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Legal and Ethical Problems in Clinical Research*
Published in Gary M. Matoren, The Clinical Research Process in the Pharmaceutical Industry, 2020
Robert J. Levine, Angela R. Holder
Although IRBs are mandated by federal regulations to protect the rights and welfare of research subjects, in future cases involving research injuries their utility value in the defense of investigators may well be demonstrated. In addition to the ethical responsibilities for informing a patient or research subject about proposed interventions, documentation of informed consent, as it is applied in the context of medical research, is actually designed to protect the investigator rather than the subject [1, p. 98]. In standard medical practice, patients almost always sign very general consent forms. Most hospitals have but one surgical consent form, for example, in which the specific procedure is written in on a blank. The consent form states only that "the risks and hazards of the above procedure have been explained to my satisfaction." By contrast, consent forms for research explicate the risks of each procedure and each drug that is to be administered. Almost all courts would hold that a signature on such a document cannot be disavowed on grounds that the subject did not read or understand what he or she had signed. As long as the specific risk that materializes is listed on the consent form, any subject suing the investigator in almost any jurisdiction would be held to have assumed the risk and thus would be unable to recover damages.
Learner Identities
Published in A. O. Mahendran, Moments of Rupture: The Importance of Affect in Medical Education and Surgical Training, 2019
Norms in training are necessary to establish stability and organised structure, so that teachers and learners, alike, get a sense of what must be taught and how this is best accomplished. They are also essential for setting a good standard of practice that ensures the safety and welfare of patients. However, norms are problematic if and when they obscure ways of learning that, while legitimate, lie outside the scope of these norms.
Pharmacoeconomics
Published in David Kernick, Getting Health Economics into Practice, 2018
Some countries or regions have set up very formal and rigid systems to determine which medicines should be reimbursed by the state. In the UK, the relevant agency is NICE6 which has the role of not just evaluating medicines but of other new technologies as well. So far, however, about two-thirds of its work has been medicine related. It reviews new medicines both clinically and economically and then presents ‘guidance’ on which, managerially if not legally, is taken to be the NHS standard of practice.
Analysis, comparison and representation of occupational exposure to a static magnetic field in a 3-T MRI site
Published in International Journal of Occupational Safety and Ergonomics, 2022
Valentina Hartwig, Cristiano Biagini, Daniele De Marchi, Alessandra Flori, Chiara Gabellieri, Giorgio Virgili, Luca Fabiano Ferrante Vero, Luigi Landini, Nicola Vanello, Giulio Giovannetti
The procedure performed by each worker during the measurement session is described in Table 2. All of the considered procedures are part of standard clinical practice or are representative of research activity. Patient preparation for a brain MRI examination generally involves the following tasks: accompanying the patient to the scanner bed; positioning the patient in a comfortable position; attaching the cables for monitoring vital signs. Moreover, the procedure can include, or not, coil positioning and head alignment using the laser indicators. Before each measurement session, an interview was conducted with the worker: he/she was asked to describe the procedure that was about to be performed and talk about his/her practice related to the daily work.
Personalizing treatments for patients based on cardiovascular phenotyping
Published in Expert Review of Precision Medicine and Drug Development, 2022
The current state-of-the-art in advanced phenotyping for cardiovascular disease remains firmly in the discovery phase as many studies have reported findings but have not provided a pathway to move toward the clinic. Two recent studies illustrate that the reception for precision cardiovascular phenotyping in current clinical practice is somewhat lukewarm. A pilot study of 110 patients was done to examine the impact of pharmacogenetic profiling and clinical decision-making support to decrease adverse drug reactions. Genomic analysis of CYP 450 genes to guide medication use was associated with a decrease in emergency department visits and hospitalizations. However, only 77% of the pharmacogenetic profiling and decision support recommendations were followed by clinicians [93]. The idea of using rapid genetic profiling to facilitate in-hospital treatment has also been studied. Rapid whole genome sequencing to guide drug selection for cardiovascular care was assessed in a small pilot study that included 50 patients with acute cardiovascular events or cardiac arrest. While rapid whole genome sequencing found that ~64% of the participants had one pharmacogenetic variant that would inform pharmacologic management of cardiovascular disease, only 14% were considered actionable [94]. Thus, in one case, results were not always followed by the managing physician and in the other the results were likely not superior to standard clinical practice.
The Lean and Agile Multi-dimensional Process (LAMP) – a new framework for rapid and iterative evidence generation to support health-care technology design and development
Published in Expert Review of Medical Devices, 2020
Melody Ni, Simone Borsci, Simon Walne, Anna P. Mclister, Peter Buckle, James G. Barlow, George B. Hanna
Closely related to this is integration of new technology in terms of both functionalities and interfaces during its implementation. Technologies developed and introduced sequentially, by different manufacturers, at different times seldom work well together. Worse still, by competing for limited attention of busy clinicians, the benefits they are designed to deliver are being canceling out. For instance, alarm fatigue has become a well-known issue in a busy clinical environment. The issue is becoming acute as health-apps are being developed at an unprecedented speed and are routinely used in combination with other apps. This threatens the fidelity of clinical guidelines which underpins standard clinical practice. To achieve smooth integration requires forward thinking in regulation, clinical guideline development, and technology assessments. Assessments of ‘compatibility’ of a new concept with the existing clinical environment should become an integral part of early assessments, above and beyond the comparison against current practice for establishing value. Such considerations must also inform design of clinical studies so that relevant risks can be measured and mitigated before introducing the technology into the clinical practice.