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BMC Medical Ethics

Antonia-Sophie Skierka, Karin B Michels
BACKGROUND: In October 2013, the Declaration of Helsinki was revised a seventh time in its 50 year history. While it is the most widely accepted set of ethical principles for the protection of patients participating in medical research, the Declaration of Helsinki has also been subject of constant controversy. In particular, its paragraph on the use of placebo controls in clinical trials divides the research community into active-control and placebo orthodox proponents, both continuously demanding revisions of the Declaration of Helsinki in favour of their position...
March 15, 2018: BMC Medical Ethics
Ludovica De Panfilis, Roberto Satolli, Massimo Costantini
BACKGROUND: This article proposes a retrospective analysis of a compassionate use (CU), using a case study of request for Avelumab for a patient suffering from Merkel Cell Carcinoma. The study is the result of a discussion within a Provincial Ethics Committee (EC) following the finding of a high number of requests for CU program. The primary objective of the study is to illustrate the specific ethical and clinical profiles that emerge from the compassionate use program (CUP) issue. The secondary goals are: a) to promote a moral reflection among physicians who require approval for the CUP and b) provide the basis for recommendations on how to request CUP...
March 9, 2018: BMC Medical Ethics
Yen-Ko Lin, Chao-Wen Chen, Wei-Che Lee, Yuan-Chia Cheng, Tsung-Ying Lin, Chia-Ju Lin, Leiyu Shi, Yin-Chun Tien, Liang-Chi Kuo
BACKGROUND: We investigated whether, in the emergency department (ED), educational video-assisted informed consent is superior to the conventional consent process, to inform trauma patients undergoing surgery about the procedure, benefits, risks, alternatives, and postoperative care. METHODS: We conducted a prospective randomized controlled trial, with superiority study design. All trauma patients scheduled to receive trauma-related debridement surgery in the ED of Kaohsiung Medical University Hospital were included...
March 9, 2018: BMC Medical Ethics
Corine Mouton Dorey, Holger Baumann, Nikola Biller-Andorno
BACKGROUND: There is a growing interest in aggregating more biomedical and patient data into large health data sets for research and public benefits. However, collecting and processing patient data raises new ethical issues regarding patient's rights, social justice and trust in public institutions. The aim of this empirical study is to gain an in-depth understanding of the awareness of possible ethical risks and corresponding obligations among those who are involved in projects using patient data, i...
March 7, 2018: BMC Medical Ethics
Jean-Christophe Bélisle-Pipon, Geneviève Rouleau, Stanislav Birko
BACKGROUND: Increasing attention and efforts are being put towards engaging patients in health research, and some have even argued that patient engagement in research (PER) is an ethical imperative. Yet there is relatively little empirical data on ethical issues associated with PER. METHODS: A three-round Delphi survey was conducted with a panel of early-career researchers (ECRs) involved in PER. One of the objectives was to examine the ethical dimensions of PER as well as ECRs' self-perceived level of preparedness to conduct PER ethically...
March 7, 2018: BMC Medical Ethics
Anita Ho, Oliver Quick
BACKGROUND: This debate article explores how smart technologies may create a double-edged sword for patient safety and effective therapeutic relationships. Increasing utilization of health monitoring devices by patients will likely become an important aspect of self-care and preventive medicine. It may also help to enhance accurate symptom reports, diagnoses, and prompt referral to specialist care where appropriate. However, the development, marketing, and use of such technology raise significant ethical implications for therapeutic relationships and patient safety...
March 6, 2018: BMC Medical Ethics
Phaik Yeong Cheah, Norbert Steinkamp, Lorenz von Seidlein, Ric N Price
BACKGROUND: The use of placebos in randomised controlled trials is a subject of considerable ethical debate. In this paper we present a set of considerations to evaluate the ethics of placebo controlled trials that includes: social value of the study; need for a randomised controlled trial and placebo; standards of care; risks of harm due to administration of placebo and the harm benefit balance; clinical equipoise; and double standards. We illustrate the application of these considerations using a case study of a large ongoing multicentre, placebo-controlled, double-blinded, randomised trial to determine primaquine anti-relapse efficacy in vivax malaria...
