'No Time to be Lost!' Ethical considerations on consent for inclusion in emergency pharmacological research in severe traumatic brain injury in the European Union.
Ontology highlight
ABSTRACT:
SUBMITTER: Kompanje EJ
PROVIDER: S-EPMC2225997 | biostudies-other | 2007 Sep
REPOSITORIES: biostudies-other
Similar Datasets
Project description:Clinical trials to address the COVID-19 public health emergency have broadly excluded pregnant people from participation, illustrating a long-standing trend of clinical trial exclusion that has led to a clear knowledge gap and unmet need in the treatment and prevention of medical conditions experienced during pregnancy and of pregnancy-related conditions. Drugs (includes products such as drugs, biologics, biosimilars and vaccines) approved for a certain medical condition in adults are also approved for use in pregnant adults with the same medical condition, unless contraindicated for use in pregnancy. However, there are limited pregnancy-specific data on risks and benefits of drugs in pregnant people, despite their approval for all adults. The United States Food and Drug Administration-approved medical products are used widely by pregnant people, 90% of whom take at least 1 medication during the course of their pregnancy despite there being sparse data from clinical trials on these products in pregnancy. This overall lack of clinical data precludes informed decision-making, causing clinicians and pregnant patients to have to decide whether to pursue treatment without an adequate understanding of potential effects. Although some United States Food and Drug Administration initiatives and other federal efforts have helped to promote the inclusion of pregnant people in clinical research, broader collaboration and reforms are needed to address challenges related to the design and conduct of trials that enroll pregnant people, and to forge a culture of widespread inclusion of pregnant people in clinical research. This article summarizes the scientific, ethical, and legal considerations governing research conducted during pregnancy, as discussed during a recent subject matter expert convening held by the Duke-Margolis Center for Health Policy and the United States Food and Drug Administration on this topic. This article also recommends strategies for overcoming impediments to inclusion and trial conduct.
| S-EPMC9351207 | biostudies-literature
Project description:ImportancePragmatic clinical trials that seek informed consent after randomization (ie, postrandomization consent) are increasingly used, but debate on ethics persists because control arm patients are not specifically informed about the trials and randomization occurs before consent for the trials. The public's attitude toward postrandomization consent trials is unknown, but the way the trials are described could bias people's views.ObjectivesTo assess the attitudes of the US general public toward postrandomization informed consent for pragmatic trials and to measure potential framing and other factors associated with those attitudes.Design, setting, and participantsAn online, 2 × 2 experimental survey (fielded between February 23 and April 3, 2018) portraying 4 scenarios of postrandomization informed consent (with prior broad consent for medical record use) was conducted. These scenarios included traditional randomized clinical trial language framing vs alternative framing in a high-stakes trial (ie, survival in leukemia) or low-stakes trial (ie, blood glucose level in diabetes). A total of 3793 individuals invited to participate were part of an existing panel representative of the US general public (GfK KnowledgePanel).Main outcomes and measuresThe proportion of participants who would recommend that an ethics review board approve a postrandomization consent pragmatic trial.ResultsA total of 2042 of 3739 invitees (54.6%) responded; after exclusion of 38 incomplete surveys, 2004 participants were included in the analysis. Of these, 997 (49.8%) were women, 1440 (71.9%) were white non-Hispanic, 199 (9.9%) were black non-Hispanic, and 233 (11.6%) were Hispanic. Mean (SD) age was 47.5 (17.4) years. Across scenarios, weighted data showed that 75.4% of the participants would recommend approval of the postrandomization consent pragmatic trial, 20.4% would probably not recommend approval, and 4.2% would definitely not recommend approval. Approval was not sensitive to framing language (traditional vs new framing in high-stakes scenario, 74.3% vs 76.8%, P = .40; in low-stakes scenario, 77.7% vs 72.9%, P = .10) or to the stakes (low vs high stakes in traditional framing, 77.7% vs 74.3%, P = .25; in new framing, 72.9% vs 76.8%, P = .18). Better understanding of the postrandomization consent design was associated with higher rate of approval (78.1% vs 65.0%, P = .002 for high-stakes scenario; 77.2% vs 64.9%, P = .004 for low-stakes scenario), especially among those with less education. However, opinions about personal involvement in the control arm were more cautious (range depending on scenario, 45.6%-59.7%) and sensitive to stakes but not to framing.Conclusions and relevanceThe public's generally high rate of approval of the ethics of postrandomization informed consent for pragmatic trial designs does not appear to be affected by whether postrandomization consent design is framed using traditional randomized clinical trial terminology, regardless of the stakes of the trial. Promoting better understanding of the design may increase its acceptance by the public.
