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BMC Medical Ethics

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https://www.readbyqxmd.com/read/28629343/comparative-effectiveness-research-what-to-do-when-experts-disagree-about-risks
#1
Reidar K Lie, Francis K L Chan, Christine Grady, Vincent H Ng, David Wendler
BACKGROUND: Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Committees (ERCs) should evaluate the risks of comparative effectiveness research. MAIN TEXT: We discuss what has been a prominent focus in the debate about comparative effectiveness research, namely that it is justified when "nothing is known" about the comparative effectiveness of the available alternatives...
June 19, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28599638/development-of-a-consensus-operational-definition-of-child-assent-for-research
#2
Alan R Tait, Michael E Geisser
BACKGROUND: There is currently no consensus from the relevant stakeholders regarding the operational and construct definitions of child assent for research. As such, the requirements for assent are often construed in different ways, institutionally disparate, and often conflated with those of parental consent. Development of a standardized operational definition of assent would thus be important to ensure that investigators, institutional review boards, and policy makers consider the assent process in the same way...
June 9, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28583175/are-advance-directives-helpful-for-good-end-of-life-decision-making-a-cross-sectional-survey-of-health-professionals
#3
Eimantas Peicius, Aurelija Blazeviciene, Raimondas Kaminskas
BACKGROUND: This paper joins the debate over changes in the role of health professionals when applying advance directives to manage the decision-making process at the end of life care. Issues in relation to advance directives occur in clinical units in Lithuania; however, it remains one of the few countries in the European Union (EU) where the discussion on advance directives is not included in the health-care policy-making agenda. To encourage the discussion of advance directives, a study was designed to examine health professionals' understanding and preferences related to advance directives...
June 5, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28569156/how-chinese-clinicians-face-ethical-and-social-challenges-in-fecal-microbiota-transplantation-a-questionnaire-study
#4
Yonghui Ma, Jinqiu Yang, Bota Cui, Hongzhi Xu, Chuanxing Xiao, Faming Zhang
BACKGROUND: Fecal microbiota transplantation (FMT) is reportedly the most effective therapy for relapsing Clostridium Difficile infection (CDI) and a potential therapeutic option for many diseases. It also poses important ethical concerns. This study is an attempt to assess clinicians' perception and attitudes towards ethical and social challenges raised by fecal microbiota transplantation. METHODS: A questionnaire was developed which consisted of 20 items: four items covered general aspects, nine were about ethical aspects such as informed consent and privacy issues, four concerned social and regulatory issues, and three were about an FMT bank...
May 31, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28558751/a-14-day-limit-for-bioethics-the-debate-over-human-embryo-research
#5
Giulia Cavaliere
BACKGROUND: This article explores the reasons in favour of revising and extending the current 14-day statutory limit to maintaining human embryos in culture. This limit is enshrined in law in over a dozen countries, including the United Kingdom. In two recently published studies (2016), scientists have shown that embryos can be sustained in vitro for about 13 days after fertilisation. Positive reactions to these results have gone hand in hand with calls for revising the 14-day rule, which only allows embryo research until the 14th day after fertilisation...
May 30, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28545519/staff-s-normative-attitudes-towards-coercion-the-role-of-moral-doubt-and-professional-context-a-cross-sectional-survey-study
#6
Bert Molewijk, Almar Kok, Tonje Husum, Reidar Pedersen, Olaf Aasland
BACKGROUND: The use of coercion is morally problematic and requires an ongoing critical reflection. We wondered if not knowing or being uncertain whether coercion is morally right or justified (i.e. experiencing moral doubt) is related to professionals' normative attitudes regarding the use of coercion. METHODS: This paper describes an explorative statistical analysis based on a cross-sectional survey across seven wards in three Norwegian mental health care institutions...
May 25, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28539111/written-versus-verbal-consent-a-qualitative-study-of-stakeholder-views-of-consent-procedures-used-at-the-time-of-recruitment-into-a-peripartum-trial-conducted-in-an-emergency-setting
#7
J Lawton, N Hallowell, C Snowdon, J E Norman, K Carruthers, F C Denison
BACKGROUND: Obtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrolment followed, later, by obtaining written consent, have been advocated by some clinicians and bioethicists but have received little empirical attention. We explored women's and staff views about the consent procedures used during the internal pilot of a trial (GOT-IT), where the protocol permitted staff to gain verbal consent at recruitment...