March 6, 2018: BMC Medical Ethics
Irene Tuffrey-Wijne, Leopold Curfs, Ilora Finlay, Sheila Hollins
BACKGROUND: Euthanasia and assisted suicide (EAS) have been legally possible in the Netherlands since 2001, provided that statutory due care criteria are met, including: (a) voluntary and well-considered request; (b) unbearable suffering without prospect of improvement; (c) informing the patient; (d) lack of a reasonable alternative; (e) independent second physician's opinion. 'Unbearable suffering' must have a medical basis, either somatic or psychiatric, but there is no requirement of limited life expectancy...
March 5, 2018: BMC Medical Ethics
Hans Magnus Solli, António Barbosa da Silva
BACKGROUND: The article defines a comprehensive concept of cognitive objectivity (CCCO) applied to embodied subjects in health care. The aims of this study were: (1) to specify some necessary conditions for the definition of a CCCO that will allow objective descriptions and assessments in health care, (2) to formulate criteria for application of such a CCCO, and (3) to investigate the usefulness of the criteria in work disability assessments in medical certificates from health care provided for social security purposes...
March 2, 2018: BMC Medical Ethics
Dorien T Beeres, Darren Cornish, Machiel Vonk, Sofanne J Ravensbergen, Els L M Maeckelberghe, Pieter Boele Van Hensbroek, Ymkje Stienstra
BACKGROUND: With a large number of forcibly displaced people seeking safety, the EU is facing a challenge in maintaining solidarity. Europe has seen millions of asylum seekers crossing European borders, the largest number of asylum seekers since the second world war. Endemic diseases and often failing health systems in their countries of origin, and arduous conditions during transit, raise questions around how to meet the health needs of this vulnerable population on arrival in terms of screening, vaccination, and access to timely and appropriate statutory health services...
March 2, 2018: BMC Medical Ethics
Atsushi Asai, Sakiko Masaki, Taketoshi Okita, Aya Enzo, Yasuhiro Kadooka
BACKGROUND: Destination therapy (DT) is the permanent implantation of a left ventricular assist device (LVAD) in patients with end-stage, severe heart failure who are ineligible for heart transplantation. DT improves both the quality of life and prognosis of patients with end-stage heart failure. However, there are also downsides to DT such as life-threatening complications and the potential for the patient to live beyond their desired length of life following such major complications...
February 27, 2018: BMC Medical Ethics
Cory E Goldstein, Charles Weijer, Jamie C Brehaut, Dean A Fergusson, Jeremy M Grimshaw, Austin R Horn, Monica Taljaard
BACKGROUND: Pragmatic randomized controlled trials (RCTs) are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. METHODS: We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis...
February 27, 2018: BMC Medical Ethics
Ciara Staunton, Paulina Tindana, Melany Hendricks, Keymanthri Moodley
BACKGROUND: Genomic biobanking research is undergoing exponential growth in Africa raising a host of legal, ethical and social issues. Given the scientific complexity associated with genomics, there is a growing recognition globally of the importance of science translation and community engagement (CE) for this type of research, as it creates the potential to build relationships, increase trust, improve consent processes and empower local communities. Despite this level of recognition, there is a lack of empirical evidence of the practise and processes for effective CE in genomic biobanking in Africa...
February 27, 2018: BMC Medical Ethics
Agnieszka Ignatowicz, Anne-Marie Slowther, Patrick Elder, Carol Bryce, Kathryn Hamilton, Caroline Huxley, Vera Forjaz, Jackie Sturt, Frances Griffiths
BACKGROUND: Digital communication between a patient and their clinician offers the potential for improved patient care, particularly for young people with long term conditions who are at risk of service disengagement. However, its use raises a number of ethical questions which have not been explored in empirical studies. The objective of this study was to examine, from the patient and clinician perspective, the ethical implications of the use of digital clinical communication in the context of young people living with long-term conditions...