| S-EPMC6324565 | biostudies-literature
Project description:Phylogenetic analysis of pathogens is an increasingly powerful way to reduce the spread of epidemics, including HIV. As a result, phylogenetic approaches are becoming embedded in public health and research programmes, as well as outbreak responses, presenting unique ethical, legal, and social issues that are not adequately addressed by existing bioethics literature. We formed a multidisciplinary working group to explore the ethical issues arising from the design of, conduct in, and use of results from HIV phylogenetic studies, and to propose recommendations to minimise the associated risks to both individuals and groups. We identified eight key ethical domains, within which we highlighted factors that make HIV phylogenetic research unique. In this Review, we endeavoured to provide a framework to assist researchers, public health practitioners, and funding institutions to ensure that HIV phylogenetic studies are designed, done, and disseminated in an ethical manner. Our conclusions also have broader relevance for pathogen phylogenetics.
| S-EPMC7327184 | biostudies-literature
Project description:ObjectiveConducting research in the emergency department (ED) is often complicated by patients' acute and chronic illnesses, which can adversely affect cognition and subsequently capacity to consent for research, especially in older adults. Validated screening tools to assess capacity to consent for research exist, but neither the frequency of use nor which ones are used for ED research are known.MethodsWe conducted a scoping review using standard review techniques. Inclusion criteria included (1) randomized controlled trials (RCTs) from publication years 2014-2019 that (2) enrolled participants only in the ED, (3) included patients aged 65+ years, and (4) were fully published in English. Articles were sourced from Embase and screened using Covidence.ResultsFrom 3130 search results, 269 studies passed title/abstract and full text screening. Average of the mean or median ages was 55.7 years (SD 14.2). The mean number of study participants was 311.9 [range 8-10,807 participants]. A few (n = 13, 4.8%) waived or had exception from informed consent. Of the 256 studies requiring consent, a fourth (26.5%, n = 68) specifically excluded patients due to impaired capacity to consent. Only 11 (4.3%) documented a formal capacity screening tool and only 13 (5.1%) reported consent by legally authorized representative (LAR).ConclusionsMost RCTs enrolling older adults in EDs did not report assessment of capacity to consent or use of LARs. This snapshot of informed consent procedures is potentially concerning and suggests that either research consent processes for older patients and/or reporting of consent processes require improvement.
| S-EPMC9337842 | biostudies-literature
Project description:The intensifying pace of research based on cross-cultural studies in the social sciences necessitates a discussion of the unique challenges of multi-sited research. Given an increasing demand for social scientists to expand their data collection beyond WEIRD (Western, educated, industrialized, rich and democratic) populations, there is an urgent need for transdisciplinary conversations on the logistical, scientific and ethical considerations inherent to this type of scholarship. As a group of social scientists engaged in cross-cultural research in psychology and anthropology, we hope to guide prospective cross-cultural researchers through some of the complex scientific and ethical challenges involved in such work: (a) study site selection, (b) community involvement and (c) culturally appropriate research methods. We aim to shed light on some of the difficult ethical quandaries of this type of research. Our recommendation emphasizes a community-centred approach, in which the desires of the community regarding research approach and methodology, community involvement, results communication and distribution, and data sharing are held in the highest regard by the researchers. We argue that such considerations are central to scientific rigour and the foundation of the study of human behaviour.
| S-EPMC7542829 | biostudies-literature
Project description:ChatGPT has promising applications in health care, but potential ethical issues need to be addressed proactively to prevent harm. ChatGPT presents potential ethical challenges from legal, humanistic, algorithmic, and informational perspectives. Legal ethics concerns arise from the unclear allocation of responsibility when patient harm occurs and from potential breaches of patient privacy due to data collection. Clear rules and legal boundaries are needed to properly allocate liability and protect users. Humanistic ethics concerns arise from the potential disruption of the physician-patient relationship, humanistic care, and issues of integrity. Overreliance on artificial intelligence (AI) can undermine compassion and erode trust. Transparency and disclosure of AI-generated content are critical to maintaining integrity. Algorithmic ethics raise concerns about algorithmic bias, responsibility, transparency and explainability, as well as validation and evaluation. Information ethics include data bias, validity, and effectiveness. Biased training data can lead to biased output, and overreliance on ChatGPT can reduce patient adherence and encourage self-diagnosis. Ensuring the accuracy, reliability, and validity of ChatGPT-generated content requires rigorous validation and ongoing updates based on clinical practice. To navigate the evolving ethical landscape of AI, AI in health care must adhere to the strictest ethical standards. Through comprehensive ethical guidelines, health care professionals can ensure the responsible use of ChatGPT, promote accurate and reliable information exchange, protect patient privacy, and empower patients to make informed decisions about their health care.
