Medical conferences are organised by professional bodies with a view to providing an opportunity of continuing medical education and improving the practices of medical professionals. Of late these events have degenerated into entertainment extravaganzas and no longer remain pure academic exercises. This article discusses the possible reasons behind the current state of decay and mechanisms to improve the state of affairs.

The development of cancer therapies is a long and arduous process. Because it can take several years for a cancer agent to pass clinical testing and be approved for use, terminal cancer patients rarely have the time to see these experimental therapies become widely available. For most terminal cancer patients the only opportunity they have to access an experimental drug that could potentially improve their prognosis is by joining a clinical trial. Unfortunately, several aspects of clinical trial methodology that are set in place in order to optimise drug development for the benefit of future generations of cancer patients, pose significant limitations to current patient participation. Therefore, several terminal cancer patients believe that they should have the right to access experimental agents that have passed initial safety testing without having to participate in clinical trials. However, granting off-trial access to patients could be detrimental to the scientific process of drug development, and thus could pose significant risks to the health of future patients relying on sound research. Examining this matter through two divergent ethical lenses, rights-based ethics and communitarian ethics, may provide new insight into the issues surrounding the balance between the autonomous rights of current terminal cancer patients, and the needs of future patients and the values of society.

In theory, physicians subscribe to and in their actions personify a set of virtues whose performance demands personal engagement. At the same time, they are instructed in their professional roles to remain emotionally and personally distant from those they are called to treat. The result, the authors argue, is an ethical conflict whose nature is described through an analysis of two narratives drawn from an online blog for young physicians. Confusion over professional responsibilities and personal roles were found to affect physicians' perceptions of their clinical duties and their social roles. In addition, it sets in sharp relief contemporary debates on physician training and the ethical nature of medical professionalism. Practically, the authors suggest, the confusion may contribute to early physician burnout. Methodologically, this paper promotes the use of online discussion sites as rich repositories providing an insight into real dilemmas and the actual perception of physicians' attempts to address them. It thus promotes use of such sites as a resource in which assumptions about physicians' own perceptions about the nature of their role in contemporary society can be tested.

Caster Semenya, a South African 18-year-old, won the 800-metre track running title at the Berlin World Athletics Championships in 2009. Only 3 h later, her gender was being harshly contested. The investigation of the International Association of Athletics Federations (IAAF) was neither discreet nor respectful of her privacy. Caster's case has implications for the ethics of sports and debates about gender and enhancement, and for the philosophical debate about the nature of categories and the classification of people. The IAAF has not disclosed the results of their tests on Caster, and the South African Ministry of Sport has decreed that in any case she can continue running with women in her own country. But could a scientific or medical test offer uncontroversial answers regarding Caster's gender? The concept of ‘gender’ is partly a social construction. The authors argue that ethics may guide science and medicine at addressing such questions.

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.

In 1992, Eluana Englaro was involved in a car accident in Italy that eventually left her in a permanent vegetative state requiring artificial nutrition and hydration. This paper, after briefly reviewing Eluana's case, gives a chronicle of Eluana last months until her death on 9 February 2009, and discusses the right-to-die controversy in Italy. For many years, Mr Englaro, Eluana's father, would litigate to enforce what he considered to be his daughter's wish to discontinue life-prolonging treatment. In July 2008, the Court of Appeal of Milan has given its authorisation for artificial life support to be withdrawn. This ruling sparked a crusade, led by the government and the Vatican, against the court and Eluana's father, which included insinuations that the latter was murdering his daughter. Public opinion has overwhelmingly been sympathetic to the father's difficult decision, in stark contrast to the reactionary stance taken by the government. With the notable advances of medicine, doctors are increasingly faced with ethical issues. The vegetative state is just one of the many clinical conditions that obligate health professionals to reflect on ethical matters. The withdrawal of life-supporting care, and of artificial nutrition and hydration in particular in permanent vegetative state patients remains a measure which violates a tradition and a consolidated practice. It was thus inevitable that it would create great controversy. We should work towards making a decision process that ensures that continuation or suspension of artificial nutrition and hydration follows an explicit procedure, promoting the sharing and respect of the diverse moral responsibility of family members, nursing and medical staff.

In The Netherlands, it is openly acknowledged that the parents' ability to take care of their child plays a role in the decision-making process over administration of life-prolonging treatment to severely defective newborn babies. Unlike other aspects of such decision-making process up until the present time, the ‘ability to take care’ has not received specific attention in regulation or in empirical research. The present study is based on interviews with neonatologists in two Dutch NICUs concerning their definition of the ability to take care and its relevance in non-treatment decisions. All of the respondents think that the ability to take care consists of more than one factor. Most doctors mention the parents' emotional state, social network and cognitive abilities. Some doctors mention the presence of psychological conditions in the parents, their financial situation and physical condition. A few refer to the parents' experience and age, their chances to have another baby and their cultural background. Most doctors think the ability to take care has a secondary relevance in the decision-making process, while the primary concern is assessing the condition of the child. A substantial minority thinks the ability to take care does not play any role, while one doctor thinks it is a factor of primary importance. The study constitutes an important stepping-stone for future research in The Netherlands and elsewhere.