February 23, 2018: BMC Medical Ethics
Conny A M F H Span-Sluyter, Jan C M Lavrijsen, Evert van Leeuwen, Raymond T C M Koopmans
BACKGROUND: Patients in a vegetative state/ unresponsive wakefulness syndrome (VS/UWS) pose ethical dilemmas to those involved. Many conflicts occur between professionals and families of these patients. In the Netherlands physicians are supposed to withdraw life sustaining treatment once recovery is not to be expected. Yet these patients have shown to survive sometimes for decades. The role of the families is thought to be important. The aim of this study was to make an inventory of the professional perspective on conflicts in long-term care of patients in VS/UWS...
February 22, 2018: BMC Medical Ethics
Corinna Porteri
BACKGROUND: The proposal of the new criteria for the diagnosis of Alzheimer's disease (AD) based on biomarker data is making possible a diagnosis of AD at the mild cognitive impairment (MCI) or predementia/prodromal- stage. Given the present lack of effective treatments for AD, the opportunity for the individuals to personally take relevant decisions and plan for their future before and if cognitive deterioration occurs is one the main advantages of an early diagnosis. MAIN BODY: Advance directives are largely seen as an effective tool for planning medical care in the event the subject becomes incompetent...
February 20, 2018: BMC Medical Ethics
George Rugare Chingarande, Keymanthri Moodley
BACKGROUND: Compensation for research related injuries is a subject that is increasingly gaining traction in developing countries which are burgeoning destinations of multi center research. However, the existence of disparate compensation rules violates the ethical principle of fairness. The current paper presents a comparison of the policies of Brazil, Russia, India, China and South Africa (BRICS). METHODS: A systematic search of good clinical practice guidelines was conducted employing search strategies modeled in line with the recommendations of ADPTE Collaboration (2007)...
February 17, 2018: BMC Medical Ethics
Christine Englschalk, Daniela Eser, Ralf J Jox, Alexander Gerbes, Lorenz Frey, Derek A Dubay, Martin Angele, Manfred Stangl, Bruno Meiser, Jens Werner, Markus Guba
BACKGROUND: The allocation of any scarce health care resource, especially a lifesaving resource, can create profound ethical and legal challenges. Liver transplant allocation currently is based upon urgency, a sickest-first approach, and does not utilize capacity to benefit. While urgency can be described reasonably well with the MELD system, benefit encompasses multiple dimensions of patients' well-being. Currently, the balance between both principles is ill-defined. METHODS: This survey with 502 participants examines how urgency and benefit are weighted by different stakeholders (medical staff, patients on the liver transplant list or already transplanted, medical students and non-medical university staff and students)...
February 12, 2018: BMC Medical Ethics
Tenzin Wangmo, Sirin Hauri, Eloise Gennet, Evelyn Anane-Sarpong, Veerle Provoost, Bernice S Elger
BACKGROUND: A review of literature published a decade ago noted a significant increase in empirical papers across nine bioethics journals. This study provides an update on the presence of empirical papers in the same nine journals. It first evaluates whether the empirical trend is continuing as noted in the previous study, and second, how it is changing, that is, what are the characteristics of the empirical works published in these nine bioethics journals. METHOD: A review of the same nine journals (Bioethics; Journal of Medical Ethics; Journal of Clinical Ethics; Nursing Ethics; Cambridge Quarterly of Healthcare Ethics; Hastings Center Report; Theoretical Medicine and Bioethics; Christian Bioethics; and Kennedy Institute of Ethics Journal) was conducted for a 12-year period from 2004 to 2015...
February 7, 2018: BMC Medical Ethics
Gert J van der Wilt, Janneke P C Grutters, Angela H E M Maas, Herbert J A Rolden
BACKGROUND: The participation of vulnerable patients in clinical research poses apparent ethical dilemmas. Depending on the nature of the vulnerability, their participation may challenge the ethical principles of autonomy, non-maleficence, or justice. On the other hand, non-participation may preclude the building of a knowledge base that is a prerequisite for defining the optimal clinical management of vulnerable patients. Such clinical uncertainty may also incur substantial economic costs...
February 5, 2018: BMC Medical Ethics
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