May 24, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28506267/a-qualitative-study-on-acceptable-levels-of-risk-for-pregnant-women-in-clinical-research
#8
Indira S E van der Zande, Rieke van der Graaf, Martijn A Oudijk, Johannes J M van Delden
BACKGROUND: There is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as a case-study...
May 15, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28494760/the-picture-talk-project-starting-a-conversation-with-community-leaders-on-research-with-remote-aboriginal-communities-of-australia
#9
E F M Fitzpatrick, G Macdonald, A L C Martiniuk, H D'Antoine, J Oscar, M Carter, T Lawford, E J Elliott
BACKGROUND: Researchers are required to seek consent from Indigenous communities prior to conducting research but there is inadequate information about how Indigenous people understand and become fully engaged with this consent process. Few studies evaluate the preference or understanding of the consent process for research with Indigenous populations. Lack of informed consent can impact on research findings. METHODS: The Picture Talk Project was initiated with senior Aboriginal leaders of the Fitzroy Valley community situated in the far north of Western Australia...
May 11, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28476115/self-tests-for-influenza-an-empirical-ethics-investigation
#10
Benedict Rumbold, Clare Wenham, James Wilson
BACKGROUND: In this article we aim to assess the ethical desirability of self-test diagnostic kits for influenza, focusing in particular on the potential benefits and challenges posed by a new, mobile phone-based tool currently being developed by i-sense, an interdisciplinary research collaboration based (primarily) at University College London and funded by the Engineering and Physical Sciences Research Council. METHODS: Our study adopts an empirical ethics approach, supplementing an initial review into the ethical considerations posed by such technologies with qualitative data from three focus groups...
May 5, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28464877/assessment-of-knowledge-about-biobanking-among-healthcare-students-and-their-willingness-to-donate-biospecimens
#11
Leena Merdad, Lama Aldakhil, Rawan Gadi, Mourad Assidi, Salina Y Saddick, Adel Abuzenadah, Jim Vaught, Abdelbaset Buhmeida, Mohammed H Al-Qahtani
BACKGROUND: Biobanks and biospecimen collections are becoming a primary means of delivering personalized diagnostics and tailoring individualized therapeutics. This shift towards precision medicine (PM) requires interactions among a variety of stakeholders, including the public, patients, healthcare providers, government, and donors. Very few studies have investigated the role of healthcare students in biobanking and biospecimen donations. The main aims of this study were (1) to evaluate the knowledge of senior healthcare students about biobanks and (2) to assess the students' willingness to donate biospecimens and the factors influencing their attitudes...
May 2, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28449689/on-classifying-the-field-of-medical-ethics
#12
EDITORIAL
Kristine Bærøe, Jonathan Ives, Martine de Vries, Jan Schildmann
In 2014, the editorial board of BMC Medical Ethics came together to devise sections for the journal that would (a) give structure to the journal (b) help ensure that authors' research is matched to the most appropriate editors and (c) help readers to find the research most relevant to them. The editorial board decided to take a practical approach to devising sections that dealt with the challenges of content management. After that, we started thinking more theoretically about how one could go about classifying the field of medical ethics...
April 27, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28449670/ethics-of-health-research-with-prisoners-in-canada
#13
Diego S Silva, Flora I Matheson, James V Lavery
BACKGROUND: Despite the growing recognition for the need to improve the health of prisoners in Canada and the need for health research, there has been little discussion of the ethical issues with regards to health research with prisoners in Canada. The purpose of this paper is to encourage a national conversation about what it means to conduct ethically sound health research with prisoners given the current realities of the Canadian system. Lessons from the Canadian system could presumably apply in other jurisdictions...
April 27, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28446164/core-information-sets-for-informed-consent-to-surgical-interventions-baseline-information-of-importance-to-patients-and-clinicians
#14
Barry G Main, Angus G K McNair, Richard Huxtable, Jenny L Donovan, Steven J Thomas, Paul Kinnersley, Jane M Blazeby
BACKGROUND: Consent remains a crucial, yet challenging, cornerstone of clinical practice. The ethical, legal and professional understandings of this construct have evolved away from a doctor-centred act to a patient-centred process that encompasses the patient's values, beliefs and goals. This alignment of consent with the philosophy of shared decision-making was affirmed in a recent high-profile Supreme Court ruling in England. The communication of information is central to this model of health care delivery but it can be difficult for doctors to gauge the information needs of the individual patient...
