http://www.biomedcentral.com/bmcmedethics/ The latest research articles published by BMC Medical Ethics 2009-11-12T00:00:00Z This is an RSS newsfeed from BioMed Central It is intended to be used with an RSS reader. For more information about RSS newsfeeds from BioMed Central, visit http://www.biomedcentral.com/info/about/rss/ Background: Multidisciplinary study groups have produced documents in an attempt to support decisions regarding whether to resuscitate "at risk" newborns or not. Moreover, there has been an increasingly insistent request for juridical regulation of neonatal resuscitation practices as well as for clarification of the role of parents in decisions regarding this kind of assistance. The crux of the matter is whether strict guidelines, reference standards based on the parameter of gestational age and authority rules are necessary.DiscussionThe Italian scenario reflects the current animated debate, illustrating the difficulty intrinsic in rigid guidelines on the subject, especially when gestational age is taken as a reference parameter for the medical decision.SummaryConcerning the decision to interrupt or not to initiate resuscitation procedures on low gestational age newborns, physicians do not need rigid rules based on inflexible gestational age and birth weight guidelines. Guidance in addressing the difficult and trying issues associated with infants born at the margins of viability with a realistic assessment of the infant's clinical condition must be based on the infant's best interests, with clinicians and parents entering into what has been described as a "partnership of care". http://www.biomedcentral.com/1472-6939/10/19 Emanuela Turillazzi Vittorio Fineschi BMC Medical Ethics 2009, 10:19 2009-11-12T00:00:00Z doi:10.1186/1472-6939-10-19 BMC Medical Ethics 1472-6939 10 19 2009-11-12T00:00:00Z XML Background: An important principle underlying the Dutch Euthanasia Act is physicians' responsibility to alleviate patients' suffering. The Dutch Act states that euthanasia and physician-assisted suicide are not punishable if the attending physician acts in accordance with criteria of due care. These criteria concern the patient's request, the patient's suffering (unbearable and hopeless), the information provided to the patient, the presence of reasonable alternatives, consultation of another physician and the applied method of ending life. To demonstrate their compliance, the Act requires physicians to report euthanasia to a review committee. We studied which arguments Dutch physicians use to substantiate their adherence to the criteria and which aspects attract review committees' attention. Methods: We examined 158 files of reported euthanasia and physician-assisted suicide cases that were approved by the review committees. We studied the physicians' reports and the verdicts of the review committees by using a checklist. Results: Physicians reported that the patient's request had been well-considered because the patient was clear-headed (65%) and/or had repeated the request several times (23%). Unbearable suffering was often substantiated with physical symptoms (62%), function loss (33%), dependency (28%) or deterioration (15%). In 35%, physicians reported that there had been alternatives to relieve patients' suffering which were refused by the majority. The nature of the relationship with the consultant was sometimes unclear: the consultant was reported to have been an unknown colleague (39%), a known colleague (21%), otherwise (25%), or not clearly specified in the report (24%). Review committees relatively often scrutinized the consultation (41%) and the patient's (unbearable) suffering (32%); they had few questions about possible alternatives (1%). Conclusion: Dutch physicians substantiate their adherence to the criteria in a variable way with an emphasis on physical symptoms. The information they provide is in most cases sufficient to enable adequate review. Review committees' control seems to focus on (unbearable) suffering and on procedural issues. http://www.biomedcentral.com/1472-6939/10/18 Hilde Buiting Johannes van Delden Bregje Onwuteaka-Philipsen Judith Rietjens Mette Rurup Donald van Tol Joseph Gevers Paul van der Maas Agnes van der Heide BMC Medical Ethics 2009, 10:18 2009-10-27T00:00:00Z doi:10.1186/1472-6939-10-18 BMC Medical Ethics 1472-6939 10 18 2009-10-27T00:00:00Z XML Background: HIV prevention research in resource-limited countries is associated with a variety of ethical dilemmas. Key amongst these is the question of what constitutes an appropriate standard of health care (SoC) for participants in HIV prevention trials. This paper describes a community-focused approach to develop a locally-appropriate SoC in the context of a phase III vaginal microbicide trial in Mwanza City, northwest Tanzania. Methods: A mobile community-based sexual and reproductive health service for women working as informal food vendors or in traditional and modern bars, restaurants, hotels and guesthouses has been established in 10 city wards. Wards were divided into geographical clusters and community representatives elected at cluster and ward level. A city-level Community Advisory Committee (CAC) with representatives from each ward has been established. Workshops and community meetings at ward and city-level have explored project-related