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"Biomedical Research ethics."
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Stakeholder views on the acceptability of human infection studies in Malawi
Background
Human infection studies (HIS) are valuable in vaccine development. Deliberate infection, however, creates challenging questions, particularly in low and middle-income countries (LMICs) where HIS are new and ethical challenges may be heightened. Consultation with stakeholders is needed to support contextually appropriate and acceptable study design. We examined stakeholder perceptions about the acceptability and ethics of HIS in Malawi, to inform decisions about planned pneumococcal challenge research and wider understanding of HIS ethics in LMICs.
Methods
We conducted 6 deliberative focus groups and 15 follow-up interviews with research staff, medical students, and community representatives from rural and urban Blantyre. We also conducted 5 key informant interviews with clinicians, ethics committee members, and district health government officials.
Results
Stakeholders perceived HIS research to have potential population health benefits, but they also had concerns, particularly related to the safety of volunteers and negative community reactions. Acceptability depended on a range of conditions related to procedures for voluntary and informed consent, inclusion criteria, medical care or support, compensation, regulation, and robust community engagement. These conditions largely mirror those in existing guidelines for HIS and biomedical research in LMICs. Stakeholder perceptions pointed to potential tensions, for example, balancing equity, safety, and relevance in inclusion criteria.
Conclusions
Our findings suggest HIS research could be acceptable in Malawi, provided certain conditions are in place. Ongoing assessment of participant experiences and stakeholder perceptions will be required to strengthen HIS research during development and roll-out.
Journal Article
Animal ethos : the morality of human-animal encounters in experimental lab science
\"What are the moral challenges and consequences of animal research in academic laboratory settings? Animal Ethos considers how the inescapable needs of lab research necessitate interspecies encounters that, in turn, engender unexpected moral responses among a range of associated personnel. Whereas much has been written about codified, bioethical rules and regulations that inform proper lab behavior and decorum, Animal Ethos, as an in-depth, ethnographic project, probes the equally rich--yet poorly understood--realm of ordinary or everyday morality, where serendipitous, creative, and unorthodox thought and action evidence concerted efforts to transform animal laboratories into moral, scientific worlds. The work is grounded in efforts to integrate theory within medical anthropology (and, more particularly, on suffering and moral worth), animal studies, and science and technology studies (STS). Contrary to established scholarship that focuses exclusively on single professions (such as the researcher or technician), Animal Ethos tracks across the spectrum of the lab labor hierarchy by considering the experiences of researchers, animal technicians, and lab veterinarians. In turn, it offers comparative insights on animal activists. When taken together, this range of parties illuminates the moral complexities of experimental lab research. The affective qualities of interspecies intimacy, animal death, and species preference are of special analytical concern, as reflected in the themes of 'Intimacy,' 'Sacrifice,' and 'Exceptionalism' that anchor this work\"--Provided by publisher.
Book
The ethics of using placebo in randomised controlled trials: a case study of a Plasmodium vivax antirelapse trial
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.
Main Body
There is an urgent need for primaquine anti-relapse studies in order to rationalise the management of a potentially fatal disease. An ethical justification for the use of the placebo arm is provided on the grounds that the actual current applied standard of care in most endemic places does not include primaquine. It has also been argued that there is clinical equipoise among the primaquine study arms and that the risk of harms of being in the placebo arm is the risk of having relapse, which is no more than not being included in the trial, and that there are no double standards.
Conclusion
Based on our set of considerations, we conclude that a placebo arm is not only justified but imperative in this study. We propose that similar considerations should be prospectively applied to other placebo controlled trials and observational control arms where no treatment is offered.
Journal Article
Dynamic Consent: a potential solution to some of the challenges of modern biomedical research
Background
Innovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment.
Methods
An interdisciplinary workshop jointly organised by the University of Oxford and the COST Action CHIP ME gathered clinicians, researchers, ethicists, lawyers, research participants and patient representatives to discuss experiences of using Dynamic Consent, and how such use may facilitate the conduct of specific research tasks. The data collected during the workshop were analysed using a content analysis approach.