Infectious and parasitic diseases cause massive health problems in the developing world. Research and development of drugs for diseases that mainly affect poor people in developing countries is limited. The advance market commitment (AMC) idea is an incentivising mechanism for research and development of drugs for neglected diseases. Discussion of the AMC idea is of renewed interest given the launch in June 2009 of the first AMC. This pilot AMC is designed to, among other things, test the idea for potential future applications. This paper is a critique of the AMC idea. It seeks to show that the idea has a hitherto unrecognised theoretical flaw that should make policy-makers and donors hesitant to embrace future applications of the idea.

To evaluate the modes of death and treatment offered in the last 24 h of life to patients dying in 10 Brazilian intensive care units (ICUs) over a period of 2 years.

Cross-sectional, multicentre, retrospective study based on medical chart review. The medical records of all patients that died in seven paediatric and three adult ICUs belonging to university and tertiary hospitals over a period of 2 years were included. Deaths in the first 24 h of admission to the ICU and brain death were excluded.

Two intensive care fellows of each ICU were trained in fulfilling a standard protocol (=0.9) to record demographic data and all medical management provided in the last 48 h of life. The Student t test, Mann–Whitney U test, 2 test and RR were used for data comparison.

1053 medical charts were included (59.4% adult patients). Life support limitation was more frequent in the adult group (86% vs 43.5%; p<0.001). A ‘do not resuscitate’ order was the most common life support limitation in both groups (75% and 66%), whereas withholding/withdrawing were more frequent in the paediatric group (33.9% vs 24.9%; p=0.02). The life support limitation was rarely reported in the medical chart in both groups (52.6% and 33.7%) with scarce family involvement in the decision making process (23.0% vs 8.7%; p<0.001).

Life support limitation decision making in Brazilian ICUs is predominantly centred on the medical perspective with scarce participation of the family, and consequently several non-coherent medical interventions are observed in patients with life support limitation.

The medical decision-making process is currently in flux. Decisions are no longer made entirely at the physician's discretion: patients are becoming more and more involved in the process. There is a great deal of discussion about the ideal of ‘informed consent’, that is that diagnostic and therapeutic decisions should be made based on an interaction between physician and patient. This means that patients are informed about the advantages and disadvantages of a treatment as well as alternatives to the treatment; then, based on this information they can decide whether or not they want to undergo the treatment. However, recent studies show that the realisation of the ideal of ‘shared decision-making’ faces a number of difficulties related to the fact that patients are not provided with complete and accurate information. Using the example of breast cancer screening, this article examines the question of whether, in light of these difficulties, the ideal of informed decision-making is only an illusion or whether concrete steps can be taken towards the realisation of this ideal.

The ‘right to the truth’ involves disclosing all the pertinent facts to a patient so that an informed decision can be made. However, this concept of a ‘right to the truth’ entails certain ambiguities, especially since it is difficult to apply the concept in medical practice based mainly on current evidence-based data that are probabilistic in nature. Furthermore, in some situations, the doctor is confronted with a moral dilemma, caught between the necessity to inform the patient (principle of autonomy) and the desire to ensure the patient's well-being by minimising suffering (principle of beneficence). To comply with the principle of beneficence as well as the principle of non-maleficence ‘to do no harm’, the doctor may then feel obliged to turn to ‘therapeutic privilege’, using lies or deception to preserve the patient's hope, and psychological and moral integrity, as well as his self-image and dignity. There is no easy answer to such a moral dilemma. This article will propose a process that can fit into reflective practice, allowing the doctor to decide if the use of therapeutic privilege is justified when he is faced with these kinds of conflicting circumstances. We will present the conflict arising in practice in the context of the various theoretical orientations in ethics, and then we will suggest an approach for a ‘practice of truth’. Last, we will situate this reflective method in the broader clinical context of medical practice viewed as a dialogic process.

This article describes the issues encountered when designing a study to evaluate recruitment of minority ethnic groups into clinical cancer research in order to monitor adherence to the principles for good practice set out in the Department of Health, Research Governance Framework, England.

(i) A review of routine data sources to determine whether their usefulness as a source of data on prevalence of cancer in the population by ethnic category. (ii) A local case study at one hospital trust to ascertain whether the ethnicity of cancer trial participants was representative of admitted cancer patients.

(i) The lack of a comparator population makes it problematic to assess recruitment levels by ethnic group in clinical research. (ii) The odds of being in a trial were 30% lower for a member of a minority ethnic group compared to a white cancer patient after adjusting for disease, age and gender, OR 0.70 (0.53 to 0.94). These results differed for each ethnic group; Asian patients did not appear under-represented while Black and Chinese did so. However, there are important caveats to the findings based on the limited recording of ethnicity.

The lack of available data on the ethnicity of participants in clinical research and the prevalence of cancer in the population according to ethnicity makes it difficult to design a study to monitor representation of minority ethnic groups. This information is necessary to assess adherence to the Research Governance Framework principle that research evidence reflects the diversity of the population.