concerns using tools adapted from participatory learning and action techniques e.g. chapati diagrams, pair-wise ranking. Secondary stakeholders representing local public-sector and non-governmental health and social care providers have formed a trial Stakeholders' Advisory Group (SAG), which includes two CAC representatives. Results: Key recommendations from participatory community workshops, CAC and SAG meetings conducted in the first year of the trial relate to the quality and range of clinic services provided at study clinics as well as broader standard of care issues. Recommendations have included streamlining clinic services to reduce waiting times, expanding services to include the children and spouses of participants and providing care for common local conditions such as malaria. Participants, community representatives and stakeholders felt there was an ethical obligation to ensure effective access to antiretroviral drugs and to provide supportive community-based care for women identified as HIV positive during the trial. This obligation includes ensuring sustainable, post-trial access to these services. Post-trial access to an effective vaginal microbicide was also felt to be a moral imperative. Conclusion: Participatory methodologies enabled effective partnerships between researchers, participant representatives and community stakeholders to be developed and facilitated local dialogue and consensus on what constitutes a locally-appropriate standard of care in the context of a vaginal microbicide trial in this setting.Trial registrationCurrent Controlled Trials ISRCTN64716212 http://www.biomedcentral.com/1472-6939/10/17 Andrew Vallely Charles Shagi Shelley Lees Katherine Shapiro Joseph Masanja Lawi Nikolau Johari Kazimoto Selephina Soteli Claire Moffat John Changalucha Sheena McCormack Richard Hayes BMC Medical Ethics 2009, 10:17 2009-10-09T00:00:00Z doi:10.1186/1472-6939-10-17 BMC Medical Ethics 1472-6939 10 17 2009-10-09T00:00:00Z XML Background: A recent paper presents an argument and mechanism for the possible stopping of clinical trials early based on opportunity costs.DiscussionAlthough we agree that the costs and opportunity costs of clinical trials need to be reduced wherever possible, we raise concerns about the motivation and mechanism for stopping clinical trials early raised by Lavery et al.SummaryWe argue that there are already enough acceptable criteria and actors in the clinical trials arena to justify early stoppage of clinical trials, and argue that factors other than efficacy need to be carefully considered, especially in developing country contexts. http://www.biomedcentral.com/1472-6939/10/16 Douglas Wassenaar Gita Ramjee BMC Medical Ethics 2009, 10:16 2009-09-30T00:00:00Z doi:10.1186/1472-6939-10-16 BMC Medical Ethics 1472-6939 10 16 2009-09-30T00:00:00Z XML Background: Assessment of capacity to consent to treatment is an important legal and ethical issue in daily medical practice. In this study we carefully evaluated the capacity to consent to treatment in patients admitted to an acute medical ward using an assessment by members of the medical team, the specific Silberfeld's score, the MMSE and an assessment by a senior psychiatrist. Methods: Over a 3 month period, 195 consecutive patients of an internal medicine ward in a university hospital were included and their capacity to consent was evaluated within 72 hours of admission. Results: Among the 195 patients, 38 were incapable of consenting to treatment (unconscious patients or severe cognitive impairment) and 14 were considered as incapable of consenting by the psychiatrist (prevalence of incapacity to consent of 26.7%). Agreement between the psychiatrist's evaluation and the Silberfeld questionnaire was poor (sensitivity 35.7%, specificity 91.6%). Experienced clinicians showed a higher agreement (sensitivity 57.1%, specificity 96.5%). A decision shared by residents, chief residents and nurses was the best predictor for agreement with the psychiatric assessment (sensitivity 78.6%, specificity 94.3%). Conclusion: Prevalence of incapacity to consent to treatment in patients admitted to an acute internal medicine ward is high. While the standardized Silberfeld questionnaire and the MMSE are not appropriate for the evaluation of the capacity to consent in this setting, an assessment by the multidisciplinary medical team concurs with the evaluation by a senior psychiatrist. http://www.biomedcentral.com/1472-6939/10/15 Sylfa Fassassi Yanik Bianchi Friedrich Stiefel Gerard Waeber BMC Medical Ethics 2009, 10:15 2009-09-02T00:00:00Z doi:10.1186/1472-6939-10-15 BMC Medical Ethics 1472-6939 10 15 2009-09-02T00:00:00Z XML Background: Much attention has been devoted to ethical issues related to randomized controlled trials for HIV treatment and prevention. However, there has been less discussion of ethical issues surrounding families involved in observational studies of HIV transmission. This paper describes the process of ethical deliberation about how best to obtain informed consent from sex partners of injection drug users (IDUs) tested for HIV, within a recent HIV study in Eastern Europe. The study aimed to assess the amount of HIV serodiscordance among IDUs and their sexual partners, identify barriers to harm reduction, and explore ways to optimize intervention programs. Including