Results
Dynamic Consent can provide practical, sustainable and future-proof solutions to challenges related to participant recruitment, the attainment of informed consent, participant retention and consent management, and may bring economic efficiencies.
Conclusions
Dynamic Consent offers opportunities for ongoing communication between researchers and research participants that can positively impact research. Dynamic Consent supports inter-sector, cross-border approaches and large scale data-sharing. Whilst it is relatively easy to set up and maintain, its implementation will require that researchers re-consider their relationship with research participants and adopt new procedures.
Journal Article
Ethical aspects of brain computer interfaces: a scoping review
Background
Brain-Computer Interface (BCI) is a set of technologies that are of increasing interest to researchers. BCI has been proposed as assistive technology for individuals who are non-communicative or paralyzed, such as those with amyotrophic lateral sclerosis or spinal cord injury. The technology has also been suggested for enhancement and entertainment uses, and there are companies currently marketing BCI devices for those purposes (e.g., gaming) as well as health-related purposes (e.g., communication). The unprecedented direct connection created by BCI between human brains and computer hardware raises various ethical, social, and legal challenges that merit further examination and discussion.
Methods
To identify and characterize the key issues associated with BCI use, we performed a scoping review of biomedical ethics literature, analyzing the ethics concerns cited across multiple disciplines, including philosophy and medicine.
Results
Based on this investigation, we report that BCI research and its potential translation to therapeutic intervention generate significant ethical, legal, and social concerns, notably with regards to personhood, stigma, autonomy, privacy, research ethics, safety, responsibility, and justice. Our review of the literature determined, furthermore, that while these issues have been enumerated extensively, few concrete recommendations have been expressed.
Conclusions
We conclude that future research should focus on remedying a lack of practical solutions to the ethical challenges of BCI, alongside the collection of empirical data on the perspectives of the public, BCI users, and BCI researchers.
Journal Article
Improving the trustworthiness, usefulness, and ethics of biomedical research through an innovative and comprehensive institutional initiative
The reproducibility crisis triggered worldwide initiatives to improve rigor, reproducibility, and transparency in biomedical research. There are many examples of scientists, journals, and funding agencies adopting responsible research practices. The QUEST (Quality-Ethics-Open Science-Translation) Center offers a unique opportunity to examine the role of institutions. The Berlin Institute of Health founded QUEST to increase the likelihood that research conducted at this large academic medical center would be trustworthy, useful for scientists and society, and ethical. QUEST researchers perform \"science of science\" studies to understand problems with standard practices and develop targeted solutions. The staff work with institutional leadership and local scientists to incentivize and support responsible practices in research, funding, and hiring. Some activities described in this paper focus on the institution, whereas others may benefit the national and international scientific community. Our experience, approaches, and recommendations will be informative for faculty leadership, administrators, and researchers interested in improving scientific practice.
Journal Article
Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands
Background
Disproportionate regulation of health and medical research contributes to research waste. Better understanding of exemptions of research from ethics review in different jurisdictions may help to guide modification of review processes and reduce research waste. Our aim was to identify examples of low-risk human health and medical research exempt from ethics reviews in Australia, the United Kingdom, the United States and the Netherlands.
Methods
We examined documents providing national guidance on research ethics in each country, including those authored by the National Health and Medical Research Council (Australia), National Health Service (United Kingdom), the Office for Human Research Protections (United States) and the Central Committee on Research Involving Humans (the Netherlands). Examples and types of research projects exempt from ethics reviews were identified, and similar examples and types were grouped together.
Results
Nine categories of research were exempt from ethics reviews across the four countries; these were existing data or specimen, questionnaire or survey, interview, post-marketing study, evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, audit and service evaluation, and other exemptions. Existing non-identifiable data and specimens were exempt in all countries. Four categories – evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, and audit and service evaluation – were exempted by one country each. The remaining categories were exempted by two or three countries.
Conclusions
Examples and types of research exempt from research ethics reviews varied considerably. Given the considerable costs and burdens on researchers and ethics committees, it would be worthwhile to develop and provide clearer guidance on exemptions, illustrated with examples, with transparent underpinning rationales.
Journal Article