April 26, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28399922/the-elusive-ideal-of-inclusiveness-lessons-from-a-worldwide-survey-of-neurologists-on-the-ethical-issues-raised-by-whole-genome-sequencing
#15
Thierry Hurlimann, Iris Jaitovich Groisman, Béatrice Godard
The anticipation of ethical issues that may arise with the clinical use of genomic technologies is crucial to envision their future implementation in a manner sensitive to local contexts. Yet, populations in low- and middle-income countries are underrepresented in studies that aim to explore stakeholders' perspectives on the use of such technologies. Within the framework of a research project entitled "Personalized medicine in the treatment of epilepsy", we sought to increase inclusiveness by widening the reach of our survey, inviting neurologists from around the world to share their views and practices regarding the use of whole-genome sequencing in clinical neurology and its associated ethics...
April 11, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28388916/a-critique-of-the-regulation-of-data-science-in-healthcare-research-in-the-european-union
#16
John M M Rumbold, Barbara K Pierscionek
The EU offers a suitable milieu for the comparison and harmonisation of healthcare across different languages, cultures, and jurisdictions (albeit with a supranational legal framework), which could provide improvements in healthcare standards across the bloc. There are specific ethico-legal issues with the use of data in healthcare research that mandate a different approach from other forms of research. The use of healthcare data over a long period of time is similar to the use of tissue in biobanks. There is a low risk to subjects but it is impossible to gain specific informed consent given the future possibilities for research...
April 8, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28381305/fair-is-fair-we-must-re-allocate-livers-for-transplant
#17
Brendan Parent, Arthur L Caplan
The 11 original regions for organ allocation in the United States were determined by proximity between hospitals that provided deceased donors and transplant programs. As liver transplants became more successful and demand rose, livers became a scarce resource. A national system has been implemented to prioritize liver allocation according to disease severity, but the system still operates within the original procurement regions, some of which have significantly more deceased donor livers. Although each region prioritizes its sickest patients to be liver transplant recipients, the sickest in less liver-scarce regions get transplants much sooner and are at far lower risk of death than the sickest in more liver-scarce regions...
April 5, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28376811/smart-homes-private-homes-an-empirical-study-of-technology-researchers-perceptions-of-ethical-issues-in-developing-smart-home-health-technologies
#18
Giles Birchley, Richard Huxtable, Madeleine Murtagh, Ruud Ter Meulen, Peter Flach, Rachael Gooberman-Hill
BACKGROUND: Smart-home technologies, comprising environmental sensors, wearables and video are attracting interest in home healthcare delivery. Development of such technology is usually justified on the basis of the technology's potential to increase the autonomy of people living with long-term conditions. Studies of the ethics of smart-homes raise concerns about privacy, consent, social isolation and equity of access. Few studies have investigated the ethical perspectives of smart-home engineers themselves...
April 4, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28376801/factors-affecting-willingness-to-share-electronic-health-data-among-california-consumers
#19
Katherine K Kim, Pamela Sankar, Machelle D Wilson, Sarah C Haynes
BACKGROUND: Robust technology infrastructure is needed to enable learning health care systems to improve quality, access, and cost. Such infrastructure relies on the trust and confidence of individuals to share their health data for healthcare and research. Few studies have addressed consumers' views on electronic data sharing and fewer still have explored the dual purposes of healthcare and research together. The objective of the study is to explore factors that affect consumers' willingness to share electronic health information for healthcare and research...
April 4, 2017: BMC Medical Ethics
https://www.readbyqxmd.com/read/28376776/the-ecouter-methodology-for-stakeholder-engagement-in-translational-research
#20
Madeleine J Murtagh, Joel T Minion, Andrew Turner, Rebecca C Wilson, Mwenza Blell, Cynthia Ochieng, Barnaby Murtagh, Stephanie Roberts, Oliver W Butters, Paul R Burton
BACKGROUND: Because no single person or group holds knowledge about all aspects of research, mechanisms are needed to support knowledge exchange and engagement. Expertise in the research setting necessarily includes scientific and methodological expertise, but also expertise gained through the experience of participating in research and/or being a recipient of research outcomes (as a patient or member of the public). Engagement is, by its nature, reciprocal and relational: the process of engaging research participants, patients, citizens and others (the many 'publics' of engagement) brings them closer to the research but also brings the research closer to them...
April 4, 2017: BMC Medical Ethics
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