IDUs, either HIV-positive or at high risk for HIV, and their sexual partners would help to gain a more complete understanding of barriers to and opportunities for intervention.DiscussionThis paper focuses on the ethical dilemma regarding informed recruitment: whether researchers should disclose to sexual partners of IDUs that they were recruited because their partner injects drugs (i.e., their heightened risk for HIV). Disclosing risks to partners upholds the ethical value of respect for persons through informed consent. However, disclosure compromises the IDU's confidentiality, and potentially, the scientific validity of the research. Following a brief literature review, we summarize the researchers' systematic evaluation of this issue from ethical, scientific, and logistical perspectives. While the cultural context may be somewhat unique to Eastern Europe and Central Asia, the issues raised and solutions proposed here inform epidemiological research designs and their underlying ethical tensions.SummaryWe present ethical arguments in favor of disclosure, discuss how cultural context shapes the ethical issues, and recommend refinement of guidance for couples research of communicable diseases to assist investigators encountering these ethical issues in the future. http://www.biomedcentral.com/1472-6939/10/14 Louise-Anne McNutt Elisa Gordon Anneli Uuskula BMC Medical Ethics 2009, 10:14 2009-08-27T00:00:00Z doi:10.1186/1472-6939-10-14 BMC Medical Ethics 1472-6939 10 14 2009-08-27T00:00:00Z XML Background: The consent process for a genetic study is challenging when the research is conducted in a group stigmatized because of beliefs that the disease is familial. Podoconiosis, also known as 'mossy foot', is an example of such a disease. It is a condition resulting in swelling of the lower legs among people exposed to red clay soil. It is a very stigmatizing problem in endemic areas of Ethiopia because of the widely held opinion that the disease runs in families and is untreatable. The aim of this study was to explore the impact of social stigma on the process of obtaining consent for a study on the genetics of podoconiosis in Southern Ethiopia. Methods: We adapted a rapid assessment tool validated in The Gambia. The methodology was qualitative involving focus-group discussions (n = 4) and in-depth interviews (n = 25) with community members, fieldworkers, researchers and staff of the Mossy Foot Treatment and Prevention Association (MFTPA) working on prevention and treatment of podoconiosis. Results: We found that patients were afraid of participation in a genetic study for fear the study might aggravate stigmatization by publicizing the familial nature of the disease. The MFTPA was also concerned that discussion about the familial nature of podoconiosis would disappoint patients and would threaten the trust they have in the organization. In addition, participants of the rapid assessment stressed that the genetic study should be approved at family level before prospective participants are approached for consent. Based on this feedback, we developed and implemented a consent process involving community consensus and education of fieldworkers, community members and health workers. In addition, we utilized the experience and established trust of the MFTPA to diminish the perceived risk. Conclusion: The study showed that the consent process developed based on issues highlighted in the rapid assessment facilitated recruitment of participants and increased their confidence that the genetic research would not fuel stigma. Therefore, investigators must seek to assess and address risks of research from prospective participants' perspectives. This involves understanding the issues in the society, the culture, community dialogues and developing a consent process that takes all these into consideration. http://www.biomedcentral.com/1472-6939/10/13 Fasil Tekola Susan Bull Bobbie Farsides Melanie Newport Adebowale Adeyemo Charles Rotimi Gail Davey BMC Medical Ethics 2009, 10:13 2009-08-22T00:00:00Z doi:10.1186/1472-6939-10-13 BMC Medical Ethics 1472-6939 10 13 2009-08-22T00:00:00Z XML Background: Umbilical cord banks are a central component, as umbilical cord tissue providers, in both medical treatment and scientific research with stem cells. But, whereas the creation of umbilical cord banks is seen as successful practice, it is perceived as a risky style of play by others. This article examines and discusses the ethical, medical and legal considerations that arise from the operation of umbilical cord banks in Mexico.DiscussionA number of experts have stated that the use of umbilical cord goes beyond the mere utilization of human tissues for the purpose of treatment. This tissue is also used in research studies: genetic studies, studies to evaluate the effectiveness of new antibiotics, studies to identify new proteins, etc. Meanwhile, others claim that the law and other norms for the functioning of cord banks are not consistent and are poorly defined. Some of these critics point out that the confidentiality of donor information is handled differently in different places. The fact that private cord banks offer their services as "biological insurance" in order to obtain informed consent by promising the parents that the tissue that will be stored insures the health of their child