| S-EPMC10457697 | biostudies-literature
Project description:IntroductionResearch studies on emergency care in low- and middle-income countries (LMICs) face many ethical considerations, including obtaining valid informed consent from vulnerable patients. This study aims to describe the body of literature related to the ethical considerations associated with emergency care research in low- and middle-income settings.MethodsA scoping review was conducted to identify literature published between 2000 and 2020 related to ethical considerations associated with emergency care research in the LMIC setting. Titles and abstracts were screened in duplicate, and full texts were reviewed and extracted by the principal author.ResultsIn total, 1087 articles were identified and 17 articles were included. Major themes identified in the literature included risk versus benefit assessments, patient vulnerabilities, consent, community engagement, clinical roles, ancillary care provision, and regulation of research. Alternative models of consent are often used in emergency care research, including surrogate consent, community consent, and waiver of consent. Challenges and best practices with these alternative models of consent in LMICs are discussed.DiscussionGaps remain in the literature describing the ethics of emergency care research in LMICs, including clear guidelines for protecting vulnerable patients and designing ethical consent processes. Best practices identified include community engagement for designing research studies, identifying acceptable risk profiles, and allocating benefits. Continuous and rigorous assessment of the quality of consent is also needed.
| S-EPMC8762361 | biostudies-literature
Project description:There are, in mankind, two kinds of heredity: biological and cultural. Cultural inheritance makes possible for humans what no other organism can accomplish: the cumulative transmission of experience from generation to generation. In turn, cultural inheritance leads to cultural evolution, the prevailing mode of human adaptation. For the last few millennia, humans have been adapting the environments to their genes more often than their genes to the environments. Nevertheless, natural selection persists in modern humans, both as differential mortality and as differential fertility, although its intensity may decrease in the future. More than 2,000 human diseases and abnormalities have a genetic causation. Health care and the increasing feasibility of genetic therapy will, although slowly, augment the future incidence of hereditary ailments. Germ-line gene therapy could halt this increase, but at present, it is not technically feasible. The proposal to enhance the human genetic endowment by genetic cloning of eminent individuals is not warranted. Genomes can be cloned; individuals cannot. In the future, therapeutic cloning will bring enhanced possibilities for organ transplantation, nerve cells and tissue healing, and other health benefits.
| S-EPMC4517218 | biostudies-other
Project description:Digital Pathology (DP) is a platform which has the potential to develop a truly integrated and global pathology community. The generation of DP data at scale creates novel challenges for the histopathology community in managing, processing, and governing the use of these data. The current understanding of, and confidence in, the legal and ethical aspects of DP by pathologists is unknown. We developed an electronic survey (e-survey), comprising 22 questions, with input from the Royal College of Pathologists (RCPath) Digital Pathology Working Group. The e-survey was circulated via e-mail and social media (Twitter) through the RCPath Digital Pathology Working Group network, RCPath Trainee Committee network, the Pathology image data Lake for Analytics, Knowledge and Education (PathLAKE) digital pathology consortium, National Pathology Imaging Co-operative (NPIC), local contacts, and to the membership of both The Pathological Society of Great Britain and Ireland and the British Division of the International Academy of Pathology (BDIAP). Between 14 July 2020 and 6 September 2020, we collected 198 responses representing a cross section of histopathologists, including individuals with experience of DP research. We ascertained that, in the UK, DP is being used for diagnosis, research, and teaching, and that the platform is enabling data sharing. Our survey demonstrated that there is often a lack of confidence and understanding of the key issues of consent, legislation, and ethical guidelines. Of 198 respondents, 82 (41%) did not know when the use of digital scanned slide images would fall under the relevant legislation and 93 (47%) were 'Not confident at all' in their interpretation of consent for scanned slide images in research. With increasing uptake of DP, a working knowledge of these areas is essential but histopathologists often express a lack of confidence in these topics. The need for specific training in these areas is highlighted by the findings of this study.
| S-EPMC8822384 | biostudies-literature
Project description:BackgroundEuropean Member States, the European Commission and its agencies work together to enhance preparedness and response for serious cross-border threats to health such as Ebola. Yet, common understanding of public health emergency preparedness across EU/EEA countries is challenging, because preparedness is a relatively new field of activity and is inherently fraught with uncertainty. A set of practical, widely accepted and easy to use recommendations for generic preparedness that bundles the activities described in separate guidance documents supports countries in preparing for any possible health threat. The aim of this consensus procedure was to identify and seek consensus from national-level preparedness experts from EU/EEA countries on key recommendations of public health emergency preparedness.MethodsTo identify key recommendations and to prioritize the recommendations we started with a literature consensus procedure, followed by a modified Delphi method for consultation of public health emergency preparedness leaders of EU/EEA countries. This consisted of six consecutive steps: a questionnaire to achieve consensus on a core set of recommendations, a face-to-face consultation, preselection of prioritized recommendations, a questionnaire to achieve consensus on the prioritized set and a face-to-face consensus meeting to further prioritize recommendations.ResultsAs a result, EU/EEA experts selected 149 recommendations as core preparedness principles and prioritized 42. The recommendations were grouped in the seven domains: governance (57), capacity building and maintenance (11), surveillance (19), risk-assessment (16), risk- and crisis management (35), post-event evaluation (6) and implementation of lessons learned (5).ConclusionsThis prioritised set of consensus principles can provide a foundation for countries aiming to evaluate and improve their preparedness for public health emergencies. The recommendations are practical, support generic preparedness planning, and can be used by all countries irrespective of their current level of preparedness.
| S-EPMC7527265 | biostudies-literature