in the future raises the issue of whether the consent is freely given or given under coercion. Another consideration that must be made in relation to privately owned cord banks has to do with the ownership of the stored umbilical cord.SummaryConflicts between moral principles and economic interests (non-moral principles) cause dilemmas in the clinical practice of umbilical cord blood storage and use especially in privately owned banks. This article presents a reflection and some of the guidelines that must be followed by umbilical cord banks in order to deal with these conflicts. This reflection is based on the fundamental notions of ethics and public health and seeks to be a contribution towards the improvement of umbilical cord banks' performance. http://www.biomedcentral.com/1472-6939/10/12 Moises Serrano-Delgado Barbara I Novello-Garza Edith Valdez-Martinez BMC Medical Ethics 2009, 10:12 2009-08-14T00:00:00Z doi:10.1186/1472-6939-10-12 BMC Medical Ethics 1472-6939 10 12 2009-08-14T00:00:00Z XML Background: Research participants may not adequately understand the research in which they agree to enroll. This could be due to a myriad of factors. Such a missing link in the informed consent process contravenes the requirement for an "informed" consent prior to the commencement of research. This study assessed the post consent understanding of Nigerian study participants of the oral health research they were invited to join. Methods: A descriptive cross sectional study with research participants who had just consented to one of three ongoing research studies on oral health. Study sites included two centers, one in the northern and one in the southern part of Nigeria. Data were collected using a combination of quantitative and qualitative methods. Results: A total of 113 research participants were interviewed. The southern part of the country had 58 respondents with the north having 55. The age range was 21 – 80 years. Mean age was 46.1 (SD16.3). The sample was predominantly male (69.9%) and married (64.6%). There was poor understanding of some key elements of the informed consent process such as involvement in research, benefits, contacts, confidentiality and voluntariness. Some identified factors potentially compromising understanding were poverty, illiteracy, therapeutic misconception and confusion about the dual roles of the Dentist and the researcher. Conclusion: The participants recruited into the oral health research in Nigeria did not adequately understand the studies they were invited to join nor do they understand their rights as research participants. Measures should be taken to include research bioethics into the curricula of Dental schools and to train oral health researchers in the country on research ethics. http://www.biomedcentral.com/1472-6939/10/11 Olaniyi Taiwo Nancy Kass BMC Medical Ethics 2009, 10:11 2009-08-01T00:00:00Z doi:10.1186/1472-6939-10-11 BMC Medical Ethics 1472-6939 10 11 2009-08-01T00:00:00Z XML Background: Stigma refers to a distinguishing personal trait that is perceived as or actually is physically, socially, or psychologically disadvantageous. Little is known about the opinion of those who have more or less stigmatizing health conditions regarding the need for consent for use of their personal information for health research. Methods: We surveyed the opinions of people 18 years and older with seven health conditions. Participants were drawn from: physicians' offices and clinics in southern Ontario; and from a cross-Canada marketing panel of individuals with the target health conditions. For each of five research scenarios presented, respondents chose one of five consent choices: (1) no need for me to know; (2) notice with opt-out; (3) broad opt-in; (4) project-specific permission; and (5) this information should not be used. Consent choices were regressed onto: demographics; health condition; and attitude measures of privacy, disclosure concern, and the benefits of health research. We conducted focus groups to discuss possible reasons for observed consent choices. Results: We observed substantial variation in the control that people wish to have over use of their personal information for research. However, consent choice profiles were similar across health conditions, possibly due to sampling bias. Research involving profit or requiring linkage of health information with income, education, or occupation were associated with more restrictive consent choices. People were more willing to link their health information with biological samples than with information about their income, occupation, or education. Conclusions: The heterogeneity in consent choices suggests individuals should be offered some choice in use of their information for different types of health research, even if limited to selectively opting-out. Some of the implementation challenges could be designed into the interoperable electronic health record. However, many questions remain, including how best to capture the opinions of those who are more privacy sensitive. http://www.biomedcentral.com/1472-6939/10/10 Donald Willison Valerie Steeves Cathy Charles Lisa Schwartz Jennifer Ranford Gina Agarwal Ji Cheng Lehana Thabane BMC Medical Ethics 2009, 10:10 2009-07-24T00:00:00Z doi:10.1186/1472-6939-10-10 BMC Medical Ethics 1472-6939 10 10 2009-07-24T00:00:00Z XML